Rajarsi Das Thesis... U

INTELLECTUAL PROPERTY
PROTECTION IN BIOTECH INVENTION

IN INDIA: A SOCIO-LEGAL STUDY
The thesis submitted to the University of Burdwan for the award of

Doctor of Philosophy (Ph.D.) in Law
under UGC’s Regulation - 2009
UNDER SUPERVISION OF:
DR. SHASHI NATH MANDAL, WBES

Assistant Professor of Law
P.G. Department of Law
Hooghly Mohsin College
Govt. of West Bengal
&
DR. P.K. ACHARYA
Assistant Professor of Law
P.G. Department of Law
The University of Burdwan
SUBMITTED BY:
RAJARSI DAS
Lecturer in Law, Jogesh Chandra Chaudhuri Law College
Kolkata
DEPARTMENT OF LAW
UNIVERSITY OF BUDRWAN
CERTIFICATE
I have great pleasure in certifying that Mr. RAJARSI DAS,

M.Sc.(Zoology), LL.B.(Hons), LL.M. (Cal), Lecturer, Jogesh
Chandra Chaudhuri Law College, Kolkata, a registered candidate for
Ph.D degree in Law bearing Registration No. R-
Ph.D./Regn./A/Law/150/1(4) of the University of Burdwan, has
completed his research work on “INTELLECTUAL PROPERTY
PROTECTION IN BIOTECH INVENTION IN INDIA: A
SOCIO-LEGAL STUDY” under my guidance and supervision for
the award of the Degree of Doctor of Philosophy in Law. He has
complied with all the formalities for submitting the thesis leading to
the award of the Ph.D. Degree in law of the University of Burdwan.
This is also to certify that no research work has, to the best of my

knowledge, been done on this topic in present format in any Indian or
Foreign University and that the work has been done by the candidate
himself.
Dr. Shashi Nath Mandal
Supervisor
Dr. P. K. Acharya THE UNIVERSITY OF BURDWAN
Retd. Asst. Professor GOLAPBAG, BURDWAN-713 104
DEPARTMENT OF LAW WEST BENGAL, INDIA
Phone : 0342 2656549, 2558554,
Fax : 91-0342-2530452
Date:
CERTIFICATE
I have great pleasure in certifying that Mr. RAJARSI DAS,

M.Sc.(Zoology), LL.B.(Hons), LL.M. (Cal), Lecturer, Jogesh Chandra
Chaudhuri Law College, Kolkata, a registered candidate for Ph.D degree
in Law bearing Registration No. R-Ph.D./Regn./A/Law/150/1(4) of the
University of Burdwan, has completed his research work on
“INTELLECTUAL PROPERTY PROTECTION IN BIOTECH
INVENTION IN INDIA: A SOCIO-LEGAL STUDY” under my
guidance and supervision for the award of the Degree of Doctor of
Philosophy in Law. He has complied with all the formalities for
submitting the thesis leading to the award of the Ph.D. Degree in law of
the University of Burdwan.
This is also to certify that no research work has, to the best of my

knowledge, been done on this topic in present format in any Indian or
Foreign University and that the work has been done by the candidate
himself.
Dr. P. K. Acharya
Supervisor
i
CONTENTS
Preface x
Acknowledgement xi-xiii
Table of Cases xiv
Abbreviations xv-xvii
CHAPTER 1
INTRODUCTION 1-24
1.1 Introduction 1
1.2 Intellectual Property 2
1.3 Intellectual Property Right (IPR) 3
1.4 Intellectual Property Right and Patent 4
1.4.1 Invention, Innovation and IP Protection 4
1.4.2 Novelty and Inventiveness 5
1.4.3 Commercialization of Inventions 5
1.4.4 Term of Patent 6
1.4.5 Territorial Scope 6
1.4.6 Patentability 6
1.4.7 Utility of Patent 6
1.4.8 Application for Patent 7
1.4.9 Content of Patent Application 7
1.4.10 Expiry of Patent 8
1.5 Traditional Knowledge (TK) 8
1.6 Biotechnology 8
1.5.1 Evolution of Biotechnology 9
1.6.2 Needs of Biotechnology 10
1.6.3 Applications of Biotechnology 11
1.6.3.1 Biotechnology in Plant Sciences 11
ii
1.6.3.2 Biotechnology in Animal Sciences 11

1.6.3.3 Medicine (Pharmaceuticals and Drugs) and Medical
Sciences 11
1.6.3.4 Biotechnology in Agriculture 12
1.7 Intellectual Property Protection and Biotech Invention 12
1.7.1 Patents and Biotechnology Protection 13
1.7.2 Patenting of Micro-Organisms and Cells 14
1.7.3 Patenting of Animals 16
1.7.4 Transgenic Animals and Patent 16
1.7.5 TRIPS and Biotechnology Patent 17
1.8 Literature Review 20
1.9 Research Problem 21
1.10 Hypothesis 22
1.11 Research Methodology 22
1.12 Plan of the Research 23
CHAPTER 2
DEVELOPMENT OF INTELLECTUAL PROPERTY RELATED
TO BIOTECH INVENTIONS: INTERNATIONAL
PERSPECTIVES 25-83
2.1 Introduction 25
2.2 International Legal Instruments and Conventions on Patents and
Biotechnology 26
2.2.1 Paris Convention for the Protection of Industrial Property,
1883 29
2.2.2 The Budapest Treaty on the International Recognition of the
Deposit of Microorganisms for the Purposes of Patent
Procedure 31
2.2.3 The Patent Cooperation Treaty (PCT) 32
2.2.3.1 Advantages for Patent Offices 34
2.2.3.2 Advantages for the Applicant 35
2.2.3.3 Advantages on National Economy for Industry 35
iii
2.2.3.4 Technical Information 37

2.2.4 The Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS) 38
2.2.4.1 Provisions Relating to Patents in the TRIPS
Agreement 39
2.2.5 Other International Legal Instruments 40
2.2.5.1 Directive 98/44/Ec of the European Parliament and of
the Council of 6 July 1998 on the Legal Protection of
Biotechnological Inventions 41
2.2.5.2 The International Union for the Protection of New
Varieties of Plants (UPOV) 42
2.2.5.2.1 What is the Purpose of the UPOV
Convention? 42
2.2.5.2.2 What is the Necessity of such a Protection? 43
2.2.5.3 The Convention on Biological Diversity (CBD) 44
2.2.5.3.1 Cartagena Protocol on Biosafety 46
2.2.5.3.2 Nagova Protocol 46
2.2.5.4 Rio Declaration on Environment and Development 47
2.3 Development in Patenting Biotechnological Inventions in United
States, Europe, China etc. 50
2.3.1 Development in Patenting Biotechnological Inventions in the
United States (U.S.) 52
2.3.1.1 Industrial Applicability Requirement in the United
States 54
2.3.1.2 The Disclosure (Written Description) Requirement in
the United States 54
2.3.1.3 The Onco Mouse Case 55
2.3.2 Development in Patenting Biotechnological Inventions in
Europe 58
2.3.2.1 Second Prerequisites 60
2.3.2.1.1 „Ordre Public‟ and Morality 60
2.3.2.1.2 Morality after the Directive 61
iv
2.3.2.1.3 Plant and Animal Varieties 61

2.3.2.1.4 Patentability of Therapeutic and Diagnostic
Methods 63
2.3.2.1.5 The Essential Requirements 63
2.3.2.2 Industrial Applicability/Utility Requirement in Europe 70
2.3.2.3 The Onco Mouse in Europe 70
2.3.3 Development in Patenting Biotechnological Inventions in
China 73
2.3.3.1 Subject Matter 74
2.3.3.2 Claims 76
2.3.3.3 Novelty 77
2.3.3.4 Inventiveness 78
2.3.3.5 Sufficiency of Disclosure 78
2.3.3.6 Infringement Procedures 79
2.4 Conclusion 80
CHAPTER 3
NEED FOR PROTECTION OF INDIAN BIOTECH
INVENTIONS 84-133
3.1 Introduction 84
3.2 Future Prospects and Opportunities of the Biotechnological Industry
in India 84
3.2.1 Application and Scope of Biotechnology 86
3.2.2 Beginning of Biotechnology 88
3.2.3 Crop Improvement 89
3.2.4 Harnessing Microbes for Health 90
3.3 Indian Biotech Invention: Overview and Brief History 90
3.3.1 First Generation of Biotechnology 93
3.3.2 Second Generation of Biotechnology 93
3.3.3 Third Generation of Biotechnology 93
3.3.4 Advantages of Biotechnology 94
v
3.3.5 Possible Harms of Biotechnology 95

3.4 Justifications of Protection of Biotechnology Inventions under
Intellectual Property Law 96
3.4.1 Arguments for giving Protection 97
3.5 Traditional Knowledge and its Protection in India 101
3.5.1 Economics of Traditional Knowledge 104
3.6 Study of Selected Cases 104
3.6.1 The Turmeric Controversy 104
3.6.1.1 Turmeric (Curcumalongal Zingiberacea) 105
3.6.1.2 The Issue 105
3.6.1.3 Chronological History of the Case 108
3.6.1.4 Case Highlights 108
3.6.2 The Neem Controversy 109
3.6.2.1 Neem (Azadirachta Indica) 109
3.6.2.2 The Issue 109
3.6.2.3 Description 110
3.6.2.4 The Defences 111
3.6.2.5 The Different Patents Issued on Neem by USPTO 112
3.6.2.6 Some Indian Companies also granted Patents on
Different Claims 112
3.6.2.7 Importance of the Case 112
3.6.3 The Basmati Case 114
3.6.3.1 Basmati (Oryza Sativa) 114
3.6.3.2 The Issue in Basmati 115
3.6.3.3 The Controversies 117
3.6.4 The Wheat Grain 118
3.6.5 The Pharmaceutical and Agricultural Chemical Products 119
3.6.5.2 The Arguments of the Appellate Body 120
vi
3.6.5.3 The Defences 122

3.6.5.4 The Major Issues raised by India 122
3.6.5.4.1 Article 70.9 of the TRIPS Agreement 124
3.7 Biotechnology Companies in India 125
3.7.1 Shantha Biotech 125
3.7.2 Dr. Reddy‟s Laboratory (DRL) 126
3.7.3 Ranbaxy Laboratories 127
3.7.4 Wockhardt Ltd. 128
3.8 Conclusion 131
CHAPTER 4
SOCIAL IMPACT OF BIOTECH INVENTIONS AND
PROTECTION ISSUES 134-181
4.1 Introduction 134
4.2 Impact of TRIPS Agreement on Biotechnology Inventions 136
4.2.1 TRIPS Agreement and Biotechnology in India 140
4.2.2 The Novartis Challenge 142
4.2.2.1 Application before Chennai Patent Office 142
4.2.2.2 Petition before High Court at Madras 143
4.2.2.3 Issues 145
4.2.2.4 Decision of High Court 145
4.2.2.5 Appeal before Hon‟ble Apex Court 150
4.3 Patenting Micro-Organisms 152
4.3.1 Diamond V. Chakrabarty 153
4.3.2 Patentability of Micro-Organisms and the Indian Scenario 155
4.4 Patents for Higher Life Forms and Cloning 157
4.4.1 Current Status of Cloning in India 163
4.5 Rights in Plant Varieties 164
4.5.1 Protection of New Plant Variety 166
4.6 Medical Patents and Access to Drugs 166
vii
4.6.1 Pharmaceutical Patent Issues 170

4.7 Biotechnology Patent Protection, Biodiversity and Sustainable
Development 171
4.8 Patenting Biotech Inventions and the Piracy of Traditional
Knowledge 173
4.9 Morality and Patenting Biotechnological Inventions 176
4.10 Impact of Globalization 179
4.11 Conclusion 180
CHAPTER 5
DOMESTIC LEGAL FRAMEWORK RELATING TO BIOTECH
PROPERTY PROTECTION IN INDIA 182-241
5.1 Introduction 182
5.2 Intellectual Property Protection and the Indian Patent Law 184
5.2.1 Origin and Development of Patent Law in India 185
5.2.1.1 Legislative Development of the Patent Law in India 185
5.2.2 Protection of Patentable Inventions in India 193
5.2.2.1 Utility 194
5.2.2.2 Novelty 194
5.2.2.3 Obviousness 195
5.2.2.4 Specification 195
5.2.3 Non-Patentable Inventions 195
5.2.3.1 Various types of Non-Patentable Inventions 195
5.2.3.2 Examples of Non-Patentable Inventions 197
5.3 Intellectual Property Protection and Biotechnological Patents in
India 197
5.3.1 Traditional Knowledge and Indian Legal Regime 199
5.3.1.1 National Biological Authority and Traditional
Knowledge 199
5.3.2 Medical Biotechnology 201
5.3.3 Agriculture Biotechnology 203
viii
5.3.4 Bioinformatics 204

5.4 The Relevant Amendments to the Indian Patents Act and Biotech
Invention Issues 205
5.4.1 The Patents (Amendment) Act 1999 205
5.4.1.1 Invention 206
5.4.1.2 Non Patentability 206
5.4.1.3 Chemical Process 207
5.4.1.4 International Applications 208
5.4.2.1 Patenting Life Forms & Essentially Biological
Processes 209
5.4.2.2 Restrictions with respect to Agriculture Related
Inventions 210
5.4.2.3 Diagnostic and Therapeutic Treatment in Relation to
Agriculture 211
5.4.3.1 Patentability Exclusion before January 2005 214
5.4.3.2 The Mailbox Provision 215
5.5 Intellectual Property Protection and Biodiversity 217
5.5.1 National Biological Diversity Legislation and Policy 220
5.6 Other Domestic Legal Frameworks On Biotech Property Protection 225
5.6.1 The Protection of Plant Variety and Farmers‟ Rights Act,
2001 226
5.6.1.1 The Background 226
5.6.1.2 Plant Varieties Authority 227
5.6.1.3 Registration 227
5.6.1.4 Farmer‟s Rights 228
5.6.1.5 Right on Registration 228
5.6.1.6 Prohibition of Registration 229
5.6.1.7 Compulsory Licences 229
ix
5.6.1.8 Rights in Relation to Registered Varieties 230

5.6.2 The Drugs and Cosmetics Act, 1940 (Drugs Act) 230
5.6.3 The Drug (Prices Control) Order 1995 (DPCO) Under
Essential Commodities Act, 1995 (ECA) 232
5.6.4 The Environment Protection Act, 1986 (EPA) 233
5.6.4.1 Genetically Modified Organism (GMOs) 233
5.6.4.2 Biotechnology and Business Law 235
5.7 Governmental Policies in Patenting Biotech Invention in India 236
5.7.1 Ownership of Intellectual Property 236
5.7.2 Transfer of Technology 236
5.7.3 Royalty to Inventors 236
5.7.4 Norms for the Private Industry 237
5.7.5 Patent Facilitating Fund 237
5.7.6 Information 237
5.7.7 March in Rights 238
5.8 Conclusion 241
CHAPTER 6
CONCLUSION AND RECOMMENDATIONS 242-256
6.1 Conclusion 242
6.2 Recommendations 251
x
PREFACE
The research project on “Intellectual Property Protection in Biotech Invention

in India: A Socio-Legal Study” carried out for Ph.D. Degree in Law has a great
social, cultural, scientific, legal, economic relevance in this present info-tech
and bio-tech world. Intellectual Property protection in biotech invention has got
a dynamic feature throughout the globe and India is not an exception to it. The
ownership and exploitation of IP protection are the key factors in determining
the success of technological inventions. Now the scope of biotechnology is
expanding to various other areas including microbiology, genomes, chemical
compositions and bio-pharma industry. The effective and efficient management
of IPR is thus, crucial in providing the right incentives for continuing
technological innovations. Thus, IP protection mechanisms are helpful for new
business opportunities and value adding knowledge based industry. But The
Indian Intellectual Property protection laws do not adequately protect
traditional knowledge or biotech knowledge so as to ensure benefit sharing and
credit to the concerned community. The Patents Act provides a long list of
inventions that are excluded from patentable subject matter, which includes
biotechnology inventions. This work tries to examine this issue in the present
shape in respect to IP protection law as it has not been matured enough to
protect multifarious Indian issues and its social impact.
Dated:
RAJARSI DAS
xi
ACKNOWLEDGEMENT
Like a newcomer who has to be guided to know the actual way to his goal, I
too needed guidance to fulfil my desire of doing research. I was fortunate
enough to have met Dr. Shashi Nath Mandal and Dr. P. K. Acharya as my
philosopher and guide. I would not have been able to proceed with my research
and complete it until and unless I would have got the cordial helps from Dr.
Shashi Nath Mandal and Dr. P. K. Acharya who are my supervisors of this
research work, without their constant support, guidance zeal, advice, rebukes
and enthusiasm this thesis would not have been a completed one. Their
involvement throughout my work in all possible ways in the preparation of this
thesis deserves special mention. They have always co-operated with me and
more specifically they entertained me whenever I have called them up and
approached them. So Firstly I would like to convey my heartful thanks and
respectful PRONAM to both of them.
Now I would take the opportunity to convey my sincere thanks to all the kind-
hearted persons of the Department of Law, the University of Burdwan, Prof.
(Dr.) Sanjeev Kumar Tiwari, Prof. (Dr.) Manik Chakraborty, Late Prof.
(Dr.) S.S.Singh, Prof. (Dr.) M.Momin (Retired), Prof. (Dr.) Sarit Kumar
Sadhu (Retired) and Dr. Jayanta Kumar Saha who have helped me in my
work in some way or the other.
I can never forget the inspirations and support that I have got from my
colleague & guide Sri Mukul Mondal, Lecturer in Law, Jogesh Chandra
Chaudhuri Law College.
I would like to thank Dr. Prem Kumar Agarwal, Head, Law section, Hooghly
Mohsin College, Prof. (Dr.) Manik Bhattacharya, Principal (Retired), Jogesh
Chandra Chaudhuri Law College, Kolkata, Prof. (Dr.) Rathin
Bandyopadhyay, Head, Dept. of Law, University of North Bengal, Late
Haldar Sir, Surendra Nath Law College. Sri Sumit Chakrabarty, Secretary,
xii
R.S.S. Law College, C.U., Dr. P. S. Ganguli, Chairman, Jyotirmoy School of

Law, C.U. They have always inspired me to do the work and submit it as early
as possible.
I would like to pay my homage and PRONAM to my teachers from then Dept.
of Law, University of Calcutta, Prof (DR.) S. S. Chatterjee, Prof (Dr.) J. K.
Das, Prof. ( Dr.) Shachi Chakrabarty, Prof (Dr.) I. G. Ahmed, Prof (Dr.)
N. K. Chakrabarty.
I would like to mention the names of my respected colleagues Dr. Sunanda

Goenka, Principal, Dr. Achina Kundu, Dr. Nilansu Bhattacharyya, Dr.
Swati Sinha (presently in Kazi Nazrul University), Dr. Sangeeta Roy
(Maitra) (presently in Hooghly Mohsin College), Sri Sambhu Prasad
Chakrabarty (presently in Amity Law School Kolkata), Dr. Mousumi
Mukherjee Banerjee and others of Jogesh Chandra Chaudhuri Law College,
Dr. Nilachal Dey of Rabindra Shiksha Sammilani Law College (then) for
always giving me inspirations. A special mention of Dr. Somnath Roy is very
much required as he has parted me with his thesis without any hesitation from
where I have got several ideas regarding the design, suggestions etc.
My sincere thanks goes to the Librarian of the Indian Law Institute (ILI),
New Delhi, the Librarian of the Central Library, the University of
Burdwan, the Librarian of the Seminar Library, Department of Law, the
University of Burdwan, the Librarian of the West Bengal National
University of Juridical Sciences (NUJS), Kolkata, the Librarian of the
Dept. of law Library, Hazra Campus, University of Calcutta. I am indebted
to Sri Sambhunath Chatterjee, Head Clerk, Department of Law, B.U., for
having me provided with all sorts of information relating to Ph.D. I cannot stay
without mentioning the name of Sri Amit Chatterjee, Assistant Librarian,
Jogesh Chandra Chaudhuri Law College who has helped me in all the possible
ways by lending me books, AIRs and SCCs from the library.
xiii
A great thanks from the core of my heart to my friends Sri Samir Hossain,
Head, Legal, Aditya Birla Finance Ltd., Smt. Avirupa Chatterjee, Lecturer,
Surendranath Law College, Sri Susangeet Das, Judge, Sri Sangram Saha,
Judge, Sri Rajarshi Mukherjee, Judge, Smt. Alipa Biswas, Faculty, Dept. of
Law, C. U., Sri Kallol Ghosh, Judge Sri Saikat Chatterjee, Advocate, Smt.
Sangeeta Sinha, Lecturer, South Calcutta Law College, Sri Sandipan Gupta,
Officer, B. U., Md. Rajib Hassan, faculty, P.G. Dept. of law, Hooghly Mohsin
College, Sri Moti Prasad, Advocate, Supreme Court of India, Sri Amitava
Mondal, Businessman in South Korea, who have been helping me since the
very beginning of my legal education.
At last I convey my feelings for my father Sri Adhir Kumar Das, Advocate,
Calcutta High Court, my mother Smt. Sipra Das, Headmistress (Retired), S. V.
M. Girls‟ High School, my wife Smt. Swagata Das, Teacher, N.H.M. Higher
Secondary School, my daughter Rishika Das (my Sonamaa), my elder brother
Dr. Debarsi Das, Associate Professor, B.H. Medical College & Hospital, my
boudimoni Smt Indira Das, Lecturer, D.G. B.Ed. College, my nephew Mst.
Saptarsi Das, my father-in-law Sri Prabhat Biswas, Businessman, my
mother-in-Law Smt. Swapna Biswas, my brother-in-law Sri Sougata Biswas
that without them this research could not be completed.
With humble heart I submit this thesis to the University of Burdwan for the
award of Doctoral Degree of Philosophy in Law.
Dated: RAJARSI DAS

xiv
TABLE OF CASES
1. Diamond v. Chakrabarty, 447 US 303, 307 (1980). 15, 51-53, 56, 62, 130,
152-153, 159
2. Monsanto v. Stauffer (1985) R.P.C. 515, CA 58
3. Novartis AG v. Union of India (2007) 4 MLJ 1153 142-146, 150-151
4. Hybertech Inc. V Monoclonal Antibodies Inc.,

802 F 2nd 1367, 1384 (Fed. Cir 1928) 170
xv
ABBREVIATIONS
AAAS : American Association for the Advancement of

Science.
ABS : Access and Benefit Sharing
AIDS : Acquired Immuno Deficiency Syndrome
A.I.R. : All India Reporter
BMCs : Biodiversity Management Committees.
BT : Bacillus thuringiensis
CBD : Convention on Biological Diversity.
CGRFA : Commission on Genetic Resources for Food and
Agriculture.
CIOL : Council for International Organization of Medical
Science.
CITES : Convention on International Trade in Endangered
Species.
CSO : Civil Society Organization.
DBT : Central Ethics Committee
DLC : District Level Committee
DPCO : Drug (Prices Control) Order
DNA : Deaxy Ribo Nuclic Acid
DSU : Dispute Settlement Understanding
EDV : Essentially Derived Variety
EPA : Environment Protection Act
EPL : European Patent Convention
EST : Essential Sequence Tag
EU : European Union
FAO : Food and Agricultural Organization
xvi
GATT : General Agreement on Tariffs and Trade

GBPS : Gene Banking Payment System
GEAC : Genetic Engineering Approval Committee
GMD‟s : Measures to regulate Generally Modified Organisms
GTZ : Gessellschaft for Technische Zusammenarbeit
HBGF : Heparian Binding Growth Factors.
HERP : Human Embryonic Research Panel.
HUGO : Human Genome Organization.
IBSC : Institutional Biosafety Committee
ICMR : Indian Council of Medical Sciences.
IDAs : International Depository Authority
INC : Inter-governmental Negotiating Committee
IND : Investigational New Drug
LCDs : Least Developed Countries
MAFF : Ministry of Agriculture Forestry and Fisheries.
MHW : Ministry of Health Welfare
MITI : Ministry of International Trade and Industry
IP : Intellectual Property
IPR : Intellectual Property Right
IPRs : Intellectual Property Rights
ISNAR : International Service for National Agricultural
Research.
ITC : International Trade Commission
IU : International Undertaking on Plant Genetic Resources.
IVF : In Vitro Fertilization
MAT : Mutually Agreed Terms
MLJ : Madras Law Journal
MLS : Multilateral System
xvii
MNC : Multinational Corporation

NARS : National Agricultural Research Station.
NBA : National Biodiversity Authority.
NGO : Non-Governmental Organization.
NIH : National Institute of Health.
NPPA : National Pharmaceutical Pricing Authority.
PBR : Plant Breeders Rights.
PIC : Prior informed Consent
PGRFA : Plant Genetic Resources for Food and Agriculture.
PVPA : Plant Variety Protection Act.
RAFI : Rural Advancement Foundation International.
RDAC : Recombinant DNA Advisory Committee.
RLGM : Review Committee on Genetic Manipulation.
R&D : Research & Development
SBB : State Biodiversity Boards.
SNU : Seul National University.
TK : Traditional knowledge
TRIPS : Trade Related Aspects of Intellectual Property Rights.
UNEP : United Nations Environment Programme
UPOV : International Convention for the Protection if New
Varieties of Plants.
UR : Uruguay Round
USA : United States of America
USPTO : United States Patent & Trademarks Office.
WHO : World Health Organization.
WIPO : World Intellectual Property Organization.
WTO : World Trade Organization.
1
INTRODUCTION
1.1 INTRODUCTION:
Intellectual Property protection in biotech invention has got a dynamic feature
throughout the globe and India is not an exception to it. The ownership and
exploitation of intellectual property (IP) protection are the key factors in
determining the success of technological inventions. The effective and efficient
management of Intellectual Property Right (IPR) is thus, crucial in providing
the right incentives for continuing technological innovations. Thus, IP
protection mechanisms are helpful for new business opportunities and value
adding knowledge based industry. It is high time that India has to develop
appropriate laws and protective mechanism for rapid adoption of the challenges
posed by the continuously evolving technological environment of the globe.
Biotechnology is the application of technology in the process of biological

inventions, based on biotech knowledge. Earlier it was used with reference to
agricultural research. But now the scope of biotechnology is expanding to
various other areas including microbiology, genomes and chemical
compositions. The analysis of DNA structures has helped to identify the root
cause of chronic diseases and facilitated the growth of medical inventions. The
launching of human genome project in 1980, formation of „drug discovery
platform‟ and development of bioinformatics has helped to create new
pharmaceutical products and a new branch of „bio-pharma‟ industry. All
medicinal preparations were derived from plants, whether in the simple form of
plant parts or in the more complex form of extracts, mixtures, etc. Today, a
substantial number of drugs are developed from plants. The majority of these
involve the isolation of the active ingredient (chemical compound) found in a
particular medicinal plant and its subsequent modification. A semi-synthetic
2
analogue of such a compound could typically be a useful pharmaceutical

product. The pharmaceutical company makes such a drug as a form of
intellectual property protection like patent. The patent gives the company the
right to prevent anyone else from manufacturing or selling the product. Then
the company gets a commercial monopoly. Thus both the credit for the product
and the financial reward generally go to the company. The country from which
the knowledge or traditional knowledge or biotech knowledge is obtained is
simply treated as a source of raw material, whether of knowledge or of a
biological resource.
The purchase of plants in bulk to supply a manufacturing unit is increasingly
uncommon, especially with the advent of biotechnology in the pharmaceutical
field. Even where a plant source is essential, as when adequate synthetic
substitutes are not available for a particular compound, the plant need not
necessarily be purchased from the country where it originated, or even
purchased from the country from which the sample was originally taken. Plants
may be cultivated in another country, or outside their natural environment
under controlled conditions. Many plants are available in one country even
though originally from another. Similarly, samples of botanical species have
been taken and kept in collections in different countries of the world. For
example, Indian plant specimens are lodged at the Kew Herbarium in London.
1.2 INTELLECTUAL PROPERTY:

Intellectual property (IP) is the term that describes the ideas, inventions,
technologies, artworks, music and literature, that are intangible when first
created, but become valuable in tangible form as products. Intellectual
properties are the creations of the mind: inventions, literary and artistic works,
and the symbols, names, and designs used in commerce. The rationale for the
establishment of a legal framework on IPRs is that it is a signal to society that
creative and inventive ideas will be rewarded.
3
IP system is being integrated into the knowledge economy, and posing

interesting challenges to industry, government policy-makers, scholars, and
researchers in both developed and developing countries.
Intellectual Property commonly encompasses the following:

1. Patent
2. Trademarks
3. Industrial Design
4. Copyright
5. Geographical Indication of Goods
6. Integrated Circuit
7. Protection of Undisclosed Information such as Trade Secrets
These rights are awarded by the State and are monopoly rights implying that no
one can use these rights without the consent of the right holder. It is important
to know that these rights have to be renewed from time to time for keeping
them in force except in case of copyright and trademarks.
1.3 INTELLECTUAL PROPERTY RIGHT (IPR):

Intellectual Property Rights are statutory rights once granted allows the
creator(s) or owner(s) of the intellectual property to exclude others from
exploiting the same commercially for a given period of time. It allows the
creator(s)/owner(s) to have the benefits from their work when these are
exploited commercially. IPRs are granted to an inventor or creator, designer in
lieu of the discloser of his/her knowledge.
Governing Laws in India for IPR as follows:
1. The Patents Act 1970
2. The Trade Marks Act (1958 original) 1999
3. The Copyright Act 1957
4. The Design Act 2000
4
5. Geographical Indication of Goods (Registration and Protection) Act

1999
6. Plant Variety and Farmers Right Protection Act 2001
1.4 INTELLECTUAL PROPERTY RIGHT AND

PATENT:
A patent is an exclusive right granted by the government to the patentee in
respect of a new invention, which may be product or process. A patent is
granted by the patent office in which one wishes to protect his voluble
invention. A patent covers every area of technology from pencil to helicopter.
A patent is a contract between the inventor or applicant for the patent and the
State, whereby the inventor or applicant gets a monopoly from the State for a
certain period in return for disclosing full details of the invention. The patent
system thus ensures that information on new inventions is made available for
eventual public use so as to encourage technical and economic development
and discourage secrecy.
If an inventor or company has an invention, which they consider to be novel
and inventive, they may apply for a patent. This may be granted only after a
detailed examination by a patent office. Once the patent is granted the inventor
or applicant has the sole right to make, use or sell the invention for a limited
period. This period is usually twenty years.
“Patent” means a patent for any invention granted under this Act 1. Patent
enables its owners to exclude from making, using and selling its inventions.
1.4.1 Invention, Innovation and IP Protection:

An invention means a new product or process involving an inventive step and
capable of industrial application. An Innovation means- the successful
exploitation of new ideas in the form of a useful machinery or process, by any
1
Section 2(1)(m) of The Patents Act, 1970 (39 of 1970)
5
person, using own intellect is called as innovation. Every innovation may not
be patentable invention but every invention is an innovation. All the inventions
are the innovations and are patentable, but all the innovations are not the
patentable inventions.
1.4.2 Novelty and Inventiveness:

In order to be suitable for patenting, an invention must be novel and inventive.
An invention is considered to be novel if it has not been disclosed to the public
at the time that the patent application was made. As long as the date of the
patent application precedes any disclosure of details of the invention to the
public, the invention can be validly patented. If however, details of the
invention have been disclosed to the public before applying for a patent, then
the invention is no longer considered to be novel in a patenting sense and it will
not be possible to protect it validly through the patent system.
It is important to be aware of the danger of premature disclosure of details of
an invention. Even after a patent application has been filed, details of the
invention should only be disclosed as part of a planned programme of
commercial exploitation.
Another requirement for a valid patent is inventiveness. This means that the
invention must contain an inventive step. This can be the most difficult thing to
show. A patent examiner may decide that the invention is obvious i.e. that
somebody knowledgeable in the subject area, when familiarised with all earlier
patents or other technology in the area, would have immediately been led to the
same conclusion.
1.4.3 Commercialization of Inventions:

Many inventors feel that filing a patent application is the most important and
first thing they must do once they have an idea. This is rarely the case.
Patenting an invention is not the only consideration and rushing to file an
application may actually be the wrong thing to do first.
6
Patents are of no value unless the commercial worth of the product or

technology can be demonstrated and exploited. Many patentable inventions
have failed not because they didn't work, or because they had been invented
before, but because the inventor was unable to exploit them commercially.
Inventing is increasingly being seen as a business. One must invest in the
business if he wishes to make a return, and management and marketing skills
are every bit as important as technical skills. If the inventor does not have all
the skills required, it may be necessary to put together a team or partnership to
exploit the project or to license the invention to an existing company who
already has related products.
1.4.4 Term of Patent:

The term of patent is for twenty years, provided the maintenance fee is paid at
the end of every year as per term of the grant of patent.
1.4.5 Territorial Scope:

Patent laws are territorial; a separate patent must be obtained in each country.
Indian patent office protects invention only filed in India.
1.4.6 Patentability:
Only inventions are patentable. An invention must be new, useful and must
involve inventive steps compared to closest prior art. A new and unobvious
product, process, apparatus or composition of matter will generally be
patentable.
1.4.7 Utility of Patent:

To enjoy the exclusive rights over the invention. If the inventor does not get the
patent rights over his invention and introduces his product/process based on his
invention in the market, anybody can copy his invention and exploits it
7
commercially. To debar others from using, selling or working out his invention,
the inventor must go for getting a patent.
1.4.8 Application for Patent:

An application for obtaining a patent can be made by a true and first inventor
who holds the rightful ownership in the invention due to fact that he invented
the same or by any person who is an assignee/legal representative of the first
and true inventor. Also a legal heir of the first and true inventor can apply for
patent in case of the death of the true and first inventor.
1.4.9 Content of Patent Application:

A patent application has the following information:
1. Bibliographic: It is in structure format. It contains the title of the
invention, date of filing, country of filing, inventor's name etc.
2. Background of the invention or State of the art: In this the inventor lists
the state of the art available on the date of filing his invention. Here the
inventor lists the shortcomings/drawbacks found in the state of the art and
defines his problem.
3. Description of the invention: In this the inventor describes his invention
duly supported by a series of workable examples along with
diagrams/charts, if needed. The invention has to be described in complete
details, so that any person, who is skilled in the art can work out the
invention.
4. Claims: In the last, the inventor has to bring out a series of claims
establishing his rights over the state of the art. It is this portion, upon
which the protection is granted and not on the description of the
invention. This has to be carefully drafted.
8
1.4.10 Expiry of Patent:

A patent can expire in the following ways:
1. The patent has lived its full term i.e. the term specified by the Patent Act
of the country. Generally it is 20 years from the date of filing.
2. The patentee has failed to pay the renewal fee. A patent once granted by
the Government has to be maintained by paying annual renewal fee.
3. The validity of the patent has been successfully challenged by an
opponent by filing an opposition either with the patent office or with the
courts.
1.5 TRADITIONAL KNOWLEDGE (TK):

The knowledge continually developed, acquired, used, practised, transmitted
and sustained by the communities/individuals through generations is called
Traditional Knowledge.
In India traditional knowledge including the existing oral knowledge cannot be
protected under the provisions of the existing IPR Laws/Acts, as mentioned
herein above. However, if there is a substantial improvement in the existing
traditional knowledge and if it can fulfil the requirements of the definition of
the invention, then the patent application can be filed.
1.6 BIOTECHNOLOGY:
The word “biotechnology” was actually coined early in the 20th century by an
agricultural engineer from Hungary, named Kar l Earky, who explained it in
such a way that the technology which includes all such work by which the
products are produced from raw materials with the aid of living organisms.
Subsequently, over the period, the definition of biotechnology acquired a
confusing status due to various interpretations.2
2
Dr. K. K. Tripathi, Biotechnology and IPR Regime: In the Context of India and
Developing Countries, “Biotech Patent Law”,1st Ed.( the Icfai University Press,2007)
Hyderabad, p.187
9
Classical biotechnology may be defined loosely as the production of usual

products by living organisms, and as such it has been with us for a long time.
The first official broad definition given by the US Office of Technology
Assessment states, “biotechnology includes any technique that uses living
organisms (or parts of organisms) to make or modify products, to improve
plant or animals or to develop microorganisms for specific use”.3
1.6.1 Evolution of Biotechnology:

Biotechnology can be traced back to various stages of its development.
The first generation of biotechnology can be based on the traditional
knowledge in various tribes like preparing fermented foods, medical distillates
etc.
Second generation of biotechnology may be considered when the utilisation of
microorganisms started on industrial scale during the Pasteur era which
involved mass production of alcohol, fermentation of antibiotics, development
of classical vaccines like for cholera, typhoid, yellow fever etc.
The third generation of biotechnology, as distinct from classical fermentation
technology, began in 1970s with the two basic techniques of recombinant DNA
technology and Hybridoma technology. In the first of these, also referred to as
gene splicing or genetic engineering, genetic material from an external source
is inserted into a cell in such a way that it causes the production of a desired
protein by the cell; in the second, different types of immense, all are fused
together to form a hybrid cell line producing monoclonal antibodies.4
The fourth generation of biotechnology would see further advances where
interdisciplinary techniques like information technology and nano-technology
would get involved in further advancement of this discipline, especially
utilising the bioinformatics which is the foundation of modern biotechnology.
3
Philip W. Grubb, Patents for Chemical, Pharmaceuticals and Biotechnology, 4th Ed,(New
Delhi: Oxford University Press) 2006. at p.245-246
4
Available at http://www.iprcommission.org , visited on 3.8.2016
10
Bioinformatics can be broadly defined as the use of computers to handle

biological information.
1.6.2 Needs of Biotechnology:

The population of India is more than 1 billion and as per projection it may
cross 1.5 billion by 2030. This will bring huge burden on biological resources
(animal/plant) to provide food for all. Naturally occurring animal, plant or
microbial strains have few limitations for them to be utilized for desired
products due to following reasons-
1. Purity of the living stock
2. Production of undesired products
3. Secretion of toxic metabolic by-products
4. Inability to withstand harsh biochemical processes/treatments
5. Higher production cost
6. Susceptible to disease and other environmental conditions
The existing technology today enables us to engineer plants and animals,
marketing them suitable for maximum production. Living organism has a
complex cellular structure, metabolic pathways, genetic make-up, behaviour in
the synthetic growth media and understanding these processes can help us to
modulate specific process/environmental condition or metabolic pathways to
achieve the goal of biotechnology. Advancement in different fields of science
has paved ways to solve several issues responsible for lower yield of products.
The foundation of biotechnology relies on the research & development
activities in different areas of science and interaction of interdisciplinary areas.
The research in the field of plant biotechnology allowed us to produce plants
through micro-propagation but with the evident advancement of genetic
engineering, it is now possible to produce plant with predefined characteristics
imprinted at genetic level through genetic engineering. The similar relationship
may also exist for many other overlapping areas and as a result
biotechnological operation output is amplified several folds.
11
1.6.3 Applications of Biotechnology:

Biotechnology has influenced human life in many ways by inventions to make
his life more comfortable. Many scientific fields contribute to biotechnology
and in return it gives product for their advancement. The brief description of
application of biotechnology in different field is stated in the follows
paragraphs.
1.6.3.1 Biotechnology in Plant Sciences:

Genetic Engineering has allowed to produce genetically modified plants with
diversified properties such as resistance against pest, drought and abiotic stress.
It has enabled us to produce edible plants with short life-span or ability to grow
in different season to increase the number of crops in a year to ultimately
increase the food production. Horticulture has used biotechnology tools to
produce plants with multiple color, shades, aroma to increase the production of
natural colors and scent.
1.6.3.2 Biotechnology in Animal sciences:

One of the early application of biotechnology in animal science is developing
method to separate cheese and other food products from milk by enzyme and
microbes. Genetic engineering in conjugation with cell biology and
biochemistry has developed multiple products of animal origin. Transgenic
animal strains with desired phenotype such as high milk yielding animals,
fishes and hens with more fat content.
1.6.3.3 Medicine (Pharmaceuticals and Drugs) and Medical

Sciences:
Biotechnology helped identification of drug like molecules, antibiotics and
other medicines. At present a number of antibiotics are being produced by
fermentation or in cell based systems. Apart from antibiotic, vaccine,
12
diagnostic kits and other immunotherapy are gift of biotechnological

advancement. Development of artificial limb, arms, heart and medical
procedures to perform open-heart operation, dialysis, artificial insemination,
test-tube baby and other medical procedures.
1.6.3.4 Biotechnology in Agriculture:

In India, biotechnology research and development (R & D) is in progress
particularly in crop improvement. The most promising benefit from genetic
engineering is the use of recombinant DNA techniques, because it is possible to
break through natural species barriers systematically by moving genes from
one species to another that do not combine in nature. The genetically modified
(GM) crops have been developed by using input traits (e.g. resistance to insect
pests and plant diseases), output traits (e.g. delayed fruit ripening, better taste,
nutritious, elimination of saturated fats in cooking oils, elimination of
allergens, better delivery of necessary nutrients) agronomic traits (e.g.
resistance to drought, salinity, acidity, flood, etc. and increase in crop yield).
1.7 INTELLECTUAL PROPERTY PROTECTION

AND BIOTECH INVENTION:
For thousands of years human beings have been exploiting biological resources
for medical, agricultural and other purposes. Modern biotechnology is only the
latest fashion by which man is able to use his natural environment to feed, cure
and house him. In the last decade the application of modern biotechnology for
agricultural, ecological and medical purposes has sparked great hoes for the
extent to which man can explore and exploit biological resources for his
wellbeing. Biotech inventions are gaining popularity as they help identify the
root cause of chronic diseases and suggest remedies. Biotechnology is a new
area of science that compounds life sciences of chemical sciences. Genes in
plants, providing for certain special features, would be isolated and put together
13
into one plant with the help of biotechnology. Through the process of
biotechnology by manipulation of genes new variety of animals can be
invented. These new variety of animals can be used for different purposes such
as production of medicines, for experimental for testing of medicines and
treating methods. Earlier patents were not granted to genetically modified
organisms and other products derived from living systems. With the
advancement of the technology, protection of biotechnological invention also
started. But protection to the inventions which involve more of living
organisms, became more complex and controversial. The standard tests of
patent law are obstacles for grant of patents to the biotech inventions. Non-
grant of patent encourages uncontrolled piracy of new inventions and the
original owners suffer economic losses because of low returns on their huge
investments in the research. Now TRIPs agreement seeks to enforce US style
patent laws around the world. This agreement covers everything from
pharmaceuticals to information technology software and human gene
sequences. 5 At this juncture, the Researcher points out impact of extension of
patent protection to biotech-invention in India.
1.7.1 Patents and Biotechnology Protection:

The ownership and exploitation of intellectual property rights are the key
factors in determining the success of any technological invention introduced in
the market that provide the means for technological progress to continue or to
be made thereby support the competitiveness of the industry of the country.
The regulatory mechanisms in IPR have their own problems in the coming
scenario of emerging technologies especially in biotechnology.
Biotechnology is the result of efforts of intellect, the application of human
intelligence and knowledge to the biological processes. These human
5
Archana K., “Do We Need Patent Protection to Biotechnology Inventions?” International
Journal of Scientific and Research Publications, Volume 3, Issue 4, April 2013, ISSN
2250-3153
14
intellectual efforts deserve protection. The new plants, animal varieties, new
methods of treatments, new crops producing food articles as such are the
inventions of biotechnology. These inventions have to be protected for
obtaining the fruits of biotechnology.
Biotechnology has based a whole new industry and patent protection for
biotechnological inventions is of immense commercial importance. But patent
law and practice have had serious difficulties in keeping up with the rapid
scientific progress in this field and issues such as inventive steps, sufficiency
of disclosure and permissible breadth of claims have proud troublesome. There
has been much litigation of biotech plants and courts have found it difficult in
such a rapidly moving field to determine what the general knowledge of the
skilled person was at the time invention was made. A procedure to find and
clone a specific gene and to express it in a suitable mode has may have been a
breakthrough at the time when it was first done and purely routine work, not
many years later. There is also the problem of opposition by special interest
groups against anything to do with genetic engineering and particularly against
the existence of patents in this area.6
1.7.2 Patenting of Micro-Organisms and Cells:

Patents on biotechnological processes date from the early days of the United
States. Louis Pasteur received a patent for a process of fermenting beer. Acetic
acid fermentation and other food patents date from the early 1800s, while
therapeutic patents in biotechnology were issued as early as 1895. The
development of recombinant DNA technology (rDNA), i.e., the controlled
joining of DNA from different organisms has resulted in greatly increased
understanding of the genetic and molecular basis of life. Following the first
successful directed insertion of recombinant DNA into a host micro-organism
in 1973, scientific researchers began to recognize the potential for directing the
6
C.B.Raju, Intellectual Property Rights, 1st Ed., (New Delhi: Serials Publications), 2006
15
cellular machinery to develop new and improved products and processes in a

wide variety of industrial sectors. Many of these products were micro-
organisms (microscopic living entities) or cells (the smallest component of life
capable of carrying on all essential life processes). With the development of
recombinant DNA technology, the potential of patenting the living organism
resulting from the technology arose.
Prior to 1980, patents were not granted for such inventions, deeming them to be
“products of nature” and not statutory subject matter. Although patent
applications were rejected if directed to living organisms per se, patent
protection was granted for many compositions containing living things (e.g.,
sterility test devices containing living microbial spores, food yeast
compositions, vaccines containing attenuated bacteria, milky spore insecticides,
and various dairy products). In the absence of congressional action, it took a
catalytic court decision to clarify the issue of patentability of living subject
matter.
The Supreme Court‟s single foray into biotechnology occurred in 1980 with its
ruling in the patent law case of Diamond –Vs- Chakrabarty7. The fact of the
case was that Chakrabarty had developed a genetically modified bacterium
capable of breaking down multiple components of crude oil. Because this
property was not possessed by any naturally occurring bacteria, Chakrabarty
invention was thought to have significant value for cleaning up oil spills.
Chakrabarty‟s claims to the bacteria were rejected on two grounds:
1. Micro-organisms are „products of nature‟ and
2. As living things, micro-organisms are not patentable subject matter.
Following the principle of above two level of appeals, the case was heard by
the U.S. Supreme Court, which, in a 5-4 ruling, held that a live, human-made
microorganism is patentable subject matter. The Chakrabarty decision provided
great economic stimulus to patenting of micro-organisms and cells, which in
7
447 U.S. 303 (1980).
16
turn provided stimulus to the growth of the biotechnology industry in the

1980s.8
1.7.3 Patenting of Animals:

The first animal patent was issued in April 1988 to Harvard University for
mammals genetically engineered to contain a cancer-causing gene (U.S.
4,736,866). The patented mouse was genetically engineered to be unusually
susceptible to cancer, thus facilitating the testing of carcinogens and of cancer
therapies. Specifically, the patent covers “a transgenic non-human eukaryotic
animal (preferably a rodent such as a mouse) whose germ cells and somatic
cells contain an activated onco gene sequence introduced into the animal which
increases the probability of the development of neoplasm (particularly
malignant tumors) in the animal.”9
The claim in this patent was a transgenic non-human mammal, all of whose
germ cells and somatic cells contain a recombinant activalid Onco gene
sequence introduced into the said mammal or an ancestor of the said animal at
an embryonic stage. The rat-race continued and at least 16 patents have been
awarded on inventions related to transgenic mice as models exhibiting specific
pathologies, such as ulcers, photo Parkinson‟s syndrome, inflammation, sickle
cell anaemia, Alzheimer‟s disease, HIV infection, Cutnieous melanoma,
leukaemia, thrombocytopenia etc.10
1.7.4 Transgenic Animals and Patent:

Most potentially patentable animals are likely to be transgenic animals
produced via recombinant DNA techniques or genetic engineering. Transgenic
animals are those, whose DNA or hereditary material has been augmented by
8
http://www.fas.org/ota/reports/8924.pdf, visited on 03.8.2016
9
Lee Burgender, Legal aspects and managing technology, 2nd edition 2001, South Western
College Publication p31.
10
http://www.slwk.com/SLWK/web/company/papers/paper 14.html, visited on 03.8.2016
17
adding DNA from a source other than parental germplasm, usually from
different animals or from humans. Laboratories around the world are
conducting research that involves inserting genes from vertebrates (including
humans, mammals, or other higher organisms) into bacteria, yeast, insect
viruses, or mammalian cells in culture. A variety of techniques, most developed
from early bacterial research, can now be used to insert genes from one animal
into another. These techniques are known by a number of exotic names:
microinjection, cell fusion, electroporation, retroviral transformation, and
others.11
1.7.5 TRIPS and Biotechnology Patent:

Genetic resources have in the past been declared “a common heritage of
mankind to be preserved and to be freely available to all, for use for the benefit
of present and future generations”. 12 This philosophy has done well to the
country in general and to the society in particular, in the long run by enabling
access to such creations and knowledge to all without discrimination. But in
recent times the industrial countries are busy in the protection and privatization
of inventions in the area of living objects or substances such as patenting of
microorganisms and animals. Such steps were generally not accepted by the
developing countries including India.
However, TRIPs agreement encourages protection of knowledge and it seeks to
enforce US style patent laws around the world. This agreement covers
everything from pharmaceuticals to information technology software and
human gene sequences, and is emerging as a major issue dividing North and
South. TRIPs agreement forces all countries to accept a medley of new biotech
patents covering genes, cell lines, organisms and living processes that turn life
11
Arnold, Beth E. and Eve, Ohgeilski-Zei, “Patenting Genes and Genetic Reasearch Tools:
Good or Bad for Innovation”, Annual Review of Genomics and Human Genetics (2002),
P. 416.
12
Lee Burgender, Legal aspects and managing technology, 2nd edition 2001, South Western
College Publication p42.
18
into commodities. Governments all over the world have been persuaded into
accepting these „patents on life‟ before anyone understood the scientific and
ethical implications.
The patenting of life-forms and living processes is covered under Article
27.3(b) of TRIPs. The TRIPS Article 27.3(b) is designed to allow the broadest
categories of patents from genetic engineering and other new biotechnologies.
The patenting of life forms and living processes is covered under Article
27.3(b) of TRIPs. This scientific briefing explains why such patents should be
revoked and banned on the following grounds:
(i) All involve biological processes not under the direct control of the
scientist. They cannot be regarded as inventions, but expropriations
from life.
(ii) The hit or miss technologies do not qualify as „inventions‟, and are
inherently hazardous to health and biodiversity.
(iii) There is no scientific basis to support the patenting of genes13,
genomes14, cells and microorganisms15, which are discoveries at
best.
(iv) Many patents are unethical; they destroy livelihoods, contravene
basic human rights, create unnecessary suffering in animals or are
otherwise contrary to public order and morality.
(v) Many patents involve acts of plagiarism of indigenous knowledge
and bio-piracy of plants (and animals) bred and used by local
communities for millennia16.
13
Gene is a stretch of genetic material (DNA or RNA) with a defined function in the
organism or cell. It usually codes for a protein
14
A genome is the totality of all the genetic material (deoxyribonucleic acid or DNA) in an
organism, which is organised in a precise, though by no means fixed or constant way. In
the case of viruses, most of them will have ribonucleic acid or RNA as the genetic
material.
15
A micro-organism is an organism that can be seen only under a microscope, usually, an
ordinary light microscope. It includes bacteria, mycoplasm, yeasts, single-celled algae and
protozoa.
19
In India, as it is mandatory for all the member countries of the WTO to adopt
the agreements of WTO, the Ministry of Science and Technology has issued
guidelines- “Instructions for Technology transfer and Intellectual Property
Rights”, which would help in enhancing the motivation of the scientists,
research institutions and universities in various research and development
projects funded by various departments of the Ministry of Science and
Technology. The salient features of these guidelines are as follows:
a) Ownership of Intellectual Property: the institution shall be encouraged
to seek protection of IPR rights in respect of the results of R&D. they
may retain the ownership of such IPRs. Institution means any technical,
scientific and academic establishment where the research is carried
through funding by central or state governments.
b) Transfer of Technology: the institutions would take necessary steps to
commercially exploit patents on exclusive or non-exclusive basis.
c) Royalty to inventors: owner institutions are permitted to retain the
benefits and earnings generated out of the IPR. Institutions may
determine the share of the inventors and other associated persons from
such earnings. However such sharing is limited to one third of such
earnings.
d) Norms for the private industry: IPR generated through joint research by
institutions and industrial concerns through joint research efforts can be
owned jointly by them on mutually agreed terms through a written
agreement. The institution or industrial concern may transfer the
technology to the third party for commercialisation on exclusive or
nonexclusive basis.
e) Patent Facilitating Fund: the owner institution shall set apart not less
than 25% of the revenues generated from IPR to create a patent
facilitating fund. The fund shall be utilised by the owner for updating
16
Cooper, I. P., Biotechnology and the Law, (New York, NY: Clark Boardman, 1985), at
p.12-22
20
the inventions, filing applications for new patents and protecting the
IPR against infringement and for building the competency in the area of
IPR and related issues.
f) Information: the institution shall submit the information relating to the
details of the patents obtained, the benefits and earnings arising out of
the IPR and the turnover of the products periodically to the
Department/ministry, which has provided the funds.17
1.8 LITERATURE REVIEW:

Bull T. Alan (1983)18 has stated that bio-tech inventions are weakly protected
throughout the world. Crespi and Straus Brier (1985)19 have covered various
international conventions and treaties for enacting domestic legal framework of
each country. R. I. Freshnev (1986)20 has mentioned that animals are creations
of nature. So animals or anything of them are not patentable. J. Parsley
Gabrielle (1990)21 has stated that agricultural scientists are the pillars of present
and future world. Dr Shiva Vandhana, Asfar H. Jafri (1997)22 have mentioned
that due to biodiversity, patent protection on biotech-inventions is water-tight
component. M. M. Ranga (1999-2000)23 has opined that animals and animals‟
body parts are not subject matters of patent protection. F.H Erbisch, K.M
17
Tripathi K. K., Biotechnology: Government of India Initiatives, Saketlnd
Digest,Feb.2002.pp.49-53.
18
Alan T. Bull, Geoffrey Holt, Malcolm D. Lilly, Biotechnology: International Trends and
Perspectives, Oxford and IBH publishing Co. Pvt. Ltd, New Delhi, Indian Edition, 1983.
19
Brier, Crespi and Straus, Biotechnology and Patent Protection, OECD, Paris, 1985.
20
Freshnev. R.I, (edited) Animal Cell Culture: A practical approach, IRL press, Washington,
First published 1986.
21
Gabrielle J. Parsley, Agricultural Biotechnology: opportunities for international
development, C.A.B International, Wallingford, United Kingdom, 1990
22
Dr Vandhana Shiva, Asfar H. Jafri, Gitanjali Bedi and Radha Holla-Bhar, The enclosure
and recovery of the common‟s, Biodiversity indigenous knowledge and intellectual
property rights, Research Foundation for Science, Technology and Ecology 1997.
23
Ranga.M.M, Animal biotechnology, Agrobios (India), Jodhpur, 1999-2000.
21
Maredia (2000)24 have stated that agricultural bio-tech inventions are to be

under the purview of patent protection. Dr. T. Ramakrishna (2003)25 has
observed that researchers must be encouraged when their inventions are rightly
protected. Bio-technology is not an exception in this regard. K. K. Tripathi,
(2007)26 has stated that Biotech inventions are getting popularity as a tool to
find out the causes of diseases.
1.9 RESEARCH PROBLEM:

The Indian intellectual property protection laws do not adequately protect
traditional knowledge or biotech knowledge to ensure benefit sharing and
credit to the concerned community. The Patent Act provides a long list of
inventions including biotechnology inventions, which are excluded from
patentable subject matter. Discovery of any living thing, occurring in nature, is
not patentable subject matter in India. Prohibited biotech subjects further
include plants and animals in whole or any part, thereof, including seeds; plant
and animal varieties, species and essential biological processes for production
or propagation of plants and animals. However, microorganisms and
microbiological processes are patentable subject matters but genetically
modified multi-cellular organisms including plants, animals, human beings and
their parts are excluded from patentability in India.
India possesses rich heritage of valuable flora and fauna and, hence has been
considered as a 'treasure house' of valuable medicinal and aromatic plant
species. The Indian systems of medicine have identified about 1500 medicinal
plants, of which about 500 species are mostly used in the preparation of
24
Erbisch F.H, Maredia K.M, Intellectual Property Rights in Agricultural Biotechnology,
University Press (India) Limited, Hyderabad, 2000.
25
Dr Ramakrishna.T (edited) Biotechnology and Intellectual Property Rights, Center for
Intellectual Property rights and Advocacy (CIPRA), National Law School of India
University, Bangalore, First Edition, 2003.
26
Tripathi Dr. K.K., Biotech Patent Law, Edited by Veena, Amicus Books, The Icfai
University Press, 2007
22
drugs.27 The Indian systems of medicine, particularly Ayurveda, Siddha, Unani,

& Homoeopathy largely have been using the plant base materials, minerals,
metals, marine and products of animal origin. There has been condemnation by
the people on this mounting trend of patenting of our medicinal plants and their
uses. Some of the well-known plants of Indian origin like Kala Zeera, Amaltas,
Indian Mustared, Karela, Brinjal, Neem, Gudmar etc. have got patents in
different countries, however, a number of patents have been effectively
contested by India. India is behind the rest of the world in the grant of patents
both quantitatively and qualitatively, even when comparison is made with our
neighbour China. The persistent governmental reluctance and lack of clear
understanding about the effects and need of patents are serious concern.
1.10 HYPOTHESIS:
The inventions, which involve more of living organisms, became controversial
issues in India due to lack of proper legal provisions. The standard tests of
patent law are obstacles for the grant of patents to the biotech inventions but on
the other hand non-grant of patent in the field encourages uncontrolled piracy
of new inventions. The original owners suffer economic losses because of low
returns on their huge investment in the research. Though in India, the existing
patent laws were amended to comply with TRIPS agreement, but appropriate
measures were not adopted to provide adequate patent protection to the
biotech-inventions in India unlike other developed States. Appropriate
amendments in the existing laws and changes in biotech policy may be helpful
in protection of Biotech Invention in India.
1.11 RESEARCH METHODOLOGY:

The present study has been concentrated on the review of the impact of IP
protection laws and inventions and its effect on the society, which is unique of
27
ibid
23
its kind and lacking primary data. Thus, to conduct the proposed study the
researcher has adopted doctrinal, non-empirical and analytical method of legal
research. Besides study of various International Treaties, Enactments,
Published Reports, Journals, Articles, Periodicals, Books, Cases, Domestic
Case Laws, Various Debates and Opinions of Committees have been consulted
during the projected research work.
1.12 PLAN OF THE RESEARCH:
In order to proceed with the present research work the entire work has been
divided into some chapters besides introduction, for smooth execution of the
work. They are as follows:
Chapter 1: Introduction:
The first chapter is the introductory in nature whereby the main
objectives of the present study have been laid down. This chapter
introduces the proposed subject of research along with due
research methodology.
Chapter 2: Development of Intellectual Property Relating to
Biotech Inventions: International Perspectives:
The second chapter deals with the phase wise growth, nature and
importance of biotechnology in respect to development of IP in
International scenario.
Chapter 3: Need for Protection of Indian Biotech
Inventions:
In the third chapter, an attempt has been made to explain the
efficacy and necessity for the protection of biotech inventions.
24
Chapter 4: Social Impact of Biotech Inventions and

Protection Issues:
This chapter discusses the issues of leaving impact by biotech
inventions and its protective matters.
Chapter 5: Domestic Legal Framework Relating to IP
Protection in India:
In this chapter, domestic laws, kind of legal framework,
provisions of related laws, policies and judicial decisions in
favour of IP have been dealt with.
Chapter 6: Conclusion and Recommendations:
This chapter concludes the research work with findings and
recommendations.
25
CHAPTER 2
DEVELOPMENT OF INTELLECTUAL
PROPERTY RELATED TO BIOTECH
INVENTIONS: INTERNATIONAL
PERSPECTIVES
2.1 INTRODUCTION:
The patent system is designed to grant inventors and innovators exclusive
rights over their inventions for a certain period of time in exchange for public
disclosure of their inventions. 1 Biotechnology is a new technique for industries
and specialists and is making astounding progress. Advances in biotechnology
are so rapid that many things are now possible, which, even a few years ago,
would have seemed unimaginable.2 It is a type of genetic engineering in
medical and veterinary research resulting in modified productions and
improved animal breeds. 3 It is the use of microorganisms, mammalian cells and
their products for industrial, agricultural, and medical purposes.
1
Ayşegul Ozdemir, ―Now the Wolf Has Indeed Come! Perspective on the Patent Protection
of Biotechnology Inventions in China‖, 53 American Journal of Comparative Law 207,
207 (2005), at p. 23-33
2
Noelle Lenoir, ―Biotechnology, Bioethics and Law: Europe‘s 21st Century Challenge‖, 69
Modern Law Review 1, 1 (2006), at p. 6-13
3
W. Cornish and D. Llewelyn, Intellectual Property: Patents, Copyright, Trade Marks and
Allied Rights, (Sweet and Maxwell, London, 2003), p.823.
26
This rapid development has led to huge problems in biotechnology, particularly

in patenting biotechnological inventions. In modern biotechnology, patents are
a controversial issue and are more interesting for the public than any other
technical field. Advances in biotechnology are bound up in ethical, religious,
political and legal issues. Breakthroughs in this area of research invariably
reach the headlines in the news. There have been reports on genome
sequencing of gene development into protein expression, and enthusiastic
discussion on the isolation of stem cell cultures, which makes human cell
cloning possible. With public interest aroused, the occasion could arise when a
scientific research institution, in order to protect their research investment,
would have to consult a patent lawyer for advice. A rapidly increasing amount
of genetic code and sequencing material is being patented provided that the
patent is not so biotechnologically broad that it creates a monopoly or
illegitimate patent production based on lack of product or potential product
specificity.4 Consequently, the idea that breakthroughs in genetic knowledge
could be monopolized by a few multinational companies is a major cause of
concern. Throughout the world, patent offices, legislators and courts are deeply
involved with these issues. Legal answers are more likely to be reached than
political or ethical considerations satisfied. The ethics surrounding these issues
must not be ignored nor can they be an obstacle to legal provision for potential
inventions.
2.2 INTERNATIONAL LEGAL INSTRUMENTS

AND CONVENTIONS ON PATENTS AND
BIOTECHNOLOGY:
During the last century, before the existence of any international convention in
the field of industrial property, it was difficult to obtain protection for industrial
4
John Salinas Lopez, ―Should Genetic Code Be Patented?‖ , Law and Society Review at
UCSB, Vol.1 (2002) Genetic Code 57.
27
property rights in the various countries of the world because of the diversity of
their laws. Moreover, patent applications had to be made roughly at the same
time in all countries in order to avoid a publication in one country destroying
the novelty of the invention in the other countries. These practical problems
created a strong desire to overcome such difficulties.
During the second half of the last century the development of a more
internationally oriented flow of technology and the increase of international
trade made harmonization of industrial property laws urgent in both the patent
and the trademark field.
When the Government of the Empire of Australia-Hungary invited the other
countries to participate in an international exhibition of inventions held in 1873
at Vienna, participation was hampered by the fact that many foreign visitors
were not willing to exhibit their inventions at that exhibition in view of the
inadequate legal protection offered to exhibited inventions.
This led to two developments: Firstly, a special Austrian law secured
temporary protection to all foreigners participating in the exhibition for their
inventions, trademarks and industrial designs. Secondly, the Congress of
Vienna for Patent Reform was convened during the same year, 1873. It
elaborated a number of principles on which an effective and useful patent
system should be based upon. Urgent government‘s action was solicited,
"to bring about an international understanding upon patent protection as soon
as possible."
As a follow-up to the Vienna Congress, an International Congress on Industrial
Property was convened at Paris in 1878. Its main result was a decision that one
of the governments should be asked to convene an International diplomatic
conference "with the task of determining the basis of uniform legislation" in the
field of industrial property.
28
Following that Congress, a final draft proposing an international "union" for

the protection of industrial property was prepared in France and was sent by the
French Government to a number of other countries, together with an invitation
to attend the 1880 International Conference in Paris. That Conference adopted
a draft convention which contained in essence the substantive provisions that
today are still the main features of the Paris Convention.
A Diplomatic Conference was convened in Paris in 1883, which ended with
final approval and signature of the Paris Convention for the Protection of
Industrial Property. The Paris Convention was signed by 11 States: Belgium,
Brazil, El Salvador, France, Guatemala, Italy, the Netherlands, Portugal,
Serbia, Spain and Switzerland. When it came into effect on July 7, 1884, Great
Britain, Tunisia and Ecuador had adhered as well, bringing the initial number
of member countries to 14. It was only during the first quarter of the 20th
century and then particularly after world war II that the Paris Convention
increased its membership more significantly.
The Paris Convention has been revised from time to time after its signature in
1883. Each of the revision conferences, starting with the Brussels Conference
in 1900, ended with adoption of a revised Act of the Paris Convention. With
the exception of the Acts concluded at the revision conferences of Brussels
(1897 and 1900) and Washington, D.C. (1911), which are no longer in force,
all those earlier Acts are still of significance, although the great majority of the
countries are now party to the latest activities, that of Stockholm Declaration of
1967.5
There are four international intellectual property treaties which are of particular
importance for the protection of biotechnology.
5
International Treaties and Conventions on Intellectual Property
http://www.wipo.int/about-ip/en/iprm/pdf/ch5.pdf visited on 30.07.2016
29
2.2.1 Paris Convention for the Protection of

Industrial Property, 1883:
The Paris Convention for the protection of industrial property (popularly
known as the "Paris Convention") is one of the first, and arguably the most
important, of the various multilateral treaties protecting intellectual property. It
addresses patent, marks, unfair competition whether or not implicating marks,
and the related industrial property of industrial designs, utility models,
geographical indications, trade names and trade secrets within the context of
unfair competition. The Convention for the most part neither defines the rights
it purports to protect nor guarantees any minimum level of protection for these
rights. The scope and quality of the protection, member nations are obligated to
provide under the Convention are, in most instances, left to domestic
legislation and tribunals to develop and define. While the enumerated
protections serve primarily industrial interests, the Convention allows party
states to retain some protectionist legislation. The lack of provisions defining
minimum substantive rights and mandating enforcement of those rights is
thought to be justification for the Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS), a multilateral treaty that seeks to address
these observed shortcomings.6
The Paris Convention was originally signed in 1883 by just 11 countries, but
now the majority of countries who have any form of intellectual property law
are parties to it. The keystone to the convention is the principle of national
treatment: an application from one convention country shall have the same
rights in a second convection country as a national of that second country. The
convention covers patents and defines them so broadly that it permits
application to any of the forms of industrial patents granted under the laws of
6
Commentary on the Paris Convention for the Protection of Industrial Property – Seth M
Reiss. Honolulu,Hawaii, United States
30
the convention countries. The most important practical result of the convention
is that it is possible to claim priority from an application made in a convention
country for all subsequent convention countries within 12 months of the
original filing.
With respect to the working of patents and compulsory licenses, the essence of
the provisions contained in Article 5A is that each country may take legislative
measures providing for the grant of compulsory licenses. These compulsory
licenses are intended to prevent the abuses which might result from the
exclusive rights conferred by a patent for invention, for example failure to
work or insufficient working. Compulsory licenses on the ground of failure to
work or sufficient working are the most common kind of coercive measure
against the patent owner to prevent abuses of the rights conferred by the patent
for invention. They are expressly dealt with by Article 5A. The main argument
for enforcing working of the invention in a particular country is the
consideration that, in order to promote the industrialization of the country,
patents for invention should not be used merely to block the working of the
invention in the country or to monopolize importation of the patented article by
the patent owner. They should rather be used to introduce the use of the new
technology into the country. Whether the patent owner can really be expected
to do so, are first of all an economic consideration and then also a question of
time. Working in all countries is generally not economical. Moreover, it is
generally recognized that immediate working in all countries is impossible.
Article 5A therefore tries to strike a balance between these conflicting interests.
Like other patentable inventions it has direct benefits with respect to
biotechnological inventions also.
31
2.2.2 The Budapest Treaty on the International

Recognition of the Deposit of Microorganisms
for the Purposes of Patent Procedure:
The Budapest Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure (i.e. the Budapest Treaty)
is a special agreement under Article 19 of the Paris Convention. It is an
international treaty signed in Budapest, Hungary, on April 28, 1977. It entered
into force on August 9, 1980, and was later amended on September 26, 1980.
The treaty is administered by the World Intellectual Property Organization
(WIPO).
The Deposit Treaty, as the full title suggests, is concerned with the deposit of
microorganisms for the purposes of patent applications. Applications for
patents for biotechnology often face considerable difficulties in describing the
nature of the invention sufficiently. The Deposit Treaty is a vehicle for solving
these problems, primarily through the setting up of a series of International
Depository Authorities (IDA) and through the recognition by all member
countries of a deposit in a single IDA. The Budapest Treaty ensures that an
applicant, i.e. a person who applies for a patent, needs not to deposit the
biological material in all countries where he/she wants to obtain a patent. The
applicant needs only to deposit the biological material at one recognized
institution, and this deposit will be recognized in all countries party to the
Budapest Treaty.
Disclosure of the invention is a generally recognized requirement for the grant
of patent. Normally, an invention is disclosed by means of a written
description. Where an invention involves a microorganism or the use of a
microorganism, which is not available to the public, such a description is not
always sufficient for disclosure. That is why in the patent procedure of an
increasing number of countries it is necessary not only to file a written
32
description but also to deposit, with a specialized institution, a sample of the

microorganism. Patent Offices are not equipped to handle microorganisms,
whose preservation requires special expertise and equipment to keep them
viable, to protect them from contamination and to protect health or the
environment from contamination. Such preservation is costly. The furnishing
of samples also requires specialized expertise and equipment. When protection
is several countries for an invention involving a microorganism of the use of a
microorganism, the complex and costly procedures of the deposit of the
microorganism might have to be repeated in each of those countries. It was in
order to eliminate or reduce such multiplication, in order to enable one deposit
to serve the purpose of all the deposits which would otherwise be necessary,
that the Treaty was concluded.
2.2.3 The Patent Cooperation Treaty (PCT):

The Patent Cooperation Treaty (PCT) is an international patent law treaty,
concluded in 1970. It provides a unified procedure for filing patent applications
to protect inventions in each of its contracting states. A patent application filed
under the PCT is called an international application, or PCT application. The
contracting states, i.e. the states which are parties to the PCT, constitute the
International Patent Cooperation Union. All activities related to PCT are
coordinated by the World intellectual Property Organisation (WIPO) situated in
Geneva. India joined the PCT on December 7, 1998.
The PCT simplifies the process of filing patent applications simultaneously in a
number of countries. Under the PCT, a single filing of an international
application is made with a Receiving Office (RO) in one language. It then
results in a search performed by an International Searching Authority (ISA),
accompanied by a written opinion regarding the patentability of the invention,
which is the subject of the application. It is optionally followed by a
preliminary examination, performed by an International Preliminary Examining
33
Authority (IPEA). Finally, the relevant national or regional authorities

administer matters related to the examination of application (if provide by
national law) and issuance of patent. The application and report are published
and the application will then move on either to an international preliminary
examination followed by national examination of alternatively straight to the
national examination stage. Unfortunately, the eventual outcome is not a 'world
patent' and there is no harmonization patent law under the PCT apart from the
procedural aspects.
The member states had the following objectives in mind:
 to make a contribution to the progress of science and technology,
 to perfect the legal protection of inventions,
 to simplify and render more economical the obtaining of protection for
inventions where protection is sought in several countries,
 to facilitate and accelerate access by the public to the technical information
contained in documents describing new inventions, and
 to foster and accelerate the economic development of developing countries
through the adoption of measures designed to increase the efficiency of
their legal systems, whether national or regional, instituted for the
protection of inventions by providing easily accessible information on the
availability of technological solutions application to their special needs and
by facilitating access to the ever expanding volume of modern technology.
Advantages of the PCT System:
The advantage of the PCT system can be looked from four angles:
1. Advantages for Patent Offices,
2. Advantages for the Applicant,
3. Advantages for the National Economy and for Industry, and
4. Technical Information
34
2.2.3.1 Advantages for Patent Offices:

More and more Patent Offices are considering how on to employ their available
manpower to the greatest advantage. This is true not only because of the
number of patent applications which they must handle but also because of the
expanding role that Patent Offices are being required to fulfil. They provide
technical advisory services to local industry either in terms of advising on
available technologies of in connection with national research and development
activities. The PCT assists Patent Offices in meeting these demands in various
ways -
Patent Offices can expect to employ their available manpower to handle more
patent applications, since those applications coming via the PCT have already
been verified with regard to compliance with formal requirements during the
international phase.
Patent Offices can save part of the cost of publishing. If the international
application has been published in an official language of the country, they can
forgo publication altogether.
Countries having a different official language may limit themselves to
publishing only a translation of the abstract which accompanies international
applications. Copies of the full text of the international application could be
supplied upon request to interested parties.
The PCT does not affect the revenue of designated offices unless they decide
voluntarily to give a rebate on national fees in view of the savings they make
through the PCT and in order to make the use of the international application
route more attractive to the applicant. In any case, the most profitable source of
revenue for most offices is from annual or renewal fees, which are not affected
by the Treaty.
35
Examining Patent Offices benefit, in respect of most applications filed by

foreigners, from an international search report and an international preliminary
examination report. Their search costs are also thereby reduced.
Non-examining Offices receive an application which has already been
examined as to form, which is accompanied by an international search report
and possibly by an international preliminary examination report. This will put
the office, and the national industry affected by a patent and/or interested in
licensing, in a much better position than under the system of filling national
applications. National authorities involved in approving licensing agreements
likewise benefits from the greater value of a patent granted on the basis of an
international application.
2.2.3.2 Advantages for the Applicant:

Applicants may file application in their own country with effect in foreign
countries, and have more time to make up their minds as to those foreign
countries in which they wise to seek protection.
If the applicant does not use the international procedure offered by the PCT, he
must start preparations for filing abroad three to six months before the
expiration of the priority period. He must prepare translations of his application
and have them put into a different form for each country. Under the PCT, the
applicant files only one application i.e. the international application within the
priority year effect in all States he has designated; that application, which may
be filed until the last day of the priority year, may be identical both as to
language and form with his own national application.
2.2.3.3 Advantages on National Economy for Industry:

International applications will be pursued in the national phase only if the
applicant believes after seeing the results of the international search and usually
36
also the international preliminary examination that there are sound economical
and technical reasons for doing so. Thus patents granted on the basis of
international applications will usually provide a sounder basis for investment
and transfer of technologies.
Technological progress is an essential factor of national economic
development. It is recognized that real technological progress cannot be
achieved or cannot continue in a country, however industrialized, without
constant stimulation of domestic inventive activities and at the same time
importation of advanced technologies from foreign countries. Since the PCT
system greatly facilitates the obtaining of patent protection on an international
level and since the patents granted through the PCT route have been subjected
to high-quality international search and usually also international preliminary
examination, more and more applicants are seeking patent protection on an
international level through the Patent Cooperation Treaty, thus preparing the
route for technology transfer and licensing agreements.
With more advanced technologies foreign investment will be stimulated. And
with more advanced technologies and more investment, there will be increased
levels of local employment and the technical skills of the local work force will
be enhanced. As the level of economic and technological development rises, an
increasing number of nationals will use and greatly benefit from the PCT
system when they seek patent protection abroad for their inventions, thus
aiding m the penetration of export markets by local industry.
The economies of many developing countries .are growing rapidly. More
investment and technology transfer in various areas depending on the country
concerned are needed as well as the creation and modernization locally of
certain types of industries and services. Since foreign investors and licensors
are relatively more interested in investing in and transferring technologies to a
country whose economy is growing and where production costs are relatively
37
low, the PCT will often serve as an indispensable part of the country's strategy
to foster its growing economy and to promote the steady rise of its economic
and technological level.
2.2.3.4 Technical Information:

A further important advantage of the PCT for developing countries lies in its
information effect. It can be very difficult to obtain a complete picture of all the
patent documents published in many countries and many languages and of the
most recent state of the art resulting from them. Since many important
inventions are the subject of PCT applications, developing countries have,
through the international publication of these applications, early and easier
Access to modern technological information. The access will be early, because
international applications are published 18 months after the priority date of the
application, It will be easier, because the application will be published in one of
the most important languages and, where not in English, with an English-
language abstract, and because the international search report, published
together with the application, will make it easier to evaluate the technology
disclosed in the application. Patent Offices of PCT Contracting States are
entitled to receive, free of charge, a copy of all published international
applications, of the PCT Gazette and of any other publication of general
interest published by the International Bureau in connection with the PCT.
The PCT offers distinct advantages for developing countries participating in
this system of international patent cooperation and requires no payment of
contributions. That there is sufficient awareness of these advantages is
confirmed by the impressive number of developing countries already party to
the Treaty.
38
2.2.4 The Agreement on Trade Related Aspects of

Intellectual Property Rights (TRIPS):
The Agreement on Trade Related Aspects of Intellectual Property Rights
(TRIPS) is an international agreement administered by the World Trade
Organization (WTO) that sets down the minimum standards for the regulation
of many forms of intellectual property. It was negotiated at the end of the
Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in
1994, its inclusion was the culmination of a program of intense lobbying by the
United States, supported by the European Union, Japan and other developed
nations.
A basic principle concerning the nature and scope of obligations under the
TRIPS Agreement is that members must give effect to the provisions of the
Agreement and accord the treatment provided for in the Agreement to the
nationals of other members. Members are free to determine the appropriate
method of implementing the provisions of the TRIPS Agreement within their
own legal system and practice, and may implement more extensive protection
than is required, provided that such additional protection does not contravene
other provisions of the Agreement. After the Uruguay round, the GATT
became the basis for the establishment of the World Trade Organization.
Because ratification of TRIPS is a compulsory requirement of World Trade
Organization membership, any country seeking to obtain easy access to the
numerous international markets opened by the World Trade Organization must
enact the strict intellectual property laws mandated by TRIPS. For this reason,
TRIPS is the most important multilateral instrument for the globalization of
intellectual property laws. Furthermore, unlike other agreements on intellectual
property, TRIPS has a powerful enforcement mechanism. States can be
disciplined through the WTO's dispute settlement mechanism.
39
2.2.4.1 Provisions relating to Patents in the TRIPS

Agreement:
Trade Related Intellectual Property Rights or TRIPS is an agreement between
member states of the World Trade Organisation (WTO) that seeks to enforce
US style patent laws around the world. This agreement covers everything from
Pharmaceuticals to information technology software and human gene
sequences, and is emerging as a major issue dividing North and South.
Many of its trademark and patent provisions were modelled on the Paris
Convention for the Protection of Industrial Property, The existing TRIPS
agreement forces all countries to accept a medley of new biotech patents
covering genes, cell lines, organisms and living processes that turn life into
commodities. Governments all over the world have been persuaded into
accepting these ‗patents on life‘ before anyone understood the scientific and
ethical implications.
The provisions of the agreement which has particular importance to patents and
biotechnology protection inter alia include the following:
 Patents shall be available for products and processes in all fields of
technology provided they are new, involve an inventive step and are
capable of application except that members may exclude, inventions,
the prevention within their territory of the commercial' exploitation of
which is necessary to protect order public (public safety) including to
protect human, animal or plant life or health or to avoid serious
prejudice to the environment, provided that such exclusion is not made
merely because the exploitation is prohibited by their law. Members
may further exclude diagnostic, therapeutic and surgical methods for
the treatment of humans or animals, plants and animals other than
microorganisms and essentially biological processes for the production
of plants or animals other than non-biological and microbiological
40
processes. Members shall however provide for the protection of plant

varieties either by patents or by an effective sui generis system or by
any combination thereof.
 Patents shall be available and patent rights enjoyable without
discrimination as to the place of invention, the field of technology and
whether products are imported or locally produced.
 Exclusive rights shall include, for products, the right to prevent third
parties from making, using, offering for sale, selling or importing the
patented product, and for processes, the right to prevent third parties
from using the process and from using, offering for sale, selling or
importing for these purposes the product obtained directly by that
process, subject to certain allowable exceptions.
 The term of protection shall be at least 20 years from the date of the
filing of the application.
2.2.5 Other International Legal Instruments:

There are few other international legal instruments and treaties which though
not directly related, have a relation with biotechnology patents. They include
the following:
 Directive 98/44/Ec of the European Parliament and Of the Council of 6
July 1998 on the Legal Protection of Biotechnological Inventions.
 The International Union for the Protection of New Varieties of Plants
(UPOV).
 The Convention on Biological Diversity (CBD).
 The Rio Declaration on Environment and Development.
41
2.2.5.1 Directive 98/44/EC of the European Parliament and

of the Council of 6 July 1998 on the Legal Protection
of Biotechnological Inventions:
Before the Directive 98/44/EC of the European Parliament and the Council of
6th July 1998, notwithstanding some decisions of the European Patent Office
and some patents already being granted by the Italian Patent Office, the
existing legal framework did not allow the patentability of living organisms in
the European Community countries.
The Directive has dramatically changed the perspectives. It ensures free
circulation of patented biotechnological products harmonizing the national
legal system of each member state, guaranteeing compliance with the European
Patent Convention signed in Munich on 5th October 1973, the Trade-Related
Aspects of Intellectual Property Rights agreement of 15th April 1994 and the
Rio de Janeiro Convention on Biological Diversity of 5th June, 1992. The legal
basis of the Directive and the fundamental principles of protection are that
discoveries as such are not considered patentable. Plant and animal varieties as
such, as well as essentially biological procedures for the production of plants
and animals are excluded from protection by patent. On the contrary, the new
field of patentability covers plants and parts of animals with new introduced
genetic characters. Methods of surgical and therapeutic treatment and
diagnostic methods applied to animal bodies are not considered inventions
suitable for industrial applications and excluded from protection by patents.
Biological materials and material isolated from its natural Government and
isolated elements of the human body with technical processes may be patented.
Excluded from patentability are inventions that are contrary to law and order or
public morality as well as processes for human cloning for reproductive
purposes and for modifying the germ-line genetic identity of human beings, as
well as the use of human embryos. The processes for modifying the genetic
42
identity of animals without any substantial medical benefit for man (with the
exception of studying new medicinal products useful for treating serious
diseases such as cancer, hepatitis or AIDS) are also excluded. The rights of
farmers are also guaranteed, by allowing them to re-sow seeds and freely use
breeding stock covered by patents on their farms, without paying costly
royalties to the holders of patents.
2.2.5.2 The International Union for the Protection of New

Varieties of Plants (UPOV):
The International Union for the Protection of New Varieties of Plants known as
―UPOV‖, is an inter-governmental organization with headquarters in Geneva.
It was established in 1961 by the UPOV Convention. The 1961 Convention
was initially ratified in 1968 by the United Kingdom, Germany and the
Netherlands. Since that time membership has grown to 60 countries (as of 15
September 2005), including the United States, Australia, China 25 European
countries and most recently, Azerbaijan and the European Community,
Notably, India Is not a member. The Convention has been revised three times
in 1972, 1978 and 1991. Given that UPOV is a separate intergovernmental
organization and not a ‗treaty‘ the organization has its own standing and is only
partially monitored by WIPO. The acronym UPOV is derived from the French
name of the organization, The mission of UPOV is to provide and promote an
effective system of plant variety protection, with the aim of encouraging the
development of new varieties of plants for the benefit of society.
2.2.5.2.1 What is the purpose of the UPOV Convention?

The purpose of the UPOV Convention is to ensure that the members of the
Union acknowledge the achievements of breeders of new varieties of plants, by
43
granting to them an intellectual property right, on the basis of a set of clearly

defined principles. To be eligible for protection, varieties have to be –
(i) distinct from existing, commonly known varieties,
(ii) sufficiently uniform,
(iii) stable, and
(iv) new in the sense that they must not have been commercialized prior to
certain dates established by reference to the date of the application for
protection.
The UPOV Convention sets out a minimum scope of protection and offers
members the possibility of taking national or regional circumstances into
account in their legislation. Like all intellectual property rights, plant breeders
rights are granted for a limited period of time, at the end of which varieties
protected by them pass into the public domain. The rights are also subject to
controls, in the public interest, against any possible abuse. It is also important
to note that the authorization of the holder of a plant breeder's right is not
required for the use of their variety for private and noncommercial purposes,
for research purposes, nor for use in the breeding of farther new varieties.
2.2.5.2.2 What is the necessity of such a protection?

Protection is afforded to plant breeders as an incentive for the development of
new varieties of plants, in order to provide sustainable progress in agriculture,
horticulture and forestry. Improved varieties are a necessary and very cost-
effective means of improving productivity, quality and marketability for
farmers and growers. Breeding new varieties of plants requires a substantial
investment in terms of skill, labour, material resources money and time. The
opportunity to obtain certain exclusive rights in respect of new varieties
provides successful plant breeders with a better chance of recovering their costs
and accumulating the funds necessary for further investment. In the absence of
44
plant breeders' rights, those aims are more difficult to achieve since there is
nothing to multiplying the breeder's variety and selling it on a commercial
scale, without recognizing in any way the work of the breeder.
2.2.5.3 The Convention on Biological Diversity (CBD):

In 1992, 170 countries met in Rio de Janeiro to discuss the details of a
proposed Biodiversity treaty, the Convention on Biological Diversity (CBD).
Even though the US delayed signing of the treaty, the other Members endorsed
the Convention. The Convention on Biological Diversity (CBD), known
informally as the Biodiversity Convention, is an international legally binding
treaty. The Convention has three main goals 7:
1. conservation of biological diversity (or biodiversity); _
2. sustainable use of its components; and
3. fair and equitable sharing of benefits arising from genetic resources.
In other words, its objective is to develop national strategies for the
conservation and sustainable use-of biological diversity. It is often seen as the
key document regarding sustainable development. The Convention was opened
for signature at the Earth Summit in Rio de Janeiro on 5 June 1992 and entered
into force on 29 December 1993.
The convention, recognized for the first time in international law that the
conservation of biological diversity is ―a common concern of humankind‖ and
is an integral part of the development process, the agreement covers all
ecosystems, species, and genetic resources. It links traditional conservation
efforts to the economic goal of using biological resources sustainably. It sets
principles for the fair and equitable sharing of the benefits arising from the use
of genetic resources, notably those destined for commercial use. It also covers
the rapidly expanding field of biotechnology through its Cartagena Protocol on
7
Tripathi K.K. 2002. ―Biotechnology: Government of India Initiatives‖. Saketlnd. Digest.
Feb., pp.49-53.
45
Biosafety8 addressing technology development and transfer, benefit-sharing

and bio-safety issues. Importantly, the Convention is legally binding; countries
that join it (‗Parties‘) are obliged to implement its provisions.
The convention reminds decision-makers that natural resources are not infinite
and sets out a philosophy of sustainable use, while past conservation efforts
were aimed at protecting particular species and habitats, the Convention
recognizes that ecosystems, species and genes must be used for the benefit of
humans. However, this should be done in a way and at a rate that does not lead
to the long-term decline of biological diversity. Some of the many issues dealt
with under the convention include:
 Measures and incentives for the conservation and sustainable use of
biological diversity.
 Regulated access to genetic resources and traditional knowledge,
including Prior Informed Consent of the party providing resources.
 Sharing, in a fair and equitable way, the results of research and
development and the benefits arising from the commercial and other
utilization of genetic resources with the Contracting Party providing
such resources (governments and/or local communities that provided
the traditional knowledge or biodiversity resources utilized).
 Access to and transfer of technology, including biotechnology, to the
governments and/or local communities that provided traditional
knowledge and/or biodiversity resources.
 Technical and scientific cooperation. Impact assessment.
 Education and public awareness.
 Provision of financial resources.
 National reporting on efforts to implement treaty commitments.
8
One international agreement which aims to ensure the safe handling, transport and use of
living modified organisms.
46
2.2.5.3.1 Cartagena Protocol on Biosafety:

The Cartagena Protocol on Biosafety of the Convention, also known as the
Biosafety Protocol, was adopted in January 2000. The Biosafety Protocol seeks
to protect biological diversity from the potential risks posed by living modified
organisms resulting from modern biotechnology. The Biosafety Protocol makes
clear that products from new technologies must be based on the precautionary
principle and allow developing nations to balance public health against
economic benefits. It will for example let countries .ban imports of a
genetically modified organism if they feel there is not enough scientific
evidence the product is safe and requires exporters to label shipments
containing genetically modified commodities such as corn or cotton.
2.2.5.3.2 Nagova Protocol:

The Nagoya Protocol on Access & Benefit Sharing was adopted on 29th
October, 2010 in Nagoya, Japan. Its objective is the fair and equitable sharing
of benefits arising from the utilization of genetic resources, thereby
contributing to the conservation and sustainable use of biodiversity. It is a
supplementary agreement to the Convention on Biological Diversity. It
provides a transparent legal framework for the effective implementation of one
of the three objectives of the CBD: the fair and equitable sharing of benefits
arising out of the utilization of genetic resources.9
The Nagoya Protocol is intended to create greater legal certainty and
transparency for both providers and users of genetic resources by:
i. Establishing more predictable conditions for access to genetic
resources, and
9
Tripathi, K.K. 1999. ―Bioinformatics: The Foundation of Present and Future
Biotechnology‖. Current Science 79(5): 2000: p. 572-575.
47
ii. Helping to ensure benefit-sharing when genetic resources leave the

contracting party providing the genetic resources.
By helping to ensure benefit-sharing, the Nagoya Protocol creates incentives to
conserve and sustainably use genetic resources, and therefore enhances the
contribution of biodiversity to development and human well-being.
The Nagoya Protocol applies to genetic resources that are covered by the CBD,
and to the benefits arising from their utilization. The Nagoya Protocol also
covers traditional knowledge (TK) associated with genetic resources that are
covered by the CBD and the benefits arising from its utilization. Domestic-
level benefit-sharing measures are to provide for the fair and equitable sharing
of benefits arising from the utilization of genetic resources with the contracting
party providing genetic resources. Utilization includes research and
development on the genetic or biochemical composition of genetic resources,
as well as subsequent applications and commercialization. Sharing is subject to
mutually agreed terms. Benefits may be monetary or non-monetary such as
royalties and the sharing of research results.
The Nagoya Protocol's success will require effective implementation at the
domestic level.
2.2.5.4 Rio Declaration on Environment and Development:

The Rio Declaration on Environment and Development 10, often shortened to
Rio Declaration, was a short document produced at the 1992 United Nations
―Conference on Environment and Development‖ (UNCED), informally known
as the Earth Summit, The Rio Declaration consisted of 27 principles intended
to guide future sustainable development around the world.
10
UNEP: Convention on Biological Diversity-Text and Annexes, June Rio de
Jeneiro,(UNEP/CBD/94/1)(1992).
48
The Rio Declaration is based upon 27 principles. The important among them
includes the following:
1. The Role of Humans:

Human beings are at the centre of concern for sustainable development.
They are entitled to a healthy and productive life in harmony with
nature.11
2. State Sovereignty:
States have, in accordance with the Charter of the United Nations and the
principles of international law, the sovereign right to exploit their own
resources pursuant to their own environmental and developmental policies, and
the responsibility to ensure that activities within their jurisdiction or control do
not cause damage to the environment of other States or of areas beyond the
limits of national jurisdiction. 12
3. The Right to Development:

The right to development must be fulfilled so as to equitably meet
developmental and environmental needs of present and future generations.
4. Environmental protection Development Process:

In order to achieve sustainable development, environmental protection shall
constitute an integral part of the development process and cannot be considered
in isolation from it. To achieve sustainable development and a higher quality of
life for all people, States should reduce and eliminate unsustainable patterns of
11
Mashelkar, R.A., ―Intellectual Property Rights and the Third World‖, Journal of
Intellectual Property Rights, 7 (4), July (2002), p 9
12
Ibid at p11
49
production and consumption and promote appropriate demographic policies.

States and people shall cooperate in good faith and in a spirit of partnership in
the fulfilment of the principles embodied in this Declaration and in the further
development of international law in the field of sustainable development.
5. Public participation:
Environmental issues are best handled with the participation of all concerned
citizens, at the relevant level. At the national level, each individual shall have
appropriate access to information concerning the environment that is held by
public authorities, including information, on hazardous materials and activities
in their communities, and the opportunity to participate in decision-making
processes. States shall facilitate and encourage public awareness and
participation by making widely available. Effective access to judicial and
administrative proceedings, including redress and remedy, be provided.
6. National Environmental Legislation:

States shall enact effective environmental legislation. Environmental standards,
management objectives and priorities should reflect the environmental and
developmental context to which they apply. Standards applied by some
countries may be inappropriate and of unwarranted economic and social cost to
other countries, in particular developing countries.
States shall develop national law regarding liability and compensation for the
victims of pollution and other environmental damage. States shall also
cooperate in an expeditious and more determined manner to develop further
international law regarding liability and compensation for adverse effects of
environmental, damage caused by activities within their jurisdiction or control
to areas beyond their jurisdiction.
50
7. Precautionary principle:
In order to protect the environment, the precautionary approach shall be widely
applied by States according to their capabilities. Where there are threats of
serious or irreversible damage, lack of full scientific certainty shall not be used
as a reason for postponing cost-effective measures to prevent environmental
degradation.
8. Indigenous People have a Vital Role:

People and their communities and other local communities have a vital role in
environment management and development because of their knowledge and
traditional practices. States should recognize and duly support their identity,
culture and interests and enable their effective participation in the achievement
of sustainable development.
2.3 DEVELOPMENT IN PATENTING

BIOTECHNOLOGICAL INVENTIONS IN
UNITED STATES, EUROPE, CHINA Etc.
Historical Review:
Inventors have been filing applications for biotechnological patents for over a
hundred years. Patent No. 3, granted in Finland on 8 November 1843,
introduced a novel method to produce yeast cultures. On 29 July 1873,
microbiologist Louis Pasteur obtained a patent from the French Patent Office
for his improved yeast-making method.
In the last 50 years, very important biological advancements have taken place.
Biological advancements usually require substantial investment for research.
Therefore, investors turn to Intellectual Property Rights (IPRs), particularly
51
patent systems, in the hopes of insuring their rights over their investment. In
this way, the concerns of biotechnological research, its inventions, and IPRs are
closely linked.
The United States was the first in the field with its decisions regarding the
patenting of ―living matter.‖ Early patents from the US were granted for
bacterial and viral vaccines. Until the 1980s, it was usually agreed that ―living
things‖ were not patentable. This policy was revised in the 1980 landmark case
of Diamond Vs. Chakrabarty13. The invention concerned the discovery of a
genetically-altered bacterium, which, when modified, could break down crude
oil. As the US Supreme Court famously noted in this case, it now seemed
possible to issue patents on ―anything under the sun that is made by man.‖ The
Court decided that Chakrabarty‘s invention was not a ―product of nature‖ but a
―man-made‖ bacterium, which did not occur naturally in nature. Thus, the court
stated, it was ―not nature‘s handiwork, but Amanda Chakrabarty‘s own;
accordingly the Court held it was patentable subject matter.‖ Thus, from then
on, an invention involving a living organism could fulfil the criteria to be
patentable subject matter, since a genetically modified bacterium, a
bioengineered microbe, had been created to provide a useful function – to
dissolve oil.
In the 1987 case of Ex parte Allen, the Board of Patent Appeals and
Interferences ruled that polyploid oysters containing three sets of chromosomes
instead of two were patentable subject matter. The decision resulted in the
United States Patent and Trademark Office (USPTO) making an announcement
that thereafter it would consider ―non-naturally occurring, non-human

multicellular living organisms, including animals, to be patentable subject
matter within the scope of the Statute.‖ Only one year later, in 1988, the first
13
447 U.S. 303 (1980).
52
patent on a mammal was granted in the U.S. for the Harvard mouse 14. Many
patent applications in the U.S. have followed for genetically modified animals.
The same case underwent a very complex process before it was finally granted
a patent in 2004. The European equivalent to the US Chakrabarty case15 was
the ―Rote Taube‖ decision. In this case, the patent application was refused
because of difficulties in reproducing the invention but it was accepted that a
process of animal breeding based on classical crosses and selection could be
patentable material.
In 1973, the European Patent Office established the European Patent
Convention (EPC), based on established national laws. Biotechnology,
although a developing new field that is making discoveries that could never
have been foreseen, is dealt with by a traditional body of law.
In July 1998, on the legal protection of biotechnological inventions, known as
the ―Biotech Patent Directive‖ was adopted. 16 Its purpose was to clarify the
distinction between what is patentable and what is not.
2.3.1 Development in Patenting Biotechnological

Inventions in the United States (U.S.):
To be eligible for a patent, an invention must fit within one of the statutory
categories of patentable subject matter established in Section 101 of the US
Patent Act:
Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter or any new and useful improvement
14
US Patent 4,736,866, The OncoMouse or Harvard mouse is a type of laboratory mouse
(Mus musculus) that has been genetically modified using modifications.
15
Diamond Vs Chakrabarty, 447 US 303 (1980)
16
EU Directive 98/44/EC
53
thereof, may obtain a patent therefore, subject to the conditions and

requirements of this title.17
The case of Diamond –Vs- Chakrabarty18 was the first time a court made a
decision to change the paradigm of enquiry for biotechnological inventions.
The meaning of the statute was clarified in a broad sense for biological
inventions in the Chakrabary decision. The U.S. Supreme Court decided in this
case that ―anything under the sun that is made by man‖ is patentable subject
matter. 19
According to the court decision, what is needed to evaluate biotechnological
patent claims is to determine whether a product is of a living nature, or is of
human invention, rather than of making one‘s judgment based on whether the
product is living or inanimate. Applying this criteria means natural products
can be seen to be biologically active substances or chemical compounds and
not merely as products of nature.
Thus, the issue is already settled. As long as the living matter applications
under 35 USC Section 101 are a product of human ingenuity – viruses, single
cells or multicellular organisms, they, can, like plants and nonhuman animals
be considered to be living matter.
A common issue arising from biological inventions is the problem of novelty
and the distinction between discovery and invention. Pure products of nature
are not patentable. To be patentable in US from subject matter of natural
origin20, a human being must impart a new form, a new quality, at least one
new property, or combinations thereof, to the original product existing in
nature. The main issue regarding patentability of biotechnological inventions
concerns the extent to which they are made publicly available and how the
claimed inventions are different from what is found in nature. Products, which
17
5 U.S.C. Section 101
18
447 U.S. 303 (1980).
19
Ibid
20
35 U.S.C. Section 102
54
have a higher purity or activity from the original, have distinguishing physical
properties or a different physical form may be patentable.
2.3.1.1 Industrial Applicability Requirement in the United

States:
In order for an invention to satisfy the 35 USC Section 101 utility requirement,
it must be useful. In 1995, the utility examination guidelines were published by
the USPTO. These guidelines stated that the utility should be both specific and
credible.
The Federal Circuit issued a patent law decision in September 2005 that
inevitably rendered hundreds of pending patent applications worthless and that
will raise the bar for proving gene sequence and protein-related inventions
useful.
The Federal Circuit ruled against the patent applicants in In re Fisher by
upholding the decision of the USPTO Board of Patent Appeals and
Interferences that bars patent protection for gene fragments that do not have a
―specific and substantial‖ utility. The court had its first opportunity to comment
on the USPTO Revised Utility Examination Guidelines of 2001 with the
presentation of the Fisher case. Focusing on the patentability of research tools,
it found that none of the claims made by Fisher to ESTs met the requirements
of the specific and substantial utility tests.
2.3.1.2 The Disclosure (written description) Requirement in

the United States:
The disclosure requirement is not covered in European legislation, but is in the
United States. The Patent Act embodies a written-description requirement to
ensure that an applicant has actually invented what is claimed and that the
public will be in possession of the claimed invention after the expiration of the
patent.67 The new guidelines issued by the USPTO, the Guidelines for
55
Examination of Patent Applications, under 35 U.S.C. Section 112, ―written

description‖ requirement, set forth the methodology for determining the
adequacy of a written description.21
For each claim, the examiner should first determine what the claim as a whole
covers and give the claim its broadest reasonable interpretation.69 The entire
patent application is then reviewed to understand how the applicant provides
support for each element of the claimed invention and determine whether the
applicant has demonstrated possession of the claimed invention. Such a review
is to be conducted from the standpoint of one of skill in the art at the time the
application was filed. Information that is well known in the art need not be
described in detail in the specification.22
In contradiction to the non-obviousness requirement, the Federal Circuit has
used the written requirement in a manner that somewhat raises the patentability
bar.
2.3.1.3 The Onco Mouse Case:23
The following case is given as an example to illustrate the importance of
patenting biotechnological inventions and also to discuss the problems
therewith.
The history of the Harvard Onco-mouse began in the early 1980s after the
successful development of a ―transgenic non-human mammal, all of whose
germ cells contain a recombinant activated onco-gene sequence introduced into
21
Guidelines for Examination of Patent Applications Under the 35 USC Section 112,
―Written Description‖ Requirement, 66 Fed. Reg. 1099 (Jan. 5 2001) (bb. p. 98)
22
Guidelines for Examination of Patent Applications Under the 35 USC Section 112,
―Written Description‖ Requirement, 66 Fed. Reg. 1099 (Jan. 5 2001) (bb. p. 98)Ibid
23
The OncoMouse or Harvard mouse is a type of laboratory mouse (Mus musculus) that has
been genetically modified using modifications designed by Philip Leder and Timophy A
Stewart (European Patent Register entry for European patent no.0169672, under
"Inventor(s)". Consulted on February 22, 2008.) of Harvard University to carry a specific
gene called an activated oncogene. The activated oncogene significantly increases the
mouse‘s susceptibility to cancer and thus makes the mouse suitable for cancer research.
The rights to the invention were owned by DuPont. Patent applications on the OncoMouse
were filed back in the mid-1980s in numerous countries such as in the United States, in
Canada, in Europe through the European Patent Office (EPO) and in Japan.
56
said mammal or an ancestor of said mammal, at an embryonic stage.‖ 24 This

invention was disclosed to art and a claim for patent was made by the President
and Fellows of Harvard College in the USA. The genetically modified mouse
with a predisposition for developing cancer was intended for use in tests.
Applications along the same lines were made in many countries: Australia,
Canada, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy,
Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United
Kingdom.
As earlier mentioned, the U.S. Supreme Court in Chakrabarty 25 accepted that
―anything under the sun that is made by man‖ is patentable. It can be readily
assumed that inventions made beyond the sun would also be considered
patentable under the provision of the U.S. Code which reads as ―any invention
(...) title‖. In conclusion, the Court found that the claimed bacterium ―plainly
qualified as statutory subject matter.‖ Another notable point is that the Court
refused to consider moral and policy arguments against granting patents for
living matter. 26
The Court also stated that these moral and policy arguments presented issues
beyond the Court‘s capabilities and as such were more suitable for
consideration through the legislation process.
The outcome of the decision made in Chakrabarty 27 has influenced other
decisions rendered in similar situations. Particularly, it opened the door to
patenting the Onco-mouse in the United States.
24
Emir Aly Crown Mohammed, ―Cat in the Hat, a Mouse in the House - Comparative
Perceptives on the Harvard Mouse,‖ IPJ, V.18, (2004-2005), p. 170.
25
Diamond Vs Chakrabarty, 447 US 303 (1980).
26
Matthias Kamber, Coming out of the Maze: Canada Grants the Harvard Mouse, 35 George
Washington International Law Review 764 (2003).
27
Diamond Vs Chakrabarty, 447 US 303 (1980).
57
Although no objections were proposed by the commissioners, the patenting of

the Onco-mouse in the US took nearly four years. The first application was
filed on June 22, 1984 and the patent was granted on April 12, 1988.
US Patent Code28 states that ―whosoever without authority makes, offers to
sell, or sells any patented invention (...) infringes the patent.‖ However, until
recently, the US courts have applied a common law experimental use defense,
although the US courts have also taken into account certain circumstances
which restrict the application of this rule. In addition to this common law
experimental defence, there is a statutory experimental use of defences under
section 271(1) (e) of the Patent Code29, but this latter one is no longer relevant.
A direct outcome of this decision is that the private purpose exemption is
mainly related to an individual who carried out scientific experiments at home
with no commercial objective in mind. This does not cover any act carried out
by a company; therefore there is no direct relevance to this kind of exemption
for companies which are dealing with biotechnological research.
An act undertaken for experimental purposes relating to the subject matter of
the invention would also be exempt from patenting. This view supports the idea
that patent law exists to stimulate the advancement of science and should not
be used to inhibit it. Namely, the advancement of science has priority over the
enforcement of patent rights. This principle of exemption was adopted by the
community patent convention (Art. 31 b of CPC) and has been transposed into
the patent laws of various European countries.
When applying the experimental purposes exemption to biotechnological
research, one difficulty is whether the exemption covers trials carried out in
order to secure patent protection. The heart of the problem is whether such
trials are considered to be ―experiments‖ or not. According to a decision of a
28
Section 271 of the US Patent Code (35 USC)
29
US Patent Code
58
court in the Monsanto case, 30 an act cannot be considered ―experimental‖ when

the essential goal of the trial is merely to verify existing knowledge. However,
it is applied to ―research that is directed to generating new information about
the invention itself to find out how it works, or to improve on it.‖31

Inventions in Europe:
In Europe, there is a legal objection to allowing patents for living things. This
view is based on the ―product of nature‖ doctrine. If a new property of a known
article or of a previously recognized substance existing in nature is found, it is
a ―discovery‖ and not patentable as such.32 However, if an applicant proves that
a substance found in nature can be put to a new use (for example, a micro-
organism X is proved to be useful in diagnosing Y disease) or if another
technical effect is established, then such a ―living thing‖ and its use may be
patentable as an invention.33 Thus, the concept that ‗discovery‘ is necessary in
order for a patent to be granted is interpreted narrowly under the EPC 34 as well
as other exclusions.
A leading decision on patentability of naturally-occurring substances and the
distinction between discovery and invention was made by the German BpatG
(Bundespatentgericht) in the Antamanid case.35 The decision made clear that
30
Monsanto v Stauffer (1985) R.P.C. 515, CA
31
ibid
32
Guidelines for Examination, Part C, Chapter IV, Section 2.3; http://www.european-patent-
office.org/legal/ gui_lines/ index.htm.
33
Ibid
34
The European Patent Convention (EPC), also known as the Convention on the Grant of
European Patents of 5 October 1973, is a multilateral treaty instituting the European Patent
Organisation and providing an autonomous legal system according to which European
patents are granted.
35
BpatG, Beschluss vom 28.07.1977 – 16 W (pat) 64/75 ―Naturstoffe.‖
59
substances occurring naturally are patentable if they are new and have been
isolated by technical means. It also has to be publicly available in that form and
that it could not have been found without technical intervention. An isolated
gene, which is identical to the gene found in nature, may be patentable if the
gene sequence has never been isolated before.
Article 3 of the convention36 makes it clear that once the criteria have been met,
the biological products or material, or a process by means of which it is
produced, processed or used, is patentable. The isolated element of the human
body is only patentable in its natural state. The factors that make the element so
are the technical processes used to identify purity and classify it and to
reproduce it outside the human body, techniques which human beings alone are
capable of putting into practice and which nature is incapable of accomplishing
by itself.
When it comes to human beings, there is the commonly accepted approach that
such intervention and human parts should not be patented. Therefore, it would
seem important to exclude unequivocally from patent ability, processes for
modifying the germ line genetic identity of human beings and processes for
cloning human beings.
Art. 52(1) of the EPC37 defines patentable inventions as:
European patents shall be granted for any inventions which are susceptible to
industrial application, which are new and which involve an inventive step.
In Article 52(2), the second part of the article lists subjects which shall not be
regarded as inventions. Discoveries are strongly excluded from patentability in
this article.
36
The European Patent Convention (EPC).
37
The European Patent Convention
60
2.3.2.1 Second prerequisites:

2.3.2.1.1 ‘Ordre public’38 and morality:
This area is exclusive to EU Patent Law. EPC Article 53 (a) and (b) bring
further restrictions on biotechnological patents. As stated in part (a) it excludes
inventions contrary to ―ordre public‖ 39 or morality and in (b) excludes ―plant or
animal varieties or essentially biological processes for the production of plants
or animals.‖
EU Directive 98/44/EC and its 1:1 implementation into Rules 23b-e of the EPC
further specifies exceptions to patentability that are in conflict with ―ordre
public‖ or morality40. Excluded is cloning of human beings, modification of

the human germ line, using human embryos for industrial or commercial
purposes and genetic modification of animals that causes them suffering
without substantial medical benefit.41
Although EPC Art. 53(a) explicitly states that inventions contrary to the ―ordre
public‖ or morality are patentable, the meaning of these two terms are not
clarified.
The concept ordre public has an untranslatable character. It was originally used
in continental Europe. In some documents, the concept of ordre public means
public security and the physical integrity of the individual and environment, but
it is more than that. Briefly, ‗ordre public‘ means the proper order of the whole
society.42
38
Morality issue under EU Directive 98/44/EC and The European Patent Convention of
Europe
39
supra
40
supra
41
D.Schertenleib , E.I.P.R. 2004, pp.203-213 (general review on patentability of living
organisms in Europe).
42
P.W. Grubb, Patents for Chemicals, Pharmaceutical and Biotechnology, Oxford Un. Press
(2004), at p. 281.
61
Although, inventions contrary to morality are excluded from patenting43, the

grounds regarding morality are uncertain and flexible, for what is seen to be
contrary to morality changes with time and place. Sometimes attitudes even
vary in a particular country at a particular time. Moreover, there is the belief
that ―morality issues are marginal, or even irrelevant to patent law,‖ that
patents have more in common with finance, than morality. 44 However, there is
a great public concern over this matter, particularly over patenting
biotechnological inventions, since there is the fear that they may damage
society.
2.3.2.1.2 Morality after the Directive:

The European Union adopted a Directive on the Patenting of Biological
Inventions in 1998. It came into force on 6 July 1998 as Directive 98/44.28
Member States had to implement this Directive before July 2000. However,
there was some opposition to the Directive in Europe. For instance,
Netherlands applied to the Court of Justice for a modification while Germany,
France, and Austria did not implement the Directive before 2004.
First of all, the Directive defined the distinction between what is patentable and
what is not. For example, an invention relating to individual human, animal or
plant genes and gene sequences, and their functions, can be patented as long as
the other patentability criteria are fulfilled.
In the first draft of the Directive, there was no reference to morality regarding
patenting. In the course of time public concerns were voiced and the Directive
became a focus for the consideration of the ethical and social dimensions of
biotechnology.45 Those evaluating the patenting of biotechnological inventions
43
EPC Art. 53(a)
44
Ibid
45
Lionel Bently and Brad Shermann., Intellectual Properity Law (2004), Oxford Un. Press,
Oxford, p. 439.
62
were of the view that the patent system, as it stood, was an inappropriate
instrument to deal with ethical questions because the existence of a patent
cannot control how an invention is exploited.46
In the view of the evaluators, the means to control biotechnological inventions
should be the responsibility of a different regulatory system.
After discussions, the Directive compromised, accepting that inventions must
be Nonpatentable should their commercial exploitation be contrary to ‗ordre
public‘ or morality. There are institutions and organizations in the world which
play a key role in deciding on ethical issues. One such institution is the
Nuffield Council on Bioethics in the UK, which examines ethical issues raised
by new developments in biology and medicine. The Nuffield Council supports
embryonic stem cell research when it can be proved that such research is not
contrary to public welfare or morality.
2.3.2.1.3 Plant and Animal varieties:

EPC Article 53 (b) states that patents shall not be granted on ―plant or animal
varieties or essentially biological processes for the production of plants or
animals.‖ Upon first impression, it seems that even a living thing may qualify
as a ―manufacture‖ or a ―composition of matter‖ and as such would meet the
statutory subject matter requirements in the United States. 47 The EPC,
however, expressly excludes all living inventions such as ―plant or animal
varieties‖ from patentability and distinguishes them from microbiological48
ones. The term ―variety‖ creates a difficulty in this case since its definition is
still vague. This exception does not infer ―general exclusion of inventions in
46
Ibid
47
Diamond v. Chakrabarty, 206 UPSQ 193 (Sup.Ct.1980).
48
―Microbiological‖ is defined as involving mono-cellular organisms, bacteria. See
Guidelines for examination, supra note 17.
63
the sphere of animate nature‖49 and is interpreted narrowly meaning that if an

invention does not deal with a single plant or animal variety it can still be
patentable provided other requirements are satisfied.50
2.3.2.1.4 Patentability of therapeutic and diagnostic methods:

―Methods for treatment of the human or animal body by surgery or therapy and
diagnostic methods practised on the human or animal body shall not be
regarded as inventions which are susceptible to industrial application.‖51
In the US, therapeutic and diagnostic methods carried out on humans are
patentable. However, medical activities ―which means the performance of a
medical or surgical procedure on a body,‖ may be limited by 35 U.S.C. Section
287 (c). Remedies cannot be sought against a medical practitioner or a health
care entity with respect to such medical activity. However, the level of
regulation is different and the final outcome and the implications are the same,
since Europe and Japan exclude methods for treatment and diagnosis from
patentability by law and the US limits the enforcement of such patents. These
medical treatments should not be monopolized and the practitioners should be
free to use such methods for the benefit of their patents.
2.3.2.1.5 The Essential Requirements

i) Novelty
The first and clearest requirement is that nothing can be patentable which is not
new.52
49
Implementing Regulations to the Convention on the Grant of European Patents, Rule
23(c).
50
Katrina McClatchey, The European Patent Office and the European Patent: an Open
Avenue for Biotechnologists and ―Living Inventions‖, 2 Okla. J. L. & Tech. 25 (2004).
51
Art. 52(4) of the EPC
52
Philip w. Grubb, Patents for Chemicals, Pharmaceuticals and Biotechnology, Oxford,
2004, 4th Edition p.58.
64
It is widely known that the requisites for novelty and inventive application are
not easily applied to patenting procedures for biological products and
processes. This has been a continued discussion in many countries, mainly in
the United States and the European Union, and has been dealt with by new
regulations and policies on the issue.
Patents on genes have been reviewed on many grounds. A common complaint
is that genes are naturally occurring entities that exist in living organisms and
thus are not invented but discovered. This argument does not bear any weight
in science or in law. 53 The DNA sequences used by biologists are ‗new‘ in the
sense that they have never existed in that form before and also they are always
modified to an appreciable extent. The law has recognized for some time that
the DNA we use is created and not discovered.
Specifically on the subject of genetic patents, a joint statement of the USPTO,
EPO, and JPO54 confirmed that genes are patentable. More recently, the new
European Biotechnology Directive 55 and the Examination Guidelines of EPO
also support this view.
In the United States, under Section 102 of the statute, what is claimed as an
invention must be new in order to be eligible for a patent. 56 The novelty bar
calls for the examination of the relevant ―prior art,‖ which contains the
teachings of printed publications.
Section 102(a) requires that the applicant has invented the claimed invention
prior to its use by others in the United States and prior to its patenting or
description in a printed publication anywhere in the world.57 Section 102 (f)
53
Denis Schertenleib, The Patentability and Protection of DNA-BASED Inventions, (2003)
E.I.P.R., p.126
54
Reported in 7 Biotechnolgy Law Review 159 (1998).
55
Art.3.2 Directive 98/44 on the Legal Protection of Biotechnological Inventions.
56
35 U.S.C. Section 102 (a), (e), (f), (g)
57
35 U.S.C. Section 102 (a).
65
further specifies that the applicant must have been the true first inventor, and
may not have derived the invention from others.58
As Section 102 shows, the novelty requirement is treated simultaneously with
newness.59 In the substantive law of both systems, the novelty requirement is
based on the idea that the inventor cannot patent something that already exists
in the public domain. In court decisions, the concept of novelty is generally
discussed in conjunction with the product of nature doctrine.
For example, in Funk Brothers Seed Co. -Vs- Kalo Inoculant Co. 60, a patent
application was invalidated on the basis of lack of novelty, since the company‘s
claim was for a mixture of six naturally occurring bacteria which trigger
nitrogen-fixing functions in leguminous plants. This was not the same as the
Chakrabarty case,61 where the bacteria was new and human-engineered. In its
decision, the court reasoned that each bacterium is a ―manifestation of the laws
of nature, free to all men and reserved exclusively to none.‖62
In Europe, the main point of the novelty requirement is that the invention has
not been previously made available to the public. Within the realm of human
genetics, novelty is proven if the total genes or a larger gene section, including
the partial sequence, has previously been made known.
In the case of the isolation of gene sequences with no known function, even
where there is a structural partial identity between the claimed and the known
gene sequence, an inventor can acquire a use patent on the basis of the
description of a new function.63 The emergence of novelty does indeed depend
on the value of this knowledge for technical activity, rather than upon the
58
35 U.S.C. Section 102 (f).
59
35 U.S.C. Section 102.
60
333 U.S. 127 (1948).
61
447 U.S. 303 (1980).
62
Ibid
63
Andreas Oser ‗ Patenting (Partial) Gene Sequences Taking Particular Account of the EST
Issue,‘ 30 IIC 1-18 at 11.
66
purely intellectual information. On this basis, a use patent is not granted for the
means of attainment of the use, but for the previously unknown use itself.64
This fact is important in view of the high production rate of gene sequences by
the Human Genome Project. Some of these are available from public databases,
but now it is enough that this fact will not invalidate the novelty requirement
for related technological developments in the future. On the other hand, if the
new use has benefits for medicine, the court‘s definition has been changed to
compensate for the exclusion from patentability for methods of medical
treatment.
Significantly, it is now possible to patent second and additional nonmedical
uses.65 The basic assumption in patent law is that the discovery of a use for a
previously unknown thing or substance may found claims to the thing or
substance itself, whatever it is subsequently used for.66 As a result, the second
inventor can be acknowledged just for the new use claims. The Directive does
not in any way affect the concept of current patent law, according to which a
patent may be granted for any new application of a patented product.
As a result, the sequencing and isolation of the gene itself is relatively
straightforward. The inspirational work comes in with the exploration of the
functional aspects. Therefore, the patent system may be giving out rewards
incommensurate with achievement in such a case that is peculiar to the state of
the technology. Protecting initial discoveries with a broad monopoly assumes
64
Plant Growth Regulating Agent/BAYER, 1990 OJ EPO 114, at 115.
65
In Friction Reducing Additive/MOBIL OIL, 1990 OJ EPO 93, the enlarged Board of
Appeals concluded that a new use of a known compound may reflect a newly discovered
technical effect. (‗If that technical feature has not been previously made available to the
public by any of the means set out in Art 54(2) EPC, then the claimed invention is novel,
even though such technical effect may have taken place in the course of carrying out what
has previously been made available to the public‘).
66
William Cornish, Intellectual Property: Patents, Copyright, Trademarks and Allied Rights,
(4th ed) p 186.
67
that these discoveries comprise the major breakthroughs. For inventions in

human biotechnology, this is not necessarily true.
ii) Inventive Step/Non-Obviousness Requirement

This requirement is called the inventive step in Europe, and nonobviousness in
the US. The critics of patenting say that generally there is a lack of inventive
activity in innovations. They usually originate primarily from manipulation or
combination of genetic material already existing, or, more definably, it is just
the isolation of organisms and substances that occur naturally in nature. The
most frequent argument against biotechnological inventions and processes is
that they are discoveries, rather than inventions. However, the biotechnological
institutes and organizations are still making investments in this field as they see
the patent system as the only way of achieving the protection for their
innovations, once they have become known to the competitors.
The American requirement for non-obviousness states that the invention is not
patentable, if considered as a whole, it would be obvious to any person having
ordinary skill in the art. This test is similar to the inventive step test in Europe,
which focuses on the idea that inventions should be examined as a whole
product. It involves a fact-oriented determination, where failed attempts by
others to achieve the claimed invention are important.67
With special importance for biotechnology inventions, factors of ―reasonable
expectation of success‖ and ―unexpected properties‖ were introduced. 68 If the
prior art stimulates motivation for the invention and enables an expert in the art
to invent something with a reasonable expectation of success, the living
invention will be considered obvious as a result and cannot be patented. On the
67
Indre Kelmelyte, Can Living Things Be Objects Of Patents?, 2 International Journal of
Baltic Law 8 (April 2005).
68
Laurie L. Hill, The Race to Patent the Genome: Free Riders, Hold Ups, and the Future of
Medical Breakthroughs, 11 Tex. Intel. Prop. L. J. 221 (Winter 2003).
68
other hand, the invention can be non-obvious if the applicant can justify that his
invention has an unexpected yield and superior purity.
The approach of the United States Court of Appeal for the Federal Circuit
(hereinafter the ―Federal Circuit‖) to DNA-based inventions is applied in a
manner that lowers the standard bar for patentability, thus expressly making the
quality poorer. As noted earlier, non-obviousness precludes patentability if,
given the prior available technology (known as the ―prior art‖), the invention
would have been obvious to someone of ―ordinary skill in the art.‖
In the 1990‘s, two cases, In re Deuel56 and In re Bell, the Federal Circuit has,
however, rejected arguments by USPTO patent examiners who are skilled in
the art of biotechnology, that knowing a general method for identifying genes
through the use of nucleotide probes, as well as the complete or partial amino
acid sequence of a protein, renders the DNA base sequence for that protein
obvious. The Federal Circuit has justified its decisions by arguing that, with
respect to patent claims to DNA sequences, the non-obviousness determination
must focus on the DNA molecules as chemical compounds rather than on the
method for isolating the DNA. Thus, according to the Federal Circuit, any
given DNA sequence (whether a full DNA sequence that encodes a gene or a
mere sequence fragment) is obvious only if the prior art actually recites a
similar or identical sequence and not simply a method for isolating the
sequence.69 In this regard, DNA sequences can be non-obvious no matter how
easy or routine it is to isolate the sequences.
The biotechnology Patent Protection Act was signed into law in 1995. This
made sure that those patentable processes resulting in a patentable composition
of matter are patentable.
69
Arti K. Rai, ―Intellectual Property Rights In Biotechnology: Addressing New
Technology,‖ p. 834
69
The European inventive step requirement is explained in EPC Article 56. It

states that the invention must not be obvious to a person skilled in the art. The
Board of Appeal of the EPO has developed an approach, called the ―problem-
solution approach,‖ to assess whether an invention involves an inventive step.
All EPO branches apply this approach to decide whether an invention involves
an inventive step. This approach consists of three steps: closest prior art,
objective technical problem and obviousness.
 The first step, closest prior art, consists in assessing what it is the most
promising starting point from which a skilled person could have arrived at
the invention.
 The second step determines the technical problem which the claimed
invention aims to solve. This implies determining the feature(s)
distinguishing the claimed subject-matter from the closest prior art,
determining the technical effect(s) of the distinguishing feature(s), and
finally the objective technical problem is how to adapt or modify the
closest prior art to obtain the identified technical effect. The advantages to
which the patent proprietor/applicant merely refers, without offering
sufficient evidence to support the comparison with the closest prior art,
cannot be taken into consideration in determining the problem underlying
the invention and therefore in assessing inventive step.70
 The third and the last step concluded by the ―could-would approach‖. The
question is the climax to assess whether the invention involves an
inventive step. Is there any teaching in the prior art, as a whole, that
would, not simply could, have prompted the skilled person, faced with the
objective technical problem formulated when considering the technical
features not disclosed by the closest prior art, to modify or adapt said
70
Investigates the ―could-would‖ question when determining if the skilled person is
prompted to combine two prior art references.
70
closest prior art while taking account of that teaching (the teaching of the
prior art, not just the teaching of the closest prior art), thereby arriving at
something falling within the terms of the claims, and thus achieving what
the invention achieves?
 The key point of the third step is that the skilled person should not have
arrived at the claimed invention by changing it. Whether he would have
done so because the prior art incited him to do so in the hope of solving
the objective technical problem or in expectation of some improvement or
advantage is the question.
2.3.2.2 Industrial Applicability/Utility Requirement in

Europe:
The European Patent Office (EPO) showed that, in these jurisdictions, an
invention shall be considered to be susceptible (or capable) of industrial
application ―if it can be made or used in any kind of industry, including
agriculture.‖ The general understanding is that the term ―industry‖ shall be
interpreted in the broadest possible sense.
With regards to utility, the EU Directive has included a provision that needs
clear specification of the function, Recital 23 reads: Whereas, in order to
comply with the industrial application criterion it is necessary in cases66 where
a sequence or partial sequence of genes is used to produce a protein or part of a
protein, to specify which protein or part of a protein is produced or what
function it performs.
2.3.2.3 The Onco Mouse in Europe:

The patent application for the Onco-mouse in the EPO became such a lengthy
procedure that it has been called a ―saga.‖ After the filing in the US, the
71
inventors also applied for a European Patent from the European Patent Office
on June 24, 1985. This was the first-ever application to the EPO involving an
animal.
Criticism of the patent procedure focused on the question of whether an animal
as such could be patented at all. More specific concerns were voiced about the
potential for making commercial profit from engineered laboratory animals,
with a number of groups proclaiming their opposition to laboratory testing on
animals in general.
The application was refused on July 14, 1989 on the grounds that the basic
requirements of Art. 53(b) and 83 of the EPC were not met, because an animal
variety was contrary to Art. 53(b).
The exclusions from patentable inventions in Article 53(b) read as ―plant or
animal varieties or essentially biological processes for the production of plants
or animal; this provision does not apply to microbiological processes or
products thereof.‖
After the first refusal of the EPO branch Examining Board, the case was
appealed to another body of the EPO, the Board of Appeals. The Board of
Appeals criticized the Examining Board`s decision and, with their concluded
decision on May 13 1992, the EPO granted European Patent No. 0169 672 to
the Harvard Onco mouse. This patent included many of the privileges and
interests which were granted already in the earlier US patent issuance. This
created oppositions from a lot of political parties, NGOs, religious groups and
individuals.
Opposing applications were made especially by green activists, animal rights
and farming interest groups. The Opposition Division of the EPO had dealt
with the case from, on and within the influence of the new 1998 EU Directive
on biotechnological inventions. 98/44/EC71 had its final acceptance in July
71
EU Directive 98/44/EC of Eurppe
72
2004, 19 years after the patent application was made. They stated that another
criterion had to be taken into account. This key criterion found a balance
between ―suffering and substantial medical benefit‖ in Rule 23(d) of the EPC.
The Opposition Division has particularly taken into account Rule 23 (b) and
(c), which provides for patents for ―plants or animals‖ under conditions laid
down in the Rule 23 (d). Rule 23(d) also excludes from patentability ―processes
for modifying the genetic identity of animals which are likely to cause them
suffering without any substantial medical benefit to man or animal and also
animals resulting from such processes.‖ 72
The Opposition Division stated that another criterion has to be taken into
account. This key criterion found a requirement for balance between ―suffering
and substantial medical benefit‖ in Rule 23(d). The Opposition Division stated
that if there is suffering in accordance with EPC Rule 23(d), this suffering must
be balanced by a substantial medical benefit.73
When stating the benefits provided by the invention, the Opposition Division
emphasized two points. The first was that the date of the patent application
would be taken into account for the assessment, not the date at which the
assessment was actually made. This meant that later evidence from the
application date would be invalid for the assessment.84 Second, as an answer
to the question – how is the benefit to be assessed? - the Opposition Division
focused on the subjective view point of the inventor. According to the general
principles of the law, this subjective view point should be ―bona fide.‖ Thus the
inventor‘s bona fide belief would be decisive for the medical benefit which is
essential for right to patent for biotechnological inventions.85 In conclusion,
according to the opposition, Division Rule 23d (d) was not a ban to the
patentability.
72
Rule 23(d) of the EPC
73
Harvard/Oncomouse (2003) OJEPO 473, 503 (Opposition Division).
73
The opponents also argued that the Onco-mouse patent fell afoul of Article 53
(a) of the EPC. Regarding this argument, the Opposition Division said that Art.
53 (a) would only apply to exceptional cases. They also added that they had no
intention of applying extreme positions. They meant that they would not take
responsibility for possible abuses of the invention.87 According to the
Opposition Division, ordre public74 and morality issue had to be examined first
since the laws and regulations are common and these laws and regulations are
the best indicators of the values of the whole society -- what they consider to be
right or wrong.
In the end, the Opposition Division issued a written decision early in 2003
which limited the granting of a patent to rodent species considered to be
suitable animals for experiment. Some parts of the content and major principles
of this decision were given and discussed above. An appeal was also filed in
May 2003, and a final decision was rendered by the EPO Board of Appeals in
July 2004. In this decision, mice were designated instead of rodents. Finally,
after 19 years the first Onco mouse application was filed to the EPO, it was
granted a patent.
This final decision cannot be further appealed at the EPO level. However, an
application against the present patent of the Onco-mouse will be given to
obtain an invalidity decision from a court at the national level.

Inventions in China:
China is the most populous country in the world, with over 1.2 billion people—
a staggering consumer market for pharmaceutical and biotechnology products.
With a fast-growing economy based on the government's drive for economic
74
Morality issue under EU Directive 98/44/EC and The European Patent Convention of
Europe
74
reform and modernization, China has in recent years twice revised her patent
laws to promote science and technology. The first revision was adopted in 1992
and allowed, for the first time, the patenting of pharmaceuticals. However,
enforcement remained problematic, partly because of certain loopholes in the
definition of infringement in the 1992 Patent Law. The second amendment,
passed recently and scheduled to come into force in July 2001, will
significantly improve enforceability of certain patented products.75
With the imminent accession of China into the World Trade Organization, it is
important to familiarize ourselves with the basics of Chinese patent law, and to
discover how biotechnology patents can be obtained. This article gives an
overview of the main requirements for obtaining a patent in China, with
particular focus on the aspects unique to biotechnology inventions. It includes
examples of patentable and nonpatentable biotechnology subject matter, as well
as novelty and inventiveness standards of the Chinese Patent Office.
2.3.3.1 Subject Matter:

A list of subject matter is excluded from patent protection 76. This list is similar
to that found in Articles 52 and 53 of the European Patent Convention. In
contrast, the patent statute in the United States does not expressly bar any
specific subject matter from patent protection, but rather defines positively
patentable inventions under 35 USC Section 101 as "any new and useful
process, machine, manufacture, or composition of matter, or any new and
useful improvement thereof."
The standard for applying Article 25(1) of the Chinese Patent Law is consistent
with international standards, that is, a material that is a mere discovery of
75
Jacqueline Lui, a United States registered patent agent at Deacons, Alexandra House 3rd–
7th & 18th Floors, Central, Hong Kong, China
76
Article 25 of the Chinese Patent Law
75
nature is not patentable but may be given patent protection if it has been
isolated or purified from its natural environment and has been definitively
characterized. In the United States, a mere description of a discovery from
nature without stating its usefulness would also be rejected by the US Patent
and Trademark Office for lack of utility.
Article 25(3) of the Chinese Patent Law has many similarities to Article 52(4)
of the European Patent Convention in that both jurisdictions exclude methods
of surgery, therapy, and diagnosis practiced on the human or animal body, all
of which are generally allowed in the United States. Specific examples of
excluded subject matter in China include methods of treatment such as
acupuncture, radiotherapy, and immunization. Also excluded are methods of
disease diagnosis such as endoscopic and ultrasonic methods. Furthermore,
prophylactic treatment methods of diseases, methods of treating wounds,
methods of contraception, artificial insemination, and embryo transfer are also
expressly excluded from patent protection in China. These exclusions,
however, do not apply to methods not directly applied on the body. Thus,
methods of treatment and diagnosis applied to tissue and other biological
materials isolated and separated from the body are patentable subject matter.
Methods of analysis, treatment, and data collection as applied to the body for
purposes that are not disease related are also allowed, as are products and
compounds used for treatment and diagnosis of diseases.
Further examples of patentable subject matter in China include (1)
nontherapeutic cosmetic hair treatment methods such as giving permanent
waves or dyeing; (2) methods of sterilization that are not directly practiced on
the animal or human body; (3) methods of treatment and preservation of
corpses; and (4) methods of measuring physiological parameters solely for the
purpose of perfecting a medical instrument.77
77
Examination Guideline of Chinese Patent Law, Part II, Chapter 1, Section 3.3.
76
The Chinese Patent Law78 excludes animal and plant varieties from patent
protection. This exclusion is mainly directed toward organisms per se, so
methods of breeding and products derived from these organisms remain
patentable. However, for the methods of breeding to be patentable, they must
not be ―essentially biological‖ in nature; that is, human intervention should
play a key role in the success of the process in order to meet Chinese
requirements. Currently, the Chinese Patent Office gives a broad interpretation
to Article 25(4) to cover all plant and animal varieties including transgenic
ones.79 Thus, the only form of protection for plants in China is under the
Regulations for the Protection of New Varieties of Plants, which covers certain
types of vines, forest trees, fruit trees, and ornamental plants. China is a
member of the International Union for the Protection of New Varieties of
Plants (UPOV), and priority may be claimed if a prior new plant variety rights
application has been filed in a UPOV state.
2.3.3.2 Claims:
The types of acceptable claim language and format are provided in Rules 20–
23 of the Implementing Regulations of the Chinese Patent Law. The preferred
format for an independent claim is the European two-part style that contains a
preamble portion and a characterizing portion. The general requirement for
claim language is that of clarity and definiteness.
Products may generally be claimed as a compound, a composition, or a product
defined by process. A compound should be clearly defined according to its
chemical name and structure using internationally recognized nomenclature.
Genetic materials are considered chemical substances. Thus genes, DNA,
RNA, and chromosomes are patentable like any other chemical substances.
78
Article 25(4)
79
Chan, C. China Patents and Trade Marks 1 (1998).
77
Compounds that cannot be readily defined by their chemical or molecular

structures may be claimed using their physical and chemical parameters as
determined by methods well known and accepted in the art. If the product
cannot be sufficiently characterized even using these parameters, it is possible
for the product to be claimed by its process of manufacture if the product is
rendered distinct in characteristics and utility using the process cited in the
claim.
Composition of matter may be claimed in an open-ended or closed-ended
manner, with or without numerical ranges and amounts limitations. The scope
of the claim allowed is dependent on the subject matter, the description, and
what is known in the art. Closed-ended language (such as ―consisting of‖),
intermediate language (such as ―consisting essentially of‖), and open-ended
language (such as ―comprising‖) all have equivalent Chinese counterparts that
are understood and accepted by the Chinese Patent Office. Functional
limitations and use limitations may also be acceptable if they are clear and
definite, and supported by the disclosure. Method claims may be recited as a
series of steps, or as a method of use. The equivalent of "Swiss-type" claims for
pharmaceuticals may be recited to avoid rejection under Article 25(3), such as
the "use of a compound X for the preparation of a pharmaceutical composition
for the treatment of disease Y".
2.3.3.3 Novelty:
China has an "absolute" novelty requirement, with no grace period provided for
public disclosure before the filing date (priority date) except under extremely
limited conditions. Public disclosure may be in the form of printed document,
oral disclosure, or public use. Only public use and oral disclosure within China
are considered novelty destroying. However, any publicly available printed
document, whether available in China or overseas, may be considered prior art.
78
Exceptions to this rule include disclosure at an exhibition sponsored or

recognized by the Chinese government; disclosure at a prescribed academic or
technological meeting; or disclosure by any person without the consent of the
applicant, for which a six-month grace period is provided for filing the patent
application. The interpretation of these exceptions is uncertain, and it is highly
recommended that a priority date be established before any public disclosure.
2.3.3.4 Inventiveness:
The approaches to determining inventiveness are set forth in detail in the
Examination Guideline of the Chinese Patent Office. Besides the primary
approach of comparing the level of technological innovation with what is
known in the art based on the assessment of the examiner according to the
standard of that notional "person skilled in the art," secondary indicia of
inventiveness may also be considered. These are well-known tests such as
providing solution to a long-felt problem, overcoming technical prejudice,
unexpected results, and commercial success.
2.3.3.5 Sufficiency of Disclosure:

It is important to note that Rule 18(8) of the Implementing Regulations of the
Chinese Patent Law requires that the description of a patent application
describes in detail the best mode contemplated by the applicant for carrying out
the invention. For pharmaceuticals, the Chinese Patent Examiner would also be
looking for indications, animal and/or clinical test subsequent data, efficacy
range, and methods of quantitative analysis. Although the Chinese Patent
Office does allow some of this data to be submitted after the filing date, such
post-filing submission cannot be added into the specification or be used to
enlarge the scope of a claim.
79
If an application concerns a new microorganism or a microbiological process,

the Chinese Patent Office may require that a specimen of the organism be
deposited with an approved depositary institution on or before the date of filing
if the microorganism is not available to the public. Because China is a
contracting state of the Budapest Treaty, the microorganisms may be deposited
in any International Depositary Authority recognized under this treaty.
Microorganisms include not only bacteria, fungi, actinomyces, viruses,
protozoa, and algae, but also cell lines and plasmids. Once deposited, any entity
can request a sample of the microorganism after the publication of the
application. The specimen will be released upon an undertaking by the entity
not to make the specimen available to others, and to use it only for
experimental purposes before the grant of a patent.80
2.3.3.6 Infringement Procedures:

Article 11 of the 1992 law states that "no entity or individual may, without the
authorization of the patentee, make, use, or sell the patented product, or use the
patented process and use or sell the product directly obtained by the patented
process, for production or business purposes." Although infringement litigation
remains relatively rare compared to the United States, there has been some
success by patentees in enforcing their patent rights. In a recent decision by the
Chongqing Municipal No. 1 Intermediate People's Court, the defendant, South-
West Hecheng Pharmaceutical Factory, was found to have infringed on patent
No. 85105643 granted to Glaxo Group Ltd. for a process for the manufacturing
of ondansetron81 and related compounds.82
80
Implementing Regulations of the Patent Law of PRC Rules 25 and 26.
81
a drug used for the prevention of chemotherapy and radiation-induced nausea
82
Wu, Y. China Patents and Trade Marks, 4(2000), at p.61–65.
80
In the second amendment that will come into force in July 2001, "offer for
sale" will be added to the list of infringing activities. The second amendment
will further provide the means for calculating damages, including a maximum
fine of up to three times the profits obtained for passing off activities.
2.4 CONCLUSION
Historically, patent systems have been developed to encourage invention and
innovation. A patent system motivates the creation of useful inventions,
including the investment required to develop and commercialize them;
society‘s recognition of individuals who disclose their inventions and patents
enables the systematic registration of a wide range of discoveries. Without any
doubt we need a patent system. Even though patent systems and their
implementation result in massive problems, it is believed that it is necessary to
keep them.
The selected cases represent distinct and important decisions of biotech patents,
namely DNA sequences and whole living organisms. The Oncomouse patent
litigated throughout its lifetime. The main issue was driven by public concern.
This case raised new questions concerning patentability and led to landmark
decisions. Today it is accepted that DNA sequences and proteins are patentable
if its function is known. However in Europe there are strict conditions on
patenting higher organisms.
The application for the patent on the Onco-mouse 20 years ago has created a
new field and there will be new challenges for patent protection in the future
due to the rapid development of biotechnological research.
Patents on biotechnological inventions have created monopolies especially
within public health. Biotechnological patents on the one hand are giving
massive rights to the patent owners; on the other hand, patents create
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monopolies in inventions that have been aimed at the public interest. As a

result, these very conflicting situations give rise to a dilemma.
Although it is obvious that the current legal instruments are not suitable for the
protection of biotechnology, governments worldwide rely on old and
inappropriate structures for the protection of genetic inventions. Today there is
no distinction between inventions and discoveries; the inventive step is
basically irrelevant and the utility requirement is largely unessential. Regarding
their purpose, well-suited corrections and additions will contribute to new
innovations being made and help to distribute these to people worldwide.
In its report, The Nuffield Council on Bioethics recommended a rather
restrictive approach for granting patents on DNA sequences. Patents on
diagnostic tests should be sharply examined for the criterion of inventiveness,
the granting of patents on research tools should be discouraged, patents on gene
therapies should be thoroughly analysed if they are not obvious and patents on
therapeutic proteins should be narrowly defined. Patent offices and courts
should feel encouraged to make use of the patent system in a more rational way
as far as patents on DNA sequences are concerned.
The promises of biotechnology are great and must be allowed to develop within
a fair, competitive and intellectual property framework, which can only be
achieved through worldwide legislation and the establishment of a single
appellate jurisdiction.
The approach to biotechnological inventions in the United States is more
generous than in Europe. Europeans tend to stick to the morality issues and for
that reason the patent bar granting biotechnological inventions is very high. On
the contrary, the United States is more liberal, which has a global impact on the
world economy. USPTO and the Federal Circuit have badly rendered the
decisions affecting the issues. Commentators talk about the financial
motivations behind these decisions. Thus, many companies find the US an
82
attractive place to invest since it is easy to obtain a patent there. The European
countries are probably losing investment because they operate a more stringent
system than the US. The attitudes of the European countries are criticized.
One possible solution is for a related organization such as the WIPO to take
control of biotechnological patenting. As a first step, the USPTO, EPO and
JPO could come together for negotiations under WIPO‘s umbrella. In the long
term, other countries need to be involved, and it might be possible to seek an
agreement to construct a totally new system which deals with biotechnological
patent issues. It is necessary to seek a wider attendance of countries in order to
be effective for imposing new rules to these and other countries. Regarding the
cultural, political, ethical, and social differences, it could be thought that these
countries can make rules more effectively since a single system takes into
account everyone‘s needs and requirements. However, it is necessary to adopt
minimum standards for the countries starting with the US, the EU countries,
and Japan. In fact, there are many other areas in which lists of minimum
standards are already applied. These standards can be adopted through the
WIPO. Since the WIPO procedures are not compulsory, it is unknown whether
the system will work or not. In order to achieve this system, the sensitivities of
society must be improved and the public must be enlightened on this issue. The
primary initiatives may be taken by the voluntary groups including NGOs. The
lobbying activities of the companies must be reduced and politicians should be
convinced to take the issue seriously.
The risk of cancer constitutes a great danger for the human beings at present.
For instance, a lot of women are facing a risk of breast cancer, while the
children have anaemia or AIDS. Therefore, patients and the people in danger
need inventions for a better treatment and a better/long life. These inventions
are scientific in nature and are necessary for human beings to survive.
Patenting is a part of this unique system and it cannot be approached without
83
ethical considerations, no matter how much income it provides. A common set

of criteria must be taken into account and applied when issuing a patent; thus a
continuous process must be provided for these inventions.
The number of invention patent applications in China has been increasing
steadily in recent years, reaching more than 35,000 in 1999. Among the more
than 250,000 applications filed between 1985 and 1999, Chinese herbal
medicines, foodstuffs, and pharmaceuticals were the art groups that had the
highest number of applications. Although these numbers appear very small
compared to the United States, Europe, and Japan, the increasing number of
patent cases in litigation indicates that awareness of the exploitation and
enforcement of intellectual property is building, and that the Chinese economy
is becoming more technology-intensive. With China being both an important
manufacturing center and a consumer market of staggering proportions, the
time has arrived to claim your intellectual real estate before it is turned into
public property.83
Despite all political and ethical concerns, public debates and worldwide
litigation, the importance of biotechnological research in general, and of
patents in particular, is likely to further increase rather than decrease in the
future. It is in the interest of most people to increase their life span, whatever
the costs, search for new sources of nutrition for the constantly increasing
population, but also for the curiosity and motivation of scientists to find
inventions on one hand and high investments in this field on the other hand.
This branch of technology is extremely lucrative but also makes IP protection
necessary. Otherwise it may risk not achieving the very objectives it seeks to
achieve, with the end result that the disease is cured, but the patient killed.
83
Dr. Mae-Wan Ho, Genetic engineering: dreams or nightmares? The brave new world of
bad science and big business, Research foundation for science, Technology and ecology
and third world network, New Delhi, 1997, at p 45
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CHAPTER 3
NEED FOR PROTECTION OF INDIAN

BIOTECH INVENTIONS
3.1 INTRODUCTION:
In today‘s era, when people are exposed to so many physical disorders,
biotechnology plays a vital role in developing medicines, vaccines, energy
production, and conservation. To keep pace with the competitive world, India
has launched a comprehensive programme in biotechnology to make use of the
resources available. In India, the Department of Biotechnology was established
in the year 1986 under the Ministry of Science and Technology.
It is imperative that India has to keep up with, the increasing demand for food
from the ever expanding population. Agricultural land is also shrinking.
Genetic engineering of plants to increase their yield is the way to go in future.
Biotechnology can be used in a wide range of economic activity ranging from
environment, animal husbandry, medicinal and aromatic plants, bio fuels,
aquaculture and products like silk and leather.
3.2 FUTURE PROSPECTS AND OPPORTUNITIES

OF THE BIOTECHNOLOGICAL INDUSTRY
IN INDIA:
Biotechnology is an emerging sector in India. It has great prospects and
opportunities. The future of Biotechnology industry can be stated as follows:
 India has a large domestic market as well a very good expos
potential.
 According to reports, biotechnology industry in India has become the
fourth largest adopter of biotech crop in the world, replacing Canada,
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The Indian biotechnology industry is slated to become a US$ 5

billion industry by the end of 2011.
 India is gaining recognition in the field of clinical trial. A large
number of companies are providing research and development
expertise to global pharmaceutical companies. India has low cost
research base for international companies in comparison with other
countries.
 The availability of a vast pool of English speaking science graduates,
good regulatory processes and the cost advantage have positioned
India as a favourable investment destination by the way of
globalization, mergers and acquisition and alliances.
 Indian companies are also expanding overseas. The acquisition of 70
per cent stake of the German pharma company AxiCorp by Biocon is
a case in testimony.
 In terms of technology, the nano technology is the next big
opportunities.
 Stem Cell Therapy research also has huge potential. Supportive
government policy on embryonic stem cells research provides a
useful opportunity for International companies to pursue such
research in India.
 Vast and diverse disease based patient populations provide unique
opportunities for clinical research and clinical trials.
 Human bio-diversity provides unique research opportunities in
genomics.
 Plant and microbial bio-diversity provides vast prospecting
opportunities for new drugs.
 Conducive Government policy on GM crops provides useful
opportunities for agri-biotech companies1.
1
Chandra Prof. Ramesh, Issues of Intellectual Property Rights, Isha Books Delhi, 2004, at
p.71
86
3.2.1 Application and Scope of Biotechnology:

Biotechnology functions like a fruit on a tree having roots of biotechnological
sciences, microbiology, genetics, molecular biology and biochemistry and
trunk of chemical engineering. So, it is indeed difficult to define the precise
scope and extent of the applications of biotechnology. The introduction of
biotechnology to produce new products or molecules poses various challenges,
which may be technical or ethical. However, biotechnology has numerous
applications with the potential to affect every facet of our lives in positive
ways.
Some of the various applications of biotechnology are as follows:-
1. Genetic Engineering
2. Gene Cloning
3. Gene Transfer Mechanism
4. Plant cell & Tissue Culture
5. Animal Cell Culture
6. Agriculture
7. Industrial
8. Health Care
9. Environmental etc.
Biotechnology has been promoted as being necessary and essential for human
survival and as a technology that will improve the quality of life in every
country. Biotechnology presents itself as a blessing, with the potential to
improve the quality of life of every person in the world and allow sustainable
living.
Some of the possible areas for future growth in the biotechnology sector in
India include.
 HIV Vaccine
 Oral and Cervical Cancer
 Malaria Vaccine
 Crop quality enhancement
 Plant Genomic
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 Rice Genome effort

 Herbicide resistance
 Precision farming methods
 Post harvest technology
 Conversion of agriculture residue into food, fuel and feed
 Plant biotechnology
 Pollution abatement
 Biotechnology parks/incubators
 Training
The biotechnology boom will have undoubtedly have a tremendous impact on
international trade and the growth of this sector hinges on various factors such
as2-
 Possibility of technology transfer
 Protection of intellectual property rights
 Association with commerce
 International trade pressures.
 Social acceptance
 Willingness to use if.
 Sufficient resources
 Natural
 Financial
 Appropriate technology
 Availability
 Utilization
 Necessary infrastructure
 Political
 Financial
 Educational
 Technical
2
Journal Intellectual Property Rights, Vol. 19, March, July, September, 2014, at p.35
88
The biotechnology industry is poised to play a significant role in shaping the

future of the global economy India has the potential of developing into a
forerunner in the international biotechnology sector because of its non-
biological diversity and large scientific talent pool, skilled manpower and a
well-established pharmaceutical industry. The future of the Indian
biotechnology industry largely depends upon the strengthening of government
initiatives establishing linkages between the industry education and
government institutions framing effective policies and regulations and
increasing funding for innovative research and development 3.
3.2.2 Beginning of Biotechnology:

Certain practices that we would now classify as applications of biotechnology
have been in use since man‘s earliest days. Nearly 10,000 years ago, our
ancestors were producing wine, beer, and bread by using fermentation, a
natural process in which the biological activity of one-celled organisms plays a
critical role.
In fermentation, microorganisms such as bacteria, yeasts, and molds are mixed
with ingredients that provide them with food. As they digest this food, the
organisms produce two critical by-products, carbon dioxide gas and alcohol.
In beer making, yeast cells, break down starch and sugar (present in cereal
grains) to form alcohol, the froth, or head of the beer results from the carbon
dioxide gas that the cells produce. In simple terms, the living cells rearrange
chemical elements to form new products that they need to live and reproduce.
By happy coincidence, in the process of doing so they help make a popular
beverage.
Bread baking is also dependent on the action of yeast cells. The bread dough
contains nutrients that these cells digest for their own sustenance. The digestion
process generates alcohol (which contributes to that wonderful aroma of baking
3
Journal of Intellectual Rights, Vol.-14, 2015, at p.15
89
bread) and carbon dioxide gas (which makes the dough rise and forms the
honeycomb texture of the baked loaf).
Discovery of the fermentation process allowed early peoples to produce foods
by allowing live organisms to act on other ingredients. But our ancestors also
found that, by manipulating the conditions under which the fermentation took
place, they could improve both the quality and the yield of the ingredients
themselves.4
3.2.3 Crop Improvement:

Although plant science is a relatively modern discipline, its fundamental
techniques have been applied throughout human history. When early man went
through the crucial transition from nomadic hunter to settled farmer, cultivated
crops became vital for survival. These primitive farmers, although ignorant of
the natural principles at work, found that they could increase the yield and
improve the taste of crops by selecting seeds from particularly desirable plants.
Farmers long ago noted that they could improve each succeeding year‘s harvest
by using seed from only the best plants of the current crop. Plants that, for
example, gave the highest yield, stayed the healthiest during periods of drought
or disease, or were easiest to harvest tended to produce future generations with
these same characteristics. Through several years of careful seed selection,
farmers could maintain and strengthen such desirable traits.
The possibilities for improving plants expanded as a result of Gregor Mendel‘s
investigations in the mid 1860s of hereditary traits in peas, Once the genetic
basis of heredity was understood the benefits of cross-breeding, or
hybridization, became apparent plants with different desirable traits could be
used to cultivate a later generation that combined these characteristics.
An understanding of the scientific principles behind fermentation and crop
improvement practices has come only in the last hundred years. But the early
4
Journal of Intellectual Property Right, Vol-18, March, July, September, 2012, at p.23
90
crude techniques, even without the benefit of sophisticated laboratories and

automated equipment, were a true practice of biotechnology guiding natural
processes to improve man‘s physical and economic well-being.
3.2.4 Harnessing Microbes for Health:

A distinguished German scientist Buchner made the vital discovery (in 1897)
that enzymes extracted from yeast are effective in converting sugar into
alcohol. Major outbreaks of disease in overcrowded industrial cities led
eventually to the introduction, in the early years of the present century of large-
scale sewage purification systems based on microbial activity. By this time it
had proved possible to generate certain key industrial chemicals (glycerol,
acetone, and butanol) using bacteria.
Another major beneficial legacy of early 20th century biotechnology was the
discovery by another great scientist5 of penicillin, an antibiotic derived from
the mold Penicillium Large-scale production of penicillin was achieved in the
1940s. However the revolution in understanding the chemical basis of cell
function that stemmed from the post-war emergency of molecular biology was
still to come. It was this exciting phase of bioscience that led to the recent
explosive development of biotechnology.
3.3 INDIAN BIOTECH INVENTION: OVERVIEW

AND BRIEF HISTORY:
Biotechnology seems to be leading a sudden new biological revolution. It has
brought us to the brink of a world of ―engineered‖ products that are based in
the natural world rather than on chemical and industrial processes.
Biotechnology has been described as ―Janus-faced‖. This implies that there are
two sides. On one, techniques allow DNA to be manipulated to move genes
from one organism to another. On the other, it involves relatively new
5
Alexander Fleming (in 1928)
91
technologies whose consequences are untested and should be met with caution.
The term ―biotechnology‖ was coined in 1919 by Karl Ereky, an Hungarian
engineer. At that time, the term meant all the lines of work by which products
are produced from raw materials with theaid of living organisms. Ereky
envisioned a biochemical age similar to the stone and iron ages.
A common misconception is the thought that biotechnology includes only
DNA and genetic engineering. To keep students abreast of current knowledge,
teachers sometimes have emphasized the techniques of DNA science as the
―end-and-all‖ of biotechnology. This trend has also led to a misunderstanding
in the general population. Biotechnology is NOT new. Man has been
manipulating living things to solve problems and improve his way of life for
millennia.
The story of the sue of biological systems for the fulfillment of human needs
perhaps started in 6000 B.C. Infact biotechnology can be traced back to
approximately 6000 B.C. when Sumerians and Babuylonians first used yeast to
make beer. Egyptians were baking leavned bred by 4000 B.C. and in China
fermentation processes were discovered for preserving milk by lactic acid
bacteria to make yogurt and to produce cheeses. Beginning wih fermentation
use of biological processes experienced many changes over centuries. The
modern biotechnology can be traced back to the3 eighteenth century when
smallpox was practiced to invoke an immune response and prevent
development of more serious cases later on in life. During e3ighteenth century
cross-fertilization was discovered and crop rotation was practiced to increase
yield. The process of sterilization was also discovered during the eighteenth
century6.
In the nineteenth century Louis Pasteur called as the father of Biotechnology
demonstrated fermentative ability of microorganisms. During that time
epidemiological observations were used to develop the hypothesis of cross-
6
http://www.agmre.org//business/operating/historyand/trendsinagbiotechnology patentlaw,
visited on 4.6.15
92
infection by spread of childbed fever from mother to mother by physicians,

which led to the hypothesis that physicians wash their hands after examining
each patent. Another milestone during the nineteenth century was the invention
of a process of beer fermentation by Louis Pasteur in 1873. He proved that
microbes were responsible for fermentation. He also invented the
pasteurization process, which involves heating wine sufficiently to inactive
microbes. In the nineteen forties complicated techniques were introduced to the
mass cultivation of microorganisms to exclude contaminated microorganisms.
Infact Gregor Mendel‘s presentation of the law of heredity development of
Pastures rabbis vaccine, discovery of antibiotics, in 1929 and their large scale
production in Pastures rabbis vaccine, the isolation of DNA by Crick and Watts
in 1953, the discovery of chromosomes, discovery of the protozoan
plasmodium as a cause of malaria, the investigation of anthrax were all mile
stones in the development of biotechnology.
But greatest revolution took place in nineteen seventies and nineteen eighties
when product of interaction between the science of biology and technology
came into wider existence and the relationship got the name biotechnology.
Modern biotechnology has got its roots in the early nineteen eighties when
recombinant DNA technology or genetic engineering developed. Modern
biotechnology is mostly concerned with and concentrated on genetic
engineering Commercial production of human insulin through recombinant
DNA technology in the United States showcased the potential of recombinant
DNA technology. The development of process engineering and protein
engineering that involves methods of protein production through recombinant
DNA technology adds another feather to the wings of modern biotechnology.
The development of biotechnology can be classified into three generations 7.
7
http://www.agmre.org//business/operating/historyand/trendsinagbiotechnology/patentlaw,
visited on 4.6.15
93
3.3.1 First Generation of Biotechnology:

The first generation of biotechnology is based on empirical practice and
minimal scientific or technical inputs. These techniques dates back to the Stone
Age and involves using of biological organisms such as bacteria, yeasts,
enzymes and traditional methods of fermentation to produce food and drink
such as bred and wine. Production of cheese and beer by using microorganisms
was the milestone in this generation.
3.3.2 Second Generation of Biotechnology:

This generation begun during the interwar period when developments in
fermentation technology using pure cell culture and sterile manufacturing
facilities begun to yield new products. During this generation innovations such
as acetane, butanol, glycerol, vitamin B2, citric acid, and took place. The
invention of penicillin in 1928 was the milestone in the second generation.
3.3.3 Third Generation of Biotechnology:

Three important technologies namely, tissue cell culture, Hibridoma
technology and recombinant DNA technology also known as genetic
engineering were developed in the third generation. These three technologies
represent the modern biotechnology. The invention of DNA by Crick and
Watson in 1953 was the turning point in the third generation of biotechnology.
The recombinant DNA technology is the technique that involves manipulation
of genetic materials of a living being to get desired results. Indeed it is
recombinant DNA technology, which brought biotechnology into limelight
Modern biotechnology is defined on the basis of genetic engineering and is
mostly concerned with genetic engineering. The inventions of biotechnology
are playing a vital role in the industrial sector. Almost there is no field where
biotechnology has got no impact. Most of the biotechnology inventions fall in
the sphere of food, agriculture and medical industry. Certain inventions of
94
biotechnology fall in the sphere of forestry, environment, energy and

chemistry.
A current agricultural controversy involves the tomato. A recent article in the
New Yorker magazine compared the discovery of the edible tomato that came
about by early biotechnology with the new ―Flavr-Savr‖ tomato brought about
through modern techniques. In the very near future, you will be given the
opportunity to bite into the Flavr-Savr tomato, the first food created by the use
of recombinant DNA technology ever to go on sale.
What will one think as he raises the tomato to his mouth? Will he hesitate?
This moment may be for him as it was for Robert Gibbon Johnson in 1820 on
the steps of the courthouse in Salem, New Jersey. Prior to this moment, the
tomato was widely believed to be poisonous. As a large crowd watched,
Johnson consumed two tomatoes and changed forever the human-tomato
relationship. Since that time, man has sought to produce the supermarket
tomato with that ―backyard flavour.‖ Americans also want that tomato
available year-round.
New biotechnological techniques have permitted scientists to manipulate

desired traits. Prior to the advancement of the methods of recombinant DNA,
scientists were limited to the techniques of their time – cross-pollination,
selective breeding, pesticides, and herbicides. Today‘s biotechnology has its
―roots‖ in chemistry, physics, and biology. The explosion in techniques has
resulted in three major branches of biotechnology, genetic, engineering,
diagnostic techniques, and cell/tissue techniques.
3.3.4 Advantages of Biotechnology:

There are major proponents of the GM technology and USA has hailed as one
of the major supporters of the same. Following are the main advantages that
have been purported by the proponents of the technology -
95
Pest resistance: This would control done to the crops due to the pests
without any usage of chemicals.
Herbicide tolerance: This would facilitate removal of other weeds
without any damage to the plants.
Disease resistance: This may be prevented with the use of technology.
Cold tolerance: This would protect the plants from the unexpected frost
and any other natural bearings.
Drought/Salinity tolerance: This would facilitate production in hitherto
unsuitable plots for cultivation.
Nutrition: Keeping in mind the fact that poor people rely mostly on
single staple food, that vanity may be developed to take care of
malnutrition.
3.3.5 Possible Harms of Biotechnology:

Biotechnology is a powerful new technology that poses substantial and often
unique threats to biological diversity—as much as to human health,
communities and economies. Many different researchers have detailed these
threats. They are briefly summed up here. Genetically engineered crops are
designed precisely for their ecological viability and therefore could invade
various ecosystems, becoming destructive weeds in agricultural ecosystems.
There is also the threat of ―introgression,‖ or gene flow, between genetically
engineered organisms and related species. Engineered hybrid crop plants are
being bred specifically to resist certain chemical herbicides and pesticides, and,
like their conventional predecessors, may result in the pollutive use of these
inputs, as well as in excessive consumption of water. Crop plants engineered to
secrete ―bio-pesticides‖ are already resulting in corresponding tolerances in the
target populations. This may lead to a vicious cycle of more specific pesticides
and more widespread tolerances.
Genetically engineered microorganisms, such as those used for nitrogen
fixation in plants or for ―bio-remediation‖ have been shown to have
96
unpredictable and deleterious effects on soils and soil ecosystems (Holmes and
Ingham 1994, Jager and Tappeser 1995) Genetically engineered organisms
(GEOs) and biochemicals (such as bavine somatotropin, BST)-including
medicines may have profound long-term consequences on human health.
One of the greatest fallacies maintained by the promoters of biotechnology is
that one can determine the environmental and physiological impact of a
genetically engineered product by studying the closest naturally occurring
relatives. This is a misapplication of the ―principle of familiarity‖ used in the
natural sciences. It cannot account for previously unknown-or even previously
nonexistent—trait-organism combinations and their expression in different
circumstances and different ecosystems.
3.4 JUSTIFICATIONS OF PROTECTION OF

BIOTECHNOLOGY INVENTIONS UNDER
INTELLECTUAL PROPERTY LAW:
Biotechnology is one of the fastest growing areas of scientific, technical and
industrial innovation of recent times, and it is also one of the most prominent in
public discussion especially the ethical values associated with biotechnology.
Assumptions and convictions of a strongly ethical nature underpin the chief
policy and indeed political questions that have been at the center of debates on
biotechnology in recent rimes. The discovery of recombination techniques in
the beginning of nineteen seventies opened extraordinary new possibilities for
the biological modification of organisms. The potential dynamics in this field
prompted profound ethical concerns. The most obvious difference between the
patenting of biotechnology and the patenting of other forms of technology is
that it has led to the introduction of ethics into patent law. There is a series of
profound ethical and moral questions raised by the spectre of patenting life
forms. Ethical considerations do object the patenting of living beings.
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Ethically speaking living beings are creation of God, which cannot be owned
by human being through patents God is the only owner of all the living being
on this planet. Living beings are vested with inherent dignity and integrity,
which shall be protected and guaranteed. Human being cannot play with the
wisdom of God by manipulating living beings Manipulation of living beings
hits at the dignity and integrity of living beings Genetic manipulation of
organisms and its protection under intellectual property law by the patent
system had always raised hue and cry on oral and ethical issues. It is quite
obvious that patent law cannot protect immoral inventions on the question of
ethics and morality. Patent is a private right, which excludes all others except
the owner from working or using a particular invention. Patenting life amounts
to privatizing and owing life as a property, which is considered as immoral.
3.4.1 Arguments for Giving Protection:

The fundamental principles of natural law are pre moral and universal in
character. A jurisprudential enquiry into the concept of life reveals that there
are few intrinsic values attached to life. The conceptual framework of life is
connected to natural law which postulate for the inherent values of life like:
dignity, integrity, sustenance, survival and self-preservation. Nature has
provided every living being a right to self-dignity and integrity. Every living
being deserves a drive for self-preservation of natural features attribute to it by
the nature. Every living being has right to preserve the intrinsic values of life,
which should not be disturbed or tampered with. Biotechnology is capable of
removing certain natural features and incorporating certain novel features into
living beings. Manipulation of living beings, this at the inherent dignity,
integrity and natural set up of living being. Further such manipulation disturbs
the sustenance and self-preservation of natural features of life. Patenting of
biotechnology inventions is in a way an incentive for the manipulation of living
beings. Nature is integral part of every living beings life. Living beings are
associated and forming part of the nature. Any alteration or manipulation strike
98
not only at the integrity of such living beings but also at the integrity and
balance of the nature in this background it is felt that scientific and
technological developments should not disturb or destroy the values of life.
The argument in support of patenting of life quotes John Locks Labour theory,
which says that the one who labours for an invention deserves an exclusive
right over it. One who labours gifts the society a certain thing against the grant
of certain exclusive rights there by establishing a social contract deserving
exclusive right over the result of his labour. Further they quote John Bantam‘s
utilitarian theory which states that maximum benefit to the maximum members
of the society should be considered. They say that utility that biotechnology
and patenting of life fetches to the society should be considered. Society at
large is going to benefit from biotechnology inventions involving manipulation
of life; hence maximum benefit of maximum members of the society is being
served. Therefore the efforts in bringing maximum benefits to the society
deserve certain exclusive fights for a temporary period of time. However the
question here is whether John Locks labour theory or Bantam‘s Utilitarian
theory postulate for patenting of life as a reward for labouring in manipulating
a living being to do something new or to produce something new in bringing
certain utility to the society. While ethicists and fundamentalists answer
negativity to the question, the scientific community answers positively.
Argument against patenting of life states that John Lock‘s theory does not
postulate for patenting of life. Patent is a private property, which can be owned
transferred or sold just like goods. It is viewed that patenting of life amounts
owing private property rights over the making life as a market commodity.
Hence patenting of life is nothing but commodification and marketing of life,
which is a gross violation of dignity of life. Therefore patents cannot be granted
on life giving rise to property rights in life. They further say that labour in
manipulating and disturbing the integrity of living beings should not be
encouraged through patents. Labour in creation of non-natural life forms is not
backed by Locks theory since it involves distortion of intrinsic values of life.
99
Further they state that utilitarian theory does not envisage for patenting life.
Maximum benefit to the maximum members of the society should not be at the
cost of ethics which are manifestation of consciousness of maximum members
of the society.
Further they argue that nature has provided equal rights to all living beings.
Human beings do not have rights over other living beings Rights of human
beings are not superior to the rights of other living beings. Hence human beings
cannot take other living beings for granted and they cannot play with the
dignity and integrity of such living beings by manipulating them. In particular
it is argued that manipulation of animals capable of expressing feelings is
morally not right. Causing sufferings to animals for the purpose using in
experiments in the field of biotechnology is ethically questionable.
According to the ethicists patenting and owing human beings and genetic
material of human beings amounts to holding them in slavery. Slavery hits at
the dignity of human beings, which is guaranteed under different international
covenants and declarations. Human dignity is reaffirmed in the charter of
United Nationals. Universal declaration of human rights envisages for the
recognition of the inherent dignity of human beings. The declaration says that
all human beings are born with dignity and holding them in slavery shall
deprive of such dignity. The declaration says that all human beings are born
with dignity and holding them in slavery shall deprive of such dignity. The
declaration postulates for the promotion of inherent dignity and values in life.
The understanding is that scientific experimentations should not subject living
beings to torture inhuman or degrading treatment. The United States patent
offices‘ view is that granting patents on human being would violate thirteenth
amendment to the U.S. constitution, which prohibits slavery. Therefore
ethicists say the since, no human being shall be subjected to slavery. It is felt
that patenting of human being or human genetic material should not be allowed
otherwise it violates inherent dignity and integrity of human life.
100
However argument in support of patenting of life or patenting of biotechnology

inventions is that keeping in mind enormous benefits that the science called
biotechnology has brought to the modern world and potential utility of the
patenting of life ethics could be side-lined. Scientific communities along with
the supporters of life patenting say that manipulation of living beings is done
order to improve their efficiency. Manipulation intends to incorporate certain
features, which are beneficial or to remove certain features, which are not
beneficial. The intension is not to disturb integrity or dignity but to bring some
benefit to the society. They further say that biotechnology has invented
countless number of non-natural living beings or inventions involving life by
the manipulation of existing living beings, which have served and are serving
the society. With its potential to manipulate living beings in a way to benefit
the society biotechnology is promising to be capable of catering the needs of
the society8.
The inventions of biotechnology though involve manipulation of livings have
application in diverse fields yielding enormous benefit to the society. The
enormous capacity of biotechnology to isolate and commercially produce
natural compounds found inside the body of living beings cannot be
undermined. Such compounds produced through biotechnology are useful in
producing medicines to cure conical diseases in a way promising to cater the
health needs of society. The manipulation of existing crops and animals
resulted in crops and animals giving high yields at low production cost
promising to feed the hunger needs of the society. Further, biotechnology
living inventions are conical in the protection of environment and also in
improving the yield in livestock production. Therefore they say that in the light
of potential benefits of biotechnology inventions patents can be granted though
there are certain ethical objections in order to reap the fruits of biotechnology.
In this background it would be proper to discuss ethics in patenting of life in
U.S.A. where modern biotechnology and life patenting could be traced.
8
http://www.jkscience.org/archive/Volume83/multific.pdf visited on 21.2.16
101
3.5 TRADITIONAL KNOWLEDGE AND ITS

PROTECTION IN INDIA:
There is an ongoing controversy regarding the commercial exploitation of the
traditional knowledge by the multinational corporations mostly belonging to
the developed countries. Such exploitation naturally affects the interest of the
communities, which can be described as the custodians of different kinds of
traditional knowledge. As a result, certain uses of medicinal plants, indigenous
systems of medicines such as Ayurveda, agricultural methods, folklore,
traditional designs in textiles etc., which constituted the general forms of
traditional knowledge and indigenous knowledge, are facing new challenges
from the developed world.
It is based on past experiences and observations and is usually a collective
property of a society. This knowledge is transmitted from one generation to
other generation and thus remains largely undocumented. Examples of
traditional knowledge include knowledge about use of specific plants and/or
part thereof, identification of medicinal properties in plants and harvesting
practices. In India, the traditional knowledge includes the usage of neem,
turmeric and tamarind, etc., for medicinal and other purposes and Ayurveda
system of medicine. It is not only desirable to develop a system that documents
and preserves traditional knowledge created in the past, which may be on the
brink of disappearance: it is also important to envisage a system that
contributes to the promotion and dissemination of innovations which are based
on continuing use of tradition.
In the recent past, there have been several cases of biopiracy of Traditional
Knowledge from India. First it was the patent on wound healing properties of
haldi (turmeric), now patents have been obtained in other countries on
hypoglyceimic properties of karela (bitter gourd), brinjal etc. An important
criticism in this context relates to foreigners obtaining patents based on Indian
biological materials. There is also the view that the TRIPS Agreement is aiding
102
the exploitation of biodiversity by privatizing biodiversity expressed in life

forms and knowledge.
Patents are granted under national patent laws and have territorial application
only. The TRIPS Agreement provides minimum standards of protection for
intellectual property rights including patents, while WTO Members are free to
grant a higher level of protection under their national laws. Thus, India is free
to deny patents on life forms, except microorganisms and microbiological and
non-biological processes, as per the provisions of the TRIPS Agreement. At the
same time if, for example, USA chooses to grant patents on plants or other life
forms, India cannot object. Nevertheless, such patents will have force only in
USA and cannot be enforced in India. 9
To assess the WTO compatibility of a patent granted by a foreign patent office
to an invention based on biological material obtained from India, we need to
check whether the criteria of patentability (novelty, non-obviousness and
usefulness) are satisfied, and to challenge it where the criteria are not met. A
patent granted in USA on the wound healing properties of turmeric, for
examples was revoked after such an examination. The exercise could be
extended to other such patents also. Another possibility (like in the basmati
case) is that a geographical indication specific to India may be subject to
misuse abroad. In such cases, the affected parties (like exporters of basmati
rice) could take up the matter in courts abroad for restraining companies abroad
from such misuse. This has been done, for example, by successfully
challenging some trademark registrations in UK and other countries.
The problem of bio-piracy may not be resolved with such revocation actions
and domestic biodiversity legislation alone. There is a need to provide
appropriate legal and institutional means for recognizing the rights of tribal
communities on their traditional knowledge based on biological resources at
the international level. There is also a need to institute mechanisms for sharing
9
Verma S.K. and Mittal Raman, Intellectual Property Rights – A Global Vision, Indian Law
Institute, 2004, at p.33
103
of benefits arising out of the commercial exploitation of biological recourses

using such traditional knowledge. This can be done by harmonizing the
different approaches of the Convention on Biological Diversity, on the one
hand and the TRIPS Agreement on the other as the former recognizes
sovereign rights of States over their biological resources and the latter treats
intellectual property as a private right India has proposed, in this context, that
patent applicants should be required to disclose the source of origin of the
biological material utilized in their invention under the TRIPS Agreement and
should also be required to obtain prior informed consent of the country of
origin. If this is done, it would enable domestic institutional mechanisms to
ensure sharing of benefits of such commercial utilization by the patent holders
with the indigenous communities whose traditional knowledge has been used.
The proposal has not met with success in the WTO yet, but efforts are on to
forge a consensus on the issue.
3.5.1 Economics of Traditional Knowledge:

India, with approximately 8% of world‘s biodiversity and as one of the greater
storehouses of traditional knowledge, has the potential of becoming a major
player in the global trade in herbs-based formulations, medicines and
products.10 An estimate of the EXIM Bank puts the international market of
medicinal plants related trade at US $ 60 billion per year growing at about 7%
annually. It may be noticed that, although trade in medical plants from
developing countries has increased in the past few decades, with more drugs
developed, little of any benefits accrue to the source countries, and the
traditional communities. Traditional people who provided technical leads for
research, very few companies appear to have developed some practices of
10
R.A. Mashelkar, ADB. 2001. Agricultural Biotechnology, Poverty Reduction and Food
Security. Manila: Asian Development Bank. Commission on Intellectual Property Rights.
2002. Integrating intellectual property rights and development policy, London September.
Available at http:// www.iprcommission.org. Commission of the European Communities.
2002. Life Sciences and Biotechnology, COM (2002) 27 final, 3. [hereafter ―European
Commission‖] Doyle, JJ. and GJ. Persley (eds.) 1996.
104
returning some of the benefits from the commercialization of medicinal plants

traditional knowledge to the traditional people.11
3.6 STUDY OF SELECTED CASES:

Bio-piracy is understood as the ―the appropriation of knowledge and genetic
resources of farming and indigenous communities, by individuals or
institutions seeking exclusive monopoly control over these resources and
knowledge‖12. It can be safely stated that the developed countries and the
multinational companies of those countries are exploiting the richly available
traditional knowledge of the third world countries.
India being a signatory to TRIPS Agreement has become mandatory for its
compliance. These cases sent a signal to the developing countries the need to
protect their bio-resources for the benefit of its people and economy. Once the
protection is given, it becomes a ‗prior art‘ that can be a good defence for
revocation of patent infringements. The turmeric, Basmati, neem, are the
classic cases where India fought tooth and nail to protect its sovereign rights
over these resources available in nature. The positive lessons India can learn
from these cases is that the age old traditional philosophy believing that the
bio-resources are for the common heritage of the mankind is no longer safe
because of threats from developed countries. These cases throw light on the
legal issues involved in harmonizing TRIPS Agreement with the domestic
legislation.
3.6.1 The Turmeric Controversy:

Turmeric is used as a spice for flavouring Indian cooking. It also possesses
properties that make it an effective ingredient in medicines, cosmetics and a
colour die. It has been in the public domain in India from the time immemorial.
In 1995, two Indian nationals at the University of Mississippi Medical Centre
11
ibid
12
ibid
105
were granted US patent on use of turmeric in wound healing. The Indian

Council of Scientific and Industrial Research (CSIR) opposed this after its
grant and revocation of the patent was sought. The CSIR maintained that the
use of turmeric for healing wounds and rashes has been in the public domain of
traditional knowledge for thousands of years. This is a landmark case as it was
the first time that a patent based on the traditional knowledge of a developing
country had been successfully challenged. 13
3.6.1.1 Turmeric (Curcumalongal Zingiberacea):

U.S. Patent No. 5401504 5135796 54047100
Ms. Reshmee runs a beauty parlour in Delhi since 1980 and uses certain herbal
products for treating skin ailments. These products are combination of certain
selected herbs and pastes. These include turmeric and sandal paste as the main
ingredient for treating skin blemishes and tanning. These products are
developed from generations by her family and actual contents remain a secret.
She exports these products to various developed countries including U.S.A. In
1997, one of her consignments was confiscated by U.S. authorities stating that
the creams exported to U.S. having sandal and turmeric base, which have been
patented by University of Mississippi Medical Centre, amounts to infringement
of patent. Reshmee argues that turmeric and sandal has been used by Indians
and people from many developing countries since time immemorial and the
product she developed has been in the public domain from many generations. 14
3.6.1.2 The Issue:

Turmeric a tropical herb grown in East India made from the rhizomes of its
flowers. It has a deep yellow colour with bitter taste having many medicinal
properties and uses. It is used as a base for many cosmetic products and having
13
Cullet Philippe, Intellectual Property Protection, Lexis Nexis Butterworths, 2006, page 76
14
Rao R. Anita & Rao V. Bhanoji, ―Intellectual Property Rights- A Primer‖, Eastern Book
Company, First Edition, 2008, p 125
106
antiseptic qualities. The main issue involved in this turmeric case was the
patent issued by USPTO to the University of Mississippi Medical Centre in
1995 for its ―use in wound healing‖. Objections were raised by India‘s Council
of Scientific and Industrial Research (CSIR). The case focuses on two inter-
related issues. Firstly, does the claimed invention fits into the patent criteria,
i.e. the novelty, non-obviousness and utility. Secondly, the violation of IPRs
and bio-piracy under CBD. The convention on Biological Diversity (CBD)
confers sovereign rights on the country over its bio-resources (Article 15).
These issues are very critical from the developing countries‘ perspective,
especially to India as it affects India‘s exports to Japan, Sri Lanka., Taiwan,
North Africa and other regions of Middle East. It is also a cultural threat to
India as it plays extensive role in India‘s culinary, health practices and
traditional uses. In 1995 two U.S. based Indians were granted patent on use of
turmeric in wound healing and was assigned to the University of Mississippi
Medical Centre. The invention claimed under the patent was the use of
turmeric as wound healer/its oral intake to promote the healing of a wound. It is
also used as a blood purifier, treating the common cold and anti-parasitic for
many skin infections. The claimed subject-matter was the use of turmeric
powder and its administration as an antiseptic for healing wounds and skin
infections. According to U.S. law it is necessary to find adequate evidence in
the form of printed and published information that would establish the use of
turmeric as the claimed invention was known before the patent was granted.
The properties of turmeric are very well known and used by the Indians since
ages, but has become difficult to establish due to lack of proper documentation.
The ancient Indian Sanskrit, Urdu and Hindi texts were cited as evidence as to
the medicinal values of turmeric which was of great help to CSIR to defend the
case on behalf of India. Besides, these crucial issues for discussion on turmeric
and other related inventions the main focus is whether they would be the fit
subject-matter for granting patents by the USPTO. The intellectual property
right on the products of biodiversity is a glaring example on how patents have
107
been sought over on various aspects of biological resources or the products

derived from the same. Though India won the case in the revocation of the
patent on turmeric, still some complex issues need to be resolved. There is a
wide gap and lack of information to USPTO regarding the traditional
knowledge based patents, and the thorough search for patent information on
these rich biodiversity countries would help the patent office for careful
examination of the patent application. The proper documentation of these bio-
resources and the traditional knowledge would help to establish the ―prior use‖
of the product. This would save the time, technical and legal costs for those
who revoke the patent.
The hard lesson India has learnt in this case is worth mentioning. The
convention on biodiversity makes it compulsory to share the benefits of the
invention derived from the rights of the holders of traditional knowledge who
have nurtured them should be recognised in this case. It is mandatory to give
the information regarding the origin of the source. India being signatory to
CBD affirms the philosophy of conversation, sustainable use of biodiversity
and equitable sharing of the bio-resources.
Stronger concerns were expressed by many NGOs in the turmeric patent
because of the folk use of turmeric that establishes the prior art that doesn‘t fit
in the criteria for granting patents. Dr. Devendra Sharma, a Farm Scientist, is of
the opinion that WTO should protect the indigenous knowledge as the
governments of developing countries cannot chase and challenge every
indigenous knowledge based product patent. The onus should be on the
companies to prove that the product is not derived from the indigenous source.
Dr. Vandana Shiva, a global campaigner, is of the opinion that examples of
bio-piracy and protection through legislative measures would not solve the
problem unless the developing countries would fit their legal regime which is
fair and honest to protect IPRs.15
15
108
3.6.1.3 Chronological History of the Case:

• Suman K. Das and Harihar P. Cohli were granted a U.S. patent 540, 504
on 28th March, 1995 on the use of turmeric as wound healer.
• CSIR submitted 32 references from ancient Indian scriptures.
• The formal request for re-examination was filed by CSIR at USPTO on
28th October, 1996.
• The first office action in the re-examination was issued by USPTO and
was rejected as being ―anticipated by the submitted reference‖.
• The University of Mississippi Medical Centre decided to transfer the
right to the inventor and the inventor argued that the turmeric powder
and paste have different properties. They also argued that their
performances are different in two different States.
• This was rejected by USPTO saying that both are ―equivalent‖ for
healing wounds in case of the cited art.
• Subsequent to the second rejection, and the personal interview of the
inventor with the examiner, deleted some claims and restricted the
invention to ―non-healing surgical wound‖ and stating that there was no
disclosure or suggestion of using turmeric in surgically inflicted non-
healing wounds and requested the examiner to amend the claims.
• On 20th November, 1997 the amended claims were rejected and a re-
examination certificate was issued that the re-examination was closed on
21st April, 1998.
3.6.1.4 Case Highlights:

• Land mark case as being challenged by India under the traditional
knowledge before USPTO.
• This has paved the way to pass legislations on biodiversity, digital
libraries, and benefit sharing, etc.
109
• The patent-holders were non-resident Indians and CSIR had to fight

against these Indians to revoke the patent.
3.6.2 The Neem Controversy:

Neem is a tree mostly grown in India. It serves many purposes as a natural
medicine, pesticide and fertilizer. The European Patent Office granted patent in
1994 to the US Corporation. In 1995, a group of International NGOs and
representatives of Indian farmers filed a legal opposition against the patent on
the ground that the subject matter of the patent had been known and used for
centuries in Indian agriculture to protect crops and thus the invention claimed
was not novel. Ultimately, the patent was revoked in the year 2000. 16
3.6.2.1 Neem (Azadirachta Indica):

U.S. Patent No. 49466815124349
Mr. Mehta is an exporter of select herbs to U.S.A. since 1970. These select
herbs include neem leaves, barks and seeds, which are used in the preparation
of pesticides, medicines and cosmetics by certain U.S. companies. In 1998 the
U.S. Government seized the cargo sent by Mr. Mehta as it contained neem
leaves and barks on the ground that these neem properties are patented by a
U.S. multinational company.17
3.6.2.2 The Issue:

The main issue in the present case was bio-piracy and rights of the true
indigenous communities on one side and the rights of the multinational
corporations on the other, to conduct research and development by using
patents against the interest of the people who are dependent on neem as a
16
Sople Vinod, Managing Intellectual Property – the Strategic Imperative, Prentice – Hall of
India Private Ltd., 2006,page 94
17
110
source of livelihood. The extracts of the tree, leaves, bark and the seeds have
been used by the native Indian people from centuries as pesticides, medicines
and in cosmetic industry. Never was felt the need to patent this process as it
was always a part of indigenous knowledge of Indian people. The issue of
protecting the intellectual property rights over the neem tree was challenged at
the Munich (Germany) office of the EPO by three groups, i.e. the E.U.
Parliamentary Green Party, Dr. Vandana Shiva of the Indian based Research
Foundation for Science and Technology and Ecology and the International
Federation of Organic Agriculture Movement.
3.6.2.3 Description:
The plant is known as AZADIRACHTA INDICA in India. The tropical
evergreen plant is abundant in India, Burma, and South West Asia and in West
Africa. This tree is estimated to live up to 200 years. The ancient scriptures in
India and Burma dealing with agriculture, explained the various uses of neem
as a cure for fertility of the soil, livestock and plants. It used to be called as a
blessed tree and the medicinal value of the leaves was highly praised in treating
leprosy, diabetes and skin disorders. It is a versatile tree having medicinal value
from bark, leaves, seeds and flowers. The leaves are also used to cure
hypertension. Since, it is having a chemical which is resistant to termites, the
prominence and importance of it has grown tremendously. The small twigs
have been used by many Indians as toothbrush, oil is used for preparing soaps
and it is also having potent spermicidal property. The oil from the neem tree
used to be extracted with the native methods as not much of sophistication is
required and every householder uses neem in day to day life in India. 18
In 1971, a timber company took advantage of these pesticide characters of the
neem and patent for neem seeds was received and sold it to W.R. GRACE, a
U.S. based multinational. Later, W.R. GRACE secured patents over neem
emulsions which can be used for pesticide purpose and thereby preventing
18
Ibid at p.131
111
Indian companies from making these emulsions. These issues were shocking to
Indian community as they found that it is nothing but stealing and pirating the
indigenous practices and the knowledge of its people. The NGOs opposed this
and made a movement for protecting the rights of the poor farmers who live
and make a livelihood from the neem and neem seeds. There were many
protests all over India and the most important one is the protest made by
farmers of Karnataka State. They rallied outside the District Office to challenge
the IPR issues raised by the MNC on the neem tree.
3.6.2.4 The Defences:

U.S. Company W.R. GRACE pleaded that they are trying to help the Indian
economy and the people by giving more market access in the global scenario.
The patent on the neem emulsion is considered as a new invention because it
with other combinations makes the pesticides more powerful and it is a process
patent with new innovation. The research foundation for science, technology
and ecology headed by Dr. Vandana Shiva was very vocal in her protest stating
that it is nothing but a theft, piracy on Indian traditional knowledge. The Indian
Government contested the defence raised by W.R. GRACE by producing
evidence from ancient texts where neem was used in many ayurvedic medicinal
preparations, used in manufacturing pesticides and other cosmetic preparations.
The Indian Government also contested on the ground that there is no novelty
involved, a very crucial criteria for issue of the patent. The other issue of
contest on neem is the violation of Article 15 of CBD where the focus of the
attention is on sustainable development and the rights of sovereign nations over
the biological resources. The TRIPS Agreement do not specify any method for
protection of life forms but left the option to the countries to design their own
regulations to give protection to the life forms which includes the protection of
the bio-resources.
112
3.6.2.5 The Different Patents Issued on Neem by USPTO19

• The USPTO granted patent to W.R. GRACE for extraction and storage
process of neem.
• U.S. Patent No.4946681 — Granted in 1990 for the improving storage
stability of neem extracts containing azadirachtin. The inventor is James
F. Water of Ashton, Maryland, U.S.A.
• U.S. Patent No.5124349 — The patent granted in 1994 for storage of
stable insecticidal composition20.
3.6.2.6 Some Indian companies also granted patents on

different claims:
• 70/Bom/91 — Process for treating skin ailments (Hindustan Lever
Limited).
• 757/Del/93 — Preparation of Edible Neem Oil (Rohan & Haas Co.).
• 7/MAS/94 — 7 - 94 - Method for preparing ayurvedic anti-virus
compound comprising three oils mainly neem seed oil (Giri Vas
Viswanath Seth).
• 1270/127l/1272/1273/Del/93 — Process for preparation of spermicidal
agent from neem oil (National Research Development Corporation). 21
3.6.2.7 Importance Of The Case:

The neem patent can be viewed from three dimensions.
• Local indigenous farmers would no longer be able to use their products
based on neem without paying royalties as it would amount to the
infringement of patent rights.
19
United States Patent & Trademarks Office
20
21
www.neemfoundation.org visited on 02.07.16
113
• The consumers who will be using the alternative medicines based on

neem properties would no longer be getting these medicines at
affordable price.
• The community as a whole is entitled to receive the share of profits from
the multinationals in accordance with CBD.
3.6.2.8 Chronological History of the Case22:

• The bio-piracy of neem by W.R. GRACE, U.S. Department of
Agriculture and European Patent Office on the basis of U.S. application
in December 26, 1984.
• The EPO granted European patent for its application on September 14th,
1994.
• The legal battle is on the basis of non-fulfilment criteria for patents, i.e.
novelty and inventiveness.
• The EPO rejected the objection and accepted the evidence produced by
India showing the lack of inventive step and it is a community property
that could not be patented.
• In 2000, EPO ruled in India‘s favour but the U.S. multinational
preferred an appeal as the ―prior art‖ had never been published in a
scientific journal.
• Overall 90 patents were granted on neem processes and 40 applications
were received at EPO.
• The appeal was lost on 8th March, 2005 revoking the neem patent.
After six years of battle, finally the neem patent was revoked. Ms. Linda
Bullard, President of International Federation of Organic Agriculture
Movement said, that the revocation of neem patent has a great impact not only
on India but throughout the world, specially the third world who have been
fighting to have control over their bio-resources and knowledge systems from
22
114
the patent regimes of the developed countries. The historic precedent of

revocation of neem and turmeric patents should further strengthen the
protection of bio-resources by evolving an international legal regime. The other
side of the case was represented by Prof. Dr. Fritz Dolder, Faculty of Law at
the University of Basel, Switzerland who made a comment saying that this is
the first of its kind that EPO has legally conducted a bio-piracy case.23
3.6.3 The Basmati Case:

Basmati is a variety of rice from the Punjab provinces of India and Pakistan.
The uniqueness of this rice is that it is slender, aromatic and long. It originated
in this region and is a major export crop for both the countries. In 1997, the US
Rice breeding firm Rice Tec Inc. was awarded a patent relating to plant and
seeds, seeking a monopoly over various rice lines including some having
characteristics similar to Basmati lines. Concerned about the potential effect on
exports, India requested a re-examination of this patent in 2000. The patentee
in response to this request withdrew a number of claims including those
covering Basmati type lines.24
The above few examples amply proves that it is the developed countries mostly
that indulge in bio-piracy. This has become possible due to many factors like
lack of awareness about the importance of traditional knowledge, absence of
necessary and timely legislation, lack of coordination between the National
Governments and NGOs and failure on the part of various traditional people
and communities to organize themselves to protect their traditional knowledge
and to share benefits as when the same is exploited by outsiders.
3.6.3.1 Basmati (Oryza Sativa):

U.S. Patent No. 5663484, U.S. Patent No. 4522838
23
24
Journal of Intellectual Property Right, Vol-18, March, July, September, 2012, page 15
115
Sunil an exporter of Basmati rice since 1960s having trade agreements in U.S.,
E.U. and many Middle East countries. He grows Basmati rice of exportable
quality in Punjab. He uses a distinct trade mark and the consumer in the
domestic and international markets identifies Basmati by its trade name, well
accepted in the public dominion. In 1998 his consignment was seized by U.S.
authorities and was asked to pay heavy penalty for patent infringement as it
was patented by one Rice Tec Inc., a U.S. based multinational. He was puzzled
and questioned how the Indian grown Basmati with its specific aroma and
unique grain can be patented by a foreign company. The grain he conserves is
the result of his native skills and developed with a careful culture of that breed
since three to four generations in his family. He feels that his rights are
threatened by the patent issued to Rice Tec Company 25.
Basmati, the queen of fragrance and perfumed rice, is grown in the foothills of
Himalayas since thousands of years. The aroma, taste of this typical grain was
much favoured by the emperors and praised by the poets. The peculiar, special
taste of this grain is much attributed to the soil in which it was cultured. The
surrounding environment and the moisture content of the soil at the foothills of
Himalayas made this grain unique. India is the second largest after China in
cultivation of Basmati rice.
The importance of Basmati on Indian culture and in day-to-day life is
inseparable. This is used as a staple food, used in all Indian ceremonies and lot
of traditional values are attached to this grain. On the export front, Basmati has
been one of the fastest growing export commodities from India earning U.S.
$250 million every year.
3.6.3.2 The Issue in Basmati:

In 1997, an American Company Rice Tec Inc., was granted patent by the
USPTO to the aromatic rice grown outside India as Basmati. The Rice Tec was
25
116
having international market with the brand name as Kasmati, Taxmati or

Basmati lines. After having patent rights it will label the rice as Basmati and
export to international markets. It has serious repercussions on Indian exports
and India loses its stand in the markets of E.U., U.K. and other Middle East
countries and also adversely affects the livelihood of many small farmers in
India.
The Rice Tec Inc. was granted Patent No. 5663484 on Basmati lines and grains
on 2nd September, 1997. 26 The invention that Rice Tec Inc. claimed to get the
patent is the novel lines and plants and grains of these lines. The invention also
relates to the novel rice lines produced from novel rice lines and the breeding
of these lines. The other important aspect is the Starch Index (SI) that
determines the furnace of the grain after cooking. The Government of India
responded by constituting a high level ministerial group comprising
representatives of ministers, Department of Commerce Industry and External
Affairs, Council for Scientific and Industrial Research (CSIR), Agriculture
biotechnology, All India Rice Exports Association, APEDA and Indian
Council of Agriculture Research, to re-examine the patent issued to Rice Tec
Inc. The case being examined by Sagar and Suri, the law firm from Delhi,
stating that Rice Tec Inc. got the U.S. Patent for three important characters;
firstly, it developed a similar variety of rice plant with identical characters of
Basmati; secondly, Basmati the rice grains produced by these rice plants and
thirdly, the starch index. The defence they pleaded to revoke the U.S. Patent is
that it lacks novelty an important criteria for granting the patent as there is no
inventiveness in the contesting case and it lacks the ‗prior art‘. The re-
examination for revoking the patent was filed on 28th April, 2000. There are 20
claims filed by Rice Tec on Basmati, out of these, Rice Tec withdrew 11 claims
and 5 were kept as main claims. The claims related to the novel rice lines that
are capable of producing grains similar or superior to Basmati rice. The most
26
117
important victory as India could see is the change of nomenclature from

Basmati lines and grains to rice lines BAS 867, RT 1117, RT 1121.27
3.6.3.3 The Controversies:

When this case was filed, many controversial arguments were raised by
Indians. The primary objection was that U.S. government decision to grant
patents to Basmati is the violation of the provision of TRIPS Agreement.
Basmati is traditionally grown and very closely associated to India and its
people due to its specific origin from Himalayan foothills. The specific flavour,
taste and other attributes are unique due to its geographic origin which has its
clear space in TRIPS Agreement. The TRIPS Agreement defines geographical
indication as ‗goods originating in the territory of a member or region or
locality in that territory where the given quality, reputation and other characters
of the goods are essentially attributable to its geographical origin‘. (Champaign
is associated with France and Scotch Whisky to Scotland). The attitude of India
in support of the case is that it is a product of nature and India has the
sovereign rights and there is a threat to these specifically originated products.
India being signatory to convention on biodiversity, recognises the rights of
local communities, affirms the inalienable rights over biodiversity and
biodiversity related knowledge. The case of Basmati, turmeric and neem has
awaken the Indian Government out of its deep slumber and made Indian
Government to pass legislation protecting the products specific to the
geographical regions.
Thus Basmati patent involves threefold infringement on the treasures of India.
It is a bio-piracy and theft of Indian biodiversity, on farmers‘ rights, and threat
to export potential of Indian markets. This is also a trade mark deception and a
clear case of ‗passing off trade‘. The consumer is deceived by using the Rice
Tec brand Basmati which was derived from India but not grown in India. The
27
118
grains may be apparently same but in content the one grown by Rice Tec Inc.
and the original Basmati are different with different attributes.
The case has multidimensional and complex issues of violations of intellectual
property rights especially geographical indications. The present case can also
be argued from the angle of trade mark infringements. The Paris Convention
also makes it clear that trade mark which confuses the consumer; mere
reproduction of the earlier one, the translation of well-known mark is not the
subject-matter for registration under the trade mark law. The use of BAS 867
by Rice Tec Inc. attracts the violation of the spirit behind Paris Convention.
The same protection is also mentioned under Article 16.1 of the TRIPS
agreement. The argument in confirmation of trade mark based on prior use of
the trade mark to support the view, that U.S. laws are very stringent in
conferring the trade mark if they are already in public domain. The U.S. has
violated the simple rule of ‗prior art‘ in conferring a patent right to Rice Tec
Inc. as Jasmati was registered in 1993 and Kasmati in 1996. 28
The significant victory has been the change of title of the Rice Tec. Patent from
original Basmati lines and grains to rice lines BAS 867, RT 1117 and RT 1121
by the USPTO. Indian Government needs a very cautious and preventive
approach for any future claims on Basmati. This could be averted by
registering Basmati variety in accordance with the relevant provisions under
Geographical Indications of Goods (Registration and Protection) Act, 1999.
3.6.4 The Wheat Grain:

Patenting of wheat gene by Monsanto caused apprehensions among Indians.
Monsanto has patented wheat invented by crossing traditional Indian variety
with another wheat line. Monsanto developed a new wheat variety from the
primitive Indian land race named as Nap Hal. The wheat obtained from Nap
Hal would be ideal for making all bakery products. Monsanto was granted
28
Company, First Edition, 2008, at p.138
119
patent by European Patent Office based in Munich. The patent was given for
biscuits, flour and other products from the wheat as well as the plant itself. By
owning patent on the plant itself, in future the infringement cases could be filed
against the Indian farmers and other bakers for non-payment of royalties to
Monsanto for using the patented wheat. The new variety that Monsanto
developed with the unique characters like soft milling wheat is covered by the
patent. The flour from this new variety has a tremendous scope for enhancing
its profits due to the flour elasticity and also the presence of grain protein
which is soluble to prevent lumps in the batter.
The Indian community reacted and challenged Monsanto patent of Indian
wheat at EPO on 27th January, 2004. The Green Peace, RFSTE and Bharat
Karshak Samaj has jointly challenged this patent right of Monsanto. The
European database shows that Nap Hal was collected from Uttar Pradesh, in
India in 1948. This evidence has given substantial support to revoke the patent
on 5th October, 2004.
The above mentioned cases are only illustrative examples of patenting of
products belonging to a specific geographical region. Amla, ashwagandha,
karela and many other products of nature of this country might face similar
future challenges as there are many claims being patented by non-resident
Indians and multinational corporations.
3.6.5 The Pharmaceutical and Agricultural Chemical

Products:
The complainant in the present case is U.S. and E.U. (Third party) against
India. The Indian government appealed against the panel report of DSU 29 of
WTO for considering the protection for Pharmaceuticals and agricultural
chemical products under TRIPS Agreement30, and a ―means‖ for the filing for
29
Dispute Settlement Understanding
30
Article 27 of TRIPS Agreement
120
patent applications for pharmaceutical and agricultural chemical products 31.

The panel reached the conclusion that India has not complied with its
obligation under Article 70.8 and failed to establish a mechanism that
adequately preserves novelty and priority for product patents in respect of
pharmaceutical and agricultural chemical inventions during the transitional
period as mentioned in TRIPS Agreemen 32t. The Panel also made the
submission that India did not comply with its obligation under Article 70.9 for
the system of establishment of Exclusive Marketing Rights (EMRs). The panel
recommends that India should bring the transitional regime for patent
protection of pharmaceutical and agricultural chemical products in conformity
with its obligations under TRIPS regime.
3.6.5.1 Chronological History of the case:

• Panel report submitted to Dispute Settlement Board (DSB) on 5th
September, 1997.
• India notified the intention regarding the appeal concerning certain
issues of law and legal interpretation issued by the panel on 15th
October, 1997.
• Submission of appellate application on 27th October, 1997.
• U.S. filed an appellate submission on 10th November, 1997.
• The E.U. filed a third party submission on the same day.
• The oral hearing was provided on the working procedures on 14th
November, 1997.
• The DSB gave its recommendations on 4th December, 199733.
3.6.5.2 The Arguments of the Appellate Body:
India states that it has established through administrative instructions ―a
means‖ by which application for patents for Pharmaceuticals and agricultural
31
Article 70.8 of TRIPS Agreement
32
Article 65 of TRIPS Agreement
33
121
chemical products can be filed. Thus, the provisions under Articles 70.8, 70.9
and 63 of the TRIPS Agreement are complied. The contention is substantiated
by 1924 number of filings received by India as on 15th October, 1997. These
applications were received with all the procedural formalities like the date of
receipt, name of the applicant, title of the invention and published in the
official gazette of India. The patent office received 893 applications in the field
of drugs and medicines from Indian and foreign institutions. These applications
would be taken up for examination after 1st January, 2005. Thus, it supports
the argument of India that it complied with TRIPS requirement of creation of
mail box provision to establish the priority date for issuing the patents.
India assured that the patents could be granted when they are due in accordance
with Article 70.8 on the basis of applications currently submitted and determine
the novelty and priority of the inventions in accordance with the date of
application. India argued the provision regarding EMRs to pharmaceutical or
agricultural chemical product for which a patent application has been made in
accordance with Article 70.9. India also contended that Article 70.9 is a part of
transitional arrangements of the TRIPS compliance whose function is to
provide relief till necessary changes take place on the domestic front. India‘s
view in this aspect is that the panel has extended its observations and
recommendations on the need to establish predictable conditions of
competition.
India asserts, in accordance with Articles 3, 7 and 11 of DSU, the panel is to
make findings and recommendations only on matters submitted to them by the
parties to dispute, however the panel in this case has exceeded its authority
under DSU by the subsidiary claim made by U.S. to create legal certainty that
the patent applications and the patents based on them will not be rejected or
invalidated in the future.
122
3.6.5.3 The Defences:

U.S. endorses the legal findings and the conclusions of the panel report
regarding Articles 70.8, 70.9 and 63 of TRIPS Agreement. U.S. reaffirmed the
failure of the system described by India to achieve the object and the purpose
of this provision. U.S. affirms the panel observations for the establishment of
mail box system and insists that administrative system described by India does
not provide a sound legal basis for mail box applications. Finally, U.S. asserts
the panel recommendations to bring India‘s transitional regime for patent
protection of pharmaceutical and agricultural chemical products in conformity
with its obligation under TRIPS Agreement. U.S. further contends that India
failed to provide the mechanism for ―availability‖ of the right as a precedent
and granting comes later. U.S. further supports the view by citing where a U.S.
company satisfied all the requirements for grant of EMRs but not applied in
India because it did not obtain information regarding the appropriate procedure
for doing so.
U.S. further argues the consequences of India‘s view on Article 70.9 where a
national of another WTO member would have to wait till India enacts
legislation making these rights available to other member countries is
inconsistent, as they do not foster the predictable conditions of competition and
do not protect the interests and expectations of the member countries. The
procedure for grant of EMRs would balance TRIPS Agreement with respect to
pharmaceutical and agricultural chemical products. The E.U. also endorses the
panel findings concerning the failure of India to take action necessary to
implement its obligation under Article 70.8 of the TRIPS Agreement.
3.6.5.4 The Major Issues Raised by India:

• What is the proper interpretation to be given to the requirement in
Article 70.8 of the TRIPS Agreement that a member shall provide ―a
means‖ by which application for patents for inventions relating to
Pharmaceuticals and agricultural chemical products?
123
• Does Article 70.9 of the agreement requires a ―mechanism‖, in place to

provide for the grant of EMRs effective from the date of entry into force
of WTO agreement.
The content of Article 70.8 makes transition arrangements for the patent
protection for pharmaceuticals and agricultural chemical products. With the
obligations under Article 27 of TRIPS Agreement that member shall provide:
• a means by which application for patents for such inventions can be
filed.
• apply as to the date of application of this agreement the criteria for
patentability as laid down in this agreement as if the criteria were being
applied on the date of filing to claim priority date.
• providing patent protection in accordance with this agreement as from
the grant of patent for the reminder of the patent term, counted from the
filing date in accordance with the Article 33 of this agreement, for those
of these applications that meet the criteria for protection referred in sub-
para (b).
With respect to Article 70.8 India affirms that through ―Administrative
Instructions‖, ―a means‖ consistent with Article 70.8 of the TRIPS Agreement
is established. India further justified in stating that through these administrative
instructions a sound mechanism was created which provides a legal base to
preserve the novelty of inventions and priority of the applications on the basis
of date of filing is consistent with Article 70.8 of the TRIPS Agreement. The
direction from the patent office to store these applications for patent protection
to pharmaceuticals and agricultural chemical products the Controller of Patents,
Designs and Trade Marks was not to refer instructions until 1st January, 2005
is a clear indication that these administrative instructions were legally valid in
accordance with Indian law. The panel‘s opinion was that these ‗administrative
instructions‘ create certain degree of legal insecurity and it is clear that Indian
officials have ignored certain mandatory provisions of the Patents Act. Finally,
124
the panel concluded that these administrative instructions for receiving mail
box applications are not in consonance with Article 70.8 of the agreement.
The second issue raised by India with respect to Article 70.9 of the TRIPS
Agreement is to provide the mechanism for the grant of EMRs at any time
subsequent to the date of entry into the WTO agreement.
3.6.5.4.1 Article 70.9 of the TRIPS Agreement:

Where a product is subject of patent application in a member in accordance
with Article 70.8 exclusive marketing rights shall be granted for a period of 5
years after obtaining marketing approval in that member, or until a product
patent is granted or rejected in the member, whichever period is shorter.
On the basis of the content of Article 70.9 of TRIPS Agreement, there is a need
to have a mechanism ready for the grant of EMRs at any time subsequent to the
date of entry into force of WTO agreement. India argues that Article 70.9
establishes an obligation to grant EMRs for a product that is subject-matter
under Article 70.8. The panel observation is that India should have had a
mechanism in place to provide for the grant of EMRs effective from the date of
entry into force of WTO agreement and therefore violated Article 70.9 of
TRIPS Agreement.
The conclusion of appellate body is—
• Upholds the panel conclusion that India has not complied with its
obligation under Article 70.8.
• Upholds the panel conclusion that India has not complied with its
obligation under Article 70.9 of TRIPS Agreement.
The appellate body recommends the DSU to request India to bring its legal
regime for patent protection of pharmaceutical and agricultural chemical
products in conformity with Articles 70.8 and 70.9 of TRIPS Agreement.
The above cases before the DSU of WTO sent signals to India to harmonise
domestic patent legislation with the TRIPS Agreement. The Government of
India in response to Turmeric, Neem, and Basmati cases enacted the
125
Geographical Indications Act (Registration and Protection), 1999, the

Biodiversity Act of 2002 and the Plant Varieties and Farmers Right Act, 2001
to show that India made good efforts to tune its legal framework with the
TRIPS Agreement of WTO. The recent amendment to the Indian Patent Act in
2005 is in tune with the total compliance of the TRIPS Agreement. 34
3.7 BIOTECHNOLOGY COMPANIES IN INDIA:

India is home to over 300 biotech companies with a total bioscience investment
of more than $500 million. Though this is a small share of the global biotech
market, the promise of the growth of the industry in India is significant. It is
estimated that the domestic market for biotech products will grow
tremendously and India may claim 8% of the World‘s Biotechnology
Companies by 2010.35 The major players in the Indian Industry include.
Biocon, Serum Institute of India, Panacea Biotech, Nocholas Piramal,
Wockhardt Limited, Glaxo Smith Kline, Bharat Serums, Krebs Biochemical‘s
& Industries Ltd., Zydus Cadiala, Indian Immunologicals, Shantha
Biotechhmics, Biological E, Chiron, Behring Vaccines, Eli Lilly and Company.
Novo Nordisk, Mahyco Monsanto, Bharat Biotech, Abbott, Ranbaxy,
Novozymes etc. The contribution of few such companies are discussed in
details.36
3.7.1 Shantha Biotech:

This is one of the leading examples of our first category of firms – small start
ups with their own biotech products, Shantha Biotech has the credit of
developing India‘s first world class Hepatitis-B vaccine and making it available
34
Company, First Edition, 2008, page 146
35
Sharma Manju and K.K. Tripathi. 2000b. ―Excellent Opportunities in India‘s knowledge
based Biotech Industry‖. US-India cooperation in scientific research aiding entrepreneurs
in excellerating pace of revolution in fast-growing biotech industry. Business Times,
Washington D.C., XVIII (3). Society of Toxicology. 2002. P 35
36
Ibid at p 37
126
at one third of the prevailing market price of imported vaccines. This company
has an active biotechnology programme since 1994. 37 Now Pfizer Ltd., the
major pharma TNC, has obtained the first refusal rights from the Hyderabad
based Shantha Biotechnics Pvt. Ltd. for exclusively marketing the products to
be developed by the latter in future. Earlier, Pfizer had entered nto a co-
marketing agreement with Shantha Biotech for marketing the latter‘s
recombinant DNA vaccine for Hepatitis-B. Shantha Biotech is currently in
advanced stages of discussion with one European Pharma major and about
three US based pharma companies for its research projects. The Company
plans to research on protein purification, molecular cloning and expression of
native and synthetic genes. Shantha Biotech will also be offering polyclonal
and monoclonal antibody development and formulation of certain types of
vacancies. Shantha Biotech has developed in-house expertise in recombinant
DNA technology and are very strong in development of cell lines for
development of recombinant products. The company has invested Rs.100
million in the biotech facility with external funding (from Bank of Oman). 38
3.7.2 Dr. Reddy’s Laboratory (DRL):

Some of the companies like DRL have grown in the recent past. It was
established in 1984, DRL is a big pharmaceuticals company and now is setting
up biotech production facilities as per the US FDA specifications. The
company has also identified biogenetics as significant market area which is
estimated at $ 14 billion. It has pegged its brand value at Rs.9,160 Million as
against last year‘s value at Rs2,850 Millon 28.39 The biotechnology facility
37
38
Ibid at p 42
39
127
includes setting up to three class 10,000 bulk recombinant protein production

suites and new formulations facility as well. The biotechnology business would
cover therapeutics, vaccines and diagnostics. DRL has a research a research
alliance with Centre for Cellulr and Molecular Biology (CCMB) Hyderabad.
DRL has also established a research subsidiary in Atlanta called Reddy US
Therapeutics Inc., as well as a contract research subsidiary that will focus on
genomics.40
3.7.3 Ranbaxy Laboratories:

Ranbaxy, India‘s largest pharma company with sales of more than $500 million
in the year 2000, also views innovation in biotechnology as key to its future. It
is one of the oldest post independence firm founded in 1968. The company has
branched out from creating new formulations of existing drugs and has half a
dozen molecules under development. Ranbaxy has collaborations with several
U.S. and European Companies to develop new formulations and technologies.
For example, Ranbaxy and Vectura Ltd. (Both U.M.) announced in 2001 that
the Indian company‘s Ranbaxy B.V. subsidiary (the Netherlands, Antilles), will
develop oral formulations using Vectura‘s controlled release drug delivery
technology, with Ranbaxy providing clinical development, scale up,
manufacturing and marketing expertise.41 Ranbaxy has set a model in India in
terms of drug development. The model suggests that develop a molecule upto
the level a domestic company can afford to do generally upto the first phase of
the clinical trial and then outsource it to a leading MNC for further
development and lateron explore the possibilities for marketing tie-ups.42
40
Ibid at p49
41
Ibid at p 50
42
128
3.7.4 Wockhardt Ltd.:

Wockhardt Ltd. established nearly four decade ago, is the fifth largest
pharmaceutical company of India. Wockhardt has grown at over 20 per cent
annually for the last 5 years 30 . In the year 2000, it acquired Merind from the
Tata‘s and besides Wallis Laboratories, a company in the UK, apart from
entering into marketing alliance with the American Sidmak Labs. The company
is formulating its biotechnology strategy around these initiatives. It has decided
to split its business into two separate entities.43 Wockhardt Ltd. will remain as a
pharmaceutical company while the new entity would focus on Life sciences
only. The new company (the name of which has yet to be finalized) will have
all the other business namely hospitals, nutrients. IV fluid and agro vet (Crop
protection). The R&D activity is also being categorized into three divisions.
The first Division concentrates o developing new bulk drugs, (Novel drug
delivery system (NDDS)) and generics. The second division concentrates on
recombinant biotechnology. At present, the second division is focusing on
technology absorption with the assistance of scientists from abroad. The third
division is dedicated for discovery of new molecules. Wockhardt is expected to
come out with its first investigational new drug (IND) in anti-infective
therapeutic segment by end of 2002. At present, the turnover of CROs is very
close to$100 million 31.44 The major companies in this category are quintile
India, Lambda, Welbech, Lotus and SIRO Clinpharm Ltd.Indian Scientists
from leading institutions are now actively floating companies. For instance,
two scientists from Indian Institute of Scientists (IISc), Bangalore have floated
a company called Metahelix Life Sciences with $1.5 million venture capital
funding.45 The company would focus on providing contract research services in
genomics, molecular markers and bioinformatics, to being with and eventually
developing new molecules on its own.
43
Ibid at p 54
44
Ibid at p 55
45
Ibid at p 56
129
The active role of Indian Biotech Companies has become visible through
various efforts and final revenue generated by them ABLE, the Association of
Biotechnology Led Enterprises, for example, is a form of leading Indian
Biotechnology companies to generate a symbiotic interface between the
industry, the Government, academic ad research bodies, and domestic and
international investors. Recently, Serum Institute of India Ltd. has announced
an investment of Rs,1,200 crore ($270 Million) at the inauguration of India‘s
first biotech Special Economic Zone (SEZ) in Pune, The SEZ is specifically
meat for biotechnology and pharmaceutical products. All the above
developments clearly indicate the potential and bright future of biotechnology
in India.46
As biotechnology inventions are based on biological sources, as the starting
point of any biotechnological invention is biological material, having enormous
biological resources in India there going to be definite growth in the biotech
industry. Recognizing the significance of the upcoming sector of biotechnology
in the present Worlds the Government of India has come out with certain
strategic plans to boost the industry. Further the Government of India
announced special assistance and scholarships for studies and research in
biotechnology to boost expertise and manpower in the Sector. Besides bringing
changes in the patent law to give protection of biotechnological inventions,
having made all the legal arrangement India is ready to face the challenges that
biotechnological inventions and researches in different spears of biotechnology
may give rise to.
On the whole the evolution of biotechnology patent law can be traced back to
the constitution of America, which intends to foster the progress of science and
biotechnology. The judiciary of US has played an important role in the
emergence of biotechnology patent law through its innovative interpretation of
the patent law. The liberal approach of the US judiciary was supported by the
US patent office by granting patents on biotechnology inventions. The suit of
46
Ibid at p 57
130
the US judiciary and the patent office was followed by the other nations.
Initially the European Union was ahead of the US as there witnessed patent
claims on biotechnology inventions involving life. However it was the US
judiciary, which gave rise to the emergence of biotechnology patent law
through its judgments in Chakrabarty47. The decision of Chakrabarty is a
milestone and is the starting point in the evolution of biotechnology patent law.
The decision had its far-reaching impact where it influenced the entire World.
Even today Courts while adjudicating matters involving biotechnology
inventions and patent offices while granting patents on biotechnology
inventions do follow the rationality of the Chakrabarty48.
The approach of the US is very liberal their philosophy is that anything under
the sun made by man is patentable. The evolution of biotechnology patent law
is heavily influenced by this philosophy evolved by Thomas Jefferson the
author of American Patent Law. The European Union was quick enough to
follow the philosophy of America in liberally interpreting the existing patent
laws to provide patent protection of biotechnology inventions. Later the entire
World including India did follow the suit by amending their local laws or
bringing suitable legislations to give patent protection to biotechnology
inventions. Meanwhile the TRIPS agreement also postulate for patenting of
inventions in all the fields of science and including livings beings produced
through biotechnology. It is felt that the coming into being of the agreement
has streamlined and uniformed the law relating to biotechnology inventions.
Though faced strong oppositions and objections the evolution of biotechnology
patent law is complete and all inventions of biotechnology like
microorganisms, plant, animal and human genetic material including different
methods to produce the same are patentable throughout the World.
47
Diamond –Vs- Chakrabarty, 447 U.S. 303 (1980).
48
Tripathi, K.K. 2001 b. Biotechnology: Government of India Initiatives‖. Indian Investment
Center News Letter. (Ministry of Finance), March 25, 2001, pp. 4.
131
3.8 CONCLUSION:
Over the years India has developed strengths in biotechnology in public Sector
institutions. The graduation from biotechnology Development Board to
Development of biotechnology in late eighties was a decisive step to address a
wider canvas in biotechnology. In these years DBT has emerged as a manor
fore to direct biotechnology developments in India. Further, the involvement of
various agencies dealing with this technology has further helped in developing
technology capability at various levels. 49 The size of the industry is estimated
to have grown to $ 1.5 to $m 2.5 Billion between 1999 and 2002.50 There are
two major research centres in India working on stem cell line research. The
achievements in biotechnology in India could become possible only because
the Government took early initiatives for setting up institutional infrastructure
for human resource development. As of now more than 62 Universities and
Institutions are engaged in biotechnology training and education related
programmes.51 Efforts are being made to link up human res08rce development
programs according to industry requirements, and in fact, academic institutions
are also being encouraged to work in close tandem with industry. India has
attached greater importance to bioinformatics, DBT has set up 55 centres for
bioinformatics, which have been developed as strong information network.52
They are linked with databases and networks round the World. The whole
range of new initiatives to support biotechnology programmes at Indian
Institute of Technology and at Jawaharlal Nehru University are aimed in that
direction. The micropropogration technology parks at TERI.53 New Delhi and
NCL, Pune have served as an important interface between the industry and the
49
Tripathi, K.K. 2001 b. Biotechnology: Government of India Initiatives‖. Indian Investment
Center News Letter. (Ministry of Finance), March 25, 2001, pp. 11.
50
51
ibid
52
ibid
53
ibid
132
developers of the technology in the areas of 36 plant tissue culture. National

Centre for Plant Genome Research and National Brain Research Centre are
some of the recent additions. However, it is difficult to estimate precise R&D
allocations at several of these centres. The budgets of major funding agencies
like CSIR/ICMR and ICAR give only an aggregate picture. Therefore there is
an urgent need to launch a detailed survey to collect specific biotechnology
related allocations at the individual institute/laboratory level. Apart from this
DBT or some other such agency should urgently initiates an exercise for data
collection either on its own or through specialized sectoral agencies. These
initiatives coupled with other industrial promotion efforts may encourage
industry also to participate in this technology evolution exercise. Despite
phenomenal growth and rapid penetration of this technology. However, the
local firms are facing an intense competition from a whole range of
transnational corporations. The pressure is immensely acute in the agricultural
sector where Indian firms are finding it difficult to access relevant gene
sequences given the proprietary rights of TNCs as developers of these
technologies. In the pharmaceuticals sector, where advanced forms of
biotechnology are being used, firms are facing severe liquidity constraints for
investment. According to Ernst & Young, technology funding required for
Indian biotechnology sector in 2001 was $2.5 billion while by 2010 it would be
$4.8 billion.54 A larger part of this funding is for supporting development of an
idea and also for diversification of activities of Indian firms. The biosafety
policy was announced in India right in the beginning when this technological
revolution was being unfurled. A three-tier structure was put in place to
monitor biosafety regulations way back in 1987.55 Similarly, India has
announced a National Bioethics Committee as it implements the Guidelines for
54
55
Journal of Indian Law Institute, Vol. 65, Jan. Mar. 2011page 39
133
Steam cell Research. 56 The recently promulgated Plant Variety Protection Act
has brought in a rate balance between the interests for farmers and industry.
Though debate on Article 27(3) b of TRIPS57 still continues in India, an
amendment is being brought in the Patents Bill to facilitate research and
development in biotechnology. Another major challenge related to IPR regime
in India is of data management. TIFAC is the only agency in India giving
patent statistics in electronic form. However, the agency does not collect
International Patent Classification (IPC) details, which help in identifying
biotechnology patents. Thus, it is difficult to precisely work out even a board
trend in technology development in this knowledge intensive industry. The
increasing number of patents every may further complicate such estimation.
It is through continuous efforts that India has developed indigenous GMOs, but
a policy related to trade in GMOs is yet to be announced. This dichotomy is
leading to confusion at several levels of governance of this technology. It is
also important to realize that at this stage neither at the Union Government
level nor at the State Government‘s level, trained manpower available to look
into the technical details of GM crops, if at all being produced. Apart from this,
neither the quarantine nor any other agency has necessary gadgets to help in
locating transgenic material. In this context, the International Cooperation
Division of Department of biotechnology has shown farsightedness to plan an
international training course of Government employees for capacity building.
The problem is that people from quarantine agencies at the ports and other
entry points are not well equipped to detect GMO content in any agriculture
product. This calls for quick short term measure to overcome lack of
knowledge about the technology and along with that long term analysis to
respond to systemic failures at different levels.
56
ibid
57
ibid
134
CHAPTER 4
SOCIAL IMPACT OF BIOTECH

INVENTIONS AND PROTECTION
ISSUES
4.1 INTRODUCTION:
The modern biotechnology, which is a late 20th century phenomenon, is the
result of scientific advances that go well over a century. With the advent of
modern biotechnology, the innovation in commercial biotechnology has been
taking place the world over. However, the USA has pioneered the commercial
biotechnology and can be called as the world leader due to various reasons. The
other successful commercial biotech countries are Japan and Europe especially
UK, Germany and France where the industries have enjoyed the benefit of
ground breaking research carried out universities and other public funded
research institutions. Biotechnology and genomics have created enormous
commercial opportunities in the area of healthcare, agriculture environment and
industrial products.1
In the past one and half decade, India has shown excellence in scientific
performance as evidenced by number and quality of publications made each
year international journals with the research leads on cover pages and various
citations al Indian authors, but its technological and commercial performance is
low as indexed by the number of patents issued per unit of investment made in
1
Tripathi Dr. K.K., Biotech Patent Law, Veena (Ed), Amicus Books The Icfai University
Press, Hyderabad, at p.187
135
R & D2. There considerable debate going on the IPR issues since India acceded
to PCT, but still then is lot to be done in the awareness generation on the IPR
issues.
Further, the ongoing and preparative negotiations under GATS, especially for
the R & D service sectors in general and biotechnology R&D, in particular
would have a major impact on the biotech business of India and the other
developing countries.3
The ownership and exploitation of intellectual property rights are the key
factors in determining the success of any technological innovation introduced
in the market that provide the means for technological progress to continue, to
be made and thereby support the competitiveness of industry of the country.
IPRs make it possible to develop strategies for dissemination and transfer of
technologies in such a way, which may provide maximum societal benefits. It
is a well-known fact that a country‟s economic and social success is utmost
when different members of society have a common understanding, clear
division of labour and responsibility with a common understanding for the
shared societal values. The efficient management of IPRs is thus crucial in
providing the right incentives for continuing technological innovations. The
IPRs are thus helpful for new business opportunities and for value adding
knowledge-based industry. It is high time that India rapidly adapts to the
challenges posed by a continuously evolving technological environment of the
world.
The regulatory mechanisms in IPRs have their own problems in the coming
scenario of emerging technologies especially in biotechnology. The regulatory
reform-initiatives are further required to streamline and sort out the problems in
the new frontiers of IPR system. This would give further competitiveness in
other significant economic sectors involving copyright, geographical
2
Research & Development
3
Tripathi Dr. K.K., Biotech Patent Law, Edited by Veena, Amicus Books The Icfai
University Press, Hyderabad, at p.188
136
indications, right to information to the society, patenting, etc. The patenting of

new technologies, in the presently highly competitive environment provides the
most robust system in the IP protection. Nonetheless, the biggest problem,
which can be mentioned, is the copying of technologies that is becoming more
and more frequent with the emergence of new technologies. For example, 60
per cent of all patented innovations are imitated on an average within four
years; the ratio of imitation time to innovation is on an average of 70 per cent;
the ratio of imitation cost to innovation cost is on an average of about 60 per
cent. This is the reason with the advent of new technologies many corporate
houses decide to protect their product/process by other methods and the most
common is “nondisclosure” or not to protect their IP where the new
technologies have a very short span of life cycle. The most common example
of non-disclosure is the case of Coca-Cola and Pepsi who have never disclosed
their formulations to anyone till today. At the same time the innovative
industries try to keep finding better ways to protect their IP.4
4.2 IMPACT OF TRIPS AGREEMENT ON

BIOTECHNOLOGY INVENTIONS:
At the time of the TRIPS negotiations in the Uruguay Round, the US and the
EU differed in their approaches to the patenting of biotechnological inventions.
While the US believed that „anything under the sun made by man, except
human beings, was patentable, the EU was grappling with strong internal
resistance to patents on living organisms. Since the debate had not yet been
settled in Europe, WTO members agreed to a minimal agreement while
committing to revisit this provision within four years from the entry into force
of TRIPS i.e. by 1999. Article 27.3(b) of TRIPS incorporates this minimal
agreement.
4
Tripathi Dr. K.K., Biotech Patent Law, Veena (Ed), Amicus Books The Icfai University
Press, at p.189
137
Article 27 of TRIPS requires that patents be made available, for both processes
and products, in all fields of technology. Under Article 27.3(b), plants and
animals, and essentially biological processes for their production may be
excluded from patentability. However, microorganisms and microbiological or
non-biological processes must be protected. While there is uncertainty as to the
definitions of certain terms such as such as „non-biological‟ or „essentially
biological‟, clearly, microorganisms and microbiological processes are not
excluded from patent protection despite resistance from some developing
countries during the TRIPS negotiations.
There seems to be some confusion regarding the exact meaning of the term
„microorganisms‟ as mentioned in the TRIPS Agreement. Some view
„microorganism‟ as any microscopic or ultramicroscopic organism while other
limit the definition to only unicellular organisms. The proponents of this
limited view interpret the term as restricted, at best, to organisms such as
viruses, algae, bacteria, fungi and protozoa and exclusive of cell lines, genes
and gene sequences. Since the TRIPS language is drawn, to a large extent, from
the EPC, it is important to note that under the current practice of the European
Patent Office (EPO), cells and parts thereof are treated like microorganisms.
Canada, in its definition of microorganism, recognizes cell lines and
hybridomas in addition to unicellular organisms. However, in the absence of
any clear definition under TRIPS, WTO members seem to have some degree of
freedom to define microorganisms and microbiological processes in a
reasonable way, as long as this can be defended before a WTO dispute panel.
It is important to note that the three universally recognized criteria of
patentability now incorporated into Article 17.1 of TRIPS, namely, novelty,
non-obviousness and industrial applicability or utility, apply to all inventions,
including biotechnological inventions. However, the application of these
standards to biotechnological inventions has given rise to a peculiar set of
problems resolved in different and increasingly controversial ways in patent
offices and courts in the developed world. Indeed, the concept of invention
138
itself is controversial. Almost all patent laws provide that discoveries or

substances found in nature do not constitute an invention and are thus
excludable from patent grant. However, the distinction, relevant to
patentability, between the „‟discovery‟ of something that exists in nature and
the „invention‟, or the creation of something new involving a pre-determined
degree of human effort or intervention, is, in practice, difficult to make in the
field of biotechnology. TRIPS gave no guidance on this, thus giving a certain
degree of flexibility to developing countries in formulating their laws to avoid
the patenting of products of nature.
The focus of this invention versus discovery debate is whether WTO members
can exclude from patentability naturally occurring substances, such as
sequences of nucleotides (DNA), where these have been isolated through
technical processes, even if the final product merely reproduces the substance
as found in nature. Some commentators on TRIPS opine that since the term
„invention‟ has not been defined, there is some scope for defining such
exclusions in national laws. Can natural substances be excluded even if isolated
or reproduced through technical processes? Some believe that TRIPS requires
product patents on gene sequences and other such products of nature, when
they isolated through technical processes and even if the final product merely
reproduces what is found in nature. According to this view point, even if such
biological material has previously occurred in nature, it must be patentable if it
is isolated by means of a technical process, and of course, if new and non-
obvious.
The exclusion of „plants and animals‟ in Article 27.3(b) of TRIPS is clearly
broader than that of „plant and animal varieties‟ given under the European
Patent Convention (EPC), which is reiterated in the new EU Directive and in
many national patent laws of developed and developing countries. However
under Article 27.3(b) of TRIPS, if plants are excluded from patent protection,
at least an effective sui generis system must be put in place for the protection of
new plant varieties. In other words, plant breeders‟ rights (PBR) are to be
139
protected despite the optional exclusion from the patenting of plants. Countries
can also opt to give both options for the protection of plants. Unlike other
subjects under TRIPS, there is no mention of adherence to a pre-existing
international convention or to any specific details on scope of coverage, term of
protection and limitations to such protection. Therefore, while all sides accept
that plant varieties have to be given some form of effective sui generis
protection, the question is what should be the scope and details of such
protection.
There are some issues relating to patentability of biotechnological inventions
such as novelty, obviousness, utility and extent of disclosure and clarity in
claims. In addition, a few special issues such as those relating to national
policies, moral and ethical issues, environmental safety and issue of public
interest such as cloning of farm animals, gene diagnostics have also been
evolved. Thus, the patenting of the inventions in the field of biotechnology has
become important. It has also become an international issue when patenting of
such inventions was included under TRIPS agreement. Critics examine Article
27.3(b) of the TRIPS Agreement, currently under review at the WTO, and its
counterparts in the EU Patents Directive. They show that the Articles are
couched in underfined terms, designed to allow the broadest categories of
patents from genetic engineering and other new biotechnologies. They also
argue why all classes of new biotech patents should be rejected from inclusion
in TRIPS on one or more of the following grounds:
 All involve biological processes not under the direct control of the
scientist. They cannot be regarded as inventions, but expropriations
from life.
 The hit or miss technologies associated with many of the
„inventions‟ are inherently hazardous to health and biodiversity.
 There is no scientific basis to support the patenting of genes and
genomes, which are discoveries at best.
140
 A range of patents are unethical; they destroy livelihoods, contravene

basic human rights and dignity, compromise healthcare, impede
medical and scientific research, create excessive suffering in animals
or are otherwise contrary to public order and morality.
 Many patents involve acts of plagiarism of indigenous knowledge
and biopiracy of plants (and animals) bred and used by local
communities for millennia.
There are four categories of patents on life forms and living processes covered
by TRIPS:
i. Processes producing extracts of plants for medical or
industrial/agricultural purposes.
ii. Naturally occurring microorganisms, cell lines, genomes and genes
isolated from natural organisms;
iii. Transgenic techniques and constructs and the resultant transgenic
organisms;
iv. Nuclear transplant cloning and other in vitro reproductive
technologies.
4.2.1 TRIPS Agreement and Biotechnology in India:

Intellectual property rights have gathered strong impact on the modern day life
and therefore, the impact of intellectual property rights is enormous. These
intellectual property rights were promoted in an ever seen manner by the
TRIPS Agreement. It is one among the several agreements that World Trade
Organization (WTO) has negotiated in the last century. Intellectual property
rights were not there in the agenda during the WTO/GATT negotiations till
1980s. GATT negotiations started in 1947 with an objective to establish WTO
and to negotiate on various business aspects, but till 1986, intellectual property
rights and their protection were not considered. However, during the last phase
of negotiations it was agreed to have a separate agreement on Intellectual
Property Rights. Today, intellectual property rights and the TRIPS, which
regulate the field, have garnered enormous significance, more than any other
business issues, which were part of the WTO/GATT negotiations. Trade
Related Aspects of Intellectual Property Rights has mandated its member states
141
to implement the provisions of the agreement in order to promote and protect

intellectual property rights. Member states have been asked to provide
protection to different intellectual property rights by making necessary
adjustments in their existing laws or enacting new laws. India being a member
state to the TRIPS Agreement brought changes in its intellectual property laws
in fulfilment of its obligations under the Agreement.
India started amending its intellectual property laws in the year 1999 by the
first Patents Amendment Act and completed its process with the Patents third
amendment Act in March 2005. The TRIPS Agreement came into being on
1.1.1995 in general. However, for developing nations including India, it came
into being on 1.1.2005. The period between 1.1.1995 till 1.1.2005 is known as
„transition period‟, which was granted for developing nations within which
they were asked to make necessary adjustments in their legal regimes to
completely implement the provisions of the TRIPS Agreement. As far as the
impact of TRIPS on the Indian economy is concerned, critics are of the view
that it will have disastrous effects on our economy.
Protection of intellectual property rights has been made more stringent in the
Uruguay round. This has been done to protect the interest of multinational
corporations and the developed countries as the Agreement on TRIPS is highly
weighed in favour of patent holders. In India, protection of IPRs is itself a
barrier to trade. Let us see how the TRIPS Agreement is likely to work against
India. The TRIPS Agreement goes against the Indian Patent law5 in almost all
important areas, which is very much evident from the following points:
 Under the Indian Patents Act, only process patents could be granted
in food, chemicals and medicines. The TRIPS Agreement has
provided for granting of product patents also in these areas.
 Under the TRIPS Agreement, methods of agriculture and
horticulture and biotechnological process have been made patentable
5
Indian Patent Act of 1970
142
and there cannot be any exceptions as was present in the Patent Act
of 1970.
 TRIPS Agreement provides that the general term of a patent shall be
20 years. However, the Indian Patent Act had provided for a general
term of 14 years for both products as well as process patents. In
sector like food, chemicals and medicines, process patents were
granted for duration of 5 to 7 years.6
 In India, there were reasonable and effective provisions for the
compulsory licensing of patents and also for die revocation of
patents in public interest whereas under the TRIPS Agreement, there
are no such provisions.
 TRIPS also reverse the burden of proof requirement Under the
Indian legal system, the patentee had to establish a prima facie ease
that his patent has been infringed. However, under the TRIPS
Agreement, the patentee will just have to accuse a person or a
company of patent infringement and the person or the company will
have to prove that he did not infringe the patent.
4.2.2 The Novartis Challenge:

Gilivee (Gleevee in US), the Novartis, brand name drug used to treat chronic
myeloid leukemia, has been in the centre of a widely watched patent dispute in
India. The Madras High Court announced its decision on 6th August, 2007.7
4.2.2.1 Application before Chennai Patent Office:

The active ingredient in Glivee was known. The pharmaceutical salt form
underlying this anticancer drug is the beta crystalline form of imatimib
mesylate. The Novartis application related to an isomer of an existing
6
Ibid, Das Dr. J. K., Intellectual Property Rights, Kamal Law House, Kolkata, 1st Edition,
2008
7
Novartis AG v. Union of India (2007) 4 MLJ 1153
143
compound. Novartis has patented the drug in about 40 countries, including

china, Novartis sought to patent the drug in India and filed an application for
patent at the Chennai Branch of the Indian Patent Office. Norartis argued that
isomers should be considered as an invention (non-obvious) over the existing
compound. The Indian Patent Office at Chennai rejected the claim in January
2006, on the ground that the invention involved was not patentable under
section 3(d) of the Indian Patent Act, 1970, as amended in 2005 (the Act). 8
4.2.2.2 Petition before High Court at Madras:

Novartis filed two writ petition under Article – 226 of the Constitution of India
praying to issue a writ of declaration, declaring that sec. 3(d) of the Patent Act,
1970 is not complaint with the TRIPS Agreement and/or is unconstitutionally
being vague, arbitrary heard beg a single judge bench of the Madras High
Court, who found that the case involved substantive questions of law and
therefore require the attention of a two Judge Division Bench. The two-judge
bench passed a common order disposing off the writ petitions on 6th August,
2007.
The dispute was keenly watched as it involved the issue of „ever greening‟,
India‟s ability to produce generic version of the drugs and the allegations in the
suit that Indian Patent Act was not complaint with the TRIPS Agreement.
As per TRIPS Agreement, developing countries (like India) who were not
granting product patent protection to inventions had a ten year grace period to
amend their laws to make it TRIPS complaint. India amended its patent Act
through the patents (Amendment) Act, 2005 with effect from 1st January, 2005.
The Act defines an „invention‟ in its section 2 and section 3 lists the inventions
which are not patentable.9
The main thrust of the argument of the petitioner, Novartis, was that by making
the discovery of a new form of a known substance which does not result in the
8
ibid
9
ibid
144
enhancement of the known efficacy of that substance as not patentable, the

right to have an invention patented granted U/Art 27 of the TRIPS is taken
away. They argued that since the section uses only general expressions,
leaving it to the statutory authority arbitrarily in exercising its discretion.
Neither the section nor the explanation contain any guidelines on how to
exercise the discretion. Unless there are some guidelines in the amended
section itself to understand the expression „enhancement of known efficacy‟,
namely, what would be treated as „enhanced efficacy‟, and uncontrolled
discretion is given to the patent controller, which according to the petitioner
would lead to arbitrary exercise of power, violating the principle of equality
embedded in Article – 14 of the constitution of India. Further, the explanation
declares that all derivatives of a known substance shall be considered to be the
same substance unless they „differ significantly in properties with regard to
efficacy‟.10
The respondents pleaded that the amended section – 3(d) is compatible with
TRIPS. They argued that even assuming it is not so, the challenge that a
section of Indian Patents Act is not compatible with TRIPS cannot be legally
sustained before Indian courts. It was argued that India constitutionally follows
the principle of a welfare state and its first obligations is to provide good health
care to its citizens. When that is the priority commitment under the
constitution of India, the Union of India has every right to bring in a local law
in discharging their obligation under TRIPS to suit the needs and welfare of its
citizens. On the allegation that the section is vague, the Additional Solicitor
General of India, appearing for the Govt. of India argued that scientific
advances are dynamic in nature and so legislature through it fit to use general
expression in the Act leaving it to the Statutory Authority to apply its mind to
decide whether and invention is within the mischief of the section or outside it.
In exercising such discretionary power if the Statutory Authority exceeds its
10
ibid
145
discretionary power or abuse it, such an error can always be corrected by

higher forums provided in the Act itself and thereafter by courts of law.11
4.2.2.3 Issues:
The court framed the following issues for consideration as arising out of the
dispute:
(a) Assuming that the amended section is in clear breach of Article 27 of
TRIPS and thereby suffers the vice of irrationality and arbitrations violating
Art-14 of the Constitution of India, could the courts in India have jurisdiction
to test the validity of the amended section in the backdrop of such alleged
violation of TRIPS. 12
Or,
Even if the amended section cannot be struck down for the reasons as stated,
cannot the court grant a declaratory relief that the amended section is not in
compliance of Art-27 of TRIPS?
(b) If the courts in India have jurisdiction to go into the referred issue, then, is
the amended section compatible or non compatible to Art-27 of TRIPS?
These issues could the amended section be held to be violative of Art-14 of the
Constitution of India on the ground of vagueness, arbitrariness and conferring
unanalyzed powers on the statutory authority.13
4.2.2.4 Decision of High Court:

The court observed that international conventions, international treaties an
agreements and so on are essentially in the nature of a contract and hence such
treaties should be examined on principles applied in examining contracts. As
an international agreement possesses the basic nature of an ordinary contract
and as the court respects the choice of jurisdiction fixed under an ordinary
11
ibid
12
ibid
13
ibid
146
contract, there is no compelling reason to deviate from such judicial approach

when the choice of forum under an international treaty is considered. Applying
these principles, the enforceability of a treaty has to be read within its
provisions. Art-64 of TRIPS Agreement read with World Trade Organization‟s
Rules and procedures governing the settlement of disputes provides a
comprehensive settlement mechanism of any disputes arising under the
agreement. When a comprehensive dispute settlement mechanism is provided
in the Agreement itself and the petitioner is part of the Member state of WTO,
the dispute on TRIPS could be resolved under the dispute settlement
mechanism. Based on this reasoning, the court held that it has no jurisdiction
to decide the compatibility of the amended section 3(d) of the patent Act with
TRIPS. 14
The court then went on to decide whether it can give a declaratory relief as
prayed for. Analysing the precedents of Supreme Court of India, the Court
found that when an enactment infringes the fundamental rights guaranteed by
the Constitution of India and a challenge is made on that ground, they could
grant declaratory relief on a writ petition. This is a discretionary power and
when exercising this discretion, the court must keep in mind the well settled
principles of justice and fair play and should exercise the discretion only if the
ends of justice require it, for justice cannot be administered in vacuum.
The court found that the ends of justice do not favour the petitioner. The
amended section does not take away the petitioners right to carry on trade
promised by the constitution as by grant of patent, the petitioner gets only a
premonitory right over the invention lasting for a fixed period and nothing
more.15
The last issue (c) was whether the section 3(d) could be held to be violative of
Article -14 of Indian Constitution by conferring un-canalized powers on the
Statutory Authority (Controller of Patents). The counsel for the petitioner
14
ibid
15
ibid
147
argued that the section 3(d) is bad in law as the section confers wide
discretionary power on the controller and explanation is bereft of any
guidelines. In other words, the plea was that both the section and the
explanation must prescribe in clear terms for the controller, the guidelines to
decide in what circumstances it can be said that the discovery of a new form of
a known substance had resulted in enhancement of known efficacy and when
the derivatives are found to differ significantly in properties with regard to
efficacy.16
The court examined this section in detail. It observed that the section mandates
that if the discovery of a new form of a known substance must be treated as in
invention then the patent applicant should show that substance to discover has a
better therapeutic effect. Therefore, the patent applicant has to place on record
what is the therapeutic effect / efficacy of a known substance and what is the
enhancement in that known efficacy in the new invention. The controller
would be guided by these details.
The amended section is a comprehensive section covering all fields of
technology including pharmacology. It is made applicable to machine,
apparatus or a known process with a rider that mere use of a known process is
not an invention unless such a known process results in a new product or
employees at least one new reactant. The explanation would come in aid only
to understand what is meant by the expression resulting in the enhancement of
a known efficacy in the section and would operate only to the discoveries made
in the pharmaceutical field.
The explanation creates a deeming fiction where derivatives of a known
substance are deemed to be the same substance unless they differ significantly
in properties with regard to efficacy. The court held that the amended section
and the explanation give importance to efficacy, scientifically, it is possible to
show with certainty what the properties of a substance are. Therefore, what the
section read with the explanation mandates is that the patent applicant should
16
ibid
148
show the discovery has resulted in the enhancement of the known efficacy of
that substance and if the discovery is nothing other than the derivative of a
known substance, then it must be shown that the properties in the derivative
differ significantly with regard to efficacy. The court also observed that due to
advances in science and Technology it is possible to show giving necessary
comparative details that the discovery of a new form of a known substance has
resulted in enhancement of the known efficacy of the known substance and the
derivative so derived is not the same substance.17
The court held that due to the above reasons the amended section couldn‟t be
held as vague or ambiguous. The section and the explanation are capable of
being understood and worked act by the patent applications as well as the
controller. The controller would be guided by relevant details, which every
patent applicant is expected to produce to show that the new discovery has
resulted in the enhancement of known efficacy and therefore it cannot be said
that the controller has an unanalysed power to exercise.
The court thus found that section 3 (d) of the Act has inbuilt measures to guide
the statutory authority (controller) in exercising its power under the Act and
hence it cannot be held that the amended section suffers from the vice of
vagueness, ambiguity and arbitrariness. The materials placed before it will
guide the Statutory Authority. But despite that if the Authority misdirects
itself, abuses the power in and arbitrary manner and order, then the same could
be connected by hierarchy of forums provided under the Act itself. In addition,
there is further relief available before the courts of law. Hence, the amended
section cannot be invalidated solely on the ground that there is possibility of
misusing the power. The court observed that the parliament wisely uses
general terms while enacting a statute leaving it to the experts / Statutory
Authorities and then courts to understand the general expressions used in the
statute in the context in which they are used on a case to case basis. According
17
ibid
149
to the court, using general expressions in a statute is not a ground to declare a

section or an Act antivirus.
According to the court, the interpretation of a statute must be to advance the
object, which the Act wants to achieve. When the validity of any law touching
upon the economic interest of a country comes up before a court, large latitude
is allowed to the legislature. This is because the Supreme Court of India has
held that it must be presumed that the legislatures understands and correctly
appreciates the need of its own people, that its laws are directed to the
problems made manifest by experience. The Statement of Objects and Reasons
of the Patent Act, 1970 shows that the parliament enacted a new legislation
based on the charge in the political and economic conditions of the country
replacing the 1911 Act. The court held that the patents Act as it stands today is
designed to safeguard the economic interest of the country, and that being so,
the amended section need be viewed with greater latitude. A new made by
legislature can be struck down on two grounds alone, namely lack of legislative
competence and violation of any of the fundamental rights guaranteed by the
constitution. The court observed that except arguing that the amended section
3(d) must be struck down on the ground of ambiguity, arbitrariness, leading to
exercise of uncanalysed power, which the court did not agree, the petitioner
had not shown any other ground to invalidate the section. Hence, the court
rules that the section – 3(d) cannot be invalidated. While arriving at this
conclusion. The court made the following observation-
“We have born in mind the object which the Amending Act wanted to achieve,
namely to prevent ever greening; to provide easy access to the citizens of the
country to life saving drugs and discharge their constitutional obligation of
providing good health care to its citizens.”18
18
ibid
150
4.2.2.5 Appeal before Hon’ble Apex Court:

Novartis AG v. Union of India19 is a landmark decision by a two-judge bench
of the Indian Supreme Court on the issue of whether Novartis could patent
Gleevec in India, and was the culmination of a seven-year-long litigation
fought by Novartis. The Supreme Court upheld the Indian patent office's
rejection of the patent application.
The patent application at the center of the case was filed by Novartis in India in
1998, after India had agreed to enter the World Trade Organization and to
abide by worldwide intellectual property standards under the TRIPS agreement.
As part of this agreement, India made changes to its patent law; the biggest of
which was that prior to these changes, patents on products were not allowed,
while afterwards they were, albeit with restrictions. These changes came into
effect in 2005, so Novartis' patent application waited in a "mailbox" with others
until then, under procedures that India instituted to manage the transition. India
also passed certain amendments to its patent law in 2005, just before the laws
came into effect, which played a key role in the rejection of the patent
application.
The patent application claimed the final form of Gleevec (the beta crystalline
form of imatinib mesylate). In 1993, during the time India did not allow patents
on products, Novartis had patented imatinib, with salts vaguely specified, in
many countries but could not patent it in India. The key differences between
the two patent applications, were that the 1998 patent application specified the
counterion (Gleevec is a specific salt - imatinib mesylate) while the 1993 patent
application did not claim any specific salts nor did it mention mesylate, and the
1998 patent application specified the solid form of Gleevec - the way the
individual molecules are packed together into a solid when the drug itself is
manufactured (this is separate from processes by which the drug itself is
19
AIR 2013 SC 1311, 2013 6 SCC 1
151
formulated into pills or capsules) - while the 1993 patent application did not.
The solid form of imatinib mesylate in Gleevec is beta crystalline.
As provided under the TRIPS agreement, Novartis applied for Exclusive
Marketing Rights (EMR) for Gleevec from the Indian Patent Office and the
EMR were granted in November 2003. Novartis made use of the EMR to
obtain orders against some generic manufacturers who had already launched
Gleevec in India. Novartis set the price of Gleevec at USD 2666 per patient per
month; generic companies were selling their versions at USD 177 to 266 per
patient per month. Novartis also initiated a program to assist patients who
could not afford its version of the drug, concurrent with its product launch.
When examination of Novartis' patent application began in 2005, it came under
immediate attack from oppositions initiated by generic companies that were
already selling Gleevec in India and by advocacy groups. The application was
rejected by the patent office and by an appeal board. The key basis for the
rejection was the part of Indian patent law that was created by amendment in
2005, describing the patentability of new uses for known drugs and
modifications of known drugs. That section, Paragraph 3d, specified that such
inventions are patentable only if "they differ significantly in properties with
regard to efficacy." At one point, Novartis went to court to try to invalidate
Paragraph 3d; it argued that the provision was unconstitutionally vague and
that it violated TRIPS. Novartis lost that case and did not appeal. Novartis did
appeal the rejection by the patent office to India's Supreme Court, which took
the case.
The Supreme Court case hinged on the interpretation of Paragraph 3d. The
Supreme Court decided that the substance that Novartis sought to patent was
indeed a modification of a known drug (the raw form of imatinib, which was
publicly disclosed in the 1993 patent application and in scientific articles), that
Novartis did not present evidence of a difference in therapeutic efficacy
between the final form of Gleevec and the raw form of imatinib, and that
152
therefore the patent application was properly rejected by the patent office and
lower courts.
Although the court ruled narrowly, and took care to note that the subject
application was filed during a time of transition in Indian patent law, the
decision generated widespread global news coverage and reignited debates on
balancing public good with monopolistic pricing and innovation with
affordability. Had Novartis won and gotten its patent issued, it could not have
prevented generics companies in India from continuing to sell generic Gleevec,
but it could have obligated them to pay a reasonable royalty under a
grandfather clause included in India's patent law
4.3 PATENTING MICRO-ORGANISMS:

Micro-organisms also have to satisfy the novelty, utility and non-obviousness
criteria to be patentable. However, TRIPS agreement does not provide a precise
definition of the term microorganism. The term is generally understood to
include viruses, bacteria, yeast and other forms of fungi, protozoa and
unicellular algae and non-differentiated animal or plant cells. Even though
micro-organisms can be patented as per TRIPS agreement; one is often faced
with a dilemma whether at all microorganisms constitute a patentable subject
matter since they are real life forms.20
The law which opened the gates for inventions in the field of biotechnology,
particularly in microorganism, was a land marked judgement of the US
Supreme Court in1980 in Diamond v. Chakraborty.21 The dispute was with
regard to modified microorganism developed by the Ananda Chakraborty
which has the ability of breaking down the crude oil. This property introduced
into the naturally occurring bacterium to produce a genetically modified
organism. The commissioner of patent in the US field held that the subject
20
Art27 of the TRIPS Agreement
21
Diamond Vs. Chakraborty, 447 US 303 (1980)
153
matter of the invention was a living organism and was hence not patentable.
The US Supreme Court judge, however, decided in favour of the patentee and
stated that everything under sun is patentable. The landmark judgment paved
the way for the grant of a number of such biotechnology related patents.
4.3.1 Diamond V. Chakrabarty22

United States Supreme Court, 1980
Facts: 1972, Chakrabarty filed a patent application that claimed a human-made
genetically engineered bacterium, capable of breaking down multiple
components of crude oil. Chakrabarty‟s patent claims were of three types; first
process claims for the method of proceeding the bacteria, second claims for an
inoculums composed of a carrier material floating on water – such as straw –
and the new bacteria and third, claims to the bacteria themselves.
The patent examiner allowed the claims that fell into the first two categories
but rejected the claim to the bacteria. His decision rested on two grounds; (1)
that microorganisms are “products of nature” and (2) that as living things
microorganisms are not patentable subject matter under Section 101.
Chakrabarty appealed to the Patent Office Board of Appeals, which affirmed
the patent examiner‟s rejection. Chakrabarty appealed to the Court of Customs
and Patent Appeals (today such an appeal would go to the Federal Circuit),
which reversed. The Commissioner of Patents and Trademarks appealed to the
Supreme Court.”
Decision and reasoning. The question before this court is a narrow one of
statuary interpretation, requiring us to construe section 101 of the Patent Act,
specifically, we must determine whether Chakrabarty‟s microorganism
constitutes a “manufacture” or a “composition of matter” within the meaning of
the statute.
22
Diamond Vs. Chakrabarty, 447 US 303 (1980)
154
In cases of statutory construction, we begin with the language of the stature.

Unless otherwise defined, words will be interpreted according to their ordinary
meaning. And courts should nor read into the patent laws limitations and
conditions the legislature has not expressed. In choosing such expansive terms
as “manufacture” and “composition of matter,” modified by the comprehensive
“any” Congress was contemplating that the patent laws would be given wide
scope.
This is not to suggest that Section 101 has no limits or that it embraces every
discovery. The laws of nature, physical phenomena, and abstract ideas have
been held not patentable. Thus, a new mineral discovered in the earth or a new
plant discovered in the wild is not patentable subject matter. Likewise,
Emstein could not patent his celebrated law that E-me2, nor could Newton
have patented the law of gravity. Such discoveries are manifestations of nature
– free to all persons and reserved exclusively to none.
It is, of course, correct that Congress, not the courts, must define the limits of
patentability, but it is equally true that once Congress has spoken, it is the
province and duty of the judicial department to say what the law is.
Judges in this light, Chakrabarty‟s microorganism plainly qualities as
patentable matter. His claim is not to a hitherto unknown natural phenomenon,
but to a non-naturally occurring manufacture or composition of manner a
product of human ingenuity having a distinctive name, character, and use. A
previous case underscores the point. A scientist discovered six naturally
occurring root-nodule bacteria that could be mixed into a culture and used no
inoculate the seeds of leguminous plants. This court denned patentability
ruling that what was discovered was only the handwork of nature. The
combination of species produced no new bacteria, no change in the six species
of bacteria, and no enlargement of the range of their utility. Their use in
combination did not improve in any way their natural functioning. They served
the ends nature originally provided and they acted independently of any effort
by the scientist.
155
Here, by contrast, Chakrabarty has produced a new bacterium with markedly

different characteristics from any found in nature and one having the potential
for significant utility. Chakrabarty discovery is not matter‟s handwork but his
own. According it is patentable subject matter under Section 101 of the Patent
Act of 1793.
The Commissioner argues that microorganisms cannot qualify as patentable
subject matter until Congress authorized such protection. Its position rests on
the fact that genetic technology was unforeseen when Congress enacted Section
101, the Commissioner argues that the legislative process is best equipped to
weigh to weigh the competing economic, social and scientific consideration
involved and to determine whether protection. In support of this position, the
commoners relies on this court‟s recent statement that the judiciary must
proceed cautiously when asked to extend patent rights into area wholly
unforeseen by Congress.
It is, of course, correct that Congress, not the courts, must define the limits of
patentability, but it is equally true that once Congress has spoken, it is the
province and duty of the judicial department to say what the law is.23
4.3.2 Patentability of Micro-Organisms and the

Indian Scenario:
The Indian Patent Act has now a specific provision in regard to patenting of
microorganisms and microbiological processes. It is now possible to get a
patent for a microbiological process and also products emanating from such
processes. As it is difficult to describe a microorganism on paper, a system of
depositing strain of microorganisms in some recognized depositories was
evolved way back in 1949 in USA. An international treaty called “Budapest
Treaty” was signed in Budapest in 1973 and later on amended in 1980. India
23
Legal aspects and managing technology by Lee burgender, 2nd edition, 2001, south western
college publication, page 95-97.
156
became a member of this Treaty, with effect from December 17, 2001. 24 This is
an international convention governing the recognition of deposits in officially
approved culture collections for the purpose of patent applications in any
country that is a party to this treaty. Because of the difficulties and virtual
impossibility of reproducing a microorganism from a description of it in a
patent specification, it is essential to deposit a strain in a culture collection
centre for testing and examination by others. An inventor is required to deposit
the strain of a microorganism in a recognized depository, which assigns a
registration number to the deposited microorganism. This registration number
needs to be quoted in the patent application dealing with the microorganism.
Patent law25 in India has been amended with effect from January 2005 to
comply with the TRIPS agreement. The main provision of the Act is to allow
the grant of product patents in the field of chemical, pharmaceutical, food and
biotechnology. Patentable biotechnological inventions can be broadly
categorized as „Products in the form of chemicals, microorganisms, plant
extracts, fermented material; processes/methods for using useful products and
compositions/formulations of product such ns vaccines, proteins, hormones‟.
India has allowed patenting of microorganisms but the Patent Act does not
provide a definition of the term “microorganisms”. This has led to many
debates regarding patentability of microbes. The Mashelkar committee report
has clearly stated that microorganisms are patentable subject matter in India.
Further, the patents Act does not allow patenting of plants and animals per se,
essentially biological processes for the production of plants and animals and
method of treatment of human and animals. Inventions pertaining to
microorganisms and other biological material were subjected to product patent
in India, unlike many developed countries. India has started granting patents in
respect of invention related to microorganisms with effect from 20.05.2003,
24
“Making global trade work for people”. Earthscan, London. Available at http://
www.undp.org/dp/publications/globaltrade.pdf visited on 12.06.16
25
The Indian Patents Act, 1970
157
though India was not obliged to introduce laws for patenting microorganisms
per se before 31.12.2004. Microorganisms patenting per se being considered to
be a product patent, the period of protection was 5 years from the date of gram
or 7 years from the date of filing of application for patent. Now grant of patents
for microbiological inventions is for a period of 20 years from the date of
filing. The most vital and important distinction between the legal practices of
the India and developed countries is that India does not allow patenting of
microorganisms that already exist in nature as the same is considered to be a
discovery as per the provisions of Patents Act of 1970 26 and hence are not
patentable. But genetically modified versions of the same microorganisms that
result in enhancement of its known efficacies are patentable. The grants of
patent in respect of microorganisms depend upon the regulations concerning
the requirements for the deposition of microorganisms under the Budapest
Treaty of which India has become a member, and accessibility of that
microorganism from the depositories.
4.4 PATENTS FOR HIGHER LIFE FORMS AND

CLONING:
As the science of biotechnology advances, the patent issues become
increasingly contentious and complex. Recombinant DNA technology
involving the splicing and manipulation of genes is also being used to produce
animal inventions that are increasingly patentable in many countries. A primary
concern is just how far up the ladder of life proprietary rights through patents
should be allowed. It is one thing to grant a patent on genetically altered
microorganisms. It may seem quite another to permit ownership of a strain of
celery or a breed of mice or cows. The ethical and moral issues raised by the
patenting of animals have been more controversial than in the case of plants.
But patent protection now clearly extends to such higher forms of life.
26
Section 3(d) of the Patent Act of 1970
158
Traditionally, breeders have mated animals with specific physical traits to

produce offspring with certain characteristics. However, unlike the case of
plant breeding, IPRs on animal variety protection do not exist. Animal breeders
keep parental breeding lines secret, protecting their innovations through trade
secret or contract law. The technical and economic considerations for animal
breeding are very different from that of plants. The advent of genetic
engineering has changed this situation as a desired gene from one species can
now be isolated and inserted into the DNA of an egg to be implanted into a
female of the same or targeted species to produce an offspring containing this
gene. Examples of genetically engineered animals include the famous Harvard
Oncomouse useful for testing cancer drugs, pigs that produce low cholesterol
meat and animals that produce pharmaceuticals in „bioreactors‟. Since the
production of such animals requires huge R & D investments by agri-
biotechnology and pharmaco-biotechnology companies, many developed
countries such as US, EU, Australia, New Zealand and Japan, began
recognizing patents on animal inventions. In 1988, the PTO Board of Patent
Appeals and Interferences granted the first patent for transengenic non human
mammal; a mouse –called the Harvard Oncomouse – into which a gene was
inserted so that the mouse would be more susceptible to developing cancerous
tumours. By 1998 the PTO had issued around 85 animal patents and reportedly
was soon to allow nearly 90 more.
So far, the majority of the transgenic animals have been developed to aid in
drug research. Human genes responsible for specific diseases or maladies are
introduced into the animal, causing it to carry the genetic disorder. For
example, researchers have created transgenic animals that are especially
susceptible to afflictions such as AIDS, enlarged prostate, sickle cell anaemia,
and cystic fibrosis. These animals have great medical potential because they
may serve as laboratories for experiments aimed at curing or preventing
afflictions. But they also raise hostile objections, particularly form animal
rights activists and opponents of genetic engineering. For example, the
159
Foundation on Economic Trends aggressively challenged attempts by scientists

at the National Institute of Health to perform AIDS research on mice that were
genetically altered to improve the study, arguing that the experiment posed an
undue danger if the animals were to escape. Research on transgenic animals
also poses serious ethical questions about creating animals that are purposefully
deformed, often with painful and debilitating maladies. Not all research creates
diseased animals however. For example, researchers at Princeton University
created mice with better memory by inserting the so called NR2B gene into the
nuclei of fertilized eggs. This research ultimately could yield new drugs and
treatment for preventing memory loss in the elderly.
The TRIPS agreement provides that the member states may exclude plants and
animals from patentability. This option has been adopted by a number of
countries such as the United Kingdom, Europe and India. The issue of the
patentability of animals arises mainly because the patentability of animals is
considered to be moral issue rather than a legal one. Inventions which concern
plants and animals may be patentable if the technical feasibility of the
invention is not confined to a particular plant or animal variety. The onco
mouse case showed that the exclusion is confined to varieties of animal alone.
The first US patent for a living organism was granted in 1980 for the
genetically engineered microorganism that broke up components in crude oil in
the famous Chakraborty decision27 of the US Supreme Court. The Court
interpreted the intention of the legislature to mean that „anything under the sun
that is made by man‟ can be patented with this decision the USPTO began
granting patents to multi cellular organisms. The first transgenic animal patent
was granted in 1988 for the Harvard Oncomouse. In 1995 the first process
patent for human gene therapy was issued. The USPTO, however, believes that
transgenic humans are excluded under the US Constitution. While human
27
Diamond Vs. Chakrabarty, 447 U.S. 303 (1980)
160
cloning is excluded, aspects of human cloning such as a method of making a

human clone, components for use in human cloning may be patentable.28
The EPC prohibits the patenting of any inventions that is contrary to public
order and morality. In addition, patents on plants and animals varieties are
excluded although microbiological processes and products are allowed.
Initially, the European Patent Office rejected the patent application for the
Harvard Oncomouse. However, in 1991 the Technical Board of Appeals of the
EPO reversed that decision on the grounds that Article 53(b) allowed animal
patents but excluded only varieties and that in this case the human benefits
outweighed any potential drawbacks. Many products of biotechnology,
including animals, have been held to be products directly obtained from
microbiological processes and hence patentable. Most European countries do
not exclude animals from patents, but only animal breeds, even if such breeds
are produced by microbiological processes. The new biotechnological directive
makes an attempt, however controversial, to balance ethical concerns on
inventions comprising or using animal and humans or their parts with the need
to encourage the biotechnology industry in Europe. This European Directive
now clarifies that inventions that consist or contain biological material shall be
patentable, if otherwise eligible. Biological material has been defined in Article
2 as any material containing genetic information and capable of reproducing
itself or being reproduced in a biological system. Even if such biological
material has previously occurred in nature, it shall be patentable if it is isolated
by means of a technical process and of course, if new and non-obvious. Ethical
concerns led to the clause on exclusion of the human body, at any stage of
development, and the „simple‟ discovery of one of its elements, including
partial or full gene sequences. However, an element isolated from the human
body or otherwise produced by means of a technical process, including the
sequence or partial sequence of a gene, may constitute a patentable invention,
28
University Press, at p.196
161
even if the structure of that element is identical to that of a natural element.

Moreover, the industrial application of the invention must be disclosed in the
patent application. Thus, genes, including human genes, are unambiguously
patentable in the European Union, if these can be shown to be industrially
applicable. On the other hand, patent exclusions include processes for human
cloning, uses of the human embryo for industrial or commercial purposes and
processes for modifying the germ line genetic identity of human beings.
Processes for modifying the genetic identity of animals (and also animals
resulting from such a process) are excluded only when these are likely to cause
„suffering without any substantial medical benefit to man or animal‟.
In 1997, the world was struck by the announcement that biotechnology
research scientists at the Roslin Institute in Scotland had successfully cloned an
adult sheep. The birth of the lamb, which was given the name DOLLY was
greeted with both tremendous excitement and enormous fears. Traditional
gene-splicing methods of creating transgenic animals are frustrating because
they are extremely inefficient. Only about one tenth of 1% of the animals born
with these techniques assimilates the desired genetic characteristics. It thus is
somewhat of a hit-and-miss approach to creating transgenic animals. 29
Cloning can make this process much more predictable, since a transgenic
animal can provide the resource base to create a large number of identical
copies. The key to cloning is that cells contain all the genetic information
required to create exact duplicates. The problem is that cells are specialized, so
that genes that are not needed for particular functions are, in effect switched
off. In order to clone a complete animal from a cell, therefore, a way to be
found to switch these genes back on. The Roslin scientists discovered a method
to make this happen. Cloning techniques, as they are refined, have the capacity
to greatly increase the efficiency of the biotechnology industry. However, they
also have raised anxieties regarding biotechnology to new heights. This is
29
“Genomics and Its Impact on Medicine and Society: A 2001 Primer”. US Department of
Energy Online; available from http:// www.ornl.gov, visited on 12.6.16
162
particularly because it is not a great leap to begin considering the very real
possibility that the technology will soon be available to clone human beings.
And from this there emerge all the worries that heretofore were simply the wild
notions of science fiction authors, such as multiple duplications of sinister
leaders and creations of master races. A host of Nobel Prize –winning
scientists, among many others, called for voluntary bans on human cloning. In
addition, numerous pieces of legislation were rapidly introduced at both the
federal and state levels, calling for various kinds of bans on human cloning
activities and prohibitions on public funding of human cloning research. 30
The ethical issues surrounding human cloning intensified with the discovery
that stem cells from human embryos may have the potential to treat chronic
ailments, such as diabetes and Parkinson‟s disease.
Thus, the therapeutic benefits for humans may be substantial. Nonetheless,
religious leaders and others who believe that life begins at conception object to
the practice. To them it is offensive to create human beings that otherwise
would not be born and then to destroy them. Some scientists contend that an
embryo does not become a person until it is 14days old, when there is first
evidence of a nervous system. Since the cloning experimentation is performed
on embryos that are less than 10 days old, they believe that their work does not
involve human life. Legislators in the United States have a difficult time
addressing the issue. 31 On the one hand, they do not want to ruffle the feathers
of anti abortion forces, but on the other, they are reluctant to interfere with
potentially useful medical research. Some European countries have made a
policy distinction between “therapeutic cloning” which is intended to create
useful cells and “reproductive cloning” which is useful for creating babies.
Clearly cloning represents a new chapter in the biotechnology saga. How the
plot will unfold is still an open question.
30
Energy Online; available at http:// www.ornl.gov, visited on 12.6.16
31
ibid
163
4.4.1 Current Status of Cloning in India:

Curious human brain has led to numerous discoveries. Human cloning, which
was a topic of science fiction for hundreds of years, turned real with arrival of
Dolly, a cloned sheep in 1997. Cloning since its inception has le< to seemingly
unending and controversial debate worldwide on a number p medico legal,
ethical and social issues.
Clone means one or a group of genetically identical cells, organisms of plants
derived by vegetative reproduction from a single parent and also DNA
population, derived from a single hybrid DNA molecule by replication in a
eukaryotic or bacterial host cell, „[„he word “clone” is derived from Greek
word for taking a culling from a plant. Scientists traditionally used the term
“cloning” to describe different processes for duplicating biological material. In
simple terms, human cloning is a process of producing genetically identical
human beings. In general biological terms, human cloning is defined as “the
asexual replication of an existing genome or individual or a replica of a DNA
sequence, such as a gene, produced by genetic engineering”. 32 In reality, it can
have several applications like
1. Cloning is moss likely to serve as a new unusual but perhaps
efficacious treatment for infertility or sought by couples, who of a
high risk of genetic disease or other factors cannot or do not to
conceive a child;
2. Researchers believe that stem cells have a potential to serve is
replacement cells in treatment of degenerative diseases such as
Alzheimer‟s disease, Parkinson‟s disease, spinal cord damage,
diabetes cardiovascular disorders, cancer research and therapy etc;
3. Cloning technology can also be used to generate tissues and organs
for transplants. The cloned tissue or organ is a genetic match to the
recipient thus risk of tissue rejection would be eliminated;
32
Energy Online; available at http:// www.ornl.gov, visited on 12.6.16
164
4. This technology might be helpful in preservation and repopulation of

the endangered species and genetic improvements etc;
5. It may become possible to clone a dead or dying person; and
6. Researchers also hope to use cloning to help with basic research into
human diseases.
India allows experimentation with stem cell research. In India medical
termination of pregnancy is permitted under the Medical Termination of
Pregnancy Act of 1971. The resulting fatal tissues that are freely available from
the MTP Clinics and hospitals can be utilized for research purposes.
Termination of pregnancy for obtaining foetus for stem cell research or for
transplantation is not permitted. The main source of embryonic cells will be
from the ART/IVF clinics dealing with the infertility treatment where spare or
supernumery embryos will be available for the purposes. However, no embryos
can be created for the sole purpose of obtaining stem cells.
Institutional ethics committee should keep in view the ethical, legal and social
issues and should adhere to the “Ethical Guidelines for biomedical research on
human subjects” issued by the Indian Council of Medical
Research (ICMR) in October 2000. In India, only the research programmes and
not the therapeutic transplantations are permitted at present.33
4.5 RIGHTS IN PLANT VARIETIES:

Prior to the mid-1960s only a few countries (e.g., Germany, USA)34 gave
intellectual property protection to plant varieties. Because of pressure from
their plant breeding industries, 10 western European countries entered into a
diplomatic process in the early 1960s which eventually culminated in the
formation of an International Union for the Protection of New Varieties of
33
Kanchan Tanuj, Kumar T.S., Kumar ashish and Das Sanjoy, Multifaceted Aspects of
Human Cloning,available at http://www.jkscience.org/archive/volume83hive/multific.pdf
visited on 24.8 16.
34
ibid at p.44
165
plants (UPOV) and the signing of a Convention, that is, the UPOV Convention
1961. Since that time a number of other countries have become parties to the
UPOV Convention. Amendments were made to the UPOV Convention in 1978
principally to facilitate the entry of USA. 35
The UPOV convention requires that each member country must adopt national
legislation to give at least 24 genera or species protection in accordance with
the provisions of the convention, within eight years of signing. A plant variety
is protectable under the UPOV system if it is distinct, uniform, stable (DUS)
and satisfies the novelty requirement. Novelty and distinctiveness equate
broadly to novelty under patent law but are more leniently applied in
comparison to the patent rule. Satisfaction of the DUS criteria is conducted by
the national authority usually by growing the variety over at least two seasons.
There is also an important requirement that the variety be maintained
throughout the duration of protection. A country may apply the system to all
genera or species, but there is no obligation to do so and thus the system has
been extended only gradually. In addition, the UPOV convention allows
national legislation to discriminate against foreigners (including nationals of a
UPOV Convention Country) under the principal of reciprocity. Thus amongst
the UPOV members there is still some disparity in protection.
Duration of protection depends on national legislation and on the plant species
to which the variety belongs but is generally for 20-30 years.36 Grant of plant
variety rights confers certain exclusive rights on the holder, including the
exclusive right to sell the reproductive material (e.g. seed, cuttings, whole
plants) of the protected variety. However the rights do not extend to
consumption material (e.g. fruit, wheat seed grown for milling flour).
Essentially the exclusive rights define what others may or may not do in
relation to the protected varieties.
35
ibid at p.45
36
Agricultural Biotechnology, Poverty Reduction and Food Security. Manila: Asian
Development Bank. Commission on Intellectual Property Rights. 2002.
166
Plant breeders were for some time dissatisfied with the protection provided by
the UPOV system. This eventually resulted in a major diplomatic conference in
March 1991, at which the UPOV Convention was substantially revised. The
new 1991 text provides far greater protection than was afforded in the past,
most notably by requiring that all member countries apply the convention to all
genera and species, by extending the exclusive rights to include harvested
material (e.g., fruit, wheat grown for milling into flour) and, most
controversially, by allowing enforcement against farm saved seed (where a
farmer produces further seed of the protected variety from the previous year‟s
crop). However, until the national governments ratify the new convention the
system will continue to be based on the 1978 text. There will be considerable
national opposition to the strengthening of plant variety rights and thus these
changes may take years before they are implemented and may even be
superseded by greater availability of patent protection in the meantime.
4.5.1 Protection of New Plant Variety:

New plant varieties can now be protected in India under the New Plant Variety
and Farmers Rights Protection Act of 2001. New plant varieties cannot be
protected through patents. India, in addition to meeting the technical features of
UPOV, provides for rights of farmers to use the seeds from their own crops for
planting the next crop. Further, there are provisions for benefit sharing with
farmers, penalty for marketing spurious propagation material and protecting
extant varieties. There is a provision for protecting extant variety and farmers‟
varieties as well. The total period for protection is 10 years from the date of
registration.
4.6 MEDICAL PATENTS AND ACCESS TO DRUGS:

Medical patents constitute an interesting case study within the broader field of
intellectual property rights in general and biotechnology in particular because
167
this constitutes one area where the industry is highly dependent on the
availability of patents. In recent years, there have been wide ranging debates
concerning the potential contribution of the introduction of patents in
developing, countries to the development of drugs related to specific tropical
diseases. One of the perceived advantages is that it should give incentives to
the private sector pharmaceutical industry to undertake more research and
development in finding cures for diseases common in developing countries.
However, if patent protection has the capacity to raise incentives marginally, it
may also support considerably higher prices. Further it is unsure whether the
redistribution of resources to the private sector which accompanies the
introduction of patents will trigger the development of more drugs specifically
related to the needs of the poor. In fact as noted by the World Health
Organization (WHO), of the 1223 new chemical entities developed between
1975 and 1996, only 11 were for the treatment of tropical diseases. 37 Access to
drugs is of specific importance in the context of the introduction of
biotechnological patents on drugs because patents have the potential to improve
access by providing incentives for the development of new drugs as well as
restrict access because of the comparatively higher prices of patented drugs.
The magnitude of the challenge is generally illustrated by the fact that one-third
of the world‟s population does not have access to basic drugs.
Actual access to drugs is governed by a number of factors. The price of the
drugs is one of the important factors. Therefore, the fact that patented drugs are
nearly always more expensive than generic drugs is a relevant consideration.
Indeed, for a country like India which has to introduce product patents as a
result of TRIPS commitments, it has been calculated that the annual welfare
loss for a country as a whole would range from $162 million to $1.26 billion
37
168
with an annual profit transfer to foreign firms ranging between $10 and $839
million.38
Apart from price, access to drugs is not only linked to people‟s immediate
capacity or possibility to find and purchase drugs. One of the specific problems
faced by most developing countries is the fact that they have little capacity to
absorb and make use of technologies required to make drugs locally even if
they were provided freely. For the time being, there is no developing country
which has a sophisticated pharmaceutical industry of the kind that the United
States or the United Kingdom have. Only a handful of developing countries
such as India have some innovative capabilities. About 60 developing countries
have no pharmaceutical industry at all and 87 only have capacity to make
finished products.39 This tends to indicate that while the problem of access to
drags is directly related to patents, it is nevertheless broader in scope. Even if
there were no patents on drugs at all, there would still be a need for significant
support from public sources to ensure that the poor who cannot buy essential
drugs get access to them.
The intensity of the problem is well illustrated in India. The rapid growth of the
pharmaceutical industry since the 1970s has been credited to several critical
initiatives of the Government in this regard. The first was undoubtedly the
adoption of the Patents Act 1970 and the introduction of a prohibition on
product patent in the field of health. This was complemented by two other
important initiatives, the Drug Price Control Order 1970 and later a new Drug
Policy in 1978. The system put in place in the 1970s clearly sought to balance
the incentives given to the domestic private pharmaceutical industry with the
need to enhance access to drugs. Therefore, the Drug Price Control Order
included about 450 drugs in the early 1970s. Progressively, the system has been
modified towards enhancing the incentives for the private sector and reducing
the social policy tools in the regulatory framework. The number of drugs under
38
ibid at p 194
39
ibid at p 195
169
price control has come down dramatically to 74 today. The drug policy was in
particular modified in 1994 to free industry from the limitations imposed by
government regulation in line with the new economic policy adopted in 1991.
Finally, the patent regime has been revised to permit the introduction of
product patents in the field of health. All these developments have generally
benefited different segments of the, industry which is today generally
recognized as a success story. The imperative performance of the private
pharmaceutical industry does not, however, ensure in and of itself better access
to essential drugs to the neediest in the country. In fact, this is problematic in a
context where there is little public sector pharmaceutical manufacturing, no
system to ensure the free availability of essential drugs to people below the
poverty line and a decreasing number of drugs whose price is controlled. The
introduction of product patents could be construed as a „deliberately
retrogressive‟ step if no measures are taken to limit the impacts of TRIPS
compliance on access to medicines.
From a health perspective, TRIPS can be justified insofar as while it protects
the interests of the private sector pharmaceutical industry it also promotes
increased research and development in the health sector. Going beyond
controversies over the actual increases in research and development fostered by
the patent system, it has become clear over time at a minimum that the
incentives provided by the patent system do not lead the private sector to
preferentially invest in the most common diseases of the poor. As a result, one
of the few possibilities open to developing countries like India, to make sure
that the introduction of medical patents does not constitute a retrogressive step
in the implementation of the right to health is to provide significant public
resources for research and development in diseases of the poor and increased
subsidies to facilitate access for the poorest. This is, in fact, a solution
advocated by the World Bank.
170
4.6.1 Pharmaceutical Patent Issues:

Non-natural or genetically modified living beings are the results of non-natural
and genetically modified biological processes. Addition of human intelligent to
the natural processes renders it non-natural. Since patents are available to the
products as well as processes, so the task ahead for the inventor of the
biological processes was to convince the patent office that biotechnological
processes are non-natural and there is a role of human agency which
differentiate a human process and natural process. In Hybertech Inc –Vs-
Monoclonal Antibodies Inc.40, a patent was claimed for process of utilizing
protein to fight against the diseases. The inventors convinced the Court that the
method is non-natural process. Since it utilize proteins produced inside the
body on human prescription and obtained patent.
That the processes and products of genetic engineering are alive leads to
numerous other complicated legal and social issues, especially in the
pharmaceutical area. One excellent example is provided by the litigation
between Amgen and Genetics Institute over patent right erythropoietin (EOP),
a hormone secreted by the human kidney, which when purified may be used to
treat anaemia. EPO is secreted by human kidneys in such minute quantities that
its production from that source is not commercially viable. Genetics Institute
received a patent on the purified hormone in 1987.41 This alone may surprise
anybody because EPO is a natural product of the kidney. However, there is
precedence in the chemical filed, indicating that if a chemical can be found in
nature only in an unpurified form, then a patent can be received on the purified
form. Likewise, if EPO exists in nature only in an unpurified form, then the
40
Hybertech Inc –Vs- Monoclonal Antibodies Inc.,802 F.2d 1367,1384 (Fed. Cir.1928).
41
Tripathi, K.K. 1999. “Bioinformatics: The Foundation of Present and Future
Biotechnology”. Current Science 79(5): 2000: at p.572-575.
171
purified version is eligible for patent protection as an invention made through

human ingenuity.42
4.7 BIOTECHNOLOGY PATENT PROTECTION,

BIODIVERSITY AND SUSTAINABLE
DEVELOPMENT:
The relationship between IPRs and biodiversity emanates from the concept of
„bilprospecting‟. Bioprospecting is the systematic search for, and development
of, new sources of chemical compounds, genes, micro and macro organisms
and other valuable biological products. Research based industries have found it
profitable to screen natural sources such as soil samples, marine waters, insects,
tropical plants and genes in developing countries. Some feel that, as compared
to the conventional system of screening millions of synthesized chemicals,
bioprospecting, especially if it is based on traditional knowledge, may cut costs
of pharmaceutical R & D by half. The link to IPRs arises from the fact that in
many instances, bioprospectors or their licensees are granted patent rights over
the final products, without any acknowledgement of the contribution of
countries/ regions of origin or of indigenous communities. Developing
countries are demanding that when profits are gained through bioprospecting
the benefits and technologies developed should be shared with the original
suppliers of genetic resources or traditional knowledge.
In the wake of the recent advances in biotechnology and the extension of patent
protection to living organisms, both developed and developing countries
realized the importance of access to genetic resources. This was the basis for
the conclusion of the Convention on Biological Diversity (CBD) in1992 at Rio
de Janeiro. The CBD reaffirms that countries have sovereign rights over the
genetic resources in their jurisdiction and calls for the fair and equitable sharing
42
Rao R. Anita & Rao V. Bhanoji, “Intellectual Property Rights- A Primer”, Eastern Book
Company, First Edition, 2008 p.43
172
of the benefits arising out of the utilization of genetic resources. The problem
lies in the ambiguous wording and lack of credible enforcement mechanisms
for the provisions of the CBD.
The management of biological resources has been an increasingly contentious
subject at the national and international levels. This is linked in large part to the
progressive recognition of new economic opportunities arising from the use of
biodiversity, primarily the possibilities opened up by genetic engineering. As a
result, international legal frameworks for the management of biological
resources in particular the Convention on Biological Diversity 43 have had to
increasingly take into account not only the needs of biodiversity conservation
but also concerns about its potential for economic use and its contribution to
the process of economic development.
This has important repercussions from a legal perspective because the new
products developed by the biotechnology industry can often easily be copied
once they have been put on the market. As a result, the biotechnology industry
has strongly argued for the introduction of intellectual property rights over
genetically modified organisms, seeds and animals. These calls were heeded at
the international legal in the context of the negotiations for an Agreement on
Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement) as
part of the Uruguay Round of trade negotiations. The resulting TRIPS
agreement is an intellectual property rights framework that has directly little to
do with environmental management but has significant impacts on the ways in
which developing countries such as India can devise legal frameworks to
manage their biological resources.
Advances in biotechnology and their commercial applications have raised a
variety of difficult issues, including the morality of patents relating to life
43
The Convention on Biological Diversity (CBD), known informally as the Biodiversity
Convention, is a multilateral treaty. The Convention has three main goals including: the
conservation of biological diversity (or biodiversity); the sustainable use of its
components; and the fair and equitable sharing of benefits arising from genetic
resources.(wikipedia).
173
forms and the lack of legal protection for biodiversity and traditional
knowledge that may contribute to an invention. Controversy around the nature
and role of patents grows from a number of sources. There are genuine
philosophical objections to granting monopolies on the uses and products of
biodiversity by some. Similarly, there are concerns that the scope of
biotechnology patents is expanding with potentially negative impacts such as
the hindering of future research. Others argue that there is an unjust imbalance
between the expansive patent rights available to those conserving biodiversity
and associated traditional knowledge that may serve as an important resource
enabling those inventions.
4.8 PATENTING BIOTECH INVENTIONS AND

THE PIRACY OF TRADITIONAL KNOWLEDGE:
In the past the wealthiest persons were those who had owned tangible assets.
But this paradigm is now shifting. Today‟s wealthiest person is knowledge
worker. Bill Gates of Microsoft is perfect example of achieving the status of
business tycoon through expanding horizons of knowledge technology. It is
rightly said that tomorrow‟s society will be knowledge society. Tomorrow‟s
market will be a knowledge market. In this competitive age, only those nations
will survive and flourish who have the potential to convert the knowledge into
wealth. Persons, who are able to transform their knowledge into formal
specification, will meet with success in intellectual property regime.
People at large do not have the capacity to transform their knowledge into
formal specification and consequently into wealth. Some people who are
hampered because of their poverty illiteracy, isolative habitat, lack of
information and technological gadgets are unable to convert their knowledge
into wealth. On the other hand, some are able, strong and potent to use
traditional knowledge for profiteering. Some of the cases though illustrative
are;
174
1. The big business houses, hoteliers, film industries and music tycoons
are using cultural expressions of nomadic, tribal and village
community;
2. Rich traditional knowledge heritage is widely used by
pharmaceutical industry. Traditional knowledge is used in allopathic
and ayurvedic medicine.
3. Village community, tribal and indigenous people have traditional
knowledge of biodiversity. They are conserving knowledge of
biodiversity, which serve largest genetic resource for breeding
activities but gene giant or seed giant (MNC‟s) through IPR regime
may make huge profit.44
The traditional knowledge needs protection. The word traditional knowledge
has been defined by the D.G. of UNES and Cultural Organization in the
following words: the indigenous people of world possess an immense
knowledge for their environment based on centuries of living close to nature.
Living in and from richness and variety of complex ecosystem, they have an
understanding of the properties of plants and animals, the functioning of
ecosystem and the techniques of using and managing them that is particular and
often detailed. In rural communities of developing countries, locally occurring
species are relied on many sometimes, all foods, medicines, fuels, building
materials and other products. Equally the people‟s knowledge and perceptions
on environmental and their relationship with it are often important elements of
cultural identity.
The following are cogent grounds for protection of traditional knowledge:
1. Traditional knowledge has potential of being transformed into wealth
by providing leads/ clues for development of useful practices and
processes for the benefit of mankind.
44
“Human Genome Organization Calls for Open-access Sequence Repositories‟ Nature,
April p30.
175
2. The valuable leads/ clues provided by traditional knowledge can

save time, money investment of modern biotechnology and other
industries into research and product development.
3. Existing IPR system is based on individual private property rights.
Traditional knowledge is incompatible with IPR because it
emphasizes collective creation and ownership.
4. Only protection of traditional knowledge system will provide an
effective benefit sharing mechanism, which is enshrined in new IPR
legislations. It is not fair that traditional knowledge is appropriated
for commercial use without sharing of benefit.
5. Protection of traditional knowledge will be helpful in contesting
false claims of IPR.
There is a great deal of concern regarding the contribution of traditional
knowledge to the invention process. Significant anxiety exists among
traditional peoples and others that even when benefits are defined, patents
relating to such knowledge may rob these people of credit for their innovations
and infringe on their ability to carry out traditional practices and make
innovations based on that knowledge. There is a need to formally recognize the
value of this knowledge, protect the rights of the providers, and compensate
them for the use of the information. The policy of the any bioprospecting
programme should be that when traditional ethno medical knowledge is
involved in a patentable invention, if the traditional knowledge provider cannot
be recognized as an inventor, the contribution should be treated as valuable
„know how‟ and the contribution should be credited in any related publications
and in the patent as prior art, and the providers should be compensated for their
contributions as appropriate in the circumstances of the particular case. Prior
art citations formalize the contribution of such knowledge but do not claim any
monopoly rights to its use. The absence of important prior art citations may
constitute grounds to deny or invalidate a patent.
176
An attempt was made by the United Nations in the United Nation draft
declaration on rights of indigenous people 1994.45 The convention agreed that
traditional knowledge can be used only with prior approval of the community
but it did not recognize ownership rights over traditional knowledge. TRIPS
did not make any significant provision for protecting traditional knowledge. No
uniform norms were laid down for its protection.
Non-governmental actors such as indigenous people‟s organizations, other
advocacy groups are seeking to influence international agreements on benefit
sharing from biotechnological research through use of local or traditional
knowledge. A model community IPR Act has been devised by third world
network as sui generis system protecting the knowledge and innovation of local
communities. According to Section 1, para 1, the local communities shall at all
time and in perpetuity be lawful and sole custodian and stewards of all
innovations. The definition of innovation explicitly recognizes knowledge of
indigenous group or communities.
4.9 MORALITY AND PATENTING

BIOTECHNOLOGICAL INVENTIONS:
Biotechnology gives rise to a very different attitude not only among the internal
participants of the patent system viz. Scientists and lawyers but also among the
general public. Although many contradictions can be resolved scientifically but
there are some ethical and moral issues which assumes another dimension.
These concerns are rooted in the fact that biotechnology is seen by some to
„interfere with the workings of nature and creation‟. These concerns must be
clearly balanced with the aspects of providing food to the hungry and dignity to
the destitute Mahatma Gandhi said to a hungry person that God can appear
before him only in the form of bread. If biotechnology is the resort to the grant
of bread to the hungry, the ethic may demand the use of science. Mahatma
45
Ibid at p.31
177
Gandhi also said that nature has provided enough for everyone‟s needs but not
for their greeds. The use of biotechnology to satisfy the greed of the greedy
should clearly be discouraged, particularly when it raises ethical and moral
concerns.
Some developing countries are suffering economically due to the substitution
of their high value export products such as food additives, flavors, vegetable
oils and fats and medicinal products with genetically engineered products by
some developed countries. This phenomenon is not new. One such example is
the substitution of jute fibre and products by synthetic fibres causing economic
and indirectly food security hardships to Bangladesh and other jute-producing
and jute exporting countries. Such contradictions could be settled through
bilateral and multilateral negotiations on market sharing and pricing
arrangements. Public awareness of the comparative values of naturally
occurring conventional products versus engineered non-conventional products
would also mitigate the problems.
A major argument against biotechnology is that animal testing for genetic
engineering purposes is wrong because pain and suffering is inflicted upon
animals for ends that appear frivolous in contrast. On the purely moral basis
science should be research driven.
The most complex issues arise when considering genetic modification of
human beings viewed from the public perspective the threat posed by
contemporary biotechnology is the possibility that will alter human nature in an
irrevocable manner, some questions arising are:
 Do we as a human own our genetic material or does it belong to
society as a whole? The common heritage argument i.e., material
passed in abundance by vast numbers of people cannot be the subject
of a private monopoly.
 Is intervention into the human genome an attack on human dignity?
Proponents of genetic engineering argue that intervention into human genome

is necessary, ultimately leading to an increase human biodiversity, while
178
opponents, on the other hand claim such a step is making the sacred into the
profane. Only the society can ultimately decide the degree of importance to be
attached to the benefits, the hazards and their impact.
Patent shall not be granted for inventions the publication and exploitation of
which would be contrary to public order and morality. Through this gate way
have come arguments, which previously, were not considered real issues in
patent law. Biotechnology has changed all that, patent law is now one of the
central areas in which moral issues are raised. Cloning raise several ethical
issues and problems in the society. On the representation of several
organizations, press, judiciary of the American Government banned the
experiments on human cloning. This can be understood in another aspect. In
1970 when test tube baby took birth, the same kind of criticism were flooded.
Soon such criticisms are calmed down. Like this, in tomorrow, human cloning
may be helpful to human beings for the enhancement of the health and
prosperity.46
Arguments against biotechnology per se suggest that it is the creation of such
inventions which is problematic. The core objection is that biotechnology and
more specifically genetic engineering, is wrong in itself, even if the net benefits
outweigh the harm caused. Genetic engineering is considered to be intrinsically
wrong for the following reasons:
1. It is an attempt at playing god, and
2. Genes represent the common heritage of mankind and should be passed
from generation to generation without technical intervention by man.
The impact of all the above international instruments and conventions have
been discussed in detail in the next two chapters. The first chapter is a general
one dealing with the world wide impact on biotechnological inventions as a
result of above international instruments and the second chapters is a specific
one which deals with the impact the said instruments will have on a developing
country like India.
46
Article 53 of The European Patent Convention, 1973
179
4.10 IMPACT OF GLOBALIZATION:

In the era of globalization, India became the 98th Member of the Patent
Cooperation Treaty based World Intellectual Property Organization (WIPO),
which was established in 1967. Its preamble clearly states that PCT is intended
to help the economic development of developing countries by giving a boost to
the flow of technology. Under the Patent Co-operation Treaty (PCT), it is now
possible to file patent application for simultaneous protection of the patent in
all 115 countries that are anticipants of the PCT or designated countries of
one‟s choice. India is one of the countries that – participate under the PCT, as
are US, UK, Germany, Japan and France to name a few. PCT is advantageous
as it helps „lock‟ the rights to the patent. Once a PCT application sufficient
opportunity to test market the products and zoom in on the list of countries,
where it should be exploited. Several companies in India, including foreign
subsidiaries, are using the PCT route. These include companies in IT sector
and even in pharmaceuticals. The PCT is on international mechanism and the
actual grants of the patent remain the responsibility of the concerned countries.
The reason why Indian companies use PCT route is that favourable report
given under PCT is virtually a green signal for local patent authorities to speed
up the process of granting the patents. 47
The nationals / residents of different member countries, seeking grant of a
patent in more than one member country, can file an International Application
with the „National Patent Office‟. However, such applications are subject to
„International Search‟ for the establishment of PRIOR ART. The search is
conducted by the „International Search Authority‟ (ISA) are the National parent
office that fulfil criteria of having access to patent literature of various
countries from 1920 onwards.
Under chapter 2 the PCT also offers the option to the member Countries to ask
for International preliminary Examination Report (IPER) to be given on an
International Application by the PCT authorized patent office. Such IPER
47
Managing Intellectual Proprty- The Strategic Imperative by Vinod Sople, Published by
Printice Hall of India Pvt. Ltd., 2006, p-87
180
helps to assess the application for novelty, innovativeness and non-obviousness

and also the other criteria for the grant of a patent. Those who opt for the IPER
have to elect one or more member states with a view to express their intentions
to pursue a patent application.48
4.11 CONCLUSION:
Under the present international developments in the IPR system the policy
makers of developing countries have a number of policy options for the benefit
of society for safeguarding their national policies. The institutional capacities
of developing countries for policy coordination across government, policy
makers and the participatory process for IPR may be one of the weakest areas,
which need to be further strengthened. It has been observed that in the context
of the participation in international rule making, there exists lot of diversity
among developing countries where some have no permanent representation and
some are often with little contribution while some are mere spectators in the
WTO and the WIPO Forums, in comparison to participants from developed
world who are active and influential. The policy makers of India should be
vigilant and should enhance their learning process before it is too late. On the
other hand, most developing countries face financial and human resource
constraints in implementing new legislations owing to inadequate infrastructure
and office procedures and they should take the help of their neighbouring
countries like India. 49
It is important that developing countries ensure that their intellectual property
legislation and procedures emphasize, to the maximum possible extent, the
enforcement of IPRs through administrative action and through the existing
civil justice system. We should aim to recover the full costs of upgrading and
maintaining all aspects of the national intellectual property infrastructure
through national IPR registration and administrative charges. India should seek
48
Ibid at p 88
49
181
to exploit the maximum possible benefits in terms of cost reduction and

administrative efficiency from existing regional and international cooperation
mechanisms, through various bilateral agreements in IPR especially with
another developing country in the neighbourhood. Like-minded developing
countries should also make concerted efforts to support high-level dialogue on
new regional and international co-operation initiatives in IPR administration,
training and IPR statistical data collection and management.
India should encourage policy research and analysis on intellectual property
subjects in the national interest, especially pertaining to protection of plant
varieties; traditional knowledge; folklore; technology transfer; etc. In order to
meet the special needs of LDCs50, in developing the modern intellectual
property regime and wider institutional infrastructure, there is a need for
WIPO, EPO and developed countries to commit some corpus fund for technical
and financial assistance. WIPO and EPO should be formally invited to join as
donor agencies of the Integrated Framework alongside the World Bank, UNDP,
UNCTAD, WTO, and ITC, for the purpose. It is important that WIPO makes
funds available to cover the travel, accommodation and subsistence expenses of
representatives from all LDC Member States to participate in all TRIPs-related
capacity building projects of WTO, TRIPs Council meetings and in those
meetings at WIPO which such countries are eligible to attend. It is also
important that WIPO strengthen the present systems for monitoring and
evaluation of its development cooperation programmes especially for the
developing countries. With these efforts the LDCs and the developing countries
would be able to cope with the fast developing IPR regime where it is
anticipated that the developed world would maximally utilize the resources of
developing countries through various Trade Agreements of WTO.51
50
Least Developed Countries
51
182
CHAPTER 5
DOMESTIC LEGAL FRAMEWORK

RELATING TO BIOTECH PROPERTY
PROTECTION IN INDIA
5.1 INTRODUCTION:
Intellectual Property is the term used to describe the branch of law which
protects the application of thoughts, ideas and information which are of
commercial value. It thus covers the law relating to patents, copyrights,
trademarks, trade secrets and other similar rights. Mankind has used forms of
biotechnology since the dawn of civilization. However, it has been the recent
development of new biological techniques which has raised fundamental social
and moral questions and created problems in intellectual property rights.
Intellectual property protection for biotechnology is currently in a state of flux.
Whilst it used to be the case that living organisms were largely excluded from
protection, attitudes are now changing and increasingly biotechnology is
receiving some form of protections. These changes have largely taken place in
the USA and other industrialized countries, but as other countries wish to
compete in the new biotechnological markets, they are likely to change their
national laws in order to protect and encourage investment in biotechnology.
There is at the moment no clear international consensus on how biotechnology
should be treated. There are currently two main systems of protection for
biotechnology; rights in plant varieties, and patents. Both systems provide
exclusive, time –limited right of exploitation.
183
The system of patent is subjected to continuous changes in its philosophy and

in its purview. The invention of new technologies is always a subject for the
system of patent with the emergence of the two pioneer technologies of the
modern world namely information technology and biotechnology. The fact that
philosophy of patent law is dynamic and prone to continuous changes has had
its impact on patenting the invention of new technologies. The modern world is
very much influenced by these technologies. For the improvement of research
and development many inventions with great ability and function have been
claimed for patent. In today‘s world, biotechnology has become a whole new
industry and patent protection for this is of immense commercial importance.
Patents are exclusive rights granted to inventions that satisfy the criteria of
patentability in the form of novelty, non-obviousness and potential for
industrial application.
It is conceivable that the law of copyright could afford some protection for
biotechnology. Lines of genetic code are analogous to some extent with
computer program code, which has now been incorporated into the copyright
systems of most industrialised countries. However, this route to protection is
fraught with practical and conceptual difficulties and is generally thought to be
unsuitable. There is as yet no recorded case of biotechnologists claiming
copyright in their inventions.
Trademarks are also unlikely to be of much use in protecting biotechnology,
though they may of course prove important later in regard to marketing
products, processes or services. An attempt to register the name of a plant or an
animal as a trade mark is unlikely to be successful as public policy would
prevent it (in England, registrations for names of varieties of roses have been
removed from the Trade Mark register for lack of distinctiveness and because
of the likelihood of confusion.
184

AND THE INDIAN PATENT LAW:
Patent is a right in the realm of intellectual property granted for a particular
period under the law to anyone, known as the patentee, who makes full process,
machine, article of manufacture, or composition of matter, or any new and
useful improvement thereof. Upon grant of the patent, the law gives the
patentee a monopolistic right to commercially exploit the invention and also
the legal protection against unauthorized use of his patent by others. The effect
of grant of patent is quid pro quo, i.e. the monopoly is granted for the
disclosure of knowledge. The law grants this monopoly for a specified period
only and on the expiry of this period the said patentee‘s monopoly comes to an
end at which time it automatically goes into the public domain for exploitation
by anybody.
The legal system of patents thus encourages inventions by promoting their
protection and utilization so as to contribute to the development of industries,
which in turn, contributes to the promotion of technological innovation and to
the transfer and dissemination of information, knowledge and technology. In
India, the rights conferred to the patentee have been enumerated in Section 48
of the Patents Act of 1970. This law induces an inventor to disclose his
invention, to the whole world instead of keeping it as a secret. If the invention
were to be kept a secret, then the inventor would be in constant fear of it being
stolen by others. Such a disclosure not only makes the inventor famous, but
also enables him to sell it to an industrial house and thereby gain
economically.1
The Indian Patent law has been designed with the primary objective of
promoting the progress of scientific research and technology for public good. It
achieves this objective by granting exclusive rights to inventors over their
1
Company, First Edition, 2008 p57
185
inventions for a limited period of time. Through the grant of exclusive rights,
the law encourages inventors to invent and investors to invest in research and
development. The exclusive right enables the inventor to gain monetary
benefits from the invention by commercializing or including his invention. As a
result of the incentive offered by patent law, the inventor is encouraged to
create new inventions, which in turn promotes the progress of science and
technology. It is a quid pro quo or give and take relationship, where an inventor
gives his invention to the society and take exclusive rights over it for a limited
period of time, after which the invention enters the public domain.
5.2.1 Origin and Development of Patent Law in India:

5.2.1.1 Legislative Development of the Patent Law in India:
√ Act VI of 1856
√ Act XV in 1859
√ Patterns and Designs Protection Act, 1872
√ Protection of Inventions Act, 1883
√ Inventions and Designs Act, 1888
√ Indian Patents and Designs Act, 1911
√ Indian Patents Act, 1970 (39 of 1970)
√ The Repealing and Amending Act, 1974 (56 of 1974)
√ The Delegated Legislation Provisions (Amendment) Act,
1985 (4 of 1986)
√ The Patents (Amendment) Act, 1999 (17 of 1999)
√ The Patents (Amendment) Act, 2002 (38 of 2002)
√ The Patents (Amendment) Ordinance 2004 (7 of 2004)
√ The Patent Amendment 2005 (Third Amendment) 2005
 The first legislation in India relating to patents was the Act VI of 1856.
The objective of this legislation was to encourage inventions of new and
useful manufactures and to induce inventors to disclose secret of their
inventions. The Act was subsequently repealed by Act IX of 1857 since
186
it had been enacted without the approval of the British Crown. Fresh
legislation for granting ‗exclusive privileges‘ was introduced in 1 859 as
Act XV of 1859. This legislation contained certain modifications of the
earlier legislation, namely, grant of exclusive privileges to useful
inventions only and extension of priority period from 6 months to 12
months. This Act excluded importers from the definition of inventor.
This Act was based on the United Kingdom Act of 1852 with certain
departures which include allowing assignees to make application in
India and also taking prior public use or publication in India or United
Kingdom for the purpose of ascertaining novelty.2
 In 1872, the Act of 1859 was consolidated to provide protection relating
to designs. It was renamed as ―The Patterns and Designs Protection Act‖
under Act XIII of 1872. The Act of 1872 was further amended in 1883
(XVI of 1883) to introduce a provision to protect novelty of the
invention, which prior to making application for their protection were
disclosed in the Exhibition of India. A grace period of 6 months was
provided for filing such applications after the date of the opening of
such Exhibition.
 This Act remained in force for about 30 years without any change but in
the year 1883, certain modifications in the patent law were made in
United Kingdom and it was considered that those modifications should
also be incorporated in the Indian law. In 1888, an Act was introduced
to consolidate and amend the law relating to invention and designs in
conformity with the amendments made in the U.K. law.
 The Indian Patents and Designs Act, 1911, (Act II of 1911) replaced all
the previous Acts. This Act brought patent administration under the
management of Controller of Patents for the first time. This Act was
further amended in 1920 to enter into reciprocal arrangements with UK
2
Available at http://www.ipindia.nic.in/history-of-indian-patent-system.htm, visited on
12.6.17
187
and other countries for securing priority. In 1930, further amendments

were made to incorporate, inter-alia, provisions relating to grant of
secret patents, patent of addition, use of invention by Government,
powers of the Controller to rectify register of patent and increase of term
of the patent from 14 years to 16 years. In 1945, an amendment was
made to provide for filing of provisional specification and submission of
complete specification within nine months.
 After Independence, it was felt that the Indian Patents & Designs Act,
1911 was not fulfilling its objective. It was found desirable to enact
comprehensive patent law owing to substantial changes in political and
economic conditions in the country. Accordingly, the Government of
India constituted a committee under the Chairmanship of Justice (Dr.)
Bakshi Tek Chand, a retired Judge of Lahore High Court, in 1949 to
review the patent law in India in order to ensure that the patent system is
conducive to the national interest. The terms of reference included —
o To survey and report on the working of the patent system in India;
o To examine the existing patent legislation in India and to make
recommendations for improving it, particularly with reference to the
provisions concerned with the prevention of abuse of patent rights;
o To consider whether any special restrictions should be imposed on
patent regarding food and medicine;
o To suggest steps for ensuring effective publicity to the patent system
and to patent literature, particularly as regards patents obtained by
Indian inventors;
o To consider the necessity and feasibility of setting up a National
Patents Trust;
o To consider the desirability or otherwise of regulating the profession
of patent agents
188
o To examine the working of the Patent Office and the services

rendered by it to the public and make suitable recommendations for
improvement; and
o To report generally on any improvement that the Committee thinks
fit to recommend for enabling the Indian Patent System to be more
conducive to national interest by encouraging invention and the
commercial development and use of inventions.
 The committee submitted its interim report on 4th August, 1949 with
recommendations for prevention of misuse or abuse of patent right in
India and suggested amendments to sections 22, 23 & 23A of the
Patents & Designs Act, 1911 on the lines of the United Kingdom Acts
1919 and 1949. The committee also observed that the Patents Act should
contain clear indication to ensure that food and medicine and surgical
and curative devices are made available to the public at the cheapest
price commensurate with giving reasonable compensation to the
patentee.
 Based on the above recommendation of the Committee, the 1911 Act
was amended in 1950(Act XXXII of 1950) in relation to working of
inventions and compulsory licence/revocation. Other provisions were
related to endorsement of the patent with the words ‗licence of right‘ on
an application by the Government so that the Controller could grant
licences. In 1952 (Act LXX of 1952) an amendment was made to
provide compulsory licence in relation to patents in respect of food and
medicines, insecticide, germicide or fungicide and a process for
producing substance or any invention relating to surgical or curative
devices. The compulsory licence was also available on notification by
the Central Government. Based on the recommendations of the
Committee, a bill was introduced in the Parliament in 1953 (Bill No.59
of 1953). However, the Government did not press for the consideration
of the bill and it was allowed to lapse.
189
 In 1957, the Government of India appointed Justice N. Rajagopala

Ayyangar Committee to examine the question of revision of the Patent
Law and advise government accordingly. The report of the Committee,
which comprised of two parts, was submitted in September, 1959. The
first part dealt with general aspects of the Patent Law and the second
part gave detailed note on the several clauses of the lapsed bills 1953.
The first part also dealt with evils of the patent system and solution with
recommendations in regards to the law. The committee recommended
retention of the Patent System, despite its shortcomings. This report
recommended major changes in the law which formed the basis of the
introduction of the Patents Bill, 1965. This bill was introduced in the
Lok Sabha on 21st September, 1965, which however lapsed. In 1967,
again an amended bill was introduced which was referred to a Joint
Parliamentary Committee and on the final recommendation of the
Committee, the Patents Act, 1970 was passed. This Act repealed and
replaced the 1911 Act so far as the patents law was concerned.
However, the 1911 Act continued to be applicable to designs. Most of
the provisions of the 1970 Act were brought into force on 20 th April
1972 with publication of the Patent Rules, 1972.
 This Act remained in force for about 24 years without any change till
December 1994. An ordinance effecting certain changes in the Act was
issued on 31st December 1994, which ceased to operate after six
months. Subsequently, another ordinance was issued in 1999. This
ordinance was subsequently replaced by the Patents (Amendment) Act,
1999 that was brought into force retrospectively from 1st January, 1995.
The amended Act provided for filing of applications for product patents
in the areas of drugs, pharmaceuticals and agro chemicals though such
patents were not allowed. However, such applications were to be
examined only after 31-12-2004. Meanwhile, the applicants could be
190
allowed Exclusive Marketing Rights (EMR) to sell or distribute these

products in India, subject to fulfilment of certain conditions.
 The second amendment to the 1970 Act was made through the Patents
(Amendment) Act, 2002 (Act 38 0f 2002). This Act came into force on
20 th May 2003 with the introduction of the new Patent Rules, 2003 by
replacing the earlier Patents Rules, 1972
 The third amendment to the Patents Act 1970 was introduced through
the Patents (Amendment) Ordinance, 2004 w.e.f. 1st January, 2005.
This Ordinance was later replaced by the Patents (Amendment) Act
2005 (Act 15 of 2005) on 4 th April, 2005 which was brought into force
from 1-1-2005. 3
The Colonial Patent Law of 1911 secured the India Market to British Industry.
A large majority of drugs were imported from abroad until the Patents Act,
1970 brought a turnaround in India.4
The first Indian Patents Act was enacted in 1856 to grant exclusive privileges
to inventors. The aim of the Act was to enable English patent holders to acquire
control over the Indian markets. Subsequently the Patents and Designs
Protection Act 1882 was enacted which was followed by the Inventions and
Designs Act, 1888. The enactments aimed to protect the interests of the
industrialists, manufacturers and importers. Again the Patents and Designs Act
was passed in 1911 which was the first comprehensive law on the subject. 5 It
remained in force until the passing of Patents Act of 1970. The salient features
of the Act of 1970 are:
i. The patents are granted to encourage inventions and to secure that
the inventive works are to be produced on a commercial scale.
3
Available at http://www.ipindia.nic.in/history-of-indian-patent-system.htm, visited on
12.6.17
4
Managing Intellectual Proprty- The Strategic Imperative by Vinod Sople, Published by
Printice Hall of India Pvt. Ltd., 2006, p-76
5
Company, First Edition, 2008 p58
191
ii. the patents are granted to enjoy a monopoly in important matters.

iii. it recognises two kind of patents that is product patent and process
patent.
iv. no product patent can be granted to medicines, food items and
chemicals except to their manufacturing process.
Subsequently, however, it was realised that an terms of Articles 70.8 and 70.9
of the TRIPS Agreement member countries which do not provide for product
patents in the area of Pharmaceuticals and agricultural chemicals, were
required to provide with effect from the coming into force of the Agreement,
i.e., 1.1.1995, means to receive product patent applications for Pharmaceuticals
and agricultural chemicals, and on completion of certain chemicals grant
exclusive marketing rights for a period of five years or until the patent is
granted or rejected whichever is shorter. Prior to the 1999 Amendment, the
Patents Act did not provide for grant of patents in respect of agricultural,
chemicals, pharmaceuticals and for grant of exclusive marketing rights
(EMRS).6 These obligations were initially fulfilled by issuing an Ordinance on
31.12.1994 namely, the Patent (Amendment) Ordinance, 1995. Subsequently,
the Patent (Amendment) Bill, 1995 was introduced in the Lok Sabha in March,
1995. The Bill was passed by-the Lok Sabha and then introduced in the Rajya
Sabha from where it was referred to a Select Committee of the House. As the
Select Committee did not submit its report before the dissolution of the 10th
Lok Sabha, the Bill lapsed.7
The Patents (Amendments) Act, 1999 has introduced substantial changes of
significance and for reaching consequences in the Patents Act. The
Amendment has introduced provisions pertaining to claim for patent of an
invention for a substance itself intended for use, or capable of being used as
6
Tripathi K.K. 2003. ―Regulatory requirements for recombinant product application
processing‖. Express Pharma Pulse, 13th & 20th November. United Nations Development
Programme. 2003.
7
Tripathi K.K. 2002. ―Biotechnology: Government of India Initiatives‖. Saketlnd. Digest.
Feb., pp.49-53.
192
medicine or drug by inserting sub-section (2) in Section 5 of the Patents Act.

The Amendment has also brought into picture a new doctrine of exclusive
marketing rights (EMRS). The TRIPS Agreement stipulates that patents would
be available for any inventions, whether products or process in all fields of
technology, if they are new, involve an inventive step and are capable of
industrial application. It further provides that patents shall be available and
patents rights enjoyable without discrimination as to the place of invention and
the help of technology and whether products are imported or locally produced.
It also provides protection of plant varieties either by patents or by an effective
sui generis system or by combination thereof.8
The Amendment Act, 19999 by inserting sub-section (2) in Section 5 of the
Patents Act has made provision for grant of a patent in respect of an invention
for substance itself intended for use, capable of being used as medicine or drug
except the medicine or drug specified under sub-clause (v) of clause (1) of sub-
section (1) of Section 2 of the Act. The study reveals that as a result of the
aforesaid provision the patent shall be granted in all fields of pharmaceuticals
and agriculture. It will lead to the patent of micro-organisms, plant varieties,
plant, animals, non-biological and microbiological process. It means, therefore,
that the entire industrial and agricultural sectors and to an extent
biotechnological sector shall be covered under patent provisions. It is submitted
that the aforesaid provision has changed the philosophy of patent regime under
which all products whether imported or produced in India shall be protected
with act discrimination. These provisions intend to establish monopoly of
foreign trades in India. The prices of drugs may increase which may deprive
the poor and downtrodden from buying these drugs. Farmers will not be
permitted to use automatically farm saved seeds of protected varieties to sow
8
The Royal Society. 2002. ―Genetically Modified Plants for Food Use and Human Health -
An Update‖. Policy Document 4/02, The Royal Society Online; available from
http://www.royalsoc.ac.uk; accessed 21 July. The Royal Society. 2003.
9
The Patents (Amendment) Act, 1999
193
the next crop. They will have either to pay compensation for use of seeds or
obtain the approval of breeder.
The Patents (Amendments) Act, 1999 has inserted a new Chapter IVA in the
Act containing Sections 24A to 24F which provides for exclusive marketing
rights (EMRS). The EMRS enables an applicant for grant of a patent to
distribute and market his product in India from the date of filing the application
for grant of patent without going through the procedure laid down in the
Patents Act for grant of a patent. The EMRS can be granted before the grant of
patent in country where the research has its origin. In such a case, the
Government of India would not be in a position to insist on the production of
the article, which is subject matter of application, in India during the existence
of EMRS, The person in whose favour EMRS is granted would have a right to
distribute and market the product by importing the same from any other
country. Therefore, the import of any article and its sale in India may be at high
and prohibitive prices. In this way the fixation of price for the patented product
manufactured in India or imported from abroad in India is left to the discretion
of the right holder. An EMRS may be granted even if an article is not entitled
to be patented. The grant of EMRS may have adverse effects on the Indian
economy. The Patents (Amendment) Act, 2005 has introduced some changes in
the doctrine of EMRS.
5.2.2 Protection of Patentable Inventions in India:

A patent can be granted for an invention which may be related to any process
or product. The word ―Invention‖ has been defined under the Patents Act 1970
as amended from time to time. According to section 2(1)(j) of the Patents Act,
an invention means a new product or process involving an inventive step and
capable of industrial application. Besides the word invention, the Act also
defines the meaning of the word ―new invention.‖ New invention is defined as
any invention or technology which has not been anticipated by publication in
any document or used in the country or elsewhere in the world before the date
194
of filing of patent application with complete specification, i.e. the subject

matter has not fallen in public domain or that it does not form part of the state
of the art. Capable of industrial application, in relation to an invention, means
that the invention is capable of being made or used in an industry. Therefore,
the criteria for an invention to be to be patentable are as follows:
1. An invention must be novel,
2. has an inventive step, and
3. is capable of industrial application.
To be patentable, an invention should fall within the scope of patentable
subject matter as defined by the patent statute. The invention must relate to a
machine, article or substance produced by manufacture, or the process of
manufacture of an article, A patent may also be obtained for an improvement of
an article or of a process of manufacture. Previously, with regard to medicine
or drug and certain classes of chemicals, no patent was granted for me product
itself even if it was new, only the process of manufacturing the substance was
patentable. However, product patents are available for drugs and food materials
from 2005 as India‘s obligations under the TRIPS Agreement. If any substance
falls outside the scope of patentable subject matter, it cannot be patented.
5.2.2.1 Utility:
A patent can be obtained only for an invention which is useful. A patentable
invention should have utility, which implies the inventor should show some
sort of usefulness to the society. It will be patentable even if it is useful to a
minor portion of society or sometimes only to a single individual.
5.2.2.2 Novelty:
The invention claimed must be novel indicating that it should be new at the
time of conception. Novelty of invention must be considered in the light of
prior art. Prior art means the technology that that is relevant to the invention
and was publicly available at the time the invention was made. It includes prior
specifications, patents, printed and published literature and other materials
195
related to the invention. An invention is not novel if it can be anticipated in the

light of prior art.
5.2.2.3 Obviousness:
An invention should also not be obvious to a person having ordinary skill in the
art to which it relates. If the invention is obvious and does not have any
inventive step, it is not patentable. Existence of a prior publication of the
invention in any Indian specification or in any document in India or elsewhere
or public use of the invention would make an invention obvious. In order to be
ineligible for a patent, an invention should be obvious at the time of conception
of the invention and not at the time of contention of obviousness.
5.2.2.4 Specification:
Specification is an essential part of a patent. It should consist of the subject-
matter, description and at times including the drawing of the invention
indicating its scope. The specification has to enable a person with ordinary skill
in the art to practice and use the invention. It should also describe the best
mode of performing the invention.
5.2.3 Non-Patentable Inventions:

There are some products and processes, which are not patentable in India. They
are classified into two categories in the patent act -
a) Those, which are not inventions, and
b) Invention relating to atomic Energy.
5.2.3.1 Various Types of Non-Patentable Inventions:
There are several inventions which are considered to be non patentable
inventions in India vide section 3 of the Patents Act, 1970. They are as follows
1. An invention which is frivolous or which claims anything obvious
contrary to well established natural laws.
2. An invention the primary or intended use or commercial or
exploitation of which could be contrary to public order or morality or
196
which causes serious prejudice to human, animal or plant life or

health or to the environment.
3. The mere discovery of a scientific principle or the formulation of an
abstract theory or discovery of any living thing or nonliving
substances occurring in nature.
4. The mere discovery of a new form of a known substance which does
not result in the enhancement of the known efficacy of that substance
or the mere discovery of any new property or new use for a known
substance or of the mere use of a known process, machine or
apparatus unless such known process results in a new product or
employs at least one new reactant.
5. A substance obtained by a mere admixture resulting only in the
aggregation of the properties of the components thereof or a process
for producing such substance.
6. The mere arrangement or re-arrangement or duplication of known
devices each functioning independently of one another in a known
way.
7. A method of agriculture or horticulture.
8. Any process for the medicinal, surgical, curative, prophylactic
diagnostic therapeutic or other treatment of human being or any
process for a similar treatment of animals to render them free of
disease or to increase their economic value or that of their products.
9. Plants and animals in whole or any part thereof other than
microorganisms but including seeds, varieties and species and
essentially biological processes for production or propagation of
plants and animals.
10. A literary, dramatic, musical or artistic work or any other aesthetic
creation whatsoever including cinematographic works and television
productions.
197
11. A mere scheme or rule or method of performing mental act or

method of playing game.
12. A presentation of information.
13. Topography of integrated circuits
5.2.3.2 Examples of Non-Patentable Inventions:

Some examples of non patentable inventions include -
 Discovery of any natural living thing or non-living thing.
 Invention based on any new Diagnostic and Therapeutic Treatment
of any causative disease to human beings and animals.
 Use or commercial exploitation of any invention, which could be
harmful to human, animal or plant life or to the environment.
 Plants and animals, including varieties, seeds and species thereof and
biological process for the production or propagation of plants and
animals.

AND BIOTECHNOLOGICAL PATENTS IN
INDIA:
Biotechnology, a modern science of nearly thirty years old, is revolutionizing
production in certain areas of industry and agriculture. It has the potential to
provide the answers to some of the world‘s most intractable problems
concerning agriculture productivity, health, nutrition and the environment. Two
sectors were biotechnology has already made significant contributions are
pharmaceuticals and agriculture. While it is true that this technology has so far
been dominated by corporations based in industrialized countries, mainly the
United States and Europe, and has tackled mostly problems pertaining to these
countries, it potential to solve problems in developing countries cannot be
198
denied. In particular, developing countries have long possessed capabilities for

plant breeding, mainly through public sector research institutions, for which
biotechnology now provides new tools. Paradoxically, so far developing
countries have generally been wary that this technology may have adverse
effects on health and the environment. Since many of the new biotechnological
products and process are protected by intellectual rights (IPRs), additional
concerns over ethics, morality and access to these technologies tend to cloud
the debate in developing countries and in international for a such as the World
Trade Organization (WTO). Intellectual Property Rights for biotechnological
inventions also raise a related but quite distinct set of issues concerning equity.
Northern firms are accused of pirating and patenting biological material and
traditional knowledge from the gene rich developing world for profit, without
fair and equitable sharing of benefits or the appropriate transfer of the new
technologies as called for by the Convention on Biological Diversity (CBD). 10
Until recently, relatively little policy attention has been paid by the
international community to improving the access of scientists, technologists,
entrepreneurs and consumers in developing countries to these new technologies
and products that promise to change ways of living. Nevertheless, such
considerations have driven some developing country governments like India to
encourage R & D in this area in the public sector. However, given the highly
capital intensive nature of product development, most developing countries can
only hope to enter into collaborative arrangements with large multinational
corporations in order to share in the benefits of this new technology.
Developing countries that have a relatively strong research base and industrial
capacity will be more successful in this effort.
Table : Patenting Life: Milestones in Biotech Patent Protection

1873: Pasteur got US Pat no 141.072 - ―Yeast an article of manufacture‖
10
Bridge David Bain, Cases & Materials in Intellectual Property Law, Pitman Publication, 1 st
edition, 1995 p 42
199
1969: Animal Breeding Methods - German Federal Supreme Court accepts

1975: Microorganisms are patentable - German Federal Court
1980: Microorganisms become patentable in USA (Diamond vs. Chakrabarty)
1985: Plants/tissues/ tissue culture, Seeds become patentable: US PTO
1987: Multicellular Organisms are patentable - US PTO
1988: European Patent Office grants first patent on plant US PTO issues patent
on ―oncomouse‖
1995: DNA not life but chemical and patentable - EPO declaration 1998
Pharmaceuticals gets first patent covering ESTs
2001: Patent filed for 4000 human genes and proteins and codes for them by
Oxford Glyco Sciences
2002-03 - The story and controversy goes on
5.3.1 Traditional Knowledge and Indian Legal

Regime:
In India, there is no specific law that deals with protection of traditional
knowledge. But there are few Acts which protects traditional knowledge in an
indirect way like the Biodiversity Act, the Protection of Plant Varieties and
Farmer‘s Right Act, etc. traditional knowledge is essential to the food security
and health of millions of people in the developing world. In order to protect our
country from bio-piracy of traditional knowledge, a sui generis legislation may
be enacted and also a proper database needs to be created.
5.3.1.1 National Biological Authority and Traditional

Knowledge:
The Biological Diversity act, 2002 (BDA) has come into force and the National
Biological Authority (NBA) has been established. The NBA lays down
guidelines for access to biological resources, and for fair and equitable benefit
sharing besides advising the Central Government on conservation of
200
biodiversity, Section 21(2) of the Act contemplates a variety of monetary and

non-monetary companies for the benefit claimers including transfer of
technology, joint ownership, location of research facilities within a certain area,
the association of local scientists; and the setting up to venture funds. The
Biological Diversity Act has no restrictions with respect to obtaining biological
materials on local communities but implies limited restrictions on Indian
individuals/entities and stronger restrictions on foreign nationals and entities.
Regarding the transfer of information relating to research on bio resources, the
restriction is applicable to all and for the application of IP rights, all parties are
obliged to seek the approval of the NBA who may impose monetary or non-
monetary benefit sharing. Eight out of India‘s 26 States have set up their own
state biodiversity boards and the NBA has received 19 applications, five from
foreign companies and nine related to collaborative research between Indians
and non-Indians. However none of them has received approval yet because the
NBA has only held two meetings. NBA is only a regulatory body and not a
denying authority with a positive attitude towards biotechnology research. As
long as the benefit derived is shared with the local community, sovereign rights
are protected and the research does not damages the ecosystem or endanger
biodiversity, the NBA will grant approvals for progress in biotechnology
research.
In compliance with the BDA, Section 10(4) of the Patents Act, 2005 creates an
obligation to deposit and disclose the source and geographical origin of the
biological material in the patent specification. Failure to disclose or wrong
disclosure is a ground for opposition and revocation. The Patent Act2005 also
speaks of traditional knowledge as anticipating a patent. The National Institute
of Science Communication (NISCOM). Now Delhi and the Department of
Indian Systems of Medicine and Homeopathy (ISM&H). Ministry of health
and Family Welfare have come together to compile the Traditional Knowledge
Digital Library (TKDL) which would document the traditional knowledge
available in the public domain in a digitized format. Starting with the existing
201
literature in Auyrveda, it would later cover unani, siddha, naturopathy,

homeopathy and tolkiore medicine in the first phase, a Traditional Knowledge
Resource Classification (TKRC) is prepared for 2147 medicinal plants. 11 There
has been international acceptance of TKDL with the World Intellectual
Property Organization (WIPO) constituting a group of members from USPTO,
China, Japan, the European Patent Office and India for discussing the findings
of the TKDL. Task Force. The outcome is to create a new sub-class for TKRC
in the IPC and link TKRC with ayurveda India‘s TKDL database has also been
selected for a pilot study by 170 members states of WIPO. 12 When completed,
TKDL would help patent examiners easily retrieve traditional knowledge-
related information, thus avoiding the possibility of granting patents to
unoriginal inventions. Further, a review process of patents already granted in
light of the TKDL database would help in the cancellation of some patents.
5.3.2 Medical Biotechnology:

In India, the Pharma industry is one of the first to reap the benefits of
biotechnology. Human health biotechnology products account for about 60% of
the domestic market, while bio-drugs, vaccines and diagnostics have significant
market shares as well Consequently, Indian pharma is beginning to harvest the
benefits from enhanced IP protection of their products. An example is
Ranbaxy‘s NDDS for ciprofloxacin licensed to Bayer for $65 million plus
royalties. Other Indian research-based companies have earned about $70
million from R&D milestone payments CSIR has also earned revenges by
licensing its patents to the industry.13
The Indian Patient Office received 15 applications for the grant of exclusive
marketing rights (EMR). Of these, three have been allowed, four rejected and
11
Chaudhury Sudeep, ‗TRIPS Agreement and Amendment of Patent Act in India‘,
Economics and Political weekly, Vol37, No. 32, August 10(2014) p 75
12
Ibid at 67
13
Gandhi Gopalkrishna. ―IPR and India- A Viewpoint‖, Journal of Intellectual Property
Rights, Vol. 10, No.5, pp 359-360 (2005)
202
the remaining eight are pending. The Patent Office has become more open to
opportunities. Due to the emphasis on outsourcing to cut costs and retain
competitiveness. India is being considered a destination for contract research in
the pharma sector. Data exclusivity is a prerequisite for the protection of
research efforts, decisions on where to conduct clinical trials and the amount of
foreign investment in the pharmaceutical and biotech sectors.
Industry needs to collaborate with academia and a code of conduct for biotech
members has to he designed. Further, the regulatory issues are all in a very
naïve stage such as the draft guidelines for stem cell research by ICMR. The
clinical trials/ contract research industry in India gets a boost due to the
presence of a Bolar provision in the Indian Patent Act 2005. 14 Under this
provision the patented invention can be used for the purpose of collecting data
such as the clinical trial data, for approval from the appropriate authority. This
ensures that when the term of the patent expires, the manufacturer need not
wait for clinical trials/DCGI approvals etc. and straightway go for manufacture.
Novartis was the first company in India to be grated an EMR by the Indian
Patent Office for a blood cancer drug, Glivec. SmithKline Becham challenged
the order in a writ petition before the Delhi High Court. This writ was
dismissed for want of territorial jurisdiction. However, Novartis won a stay
from the Madras High Court restraining six drugs companies from
manufacturing and distributing imatinib mesylate – the active ingredient in
Novartis‘ Gilvec. The EMR provision is no longer in force from January 1,
2005. medical biotechnology offers a good possibility for Indian Industry to
establish a strong pharmaceutical sector, a growing number of small and
medium biotechnology companies, a large network of universities, research
institutes and medical schools and low cost of product evaluation.
14
Chaudhury Sudeep, ‗TRIPS Agreement and Amendment of Patent Act in India‘,
Economics and Political weekly, Vol37, No. 32, August 10(2014) p 57
203
Clinical biotechnology and contract research India has made tremendous

progress in clinical biotechnology over the past few years and has the potential
to be a key player in this highly remunerative area.
There is also an exciting opportunity of conducting longitudinal studies in
disease segments for prospecting new biomarkers and novel pharmacogenomic
companies looking outward to reduce their ballooning research cost. India is in
a good position to tap the new business.
5.3.3 Agriculture Biotechnology:

To comply with the TRIPs Agreement, India adopted a sui generic system for
plant variety protection. The Indian Parliament enacted the Protection of Plant
Varieties and Farmer‘s Rights Act of 2001 in order to spur the development of
new varieties of plants by providing protection for developers of new plan
varieties. But the protection available through patents is also available for
various plant related/derived products.
A Study by TIFAC shows that in India 484 applications have been filed
specifically referring to plants between November, 1994 and December, 2003.
These applications include 89 convention applications and 132 PCT
applications. Applications related to agricultural machinery were not included
in the analysis. Of the 484 applications, 72 applications relate to plan extracts
and 60 relate to various compositions derived from them. The top applicants
were CSIR, Avestha Gengraine, JB Chemicals & Pharma Ltd. Synit Drugs Pvt.
Ltd. Asgrow Seed Company, Tropical Botanic Garden & Res. Inst., Conster
Chemical Ltd., Hoescht Schering Agrevo GMBH, BASF Aktiengesellschaft,
Monsanto, University of Delhi, ICAR, Genesis Research, Aventis Crop
Science GMBH, Zeneca Ltd and Novartis. The most important thing to observe
is that patents are possible for many aspects of a plant and its utilization except
the plat for se. The applicant should look at multiple forms of protection and
not just think in terms of protecting plant per se. With respect to infringement
of registered seeds under the Seeds Act, there have been important decisions to
204
protect them with help of biotechnology. In emergent Genetics India Pvt. Ltd
Vs. Shailenda Shuvam, 15 the Delhi High Court applied the principles of the law
of confidentiality in giving protection to hydrid cotton seeds which are
genotypically identical, Emergent owned a copyright in the unique DNA
sequence of a hybrid variety of cotton seeds. A tort to breach of confidential
information was found that the e-employee defendants received while
employed by Emergent. The Court restrained the defendant from marketing
and selling the said cotton hybrid seeds based on the DNA finger printing
results. The principles of the copyright law were applied to protect unique
sequencing information locked inside genes of hybrid varieties of the plaintiff.
His approach was necessitated by the fact that the Protection of Plant Varieties
and Farmer‘s Rights Act had not been notified then. The Protection of Plant
Variety and Farmers Rights Act, 2001 along with the Rules, 2003 were notified
in March, 2005, and are expected to come into force soon. The Protection of
Plant Variety and Farmers Rights Authority is being constituted and is
expected to be active soon with the Chairman already appointed. The
registration process would require DUS (distinctness, uniformity and stability)
testing of the plant varieties by the authorities. DUS testing centres have been
identified based on the crop and area. Guidelines for DUS tests to be performed
have also been prescribed for different crops. However, the guidelines to be
followed for registration of transgenic plants are not clear. The
biotechnological processes involved in producing the transgenic are patentable
subject matter.
5.3.4 Bioinformatics:
Bioinformatics has proved to be a powerful tool for advanced research and
development in the field of biotechnology. As the full genome sequences, date
from micro arrays, proteomics as well as species data at the taxonomic level
15
Suit No.50 of 2004
205
became available, integration of these databases requires sophisticated

bioinformatics tools. Organizing these data into suitable databases and
developing appropriate software tools for analysing them are major challenges.
India has the potential to develop such resources. In India, Informatics for life
sciences is an emerging sector; the market size is still quite limited. India has
strengths in chemistry and computer science, software, healthcare and biology.
However, bioinformatics may not constitute patentable subject matter since it
would come under the purview of Section 3(k) and Section 3(n) of the Indian
Patent Act. However, if the bioinformatics tool can be proven not to be a
computer program per se, it may be patentable.
5.4 THE RELEVANT AMENDMENTS TO THE

INDIAN PATENTS ACT AND BIOTECH
INVENTION ISSUES:
The Indian Patents Act, 1970 was amended thrice to make it TRIPS compliant.
The patents (Amendment) Act 1999(hereinafter referred to as the 1999
amendment)
The patents (Amendment) Act 2002(hereinafter referred to as the 2002
Amendment)
The patents (Amendment) Act 2005 (hereinafter referred to as the 2005
Amendment)
The provisions of the 1999 Amendment had the retrospective effect from I
January 1995. The 2002 Amendment came into force on 30 May 2003 whereas
the 2005 Amendment became effective from 1 January 2005.
5.4.1 The Patents (Amendment) Act 1999:

The Central Government came out with amendment to the Patents Act 1970 as
the Patents (Amendment) Act 1999. The major changes on patents are
discussed below.
206
5.4.1.1 Invention:
The definition of ―invention‖ has been simplified and is in accordance with the
definition of what an invention is under TRIPS. Under the new definition, an
invention means a new product or process involving an inventive step and
capable of industrial application. ―Inventive step‖ means a feature that makes
the invention nor obvious to a person skilled in the art. ―Capable of Industrial
Application‖ in relation to an invention, means that the invention is capable of
being made or used in any kind of industry. The one direct effect of making
this definition specific could be that courts would be relieved of the task of
settling issues on ―inventiveness‖ as a criterion of registrability.16
5.4.1.2 Non Patentability:

The original prohibition contained in s3[b] has been enlarged by the new clause
in substitution defining one other invention which cannot be patented. 17 It is:
―As invention the primary or intended use or commercial exploitation of which
could be contrary to law or morality or which causes serious prejudice to
human, animal or plant life or health or to the environment.‖18
Through this, experiments in genetic modifications leading to use of products
or their commercial exploitation which may be harmful not only human beings
but also to animals or plant life or to the environment.‖ 19
Under 3 [c] as it stood before the present amendment, the mere discovery of a
scientific principle or the formulation of an abstract theory was not an
invention. The addition to this sub-clause states that the discovery of any living
thing or non-living substance occurring in nature would also not be an
invention. The obvious reason is that no man can claim to have invented these
things for the purpose of claiming the monopoly rights under patent legislation.
16
Journal of Intellectual Property Rights, vol 10, March 2006, p 111-164
17
ibid
18
ibid
19
ibid
207
A microorganism, not occurring naturally, but which is the result of human

intervention and experiment.20
One other exclusion from the category of what are inventions describes them as
follows: ―Plants and animals other than microorganisms in whole or any part
thereof including seeds, varieties and species and essentially biological
processes for production or propagation of plants and animal.‖ This is in
exercise of the right given to Member Countries [Article 27(3) (b)] to include
from patentability, ―plants and animals other than microorganism, and
essentially biological processes for the production of plants or animals other
than non-biological and micrological processes.‖21
Also excluded are: A mathematical or business method or a computer program
or algorithms: a literary dramatic musical or artistic -work or any other
aesthetic creation whatsoever including cinematographic works and television
productions, a mere scheme or rule or method of performing mental act or
method of playing a game a presentation of information, topography of
integrated circuits.
5.4.1.3 Chemical Process Defined:

According to 5[1](b), no patent shall be granted in respect of claim for the
substances themselves, but claims for the methods or processes of manufacture
shall be patentable in the case of inventions relating to substances prepared or
produced by chemical processes. The Explanation to 5 introduced now states:
For the purpose of this section, ‗chemical process‘ includes biochemical,
biotechnological and micrological process. The simple effect of this is that
inventions in these fields may be granted patent protection only in respect of
the methods or processes of manufacture constituting the invention and not the
end-product resulting from the use of the process.22
20
ibid
21
ibid
22
ibid
208
5.4.1.4 International Applications:

The amendment, necessary after India signing the Patent Cooperation Treaty,
has introduced a definition of ―international application‖23, the procedure to
deal with international applications and related matters. Under the proposed
amendment ‗international application‘ means an application for patent made in
accordance with the Patent Cooperation Treaty. Where an applicant files an
application for a patent in any convention country and designates India, that
application would be treated as an application for a patent in India and will be
dealt with in accordance with the procedure set out in the Patents Act of India,
which incorporates the relevant requirements of the Patent Cooperation Treaty
[PCT]. In this case the filing date of the application where India has been
designated, would be treated, by the Indian patent authority as the international
filing date accorded under the PCT.
The Patent Cooperation Treaty defines ‗designated office‘ as follows:
(xiii) ‗Designated Office‘ means the national office of or acting for the State
designated by the applicant under Chapter 1 of this Treaty:24
It is for the applicant desiring that an application filed by him be treated as an
international application and designate the country where also protection for
the invention is sought by him. This is relevant where the applicant intends
claiming priority in another member country on the basis of an international
application filed in any other country.
Article 8 of the PCT dealing with claim for priority in designated countries on
the filling of an application in another convention country provides that an
international application may contain a declaration, as prescribed in the
Regulations, claiming the priority of one or more earlier applicants filed in or
for any country party to the Parts Convention for the Protection of Industrial
Property.
23
ibid
24
ibid
209
Subject to what is stated following, the conditions for, and the effect of, any
priority claim declared under paragraph (1) shall be as provided in Article 4 of
the Stockholm Act of the Parts Convention for the Protection of Industrial
Property. The international application for which the priority of one or more
earlier applications filed in or for a Contracting State is claimed may contain
the designation of the State. Where, in the international application, the priority
of one or more national applications filed in or for a designated State is claimed
or where the priority of an international application having designated only one
Stale is claimed, the conditions for, and the effect of, the priority claim in that
State shall be governed by the national law of that State. 25

Through, the Second amendment to the Patent Act in 2002, the Legislature
included Clause (j) to Section 3 which excluded essentially biological
processes‖. The term ‗essentially biological process‘ has perplexed most
scholars in the field of biotechnology and patents.26
5.4.2.1 Patenting Life Forms & Essentially Biological

Processes:
Patentability of ‗essentially biological process‘ mainly revolves around
patenting of life forms that may have at least two dimension. Firstly, there is
the ethical question of the extent of private ownership that could be extended to
life forms. The second dimension relates to the use of the concept of
intellectual property as understood in the industrialized world and its
appropriateness in the face of larger dimension of rights on knowledge, their
ownership, use, transfer and dissemination. The major justification for the non
grant of patent to life forms has been based on the absence of effective system
25
ibid
26
Journal of Intellectual Property Rights, vol 13, March 2008, p 132-134
210
for distinguishing between formal and informal system of knowledge and

system for assessing its impact on public order and morality.‖27
5.4.2.2 Restrictions with Respect to Agriculture Related

Inventions:
Restricting protection of technologies related agriculture (and all life forms)
has been a part of Indian Patents Act since 1970.28 Section 3 (h) and 3 (i) are
typical examples, which survived through the amendments and are very much a
part of the current at albeit 3 (i) was modified.
Interestingly, a new section – Section 3 (j) was specifically brought into the
negative list by the 2002 Amendment, in order to avoid any possibility of
patenting of life forms, especially the plaint varieties and seeds, for which Plant
varieties and Farmers Rights Act (PPVER Act) was separately enacted by the
Indian Government as per Article 27 3(b) of TRIPS Agreement. 29 Though
Section 3 (j) did not exist till 2002, to refuse a case of patenting of life form the
patent Office relied on the definition of the word invention as per Section 2 (i)
(j) that then existed as produced below:
Invention means any new and useful:
i) Art, process, method of manner of
ii) Manufacture, machine; apparatus or other article.
iii) Substances produced by manufacture, include any new and useful
improvement of any of them and an alleged invention.
27
ibid
28
World Trade Organization (WTO) Annual Report 2005, Suresh Kumar K., ― The Current
Indian Patent Regime and the Scope of Protection in Agricultural Biotechnology: Some
Issues and Considerations‖, FAO Statement in Biotechnology (March 2000), Journal of
Intellectual Property Rights, Special Issue on Patents and Emerging Technologies, ILI
Library, p343
29
Suresh Kumar K., ― The Current Indian Patent Regime and the Scope of Protection in
Agricultural Biotechnology: Some Issues and Considerations‖, FAO Statement in
Biotechnology (March 2000), Journal of Intellectual Property Rights, Special Issue on
Patents and Emerging Technologies, ILI Library, p342-345
211
The patent office argument was reported to be that life from per se was not art
article or a substance that could be produced by ‗manufactured or a
composition. On few occasions, rejections seemed to on ethical grounds under
Section 3 (b).
Thus as of now. Sections 3 (h) 3 (j) and 3 (j) restrict the scope of patenting in
the area of agriculture. Any new plant variety arising out of innovative use of
conventional techniques as well as modern biotechnological methods is not a
subject matter of patent. Further, section 3(j) prohibits preventing of
conventional techniques/ processes such as plant breeding methods like tissue
culture techniques, grafting artificial pollination, etc. Any invention that could
be categorised as a ‗biological invention‘ would attract this provision and
hence, could not be patentable. However processes based modern
biotechnology techniques could escape the ‗essentially biological‘ clause and
hence could be patentable.
Thus it could be argued that the amendments in section 3 (i) and inclusion of 3
(j) by the 2002. Amendment were by and large to address facilitation of
protection of agricultural biotechnology related inventions. Thus, discussions in
this article are restricted to the scope of patenting to scientific innovations in‘
modern agricultural biotechnology including molecular genetics, recombinant
DNA technology genetic transformation method (akin to Agrobactering
route) and expression vectors and techniques, engineered gone cassettes, use
of such modified genes in specific crops and plants.30
5.4.2.3 Diagnostic and Therapeutic Treatment in Relation to

Agriculture:
After the patents (Amendment) Act, 2002 it became possible to patent, any
process for medicals surgical curative prophylactic. Diagnostic therapeutic or
other treatment of plants to render them free of disease or to increase their
30
ibid
212
economic value or that of their products [Section 3 (i) Interestingly this

Section combined with section 3 (j) made protection of biotechnology based
tools and process to achieve them possible for example a disease to achieve
them possible for example a disease resistant plant at the same time excluding
the possibility of protecting any process that is essentially biological for
achieving the very same objective. 31
The discussion is not about protection of the disease resistant plant per se or a
plant with enhanced nutritional level per se ( which is a subject matter for
protection under PPVFR) but protection the means a modified genetic cassette,
or a genetically engineered process to alter the plan characteristic to make if
disease resistant or enhance its nutritional comment or increase its yield.
However patent practices and the scope and breadth of allowable claims in
such patent application would only evolve over a period of time, as examiners
in the patent office gain useful experience the guideline for the practice are set
and precedents are available. At this stage one may have to wait for some case
histories of prosecution before the patent office, the Appellant board 32 and the
court system to be available.

The Patents (Amendment) Act 2005, provides protection for product as well as
process in all technical fields. The development in a way is watershed in the
history of the India patenting regime, as this gives way to the technology field
wise restrictive discrimination that existed before. Thus legally speaking, it is
now possible to obtain produce patents for drugs, pharmaceuticals, chemicals
and biotechnology products. 33 The only exception, as defined in Section 3 of
the Act now are;
31
ibid
32
ibid
33
Suresh Kumar K., ― The Current Indian Patent Regime and the Scope of Protection in
Agricultural Biotechnology: Some Issues and Considerations‖, FAO Statement in
213
a) an invention which is frivolous or which claims anything obviously

contrary to well established natural laws.
b) an invention the primary or intended use or commercial exploitation of
which could be contrary to public order or morality or which causes
serious prejudice to human, animal or plant life or health or to the
environment.
c) the mere discovery of scientific principle or formulation of an abstract
theory or discovery of any living thing or non-living substance occurring
in nature .
d) the mere discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that substance of the
mere discovery of any new property or new use for a known substance
of mere new use of a known process, machine or apparatus unless such
known process results in a new product or employs at least one new
reactant;
e) a substance obtained by mere admixture resulting only in the
aggregation of the properties of the components thereof or a process for
producing such substance;
f) the mere arrangement or re-arrangement or duplication of known
devices each functioning independently of one another in a known way.
g) (This sub-section was deleted by the 2 (x) Amendment)
h) a method of agriculture or horticulture
I) any process for medicinal, surgical, curative prophylactic, diagnostic,
therapeutic or other treatment of human beings or any process for a
similar treatment of animals to render them free of disease or to increase
their economic value or that of their products.
j) plants and animals in whole or any part thereof other than
microorganism but include seeds variants and species and essentially
Biotechnology (March 2000), Journal of Intellectual Property Rights, Special Issue on

Patents and Emerging Technologies, ILI Library, p342-345
214
biological processes for production or propagation of plants and

animals.
k) mathematical or business method or a computer program per se
algorithms
l) a literary, dramatic, musical or artistic work or any other aesthetic
creation whatsoever including cinematographic works and television
productions.
m) a mere scheme or rule or method of performing mental act or method of
plays game.
n) a presentation of information
o) topography of integrated circuits;
p) an invention which, in effect is traditions knowledge or which is an
aggregations or duplication of known properties of traditional known
competent or components.
A part from the above, inventions relating to atomic energy are not
patentable.34
5.4.3.1 Patentability Exclusion before January 2005:

Patent applications filed in patent Office on or after 1 January, 1995 are either
in the examination phase now or might have entered into the grant phase. The
most significant amendment of the 2002 Amendment is, however the mailbox
provisions and expansion of the term chemical process of Section 51(b) to
include biotechnological process. All these developments had a major say in
allowing patents in the field of biotechnological. Therefore, it would be
interesting to analyse what kind of application were field of biotechnological.
Therefore it would be interesting to analyse what kind of application were
filed between I January 1995 the effective date of WTO/TRIPS Agreement
and 1 January, 2005, the effective date of a more (or fully) TRIPS complaint
34
Section 4. The Patents (Amendment) Act 2005
215
version of the patents Act . Such an analysis would bring into the fore kind of
applications filed in the area of agricultural biotechnological as well in order to
conduct such an analysis, it necessary to understand what was not patentable
during the period of I January, 1995 and I January 2005 ( hereinafter referred
to as interim period ) which has now become patentable., The discussions
below are based on the patents (Amendment )( Act 2002, that became effective
from 20th May 2003 with all of these provisions applicable to any pending
patent application before the patent Office that was filed from 1 January,
1995.35
5.4.3.2 The Mailbox Provision:

The Patents (Amendment) Act. 2005 brought in the necessary provisions in the
Act for providing product patents in all technical fields. This amendment made
the redundant provisions of Exclusive Marketing Rights (EMR) possible in the
interim period. During the interim period, the Patent s Act under Section 5 had
provisions that restricted the grant of product patents in case of invention
relating to drugs (agrochemicals included) and chemicals According to this
Section. In the case of inventions claiming substances intended for use, or
capable of being used, as food or as medicine or drug, or relating to substances
prepared or produced by chemical process (including alloys optical glass, semi-
conductors and inter metallic compounds), no patent shall be granted in respect
of claims for the substances themselves, but claims for the methods or process
of manufacture shall be patentable.
It may be noted that the definition of the term chemical process was further
expanded to include biochemical biotechnological and microbiological process
as per the 2002 Amendment. Thus it could be presumed that patent office has
been in a position to examine patent applications relating to inventions
claiming biotechnological processes from 20 May 2003 and grant patents,
35
ibid
216
subject to meeting of other provisions in the Act. However in the case of a

patent application filed prior to 20 May 2003, the situation would be
interesting. In principle, the provisions of the Amendment would apply to any
active patent application before the patent office as on any given date after the
said .Amendment. However one may have to wait for a prosecution case law to
have clarity. The moot question however, was whether the patent office was in
a position to accept any patent application claiming a biotechnological product
or not.
During the interim period, to meet the requirements of Article 70 (8) and 70
(9) under the provisions of TRIPS agreement , there was a provision for the
patent office to receive patent applications claiming for a substance itself
intended for use or capable of being used as medicine or drug, excepting the
intermediate for the preparation of drug . This special provisions was brought
in by the 1999 Amendment and was covered under the Section 5 (2) (Chapter –
II). Such a provision is popularly called the Mailbox provision. Based on such
a mailbox application if was possible to apply for EMR for such products under
Chapter IV A of the Act. The definition of the word medicine or drug, included
agricultural chemical products. The relevant section is Section 2 (i) of the Act
( as existed till 31 December 2004) that categorical insecticides germidie3s,
fungicides weedicides and all other substances intended to be used for the
protection or preservation of plants as medicine or drug.36
Thus it is quite possible that a patent application claiming, for example, an
insect resistant gene construct or an herbicide resistant gene construct was filed
at the Indian Patent office. Whether the patent office would consider the
biotechnology related patent application claiming the gene invention is a moot
question. This applies to patent application claiming substances such as R-
DNA Plasmids vectors and promoters as well.
After a careful consideration of the mailbox provisions and the definition of
medicine and drug as per Section 2 (1) It may be inferred that it is not
36
ibid
217
possible to categorically state that the mailbox provisions could extend to

patent application pertaining to Biotechnology products. A legal argument
favouring such an extension would be the Act did not specify whether such a
herbicide of a weedicide application needed to be an external application or
systemic application or systemic application over the plant or could be an
induced trait within the plant.37
To further see whether it was obligatory for the patent office to receive such
patent application covering a product claim of genetic cassette capable of
inducting the expression of a herbicide or pesticide trait within the plant, a
close scrutiny of other provisions in the Act Specifically section in Chapter
III application for Patents is also imperative ‗None of these sections or other
sections prohibits the patent office from receiving any patent application
including agricultural biotechnology product related inventions . Therefore it
is reasonable to presume that the Indian patent office did accept patent
application related to all kinds of inventions including those claiming
biotechnological produces or process just like the way they accepted those
claiming to be drugs pharmaceutical and chemicals, in fact a patent search on
the patent applications filed in India during the period corroborates this view
point.

AND BIODIVERSITY:
Many of us are engaged in the complexity of the modern life and addicted to
the individual approaches of the development, driven by greed, hardly realize
that we are living out of me last degrading ‗eco-capita‘ of our only home called
―earth‖. Stressing, 60 percent of the earth‘s eco systems like forests, fish
stocks, animal species, land, rivers, oceans and mountains are degraded. 38
37
ibid
38
Laird, S. (ed.), Biodiversity and Traditional Knowledge, Earthscan, London, P 250 (2002)
218
Many of them are irreversibly damaged forever. To value the natural resources
of the planet requires pricing the priceless. The poor people often depend
directly on biodiversity for their day to day livelihoods. In the long run,
protecting an eco-system may cost less, and allow us to reap its benefits for
longer, than depleting its resources. Because people get the nature‘s services
for free, they tend to use them wastefully like a tenant who doesn‘t pay for
electricity; they tend to leave the lights on even when they leave the room.
In the wake of fast depletion and extinction of natural resources of diversities
and consequential transnational ramification, the Convention on Biological
Diversity, 1992 (CBD) was adopted by balancing the ‗common heritage‘ and
‗national sovereignty‘ principles. The broad agenda envisioned under the
Convention are sustainable use, fair and equitable sharing of benefits of genetic
resources which in turn obligate the member states to swing into action for
devising the Access and Benefit Sharing (ABS) system. The loss of
biodiversity resources has a direct bearing on carbon economy, sustainable
development and climate change and to every state has owes a solemn
responsibility to foster environmental justice. The Indian government has come
out slew of enactment on biodiversity, environment and IP by passing of
Biodiversity Act, Protection of Plant Varieties, Geographical Indication Act,
Forest Right Act and Patent Amendment Act.39
India‘s concern for a comprehensive legislation bears legitimacy because it is
one of the twelve mega diversity regions of the world and constitutes seven
percent of world‘s flora. Reeling under sheer ignorance, we have been able to
identify so far only 52,000 species out of a total 83,000 species of animals. 40
Most of our rich heritage of rice germ plasma reposes today in collections
39
Md. Zafar Mahfooz Nomani-Biodiversity, IPR and Sustainable Development: A Critical
Appraisal of access and benefit models of U.S., Australia and India-International Journal
of Environmental Consumerism (IJEC)-p46-61
40
The information regarding availability of 83,000 animal species has been provided by
museum of London.
219
abroad.41 The computerized data base called ―Natural Product Alert‖ located in
Chicago has far better information on medicinal uses of Indian plants than any
Indian data base. The poverty of information culture, lack of judicious
husbandry and faulty patent laws has allowed rampant bio piracy of natural
heritage and knowledge. 42
The CBD accords primacy to ‗national sovereignty‘ than to ‗common heritage‘.
The preamble as well as Article 3 states that national Government has right to
decide (he utilization of genetic resources including collection of payment of
such utilization. Such access is being subjected to a new law of Prior Informed
Consent (PIC) of the country where collection takes place in s itu and must be
on mutually agreed terms. Since consensual approach vis-à-vis mutually agreed
terms provides enough space for negotiation and bargaining, the providing
country may ask for disposal of all relevant information, viz. purpose, use and
futuristic value of genetic materials from user country. On its face, it appears
that the general conditions are imposed unilaterally by providing country. In
reality, the entire permit system is heavily seated under legacy of Trade Related
intellectual Property Rights (TRIPS) of world Trade Organization (WTO). A
National Authority must be established which will act as custodian, guarantor
and facilitator to such information by virtue of national repository of genetic
resources. The Authority should devise an outline of contractual terms and
conditions to ensure that the benefits must go to indigenous and traditional
communities. The Authority should develop Gene Banking Payment System
(GBPS) through the instrumentality of import export and IPR laws. Moreover,
access can only be granted in lieu of transfer of environment friendly
technology, compensation and information sharing. 43
41
ibid p41
42
43
ibid
220
The industrial nations want strong international protection of intellectual

property rights (IPRs) and technology transfer subservient to TRIPs Agreement
and WTO mechanism. The developing nations argue that Trade Related Aspect
of IPR protection has a tendency to monopolization by the industrial nations.
They also contend that the industrial countries argument that IPR protection is
a necessary stimulus for innovation applies only to industrialized countries.
The developing nations apprehend the inherent injustice prevalent under
royalty payment on access to genetic resources originating within their own
territories. India argued for an interpretation of Article 16 which justifies
exceptions to IPR protection in the interest of conservation of biological
diversity. Article 21 sets out the mechanism for financial resources to
developing country on a grant or concessional basis.44
5.5.1 National Biological Diversity Legislation and Policy:

Biodiversity plays a vital role in sustaining conservation of nature and
development of biotechnology industry. Biodiversity is basic to progress in
improving the productivity of plants, animals, fishes and all living organisms.
Conservation of biodiversity ensures ecological stability and also involves
protection of socio-ecological interest of the people actively associated with
conservation. All over the world legal strategies at global, regional and local
level have been developed for ensuring protection to such interest alongside
maintenance of ecological stability. 45
Biological diversity is primarily concentrated in the tropics, i.e. developing
countries. It is a well-documented fact that developing countries are rich in the
world‘s flora and fauna and 80 percent of the earth‘s terrestrial biodiversity is
confined to these countries. With only 2.5 percent of the land area, India
44
Ibid
45
Tiwari G.S.- Conservation of Biodiversity and Techniques of People Activities, 43 JILI
(2001) at p 191
221
accounts for 7-8 percent of recorded species of the world. India is equally rich
in traditional and indigenous knowledge, both coded and informal. 46
India‘s concern for a comprehensive legislation bears legitimacy, because it is
one of the twelve mega diversity regions of the world and constitutes seven
percent of the world‘s flora. The Biological Diversity Policy enunciates that
India has sovereign right over its biological resources. The Biological Diversity
Conservation Act, 2002 claims to be progressive sounding and likely to be
ranked as first national legislation in the world. The transfer of biodiversity
resources will accrue to communities. Local committees are abdicated to
decide distribution of funds available from royalty, cess and profits. The draft
also proposes that the Central Government may from time to time notify‘
threatened species and prohibit and regulate their collection. The breach of the
provisions attracts condemnation by way of imprisonment for a term up to five
years and fine up to Rs.10 lakhs. The twin provisions envisaged under CBD
viz. right to sovereignty and equitable sharing of benefits among indigenous
communities necessitates urgent restructuring in IPR regime because of
prevalent unethical dichotomies in recognition-reward system. 47
India became signatory to WTO Agreement only in 1994. According to TRIPS
‗while plants and animals other than micro-organism may be excluded from
patentability‘, the member country shall provide ‗for protection of plant
varieties by patents or by an effective sui generic system or by any combination
thereof, it also obligates on a country to provide patent on product or processes
from any field of technology which are new or represents an inventive step and
are capable of industrial application which are fundamental to CBD- Firstly.
IPR is a matter of national sovereignty and policy because it establishes
monopolies and monopolies are de facto dangerous. Secondly, life forms are
46
Verma S.K. –― Access to Biological and Genetic Resources and their Protections‖, 43 JILI
(2001), p 2
47
222
part of public domain. Subjecting the ecological and cultural wisdom and
heritage of indigenous communities to the legal regime of commercial
monopoly right under the TRIPS will place them in serious jeopardy by
denying bio access to resources. Thus, it summons urgency for adoption of
three fold strategies. Firstly, it should provide priorities to CBD over WTO-
TRIPS in the arena of biological resources and traditional knowledge system
while giving legal recognition. Secondly, Government should demand for
exclusion of all life forms and related knowledge from IPR and try to substitute
it by Diversity Related Intellectual Property Right (DRIPS). Thirdly, in the
TRIPS Review meeting, the collective right of indigenous and local community
to freely use, exchange and develop biodiversity should be recognized as a
priori right and placed over and above IPR.48
In India, preparation of Village-wise Community Biodiversity Registers
(CBRs) for documenting all knowledge, innovations and practices has been
undertaken in a few states. The stale plan for Kerala has also actively promoted
documentation of local knowledge regarding biodiversity in people‘s
biodiversity registers. One pilot project on this has been completed in
Ernakulum District. Another interesting development in Kerala is the
development of a benefit sharing arrangement between the Tropical Botanical
Garden Research Institute and the Kani tribe; based on whose knowledge a
drug was developed and then marketed. The state of Karnataka presents a
unique example of NGO initiatives in the formulation of people‘s Biodiversity
Registers (PBRs).49
As a corollary to the selling up of biodiversity registers, the concept of benefit
sharing is directly linked to the idea that knowledge of farmers and other local
communities is not susceptible to fulfilling patenting criteria and should not be
included in the patent system. Though it provides a form of monetary
compensation for use of local people‘s knowledge, the concept of benefit
48
ibid
49
ibid
223
sharing has been enshrined in the proposed BD Act which provides that the
national biodiversity fund shall be utilized, for instance, for instance, for
channeling benefits to conserves of biological resources, creators and holders
of knowledge. There is no hint that the creators and the holders of knowledge
may be the owners of these resources and should have the right to determine
whether they want to sell and at what price. Overall, benefit sharing constitutes
a useful strategy to mitigate some of the undesirable impacts of patents on
biodiversity related knowledge. Benefit sharing does not contribute to the
definition of an alternative regime to patents rather it seeks to limit the impact
of the introduction of patents in the field of biological resources. While the
monetary compensation is a welcoming provision, the right should stay with
the first holders of knowledge.50
It has also been suggested that India should develop legislation which would
extend the circle of potential holders of patents and make patents available to
local communities. Communal Intellectual Property Rights (CIPRs) are
premised on the idea that the current patent system heavily tilt towards the
northern industrial model of innovation. The idea is, therefore to foster
intellectual property laws which recognize the more informal, communal
system of innovation through which farmers and indigenous communities
produce, select, improve and breed a diversity of crop and varieties. 51
In order to promote biological invention, biological resources of developing
countries are being used as raw materials. It is a serious threat to biodiversity of
developing nations. Moreover, it has an adverse impact on ecological balance
and natural environment of third world countries. Due to economic adversity,
India is worst sufferer of it. It is resulting in a conflict between patentability of
biotechnology and conservation of biodiversity. The Committee in Trade and
Environment (CTE), a committee of WTO has provided a focus on it. CTR‘s
work programme for 2000 has laid an emphasis on determining a relationship
50
ibid
51
ibid
224
between the Convention on Biological Diversity (CBD) and the TRIPs

agreement. One member felt that there was a fundamental incompatibility
between CBD and the TRIPS agreement. The CBD referred to communal and
sovereign rights over resources of countries. The TRIPS agreement referred to
the patent and monopoly rights for individual firms. There were some CBD
provisions which may clash with the TRIPs agreement. 52
Emerging issues after RIO Conference is sustainable development. The
preamble to the WTO agreement includes direct references to the objectives of
sustainable development and need to protect and, preserve environment. 53
Convention on Biological Diversity, 1992 has strengthened the concept of
sustainable development.54
To manage and control catastrophic efforts and environmental disorders the
conservation and biodiversity and its sustainable use is essential. In order to do
that sharing of benefit and transfer of technologies are relevant issues. Thus,
CBD has provided a greater importance on environmental protection than of
IPRs. Considering the impact of these controversial issues Ministry of Human
Resource Development, Government of India has given due importance in
organizing seminars/ symposium throughout India on Intellectual Property
Rights.55
Loss of biodiversity is a serious problem in India. It is causing an ecological
disorder and environmental degradation. Preamble of CBD proclaims
conservation of biological diversity is common concern of human kind and
state have a responsibility for conserving their biological diversity and using
biological resources in a sustainable manner. Since the states have sovereign
rights over their own biological resources, to shrive and restoring ecological
balance of different pans of the country. Indian Parliament has implemented the
52
Singh Shiv Sahay – The Intellectual Property Rights, p196
53
Ibid at p. 197
54
Ibid
55
ibid
225
Biological Diversity Act, 2000 in conformity with CBD. The Act has
introduced the concept of ex-situ and in-situ conservation of biological
diversity. Under this Act except prior concern of National Authority no
foreigner shall use biological resources of India for research or commercial
activities. The provision implies conservation of natural resources with a view
to control environmental hazards. 56
U.N. Declaration on Human Environment proclaims that man has the
fundamental right to freedom, equality and adequate conditions of life in an
environment of a quality. Under such proclamation right to healthy
environment is a basic human right. Moreover, under the opinion of Indian
Judiciary right to free environment is a fundamental right under Article 21 of
the Indian Constitution. Patentability of biotechnology under TRIPS agreement
is overriding constitutional provisions of India in relation to environmental
protection. Usurpation of sovereign rights through international document is
undesirable. Therefore, it may be concluded that to protect sovereign rights
especially in the field of environmental protection, TRIPS agreement regarding
obtaining patent for technological development needs a change. Developing
nations should come forward to amend WTO rules in this connection.
5.6 OTHER DOMESTIC LEGAL FRAMEWORKS

ON BIOTECH PROPERTY PROTECTION:
There are some other laws on biotech property protection issues in India. They
are- 1. The Protection of Plant Variety and Farmers‘ Rights Act, 2001, 2. The
Drugs and Cosmetics Act, 1940 (Drugs Act), 3. The Environment Protection
Act,1986 (EPA) etc.
56
ibid
226
5.6.1 The Protection of Plant Variety and Farmers’

Rights Act, 2001:
New plant varieties can now be protected in India under the New Plant
Variety and Farmers Rights Protection Act of 2001. New plant varieties
cannot be protected through patents. India, in addition to meeting the technical
features of UPOV, provides for rights of farmers to use the seeds from their
own crops for planting the next crop. Further, there are provisions for benefit
sharing with fanners, penalty for marketing spurious propagation material and
protecting extant varieties. There is a provision for protecting extant variety
and farmers‖ varieties as well. The total period for protection is 10 years from
the date of registration.57
5.6.1.1 The Background:

This legislation has been initiated by the Central Government to meet the
Country‘s obligations as a member of the TRIPS, under Article 27.3[c] of the
TRIPS Agreement, which required member countries to provide for the
protection of plant varieties whether through patent grants or by any effective
sui generic system or by a any combination thereof. India has preferred to
introduce a separate Act dealing with the subject.58
The main objectives of the enactment is to save the farmers‘ farm produce, a
plant variety but not for the purpose of reproduction under a commercial
marketing arrangement. It contains provisions to facilitate equitable sharing of
benefits arising out of the use of plant genetic resources that may accrue to a
breeder from the sale disposal, etc. of seeds /planting material of a protected
variety. The village and farming community are compensated in case of their
traditional or local varieties being u development of new varieties. The
57
http:/www.pfc.org.in/workshop/workshop.pdf visited on 24.6.16
58
Ramappa T., International Property Rights under WTO, 1 st Edition 2000, Wheeler
Publication,, p.133-143
227
legislation extends to all categories plants, but will not cover micro-
organisms59.
5.6.1.2 Plant Varieties Authority:

The Protection of Plant Varieties and Farmers‘ Right Authority [‗the
Authority‘] is established to perform functions relating to the protection of
plant varieties. The duties and functions of the Authority includes promotion
and development of new varieties of plant and to protect rights of the farmers
and breeders; registering extant and new plant varieties to the researchers and
breeders, subject terms and conditions as may be prescribed; development of
characterization documentation of varieties; compulsory cataloguing facilities
for all varieties of plants, seeds and germplasm: providing compulsory
licensing of protected varieties if the right holder does not arrange for
production and sale of the seeds in the manner prescribed and collection of
statistics with regard to plant varieties, seeds, and germplasm for compilation
and publication.60
5.6.1.3 Registration:
Chapter IV provides for registration of plant varieties. A new variety may be
registered if it condoms to the criteria of novelty, distinctness, uniformity and
stability, but an extent variety shall be registered even if it does not conform to
the criteria of novelty [s 14(1)]. Sub Section (2) of this sect ion imposes a total
ban against registering a variety of contains any gene or gene sequence
involving any technology, including terminator technology, which is injurious
to the life or health of human beings, animals or plants.61
Chapter V deals with the processing of an application for registration of a plant
variety and provides for advertisement of the application, opposition to
59
ibid
60
ibid
61
ibid
228
registration and final decision on the application which if accepted would lead
to the issue of a certificate of registration. On receipt of a copy of the certificate
of registration the Authority will invite from any person or persons or any non-
governmental organization to submit claims of benefit sharing to such variety.
After hearing the plant breeder holding the registration and the parties the
Authority shall disposal of the claim. Where the claim is allowed the plant
breeder shall deposit the amount determined as directed under this Act to the
Gene Fund.62
5.6.1.4 Farmer’s Rights:

Section 31 sets at rest the apprehensions voiced about taking away the right of
a fanner to saving his produce for further personal use where plant breeders
rights were to be created. It is as follows : ―Nothing contained in this Act shall
affect the rights of a farmer to save, use, exchange, share or sell his farm
produce of a variety protected under this Act; provided that a farmer shall not
be entitled for such right in case where the sale is for the purpose of
reproduction under a commercial marketing arrangement.‖63
5.6.1.5 Right on Registration:

Subject to the other provisions of the Act, registration under the Act shall
confer an exclusive right on the breeder or his successor, his agent or licensee,
lo produce, sell, market, distribute, import or export the variety. However, in
the case of an extant variety unless a breeder or his successor establishes his
right, the Central Government, and in case where such extent variety is notified
for a State or for any area thereof under s5 of the Seeds Act, 1966 the state
government shall be deemed to be the owner of such right.
62
ibid
63
ibid
229
The Act providers the procedure of suing for infringement, revocation and
rectification of the registration [Chapters XIV, VIII and IXL]. 64
5.6.1.6 Prohibition of Registration:

Notwithstanding anything contained in this Act, no registration of a variety
shall be‘ made under this Act in cases where prevention of commercial
exploitation of such variety necessary to protect public order or public morality
or human, animal and plant life and health or to avoid serious prejudice to the
environment. It is the right of the central government to notify the genera or
species which may be registered as varieties under the Act, but it may exclude
any genus or species from that list only in public interest. Any variety
belonging to the excluded genera or species shall not be eligible for any
protection under the Act. However any variety so excluded, if already enjoying
any protection before such exclusion shall continue to- avail of that protection
irrespective of the exclusion (s29).
5.6.1.7 Compulsory Licences:

Chapter X provides for the issue of compulsory licences to undertake
production, distribution and sale of the seed or other propagating material of a
plant variety.
An application is to be made to the authority, after the expiry of three years
from the date of issue of a certificate of registration of a variety, on the grounds
that the reasonable requirement of the public for seeds or other propagating
materials of the variety have not been satisfied or that the seed of other
propagating material of the variety is not available to the public at reasonable
price. The grantee of a compulsory licence shall not be entitled to import the
variety relating to such licence or any seed or other propagating material of
64
ibid
230
such variety from aboard where such import would constitute an infringement
of the rights of the breeder of such variety [Section 41-45].65
5.6.1.8 Rights in Relation to Registered varieties:

No right to produce, sell, market or export, or import be exercised, in. relation
to any variety registered under the Act, save as otherwise provided in the Act,
by any person, unless he has obtained authorization as an agent or license from
the registered breeder of such under the Act [s34].66
5.6.2 The Drugs and Cosmetics Act, 1940 (Drugs

Act):
The Drugs Act and Drugs and Cosmetics Rules, 1945 (―The Rules‖) regulates
the import, manufacture, distribution and sale of drugs in India. It provides the
procedures for testing and licensing new drugs. The main object of the Act is to
ensure availability of standard quality drugs and cosmetics to the consumer in
order to achieve the objects of the Act, a drug is defined comprehensively to
include substances in the definition of drug.67 The responsibility to enforce the
Act is entrusted with both the Centre and State. The Central drugs standard
control Organization, headed by the Drugs Controller General of India
(―DCGI‖) is mainly responsible for coordinating the activities of the state drugs
control Organization lying down policies, and ensuring uniform
implementation of the Act throughout India. The enforcement of the Act is the
responsibility of the State Governments.
The procedures under the Drugs Act involve obtaining a series of approvals for
the different stages at which the drugs are tested, before the DCGI grants the
final license to allow the drug to be manufactured and marketed.
65
ibid
66
ibid
67
Section 3(b), The Drugs Act and Drugs and Cosmetics Rules, 1945
231
New Drug development is knowledge intensive, time consuming and risky. The
development process could broadly be divided in two major stages viz. Pre-
clinical and clinical. The objective of pre-clinical studies is to come up with a
molecule that is effective against the disease vector and safe in animal testing.
This is the Investigational New Drug (―IND‖) stage. This stage of investigation
may take anywhere between 3 to 5 years and cost between $100 -150 million
overseas or about Rs.40-50 crore in India. Pre-clinical investigations need an
assembly of multidisciplinary activities covering design and synthesis of new
chemical compounds, bio-activity screening for both in-vitro and in-vitro
testing, toxicity, pharmacokinetics, metabolism etc. Having established safety
and efficacy in relevant animal models, the IND is administered to small
population of healthy volunteers, in what is defined as Phase 1 of clinical trials.
The purpose is to confirm safety of drugs in humans and establish a basis for
progressing towards the nest phase that would find out the efficacy of the drug
in actual patients. The second phase clinical trials is carried out on a restricted
population (numbers determined based on an approval protocol) and is used for
proving efficacy I a disease category towards which the drug targeted. The
following phase of clinical trials (phase HI) is used for statistical validation and
observing the long-term effect of administering the drug on a larger set of
patients.68
DCGI approval has to be taken at each stage and only when all three trial
stages are successfully completed can the product be launched. If an IND
passes through all these clinical studies the compound becomes a drug that
could be marketed. The clinical studies take generally 6 to 8 years, depending
upon availability of patients, complexity of the drug and adverse reactions
encountered during the development of the drug.
In a development, the Government announced amendments to the Rules on
January 1, 2002 to streamline procedures for manufacture and import of new
68
Fresh Mandatory Norms for Clinical Testing of Drugs, The Economic Times, January 3,
2002
232
drugs.69 According to the amended rules, institution will be allowed to conduct

clinical trials, whether for clinical investigation or experiment, for a new drug
only after obtaining permission of the DCGI. Prior to this amendment,
permission was mandatory only if the drug was sought to be marketed of
India.70
5.6.3 The Drug (Prices Control) Order 1995 (DPCO)

under Essential Commodities Act, 1995 (ECA):
The DPCO was promulgated under the Essential Commodities Act, 1995
(―ECA‖)71 and is to be read with the Drugs Act. The DPCO fixes the ceiling
price of some active pharmaceuticals and formulations. The active
pharmaceuticals and formulations, which fall within the purview of the
legislation, are called scheduled drugs and scheduled formulations,
respectively. The authority set up under the legislation is the National
Pharmaceutical Pricing Authority (―NPPA‖) which is responsible for the
collection of data and the study of the pricing structure of active
pharmaceuticals and formulations. Upon the recommendation of the NPPA, the
ministry of Chemicals and Fertilizes fixes the ceiling prices of the active
pharmaceuticals and formulations and issues notifications on drugs, which are
scheduled drugs and scheduled formulations. The NPPA arrives at the
recommended prices for the scheduled drugs and formulations after collection
and analysis of data on costing which includes data on raw material
composition, packing materials, process losses, overhead allocation and
appointment, capacity utilization, technical data on manufacturing work orders
and packing work orders. The government of India has the power under the
DPCO to recover the charges changed in excess of the notified price form the
69
Fresh Mandatory norms for clinical testing of drugs, The Economic Times, January3, 2002
70
ibid
71
Section 3, the Essential Commodities Act, 1995
233
company. There are also penal provisions for the violation of any rules and
regulations under the ECA.
5.6.4 The Environment Protection Act, 1986 (EPA):

The EPA authorizes the central government to protect and improve
environmental quality, control and reduce pollution form all sources, and
prohibit or restrict the setting and /or operation of any industrial facility on
environmental grounds. The biotechnological regulatory process was
developed within the framework of this act by way of ―Rules‘ made by the
Ministry of Environment and Forests (―MoEF‖) and Department of
Biotechnology of the Ministry of Science and Technology.
5.6.4.1 Genetically Modified Organism (GMOs):

Manufacture, import and storage of GMOs in India is regulated by the
manufacture, Use, import, export and Storage of Hazardous Micro-organisms/
Genetically modified Organisms or Cell Rules, 1989 (―Rules‖). These Rules
are made under delegated powers given by the EPA. The rules are framed by
the MoEF with the objective of protecting the environment nature and health in
connection with the application of gene technology and micro-organisms. They
came into force on 1st October 1993. The Rules define micro-organisms to
include all the bacteria, viruses, fungi mycoplasma, cells lines, algae,
proteomes and nematodes indicated in the schedule and those that have not
been presently known to exist in the county.
The Rules set up following six competent authorities at a three tier level
national state and district for regulatory purpose.
* Recombinant DNA Advisory Committee (―RDAC‖) to review
developments in biotechnology at national and international levels and
recommended suitable and appropriate safety regulations for
recombinant research, use and applications in India from time to time.
234
* Review Committee on Genetic Manipulation (―RCGM‖) This monitors

safety related aspects in respect of ―on-going research projects and
activities involving generically engineered organisms/ hazardous micro-
organisms‖. The Committee is empowered to lay down procedures
restricting or prohibiting production, sale and importation of genetically
engineered organisms.
* Industrial Bio safety Committee (―IBSC‖) –This committee is required
to be set up in research instructions etc. handing micro organisms/
genetically engineered organisms.
* Genetic Engineering Approval Committee (―GEAC‖) –This committee
is to function under MoEF for approval of activities involving large-
scale use of hazardous micro-organisms and recombinants in research
and industrial production form the environmental angle.
* State Biotechnology co-ordination Committee (―SBCC‖) –This
mechanism can be set in states when necessary. It will review
periodically the safety and control measures in various industries/
institutions handing genetically engineered organisms/hazardous micro-
organisms. In fact it possesses powers in inspect, investigate and take
punitive actions in cases of violations of statutory provisions.
* District Level Committee (―DLC‖) This committee is to work under the
District Collectors to monitor the safety regulations on installations
engaged in the use of genetically modifies organisms/hazardous micro-
organisms and its application in the environment Import, export,
transport , manufacture, process use of selling of genetically engineered
micro-organisms is prohibited without the approval of the GEAC.
Further deliberate o unintentional release of genetically engineered
organisms /hazardous micro-organisms is prohibited. Moreover, the
rules prohibit the production, selling or import of substances and
products containing genetically engineered organisms or cells or micro-
organisms without the approval of this Committee.
235
The legal framework to handle entry of new drugs in India is archaic and
complicated. For a drug to reach the market India. It has to go through three
phases of clinical trials. In the US, Permission form the monitoring authority,
the Food and Drug Administration, is required only at the beginning. In India
the DCGI is required to separately give permission for each stage of the trials
and all genetically modified products have to be cleared through the above –
mentioned regulatory committees for safety. There is an urgent need to develop
a fast-track regulatory process for the evolving biotechnology industry in India.
The present time consuming, multi-body clearance-giving system needs
revamping to curb the delay in clearing projects, which will inadvertently affect
the viability of upcoming biotechnology companies.
The need to curtail the delay in clearing projects by establishing an efficient
regulatory process has been felt by the Government of India. This is clearly
reflected in the Vision Document of the Department of biotechnology that was
released in September, 2001 which states that the government is likely to set up
a single window clearance system for biotech by the year 2002. Further policy
initiatives to streamline the procedures for clinical trials clearance and
approvals for genetically modified foods and recombinant further R & D India.
5.6.4.2 Biotechnology and Business Law:

The complex nature of the Biotechnology industry brings with it a multitude of
corporate and finance issues, which require diverse legal expertise. Under the
current regulatory framework drug discovery and innovations in Biotechnology
is risky expensive and time- consuming. Success in the industry is largely
dependent not only on the strength of research capabilities but also on the
emergence of methods of financing high risk long – term Biotechnology
research through to commercialization. Servicing the Biotechnology industry
requires a comprehensive understanding of the array of needs and challenges
facing Biotechnology corporations. A coordinated multidisciplinary approach
236
is required to provide legal services at every stage of development of a

Biotechnology company.
5.7 GOVERNMENTAL POLICIES IN

PATENTING BIOTECH INVENTION
IN INDIA:
The Ministry of Science and Technology has issued the guidelines
―Instructions Technology Transfer and Intellectual Property Rights‖, which
would help in enhancing the motivation of scientists, research institutions and
universities in various research and development projects funded by various
departments of the Ministry of Science and Technology. The salient features of
these guidelines are as follows:
5.7.1 Ownership of Intellectual Property:

The institution shall be encouraged to see protection of IPR rights in respect of
the results of R&D. They may retain ownership of such IPRs. Institutions
would mean any technical, scientific or academic establishment where the
research is carried through funding by Central/State Governments.
5.7.2 Transfer of Technology:

The institutions would take necessary steps to commercially exploit patents on
exclusive or non-exclusive basis.
5.7.3 Royalty to inventors:

The owner institutions are permitted to retain the benefits and earnings
generated out of the IPR. The institution may determine the share of inventors
237
and other associated persons from such earnings. However, such shares shall be
limited to one third of the actual earnings.
5.7.4 Norms for the private industry:

IPR generated through joint research by institution(s) and industrial concern(s)
through joint research efforts can be owned jointly by them on mutually agreed
terms through a written agreement. The institution and industrial concern may
transfer the technology to a third party for commercialisation on exclusive or
non-exclusive basis. The third party, exclusively licensed to market the
innovations in India, must manufacture the product in India. The joint owners
may share the benefits and earnings arising out of commercial exploitation of
the IPR. The institution may determine the share of the inventor(s) and other
persons from such actual earnings. Such share(s) shall not exceed one third of
the actual earnings.
5.7.5 Patent Facilitating Fund:

The owner institution(s) shall set apart no less than 25 percent of the revenues
generated from IPR to create a patent facilitating fund. The fund shall be
utilised by the owner for updating the invention(s), filing new patents and
protecting the IPR against infringement and for building competency in the
area of IPR and related issues.
5.7.6 Information:
The institution(s) shall submit information relating to the details of the patents
obtained, the benefit and earnings arising out of the IPR and the turnover of the
products periodically to the Department/Ministry, which has provided the
funds.
238
5.7.7 March in rights:

The government shall have a royalty-free licence for the use of IPR for the
purposes of the Government of India.
Further, realising the potential of biotechnology and its relevance to the needs
of society, the Department of Biotechnology, under the Ministry of Science and
Technology which is the nodal ministry for all policy issues, has always
emphasised on the development of all facets of IPR in biotechnology. The
protection of inventions through patenting or through other suitable methods
has been given importance for innovations and industrial development. The
Department has been instrumental in bringing together academia, industry and
research institutions to work coherently for a strong IPR system in the country.
Since India has been practicing conventional biotechnology for a very long
time, there are many issues pertaining to unprotected intellectual property. All
inventions cannot be, or rather, should not be, protected due to various reasons
because of various strategic considerations involving moral and ethical issues,
e.g. inventions related to country‘s defence, inventions related to human and
animal body, etc. However, such unprotected intellectual property would vary
from country to country and a standard thumb rule cannot be framed for the
same because of various degrees of distinctions between discoveries and
inventions.
Generally speaking, most of the countries exclude from patenting, the
discovery of scientific theories and laws, methods of performing mental acts,
discovery of natural products and processes, production of new substances with
the use of biological processes, aesthetic creations, naturally occurring living
substances, etc. During the last two decades or so, some countries have
included patenting of many of the earlier unpatentable inventions such as
microorganisms, animals and plants. The scope of ethics and morale has also
been narrowed down considerably in due course of time. However, there is no
uniformity in all countries, although micro-organisms are currently patentable
in many countries, plant varieties are patentable or protectable under sui
239
generis systems and animals are also patentable in some countries. The
patentable materials for many biotech inventions are the genetic resources,
which had been freely available to countries before the introduction of the
Convention on Biodiversity (CBD). In the past, many such materials had freely
moved across the countries. The possession by countries of such materials is
neither illegal nor can laws be enacted to bring them retrospectively under the
principles of sovereignly. The patenting of life forms have always been a point
of concern on which the industrially developed nations thrived upon).
In Indian context, the intellectual property rights including patents are granted
under the sovereign prerogative of the country according to the patent law like
in other countries, i.e., they are effective only in the country. Pn‘ma facie the
patents are only granted to a process or a product (as on date, only Exclusive
Marketing Rights (EMR) for qualifying products), which meets the criteria of
patentability. As and when the information is received about patents being
granted on certain non-patentable items which affect the Indian interests, the
steps are taken to assess whether the grant of such patents can be challenged
under the patent laws of the country concerned. As we know, there are seven
areas of IPR under Agreement on Trade related Aspects of Intellectual Property
(TRIPs) of WTO, viz. trademarks, trade secrets, industrial designs copyrights,
integrated circuits, geographical indications and patents. In the first six areas,
Indian laws, rules and regulations, administrative procedures and judicial
system are consistent and are at par with the rest of the world. The norms of
enforcement and protection proposed in the WTO are in conformity with the
Indian system. However, in issues related to patents, Indian laws have been
substantially different from the provisions of the WTO which have been
brought in line with TRIPs with the introduction of three amendments to the
Indian Patent Act 1970. The third amendment has jus-been made to bring in
product patent to make it fully TRIPs compliant. If we look ink the provisions
of the WTO from the Indian Patents System (Indian Patents Act 1970) we see
that they have been different in various ways as follows:
240
(a) WTO provides product patents in all branches of technology while the
Indian Patents System provides only process patents and does not
provide product patents in drugs, foods and chemicals, as on date.
(b) WTO would grant patents for any new inventions with inventive step
(non obvious), capable of industrial applications (useful), whether
products or processes, in all fields of technology but provide flexibility
for exclusion from patentability in areas, like: (i) plants; (ii) animals;
(iii) diagnostic, therapeutic and surgical methods for the treatment of
humans and animals; and (iv) biological processes for the production of
plants or animals. WTO, however, provides patents on microorganisms,
and microbiological processes. In contrast, Indian patent laws do not
allow patenting of any life form; however, patents based on microbial
processes are permitted, as on date.
(c) WTO provides coverage of patent-life for all patents for a uniform
period of 20 years duration while Indian system has brought it at par
with WTO only recently, for processes only (including drugs, food and
chemicals, which was only 7 years).
(d) WTO requires protection of plant varieties either by patents or by an
effective ―sui generis‖ system or by any combination thereof, while at
present there is no system for protection of plant varieties in India,
despite the Plant Variety Protection (PVP) Act in place.
(e) The burden of proof in case of infringement in WTO is substantially on
the alleged individual who infringes a patent, while in Indian system it is
on the plaintiff.
(f) WTO does not permit discrimination between imported and domestic
products while according to the Indian law, importation does not amount
to working of the patent.
(g) WTO requires providing same advantage, favour, privilege or immunity
granted by ―a Member country‖ to the nationals of ―any other Member
country‖.
241
5.8 CONCLUSION:
Traditionally, India is a country, which has the philosophy of making
knowledge a public property. This philosophy has done well to the country in
general and to society in particular, in the long run by enabling access to such
creations and knowledge to all without discrimination. Even in the recent
times, when the whole of industrialized countries were busy in the protection
and privatization of inventions in the area of living objects/substances such as
the protection of plant varieties, patenting microorganisms and animals, such
steps were generally not accepted by the developing countries including India.
However, this philosophy and situations did not prevent industrial growth and
prosperity in developing countries, despite the fact that they were slow for
various reasons. The advancement in the technological capabilities resulting in
increased industrialization and with changes in international situations many
countries came together and transformed GATT to WTO to include their
commitments to the IPR as contained in the Agreements of WTO. Though
WTO is c rule-based organisation, it encourages TRIPs plus protection of
knowledge. The traditional Indian philosophy and practice in society has thus
been opposite to this extreme privatisation of knowledge. Therefore, consistent
with Indian culture, efforts have been made to create more room from within
the provisions of the WTO to enable India to keep inventions in modern
biology and biotechnology more in the public domain.
242
CHAPTER 6
CONCLUSION AND
RECOMMENDATIONS
6.1 CONCLUSION:
Detailed analysis of the foregoing chapters can be concluded in brief to find out
the social and legal gaps between the existing mechanisms, laws, policies and
need of changes required by the passage of time in the field of bio-tech
protection.
Paradoxically, we are in a situation today when the market requirements drive

the industry to focus on short-term results while competitor-nations are making
significant investments in science and technological innovations for long-term
benefits. There is a strong requirement for the management of culture, which
could stimulate an understanding for research related IP issues. In the coming
scenario of new technologies, a number of corporate bodies have started their
own R&D1 activities and the competitiveness of the industry is largely
determined by their ability to capture the economic benefits of scientific and
technological innovations through knowledge driven technologies in general
and biotechnology in particular. The advent of new technologies has not only
given enormous benefits to society but has also raised a number of issues in the
protection of the intellectual property. Intellectual Property Rights (IPR) on
inventions in biotechnology have become a controversial topic of discussion in
present years, as such inventions cut across issues related to science and
1
243
technology policies, ethics and economics, etc. These issues are also directly
related with the complexities of international trade. With the use of modern
biotechnology many complex issues have spurred up in the IPR regime in
general and patenting in particular. Several issues are indeed complex. Since
the inventions in biotechnology cut across various aspects related to science &
technology polices, polity of international trade, economic and ethical issues,
the business methods in biotechnology have gained more complexity. Why do
we have to familiarize ourselves with the science and issues surrounding
modern biotechnology? There are at least two reasons. The first has to do with
the potential benefits that modern biotechnology offers to humankind. The
second reason why the knowledge of biotechnology is important is that with
more biotechnology-derived products being placed on the market, chances are
that these products will find their way into most countries, even those that do
not use biotechnology for commercial purpose, but have to pay heavily due to
strong IPR protection. A government needs to be familiar with modern
biotechnology if it is to effectively regulate biotechnological products and
ensure the effects, adverse if any, on the environment, human health, and social
structures are properly managed, if not avoided.
However, developing countries like India should remember that the

institutional and economic environment within which modern biotechnology
R&D2 is being conducted differs significantly from that of Green Revolution
technologies. The latter was essentially the prerogative of public research
institutions and philanthropic foundations. In contrast, the application of
modern biotechnology to agriculture is a competitive, commercial endeavour in
which powerful private sector interests compete. Multinational companies in
the seed, agricultural, chemical, pharmaceutical and food-processing industries
play a major role in biotechnology research. Also, as a result of mergers and
acquisitions in the past years, the development of new biotechnology
2
244
applications in agriculture has become increasingly concentrated in the hands

of a few companies. The dominant companies that currently operate within the
global markets are Monsanto, Syngenta and Pioneer Hi-Bred. The Food and
Agriculture Organization has pointed out that current transgenic crop releases
are still “very narrow” in terms of crops and traits and thus have yet to address
the special needs of developing countries. While some 200 crops are currently
under field testing in developing countries and other crop-trait combinations
are being investigated, focusing mostly on virus resistance, crop quality, and in
some cases, tolerance to abiotic stresses, many crops (e.g., vegetables) and
traits (e.g., drought- and aluminum-resistance) important to developing
countries are still almost entirely neglected. There is a strong public perception
that privatisation of intellectual properties may have negative impact in all
developing countries on their agriculture and healthcare sectors followed by
concerns in regional food security. At present biotechnology is widely used for
the manufacture of therapeutic recombinant products, diagnostic devices in
animal and human health sector, genetically modified products in agriculture
sector, cleaner methods of fermentation based products for industrial use,
production of microbial consortia for the efficient decontamination of
environment, etc. The coming scenario would further see many more new and
emerging products and processes like gene therapy, creation of artificial
organisms, construction of artificial genes, and many unknown things, etc. The
next two years would witness how the developing countries would deal with
the definitions of patentable microorganisms, protection of other living
substances, distinctions between discoveries and invention, ethical issues in
biological inventions, and in the provisions for making deposits for patentable
biological materials. Genetic resources are the properties of the sovereign
States to which they are indigenous. Future accessions of such resources would
require consent from the States. The Convention on Biological Diversity
(CBD) promulgates ensuring conservation and sustainable use of biological
diversity, and fair and equitable sharing of benefits from their utilization.
245
Supply and exchange of biological materials are expected to move across the
national boundaries through the material transfer agreements on the basis of
authorized, mutually agreed terms among States, and subject to authorized
prior consent. Consequently, access legislation and access authority for genetic
materials of States would be in the making for all the CBD member countries.
Under the circumstances, a proper IPR policy thus should be in place, which
should strike a good balance between the knowledge-driven technology
products for the country and the industrial development issues, realising that
both of them could not be independent to each other. The IPRs are the lifeline
of the R&D based knowledge-based technology industry and they encompass
the right of corporate houses to have a chance of recovering their investment
and have a return on capital sufficient to safeguard the interest of the
stakeholders. In the emerging technologies the competitive edge will be a key
driver for doing and enhancing business, whereas the competitiveness is
dependent on developing new and advanced technologies. Thus, the
technological innovations are facilitated by the IPRs. In a nutshell, the
innovation will be the main anchor for developing competitive edge in the
business with emerging technologies.
Apart from developed countries, India also finds applications of biotechnology
in diverse areas as follows:
Health care:
Biotechnology can be used to arrive at novel and innovative approaches to
meet the needs of society providing better immunogens, diagnostics and tools,
etc., and healthcare management for ageing populations and poor countries.
246
Crop production:
Biotechnology can deliver improved food quality, environmental benefits and
nutritionally improved crops. It may be used to produce foods with enhanced
qualities like desired nutritional benefits.
Non-food uses of crops:

Biotechnology can also improve non-food uses of crops as sources of
industrial feedstock or new materials such as biodegradable plastics. For
example, canola is now being used to produce high-value industrial oil. Under
the appropriate economic and fiscal conditions, biomass can contribute to
alternative energy with both liquid and solid biofuels (e.g., biodiesel and
bioethanol) and processes such as bio-desulphurisation. It can provide tools for
mass propagation of tree and woody species for fuel, fodder, afforestation and
shelter in developing countries.
Environmental uses:
New ways of protecting and improving the environment are possible with
biotechnology, including bioremediation of polluted air, soil, water and waste,
as well as the development of cleaner industrial products and processes like
biocatalysis. GMOs can also be used in biomining, or the inexpensive
extraction of precious metals from low-grade ores using microbes. Plants are
also now being developed to mine precious metals (e.g., Brassica, which is
being developed to concentrate gold from the soil in their leaves).
The applications of biotechnology are so broad and the advantages so
compelling, that virtually every industry is using this technology.
Developments are underway in areas as diverse as pharmaceuticals,
diagnostics, textiles, aquaculture, forestry, chemicals, household products,
environmental clean-up, food processing and forensics to name a few.
Biotechnology is enabling these industries to make new or better products,
247
often with greater speed, efficiency and flexibility. Biotechnology holds

significant promise to the future but certain amount of risk is associated with
this area. Biotechnology must be carefully regulated so that the maximum
benefits are received with the least risk.
Biotechnology is at a crossroads in terms of public acceptance. International
developments over the next few years will certainly have a major influence on
the long term viability of biotechnology. The future of the world food supply
depends upon how well scientists, government, and the food industry are able
to communicate with consumers about the benefits and safety of this
technology.
The emergence of TRIPS Agreement has generated a global debate on
protection of IPPs with more focus on patent system. WTO-TRIPS mandate
has compelled all member countries to harmonize and synchronize their
intellectual property legal regime with TRIPS. However there are still certain
areas in which legal provisions and socio-economic perception of developed
countries vis-à-vis developing countries differ.
The biotechnology sector faces some major challenges in its quest for growth.
The chief among them is a lack of funding, particularly for firms that are just
starting out. The most likely sources of funds are government grants and
venture capital, which is a relatively young industry in India. Government
grants are difficult to secure, and due to the expensive and uncertain nature of
biotech research, venture capitalists are reluctant to invest in firms that have
not yet developed a commercially viable product. India hopes to solve its
funding problem by attracting overseas investors and partners. Before these
potential saviours will invest significant sums in the industry, however, there
needs to be better scientific and financial accountability. India is slowly
working towards these goals, but it will be a while before they are up to the
standards of Western investors.
India‟s biotechnology firms share another problem - a lack of qualified
employees. An aspiring researcher in India needs 7 to 10 years of education
248
covering a range of specialities in order to qualify to work in biotech. Even if a

student does choose to go on the biotech path, the ineffectual curriculum at
many universities makes it doubtful as to whether he will be qualified to work
in the field once finished. One estimate shows that 10% of upper-echelon
biotech recruits have come from foreign countries. While this is not a problem
per se, it drives up cost in a country whose competitive advantage is based on
cheap, high quality labour. Far from ending with scientists, there is also a
shortage of people with knowledge of biotechnology in related fields; doctors,
lawyers, programmers, marketing personnel and others.
Patenting of biotechnological inventions has become a legal reality. The
brighter aspect of granting patent is encouragement to research and innovation.
But the darker side is: (i) lack of humanism, (ii) deprivation of equal sharing of
knowledge, and (iii) concentration of benefits in favour of a few developed
countries.
As a member of WTO-TRIPS Agreement, India is bound to fulfil its legal
obligations. Patent law has been accordingly modified. India is a fast
developing nation. In the field of biotechnology, India is emerging rapidly on
biotechnology. The segments, viz. the Government, the industry, the R&D
institutes, the political system and the public at large are to work together to
realize the commercial advantages of technology. At the same time there is also
need for harmonization of patenting rights with national interests. Articles
27(2) provide adequate scope for forbidding patenting of inventions, “to protect
public order or morality including, protection of human, animal or plant life or
health or to avoid serious prejudice to the environment…” What is needed is a
strong political will and powerful and enlightened public opinion.
The development of the genetic resources of biodiversity is known as
biotechnology. Broadly defined, biotechnology includes any technique that
uses living organisms or parts of organisms to make or modify products, to
improve plants or animals, or to develop microorganisms for specific uses
(Congress of the United States, Office of Technology Assessment, 1990).
249
Mankind has used forms of biotechnology since the dawn of civilization.

However, it has been the recent development of new biological techniques (e.g.
recombinant DNA. Cell, fusion, and monoclonal antibody technology) which
has raised fundamental social and moral questions and created problems in
intellectual property rights.
Intellectual property protection for biotechnology is currently in a state of flux.
Whilst it used to be the case that living organisms were largely excluded from
protection, attitudes are now changing and increasingly biotechnology is
receiving some form of protection. These changes have largely taken place in
the USA and other industrialized countries, but as other countries wish to
complete in the new biotechnological markets, they are likely to change their
national laws in order to protect and encourage investment in biotechnology.
There are currently two main systems of protection for biotechnology, rights in
plant varieties, and patents. Both systems provide exclusive, time limited rights
of exploitation and are described in more detail below.
Keeping biotechnology „secret‟ can also be a valuable form of protection.
National treatment of trade secrets is diverse, and all attempts to harmonize
trade secret laws in Europe, for example, have failed. Most jurisdictions do
provide some form of protection against those who steal or use others‟ trade
secrets unfairly. However, the problem with this form of protection is that the
secret generally becomes public once the biotechnology is used commercially
and thus the protection is lost.
It is conceivable that the law of copyright could afford some protection for
biotechnology. Lines of genetic code are analogous to some extent with
computer program code, which has now been incorporated into the copyright
systems of most industrialized countries. However, this route to protection is
9fraught with practical and conceptual difficulties and is generally thought to
be unsuitable. There is as yet no recoded case of biotechnologists claiming
copyright in their inventions.
250
Trademarks are also unlikely to be of much use in protecting biotechnology,

though they may of course prove important later in regard to marketing
products, processes or services. An attempt to register he name of a plant or an
animal as a trade mark is unlikely to be successful as public policy would
prevent it (in England, registrations for names of varieties of roses have been
removed from the Trade Mark Register for lack of distinctiveness and because
of the likelihood of confusion).
There is at the moment no clear international consensus on how biotechnology
should be treated. Although bodies such as the World Intellectual Property
Organisation (WIPO), the United Nations Permanent body primarily
responsible for international cooperation in intellectual property), and the
Organization for Economic Cooperation and Development (OECD) have
conducted separate studies and produced various reports, these have only
sought to make governments more aware of the potential problems and to offer
some suggested solutions. In view of the highly controversial nature of
providing intellectual property protection for biotechnology, it is likely that in
the short term developments will be at a national and regional level.
The lack of awareness regarding the need to protect the diversity of genetic
resources and the related traditional knowledge as well as the respect for IPR is
a prominent factor affecting regulation development. On one hand, modern
biotechnology and seed sector that are using genetic resources and traditional
knowledge to develop new products should recognize and respect the rights of
the traditional users of these resources resulting from their contribution in
terms of conservation and development, on the other hand the producers should
respect the rights of the plant breeders in general, this lack of awareness is
perceived in all the levels of decision making.
In most of the cases the reasons for the problem of insufficiency of the
regulations are lack of proper application and lack of control under law besides,
per se, lack of awareness of the necessity to protect IPR and genetic
resources/biodiversity derived products and processes, and the efficient
251
application/control of the regulations are the lack of a national authority (or the
coordination between national authorities) and the deficiency in human and
financial resources within these authorities. The result is insufficient
application of the regulations regarding IPR and access to genetic resources
and thus disincentives for conservation innovation and transfer of technology.
6.2 RECOMMENDATIONS :
From the foregoing paragraphs concluding the research work, it is clearly
reflected that in order to get a suitable administration and legal protection,
attempts should be made primarily on:
 The conservation of biodiversity
 The protection of IPRs
 Access to and transfer of genetic resources and technology
 Training of human resources.
However, in addition to capacity building there are other areas where external
support is needed. To facilitate the control, databases to register genetic
resources and traditional knowledge should be established. Further on,
networks for exchange of experiences and information as for instance the
Technical Co-operation Network on Plant Biotechnology (REDBIO/FAO)
shall be formed and can be an appropriate vehicle to implement the above
mentioned capacity building programs.
A central element is also to assign clear mandates to the national authority and
provide them with the tools necessary to enforce the existent regulations. As a
crucial element such an authority should provide space for the participation of
all stakeholders in the most important decisions such as the design of the
regulations and its interpretation or to establish means of communication. 3
With further expenses the governments have to adjust their legislations
according to their own specific needs to achieve a balance between efficient
3
Wendt and Izquierdo, 2012
252
protection of genetic resources, efficient protection of IPRs and mechanisms to

regulate the access to genetic resources and traditional knowledge including
benefit sharing mechanisms. To achieve this, institutional capacity building as
well as assignment of sufficient financial and human resources are essential 4.
The solution of these problems are not only depending on the activities on
national level but are strongly dependent on how a better regional cooperation
could be achieved. Therefore the support of international organizations such as
FAO, WIPO, UPOV, ISNAR and others are indispensable since national
governments in developing countries lacking capacities and resources.
On the basis of general findings and conclusion reached by the researcher, he

would like to put forward following specific suggestions besides general
recommendation made hereinabove, which will certainly workout in the
protection of bio-tech inventions in the field of intellectual property right.
1. Priority on Residuary Issues of Intellectual Property

relating to Biotech Inventions:
Intellectual Property Rights for biotechnological inventions pose complex
problems relating to access to technologies, unfair exploitation of genetic
resources and fair and equitable sharing of the financial benefits. Although
steps are necessary to preserve existing biodiversity and enhance equity in
international obligations, financial benefits from genetic access may often be
exaggerated. Certainly, it would be paradoxical if the developing countries like
India forgo the potential benefits of biotechnology to solve some of their most
pressing problems of poverty, disease and malnutrition on account of these
exaggerated fears and hopes.
4
Salazar, 2011.
253
2. Adoption of Collaborative Approach:

There exists technological gap between the developed and developing countries
and the capital intensive nature of product development. So, the best way
forward for developing countries like India seems to be collaboration and not
confrontation.
3. Creation of Awareness:
The lack of awareness among the people of India regarding the true benefits of
biotechnology is another prime reason which is creating a hindrance in the
process of the growth of this sector. Myths among the people regarding the
biotechnology should immediately be cleared without any more delay.
4. Amendment in Existing Legislation:

Though a tailor made legislation to fit the needs of specific industries is not
always welcome step but in case of patent on biotechnology inventions, Indian
domestic laws should be amended with the help of various leading countries‟
domestic laws and international conventions, mentioned earlier in this research
work. We have already seen a sui generic system for protection of plant
varieties. Modifications to the existing Patent Act (specially section 3), if done
properly, may serve the purpose. Problem resolution steps and provision for
specific protection could be inserted by amendment. Instead, patent offices and
courts should make use of existing policy levers within patent law to address
and respond to new technologies.
5. Special Legislation on Biotech-Protection:

One separate legislation in order to protect and promote biotech-inventions
may serve the purpose of protection of biotech-inventions. It can also promote
the biotech-industries in national and international level. The legislation will
deal with protection, promotion, reward, punishment, recognition, assignment,
254
redressal etc. in the field of bio-technology specifically. This law will also be
encouraging for R&D5 of national and international players which may help in
revenue addition in India.
6. Independent Body for Ethical Considerations:

The ethical considerations are and should be relevant in assessing applications
for gene patents. The current manner of manufacture test is not sufficient to
accommodate such consideration. An independent body should become
relevant in assessing ethical considerations related to assessing applications for
gene patents. There should be an independent, transparent and responsible
tribunal made up of specialists in ethics, research and economics. Although
controversial, such a flexible mechanism would assist governments and
industry in enhancing people support for patents in the biotechnology area.
7. Improvement in Enforcement Mechanism:

India like vast country needs experts to handle the specialised zone. Without
enforcement there cannot be proper utilisation of laws. To protect Biotech-
inventions in this globalisation era, India should set up separate enforcement
mechanism to safeguard the inventors as well as the inventions.
8. Quicker Grant of Patent:

Research works, inventive steps, inventive processes in biotech research take
longer time period, specially in India, to get success. After achievement of
biotech-inventions, if the inventors have to wait another longer period to get
patents on their creations, it will be injustice. Moreover, for the appropriate
protection and to avoid piracy in the time of patenting process, there should be
system of quicker grant of patents which will also encourage the future
5
255
inventors. The provision relating to maximum benefit required to grant patent,

needs to be revisited for effective and time bound protection.
9. Expedient Process of Grant of Patent:

The patent granting process should be expedient. The scientists, researchers
will be more enthusiastic if they will obtain patent on their inventions in
expedient way within a shorter time period. That will encourage the others to
be in the field of research, invention like biotech invention etc.
10. Effective Training to Dispute Dealing Personnel:

Every specialised zone needs experts. In case of disputes, the inventors have to
wait a long period to get their patents. If there will be effective training for
dispute dealing personnel, the trained personnel shall dissolve the dispute in a
shorter time period. As a result, more people will come to inventive research
and nation will progress.
11. Special Court on IP Protection Related Issues:

Many Indian enactments provide provision for establishment of specialised
forum or court with experts to solve the disputes in an expedient and speedy
way. The Intellectual Property Protection related issues seek special court or
forum to provide justice.
12. Strong Impact Assessment System:

Intellectual Property Law is a social science. Here experiments are being held
in every time passing. In this social science, society is the laboratory, where the
experiments are done. In laboratory based experiments, observation is one of
the important steps to get inference. Like this, society based observations
should be with social impact assessment system so that the inferences will be
better one. The society is one changing concept. So the laws need to be
256
changed to cope up this changing society. To be changed or amended, the

Biotech laws should be in impact assessment system
13. Governmental Encouragement for the Protection of

Biotech Invention:
Not only the legislature or the judiciary has the duty to protect the Biotech
inventions, but the executive also has the duty to encourage this particular field
of biotech inventions. For better encouragement the Government can ensure the
protection issues to biotech inventions by making various rules, regulations,
bye-laws, G.Os. etc.
14. Laws to meet Global Challenges:

Now we are living in global village. The whole world is connected with
internet network. Technologies basically information technology and
biotechnology are ruling the world in this present time. So universal laws
should be there to handle the situation. India is not an exception in this regard.
India should come forward to enact laws to meet the global challenges in
protection of biotech inventions.
15. Strong Civil Society:

Today‟s society is governed by rule of law. Here, there is necessity of stronger
laws to make the society under rule of law. But there is also necessity of strong
civil society which can force the legislators to enact good laws in this regard.
*******
257
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Copyrights, West Legal Studies, Albany, United States, Second
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II) Articles:
1. ADB. 2001. Agricultural Biotechnology, Poverty Reduction and Food
Security. Manila: Asian Development Bank. Commission on Intellectual
Property Rights. 2002. Integrating intellectual property rights and
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[hereafter “European Commission”] Doyle, JJ. and GJ. Persley (eds.)
1996.
2. Rao R. Anita & Rao V. Bhanoji, “Intellectual Property Rights- A

Primer”, Eastern Book Company, First Edition, 2008
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Press. Sharma, Manju and K.K. Tripathi. 2000a. “21 si Century Belong
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D.C. XVIII (2): P 41 -44.
7. Sharma Manju and K.K. Tripathi. 2000b. “Excellent Opportunities in

India’s knowledge based Biotech Industry”. US-India cooperation in
scientific research aiding entrepreneurs in excellerating pace of
revolution in fast-growing biotech industry. Business Times,
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8. “The Safety of Foods Produced Through Biotechnology”. US Society of

Toxicology Online; available from http://www.toxicology.org; accessed
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and Human Health - An Update”. Policy Document 4/02, The Royal
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Development: a critical appraisal of access and benefit models of U.S.,
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Activities”, 43 JILI (2001)
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Protections”, 43 JILI (2001)
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and Competition Policy: A Framework for the Analysis of Economic
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Toward a New Multilateralism, Iowa L. Rev., 1991.
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Disaster for the South, EPW, May 1989.
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Intellectual Property Law, Spring 2009.
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Agricultural Technology: Interplay and Implications for Idia, 35 EPW,
2010.
III) Journals:
1. Journal of Intellectual Property Right, Vol-18, March, July, September,
2012.
2. Journal Intellectual Property Rights, Vol. 19, March, July, September,

2014.
3. Journal of Indian Law Institute, Vol. 65, Jan. Mar. 2011.
4. Journal of Intellectual Rights, Vol.-14, 2015
5. Manupatra Intellectual Property Reporter, 2014
6. International Journal of Environmental Consumerism (IJEC), Vol.-22,

2010.
7. AIR (All India Reporter).
8. India International Journal of Juridical Sciences Vol 1.
9. Indian Journal of Law and Justice Vol 5 No. 1.

272
10. SCC (Supreme Court Cases).
11. Cardozo Law Review.
12. Emory International Law Review.
13. European Intellectual Property Review (EIPR).
14. Harvard Journal of Law and Technology
15. Harvard Law Review.
16. IDEA: The Intellectual Property Law Review.
17. International Review of Intellectual Property and Competition Law ().
18. Journal of Patent and Trademark Off. Society.
19. Patent, Trademark & Copyright Journal.
20. Modern Law Review.
IV) Conventions/ Covenants/ Protocols/ Declarations:

1. The International Covenant for Civil and Political Rights (ICCPR), 1966
2. The International Covenant for Cultural and Economic Rights (ICCER),

1966
3. The European Convention for the protection of Human Rights and

Dignity of the human being with regard to the application of biology and
medicine (Convention on Human Rights and Bio-medicine)
4. United Nations Environment Programmes Technical Guidelines for

safety in Biotechnology, 1966
5. The European Union Directive on the legal protection of biotechnology

inventions, 1998
6. Budapest Treaty for the deposit of microorganisms for the purpose of

patent procedure, 1977
273
7. Patent Co-operation Treaty, 1970
8. Convention on the prohibition of the Development, production and

stockpiling of Bacteriological (Biological) and Toxin Weapons. 1975
9. Strasbourg convention on the unification of certain points of substantive

law on patents for invention 1963
10. Paris Convention for the protection of industrial property, 1883
11. The Universal Declaration of Human Rights (UDHR) 1948
12. The European Patent Convention, 1977
13. Convention on the Biological Diversity, 1992
14. The Rio Declaration on Environment and Development, 1992
15. The Trade Related aspects of Intellectual Property Rights. 1994
16. Universal Declaration on the Human Genome and Human rights, 1997
17. Directive 98/44/Ec of the European Parliament and Of the Council of 6

July 1998 on the Legal Protection of Biotechnological Inventions.
18. The International Union for the Protection of New Varieties of Plants
(UPOV), 1961
19. Cartagena Protocol, 2000
20. Nagova Protocol, 2010
V) Websites:
1. http://www.anwers.com/library/world%20of%20the%20Body-cid-8503.
2. http://www.nal.usda.gov/bic/Education_res/instate.info/bio l.html.
3. http:///www.nal.usda.gov/bic/bio21
4. http://www.ces.ncsu.edu/depts/foodsci/ext/pubs/bioapp.hunl.
5. http://www.faqs.org/nutrition/Ar-bu/Biotechnology.html
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6. http://www.aquarianonline.com/Sci-Tech/Steele_Biotech.html.
7. http://www.iscowp.org/hazards-of-biotech.html
8. http://www.wipo.int/about-ip/en/iprm/pdf/ch.5.pdf
9. http://www.lex-ip.com/Paris.pdf.
10. http://en.wikipedia.org/wiki/Patent-Cooperation_Treaty
11. http://www.rkdewan.com/iprOverview/TrademarkPatentTreaty.jsp
12. http://www.gdipo.gov.cn/wsbg/blex/images/PCTly.pdf.
13. http://en.wikipedia.org/wiki/Agreement_on_Trade-
Related_Aspects_of_Intelelctual_Property_Rights
14. http://www.i-sis.org.uk/trips2.php
15. http://www.ncbi.nlm.nih.gov/pubmed/10607844
16. http://www.patentlens.net/daisy/KeyOrgs/1236/428.html
17. http://www.upov.int/about/en/pd/pub-437.pdf
18. http://en.wikipedia.org/wiki/Convention_on_Biological_Diversity
19. http://en.wikipedia.org/wiki/Rio_Declaration_on-
Environment_and_Development
20. http://www.oecd.org/dataoecd/48/12/245-8541.pdf
21. http://ww.piperpat.com/IPInformation/Introduction/HistoryofPatents/
tabid/88
22. http://en.wikipedia.org/wiki/Patentable_subject_matter
23 http://www.cadwalader.com/assets/article/053109HughesMelmanIAM.pdf
24. http:P//www.uspto.gov/web/offices/pac/mpep/documents/2100_2106.htm
25. http://www.quizlaw.com/patents/what_is_not_patentable_subje.php
26. http://www.ciesin.org/does/008-265/008-265i.html
27. http:/www.i-sis.org.uk/trips99.php
275
28. http://www.lawyersclubindia.com
29. http://www.ielrc.org/content/a0401.pdf
30. http://www.hg.org/article.asp?id=4844
31. http://www.indiajuris.com/pdf/ptbook.pdf
32. http://www.tradechakra.com
33. http://www.slideshare.net/shradha29/patentability-of-microorganisms
34. http://www.pfc.org.in/workshop/workshop.pdf
35. http://www.jkscience.org/archive/Volume83/multific.pdf
& http://en.wikipedia.org/wiki/biotechnology
36. http://www.agmre.org/agmre/business/operatingbusiness/historyand
trendsinagbiotechnology patentlaw.html
37. http://www.ejcl.org/ejcl/75/art75-7.html
38. http:/www.ejcl.org/ejcl/75/art/75-7.html.
39. http://www.slideshare.net/shradha29/patentability-of-microorganisms,
Patentability of microorganisms-Shradha Diwan
40. Multifaceted Aspects of Human Cloning
Tanuj Kanchan, T.S. Mohan Kumar, Ashish Kumar and Sanjoy Das
http://www.jkscience.org/archive/volume83/mulfie.pdf
VI) Statutes:
1. Act VI of 1856
2. Act XV in 1859
3. Patterns and Designs Protection Act, 1872
4. Protection of Inventions Act, 1883
5. Inventions and Designs Act, 1888

276
6. Indian Patents and Designs Act, 1911
7. Indian Patents Act, 1970 (39 of 1970)
8. The Repealing and Amending Act, 1974 (56 of 1974)
9. The Delegated Legislation Provisions (Amendment) Act,1985 (4 of

1986)
10. The Patents (Amendment) Act, 1999 (17 of 1999)
11. The Patents (Amendment) Act, 2002 (38 of 2002)
12. The Patents (Amendment) Ordinance 2004 (7 of 2004)
13. The Patent Amendment 2005 (Third Amendment) 2005
14. The Drugs and Cosmetics Act, 1940 (Drugs Act),
15. The Copyright Act 1957
16. The Environment Protection Act, 1986 (EPA)
17. The Trade Marks Act (1958 original) 1999
18. Geographical Indication of Goods (Registration and Protection) Act,

1999
19. The Design Act 2000
20. Plant Variety and Farmers Right Protection Act 2001
21. The Indian Council of Medical Research (ICMR) guidelines, 2000
22. The DNA safety guidelines 1994
23. The Biological Diversity Act, 2002
24. The Magna karta, 1215
25. Venetian statute 1494
26. The United States Patents Act 1793
27. The U.S Plant Patent Act 1930

277
28. The United States Patents Code, 1952 as revised in August, 2005
29. The U.S Plant Variety Protection Act, 1970
30. The United States Process Patents Act, 1995
31. The Organ Transplantation Act of U.K.
32. The Embryology and Fertility Act of U.K
33. Human Cloning Prohibition Act, 2003
34. U.S Inventors Protection Act.
35. U.S. Boyh dole Act
36. The Constitution of America.
37. The Statute of Monopolies of U.K, 1623
38. The Human Tissue Act of U.K 1961
39. The Patents Act of U.K 1977
40. Human Organ Transplantation Act of U.K 1989
41. The Human Fertilization and Embryology Act of U.K 1990
VII) Reports:
1. WIPO study on Industrial Property Protection of Biotechnological
Inventions: Analysis of Certain Basic Issues, 1985
2. WIPO study on the protection of Inventions in the field of

Biotechnology, WIPO/Cornell University, 1987
3. Study on the Importance of Biotechnology for National Growth and

Development, 1997
4. Report of the International Bureau of WIPO on Industrial Property

Protection of Biotechnological Inventions, 1998
278
5. Report of the Nullified Council on Bioethics, London, 1993
8. Report of the National Bioethics Advisory Committee, U.S.A,

Washington, D.C, 1996
9. Human cloning and Human dignity: An ethical enquiry, Report of the

Presidents Council on Bioethics, Washigton.D.C, July 2002
10. Beyond Therapy, Biotechnology and the pursuit of happiness: A Report

of the presidents Council on Bioethics, Washington D.C October, 2005
11. Monitoring Stem Cell Research: A report of the Presidents Council on

Bioethics, Washington.D.C, January 2009
12. Reproduction and Responsibility, The Regulation of New

Biotechnologies: A report of the Presidents Council on Bioethics,
Washington.D.C, March 2010
13. Alternative sources of Human Pluripotent Stem Cells: A white paper by

the Presidents Council on Bioethics, Washington.D.C, May 2012
VIII) News Papers:

1. The Hindu
2. The Teleghaph
3. The Times of India
4. The Economic Times

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INTELLECTUAL PROPERTY

PROTECTION IN BIOTECH INVENTION

The thesis submitted to the University of Burdwan for the award of

UNDER SUPERVISION OF:

DR. SHASHI NATH MANDAL, WBES

I have great pleasure in certifying that Mr. RAJARSI DAS,

This is also to certify that no research work has, to the best of my

Dr. Shashi Nath Mandal

I have great pleasure in certifying that Mr. RAJARSI DAS,

This is also to certify that no research work has, to the best of my

1.6.3.2 Biotechnology in Animal Sciences 11

2.2.3.4 Technical Information 37

2.3.2.1.3 Plant and Animal Varieties 61

3.3.5 Possible Harms of Biotechnology 95

3.6.5.3 The Defences 122

4.6.1 Pharmaceutical Patent Issues 170

5.3.4 Bioinformatics 204

5.6.1.8 Rights in Relation to Registered Varieties 230

The research project on “Intellectual Property Protection in Biotech Invention

R.S.S. Law College, C.U., Dr. P. S. Ganguli, Chairman, Jyotirmoy School of

I would like to mention the names of my respected colleagues Dr. Sunanda

Dated: RAJARSI DAS

2. Monsanto v. Stauffer (1985) R.P.C. 515, CA 58

3. Novartis AG v. Union of India (2007) 4 MLJ 1153 142-146, 150-151

4. Hybertech Inc. V Monoclonal Antibodies Inc.,

AAAS : American Association for the Advancement of

GATT : General Agreement on Tariffs and Trade

MNC : Multinational Corporation

Biotechnology is the application of technology in the process of biological

analogue of such a compound could typically be a useful pharmaceutical

1.2 INTELLECTUAL PROPERTY:

IP system is being integrated into the knowledge economy, and posing

Intellectual Property commonly encompasses the following:

1.3 INTELLECTUAL PROPERTY RIGHT (IPR):

5. Geographical Indication of Goods (Registration and Protection) Act

1.4 INTELLECTUAL PROPERTY RIGHT AND

1.4.1 Invention, Innovation and IP Protection:

1.4.2 Novelty and Inventiveness:

1.4.3 Commercialization of Inventions:

Patents are of no value unless the commercial worth of the product or

1.4.4 Term of Patent:

1.4.5 Territorial Scope:

1.4.7 Utility of Patent:

1.4.8 Application for Patent:

1.4.9 Content of Patent Application:

1.4.10 Expiry of Patent:

1.5 TRADITIONAL KNOWLEDGE (TK):

Classical biotechnology may be defined loosely as the production of usual

1.6.1 Evolution of Biotechnology:

Bioinformatics can be broadly defined as the use of computers to handle

1.6.2 Needs of Biotechnology:

1.6.3 Applications of Biotechnology:

1.6.3.1 Biotechnology in Plant Sciences:

1.6.3.2 Biotechnology in Animal sciences:

1.6.3.3 Medicine (Pharmaceuticals and Drugs) and Medical

diagnostic kits and other immunotherapy are gift of biotechnological

1.6.3.4 Biotechnology in Agriculture:

1.7 INTELLECTUAL PROPERTY PROTECTION

1.7.1 Patents and Biotechnology Protection:

1.7.2 Patenting of Micro-Organisms and Cells:

cellular machinery to develop new and improved products and processes in a

turn provided stimulus to the growth of the biotechnology industry in the

1.7.3 Patenting of Animals: