PATENTING OF MICROORGANISMS

RESEARCH PROPOSAL

PATENTING OF MICROORGANISMS

Submitted To – Prof. Dr SC Roy

Submitted By – Ms. Bhargavi Mishra

Roll no. – 1524

7th Semester, 4th Year

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ACKNOWLEDGEMENT

I take this opportunity to express my profound gratitude and deep regards to my guide Prof. Dr. SC Roy
for his exemplary guidance, monitoring and constant encouragement throughout the course of this project.
The blessing, help and guidance given by his from time to time shall carry me a long way in the journey
of life on which I am about to embark.

I also take this opportunity to express a deep sense of gratitude to my seniors, the library staff and my
friends for their valuable information and guidance, which helped me in completing this task through
various stages.

I would also thank my Institution and my faculty members without whom this project would have been a
distant reality. I also extend my heartfelt thanks to my family and well wishers.

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INRODUCTION
Creations of the human brain are called intellect and if they have commercial value they can be
classified as property. Intellectual Property thus refers to inventions, industrial designs for
article, literary and artistic work, symbols, etc. used in commerce. Patenting is the outcome of
the works of political economists and philosophers like Locke and Hegel who first argued that
intellectual works abstracted from matter can be held as property. A patent can be understood as
an IPR relating to inventions and is the grant of exclusive right, for limited period, provided by
the Government to the patentee, in exchange of full disclosure of his invention, for excluding
others, from making, using, selling, importing the patented product or process producing that
product for those purposes.

On 16th April India signed General Agreement on Tariff and Trade (GATT) along with 116 other
countries and is now policing the implementation of the Uruguay Round Agreement. . The
agreement also established World Trade Organisation. WTO has 132 members which accounts
for 90% the world1. To comply with TRIPS agreement India as a signatory is yet to implement
it fully by far it has done it bits and pieces.2

Under WTO, no country has the option to choose the parts it likes and abstain from choosing
parts it didn’t. The TRIPS (Trade related aspect of Intellectual Property Right) agreement
imposes rules on its members, Firstly it ensures that Patent protection is is available for all fields
of technologies like agriculture, energy and healthcare. Second members can exclude certain
inventions from patentability if the exploitation of the invention would be affecting the morality
of general public. The TRIPS Agreement also stipulates further that no member country can
exclude an invention from patentability simply because domestic laws prohibits it. The Uruguay
Round Agreement on TRIPS further focused on patentable subject matter in relation to
biological materials and thereby.

1
https://www.wto.org/
2
S. Sekar, D kandavel, PATENTING MICROORGAISMS: TOWARD CREATING A POLICY FRAMEWORK,
2002

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The patentability of unicellular organisms was settled by the landmark judgement of US

Supreme Court in Diamond v. Anand Chakrabarty3 with respect to biotech patentability. In
compliance with TRIPs, the Patents Act 1970, as amended in June 2002, gives patent rights for
new microorganisms in India. Section 3(j) of the Act excludes from patentability “plants and
animals in whole or any part thereof other than micro-organisms but including seeds, varieties
and species and essentially biological processes for production or propagation of plants and
animals.” 2002 Amendment of Indian Patent Act added explanation to chemical process, which
states; chemical processes include biochemical, biotechnological and microbiological process.
Other areas involving microorganisms are also patentable in India.
This project deals with the Indian position of microorganisms patenting and international
depository authority in India. It also focuses on its patenting under TRIPS and CBD and their
relationship.

3
Diamond v. Chakrabarty, 447 U.S. 303 (1980)

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AIMS AND OBJECTIVES

The objective of this research project is to –

1. To learn about the TRIPS agreement provisions for microbial patenting.

2. To learn about the status of microbial patenting in India
3. To analyse the difference between unpatentable microorganism and patentable microorganism.
4. To learn about the changes needed in the current patent law for microorganisms in India .

HYPOTHESIS

Microogranisms are not Patentable per se

SCOPE AND LIMITATION

This Project is limited in its exhaustiveness due paucity of time and limited area available in research.

RESEARCH METHODOLOGY

This study involves the use of doctrinal method of research. The information will be gleaned from various
books on the subject of Intellectual Property Rights, articles and published research works.

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CONTENTS

1.1. INTRODUCTION ............................................................................................................. 7

1.2. STATUS OF MICROBIAL PATENTING IN INDIA ...................................................... 9

1.2.1. INTERNATIONAL DEPOSITORY AUTHORITY IN INDIA-MTCC ................. 11

1.3. MICROORGANISMS PATENTING UNDER TRIPS................................................... 12

1.3.1. POSITION UNDER CONVENTION ON BIOLOGICAL DIVERSITY ................ 14

1.3.2. RELATIONSHIP BETWEEN TRIPS AND CBD................................................... 15

1.4. CONCLUSION AND SUGGESTION ............................................................................ 17

1.5. BIBLIOGRAPHY............................................................................................................ 19

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INTRODUCTION

The dictionary definition of microorganisms is “microscopic organisms”4. These are such tiny
living things which cannot be visible from the naked eye. It includes viruses, bacteria, yeasts,
fungi, algae etc. Microorganisms have been used as tools for the production of antibiotics and
vaccines, food products etc and are also used for industrial purposes. The use of modern
biotechnology makes the potential application of microorganisms is vast.5

Prior to 1980, microorganisms were considered as products of nature and therefore, not
patentable. In 1980, the Supreme Court of US, in the case of Anand Chakrabarty6, ruled that
genetically altered microorganisms were indeed based on the following criteria:

 They were manmade;

 They were products of human manipulations and therefore considered similar to other
invention;
 They had a specified industrial application.

Chakrabarty had filed a patent application for bacteria, a strain of Pseudomonas containing
two plasmids after genetic manipulation, which had an enhanced propensity to digest oil
hydrocarbons. Although getting bugs to eat oil seems like a neat trick, the Patent Office had
initially rejected the application.

Discovery versus Invention

There is a widespread controversy regarding the consideration of microorganism as an invention

or discovery. After the National Institutes of Health (US) was refused to have patent rights over
segments of DNA isolated from the human genome, the Eurpoean Patent Office highlighted the
difference between discovery (not patentable) and invention for a microbiological substance.7

There is a close relationship between the discovery and invention. The fact that known material
or article is found to have a hitherto unknown property is a discovery and not an invention but if

4
Kollek R, Ambiguous genes, Biotech Develop Monitor, 23, 1995, 24.
5
Smith EJ, Biotechnology (Cambridge University Press, Cambridge, London), 1996
6
Patenting of Microorganism: A global view, Intellectual Property Right, 4(8) 1998, 3-4
7
ibid

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the discovery leads to the conclusion that the material can be used for making a particular article
or in a particular process, then article or process could be patentable.8

When any microorganism is discovered, it is not an invention but a microorganism is called an

invention only when it is genetically modified and the reason is human input. Genetically
modified microorganisms may perform any number of activities. If a researcher is able to
research upon a particular activity, and he is allowed patenting of his genetically modified
microorganism. Also since only inventions are qualified for patenting, naturally found
microorganisms, DNA structure, genes, blood cells, etc., can be excluded from patent protection.
Nations can also exclude certain inventions in biotechnology by relying on the exclusion
provision available under the TRIPS Agreement which permits to exclude certain inventions
which are injurious to health and environment of human and animals. On the ground of this
exception, a member state can exclude terminate type technological from the patent protection.

8
http://www.tifac.org.in

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STATUS OF MICROBIAL PATENTING IN INDIA

Being a member of TRIPS Agreement, India is required to meet minimum IP standards. i In

compliance with TRIPS, the Patents Act 1970, as amended in June 2002, gives patent rights for
new microorganisms. Section 3(j) of the Act excludes from patentability “plants and animals in
whole or any part thereof other than micro-organisms but including seeds, varieties and species
and essentially biological processes for production or propagation of plants and animals.” 2002
Amendment of Indian Patent Act added explanation to chemical process, which states; chemical
processes include biochemical, biotechnological and microbiological process. Other areas
involving microorganisms are also patentable in India. For example, a synergistic composition
containing the microorganism, which is either new or known, and a process using
microorganisms to produce a substance can both be patented. Also, the process of biosynthesis of
a new microorganism is patentable.ii

In the case of Dimminaco AG Vs Controller of Patent Design9, the Calcutta High Court of India
has addressed the issue of whether a process involving microorganisms that are living as an end
product can be patented. Dimminaco AG, a Swiss Company applied for patenting the process
for preparation of a live vaccine for Bursitis which is an infectious poultry disease and invention
is to combat with this disease. The Controller of Patents refused to allow application on the
ground that since the vaccine involved processing of certain micro organic substances; this was
the only a natural process devoid of any manufacturing activities and hence not patentable under
section 2(1) (j). However, on appeal, the Calcutta High Court diverted from above position and
rejected the contention of controller that a patent is given only for process that results either in an
article, substance, or manufacture and vaccine with a living organism is not an article, substance,
or manufacture. The Controller had claimed that the dictionary meaning of article of a “material
thing, item, a thing of a particular class or kind as distinguished from a thing of any class of
kind” and he also said that living things does not cover under this definition. The Calcutta High
Court through judicial exposition held that Indian statute on patents does not put any fetters on
patentability of microorganisms developed in a controlled environment in laboratories. The
Court ultimately concluded that a new and useful art or process is an invention, and because the

9
Dimminaco AG Vs Controller of Patent Design, (2002) I.P.L.R 255

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process is new and useful, it is apparently patentable under section 5read with section 2(j) (i) of
the Patents Act. The court determined that where the end product is a new article, the process
leading to its manufacture is an invention.

After the Dimminaco decision, the Indian Law kept pace with the needs of thriving
biotechnology industry. The Patent Amendment Act 2002 came into force in May 2003, bringing
microorganisms within the realm of patentability. Subsequently, The Patents Act, 1970 was once
again amended in the year 2005, so as to establish congruence with TRIPS and this amended
section 5 which provided for only process patents. Therefore, the deletion of this section, paves
way for product patents. To assess whether after this amendment India had indeed become
TRIPS compliant and the measures taken to ensure TRIPS compliance were in national interest,
the Mashelkar committee was set up in April 200510. One of the issues the committee dealt with
was whether it would be consistent with TRIPS to exclude microorganisms from patenting. This
committee submitted a report in December 2006 which it later withdrew citing technical
inaccuracy and plagiarism as reasons.11 The revised version of the report was submitted which
restates to a large extent the committee’s previous findings, which had been criticized for not
taking into account public health goals. The committee concluded that it shall be in total
violation of TRIPS to exclude microorganisms from patentability and that microorganisms
involving human intervention and utility are patentable subject matter under the TRIPS
Agreement, provided that they meet the prescribed patentability criteria.

DABUR Research Foundation, part of Dabur Pharma Ltd, has been granted a patent for
a strain of yeast, after the Government permitted patenting of microorganisms in India under the
Patents (Second Amendment) Bill 200212. This is the first ever patent granted for a
microorganism in India since the law came into effect. The Company has obtained both a
product patent for strain as well as a process patent that protects the manufacturing procedure,
thus giving exclusivity.

10
Mittal DP, INDIAN PATENT LAW (Taxmann Allied Servies Pvt Ltd, New Delhi), 1999
11
Elizabeth Verkey, “Law of Patents”, 1st ed. 2005, p. 165
12
Nithya Subramanian, Dabur Gets First Patent, THE HINDU, BUSINESS LINE, December 8, 2005, at New Delhi

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INTERNATIONAL DEPOSITORY AUTHORITY IN INDIA-MTCC

For the purpose of patenting of microorganisms, it is a requirement under the Budapest Treaty to
build an internationally recognized depository of microorganisms strict following the regulations
of the treaty. India has already joined the Budapest Treaty and sufficient funds have been
sanctioned to refurbish a culture collection depository, it is an expensive process.

The Microbial Type Culture Collection (MTCC) and Gene Bank- a national facility, jointly
established by the Department of Biotechnology (DBT), Government of India, and Council of
Scientific and Industrial Research (CSIR), is located in the Institute of Microbial Technology,
Chandigarh, for upgradation to India’s first DNA. This could be used by Indian scientists and
foreign scientists, especially from neighbouring countries to deposit their patentable cultures at
less expensive rates.13 On October 4, 2002, MTCC was recognized by the World Intellectual
Property Organization (WIPO), Geneva, as an International Depository Authority (IDA), and
now microorganism can be deposited here under the Budapest Treaty.

The MTCC like other IDAs follows the guidelines prescribed by Budapest Treaty on the
international recognition of the deposit of microorganisms for the purposes of Patent procedure.
It has excellent facilities for long term preservation of microorganisms and it also reserves the
right to refuse in accepting a deposit if in its view it may be a hazard or the MTCC may not be in
a position to process it. Deposit from other countries will be accepted only if it cleared by the
Authority of India. The depositor from outside India should communicate with the MTCC
regarding deposits before dispatching cultures.

13
Maselkar RA, Intellectual property rights and the third world, 2001 955-965

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MICROORGANISMS PATENTING UNDER TRIPS

The TRIPS ensures that patent protection is available for fields of technology including
agriculture, energy and healthcare. Members of TRIPS can exclude certain inventions from
patentability if the exploitation of the invention would be affecting the morality of general
public. The TRIPS agreement also stipulates further that no member country can exclude an
invention from patentability simply because domestic law prohibits it. The TRIPS Agreement
also stated that WTO (World Trade Organization) Council for TRIPS would monitor compliance
with TRIPS provisions and oversee disputes between member countries. The WTO Council has
resolved patent enforcement problems that existed before trade sanctions were imposed.
However, it tends to pass resolutions in favor of developed countries.

The patentability of biotechnology took off after the United States Supreme Court’s landmark
decision in Diamond Vs Chakrabarty.14 By acknowledging that statutorily patentable subject
matter included anything under the sun that is made by man, the court encompassed the inventive
work of biotechnology and gene sequences. Consequently, an imitation effect rippled from the
U.S. to Europe and other jurisdictions, generating a series of legislative measures to living forms.
In addition, the WTO Agreement on TRIPS internationalized biotechnological practices and
enabled genetic engineering to yield important breakthroughs in the new millennium.15 Article
27 of TRIPS provides that, subject to certain conditions, patents in all fields of technology shall
be available for any invention. There are some general exceptions to the basic rule on
patentability under the same article. TRIPS is the first globally adopted treaty to make the
patenting of life legal by requiring WTO member states to provide patent protection for all fields
of technology.16

14
Sharma Ravi and Hiddleston Sara, “Mashelkar committee on Patent Law withdraws report, seeks more time”, The
Hindu, 22 February 2007
15
Dr. Raju K D, “the debacle of Novartis patent case in India: strict interpretations of patentability criteria under
Article 27 of the TRIPS Agreement”, IJIPL 1 (1) (2008
16
Patenting of Microorganisms, TIFAC, Patent Facilitating Centre, 1999

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Clause (b) of paragraph 3 of Article 2717 of the TRIPS Agreement states as under: “Member may
also exclude from patentability (b) Plants and animals other than microorganisms, and
essentially biological processes for the production of plants or animals other than non-
biological and microbiological processes. However, Members shall provide for the production
of plants varieties either by patents or by an effective sui generis system or by any combination
thereof.” The provisions of this subparagraph shall be reviewed four years after the entry into
force of the WTO Agreement. The review could perhaps encompass three distinct but
overlapping dimensions of Article 27(3). Firstly, it may be a subject of review whether and what
form of exclusion from patentability should apply to plants and animals per se i.e.; patenting of
life forms. Secondly, the review could consider the effect of protection granted to
microorganisms, non biological and microbiological processes. Thirdly, it could be reviewed
whether and what form of protection of plant varieties through sui generis system is an effective
form of protection, effectiveness of plant variety protection. There are many grey areas in
defining the scope of patentable microorganisms and microbiological processes multilaterally.
The WTO could consider various dimensions of this in these discussions. The first is the
difference between discovery and invention - only the latter should be patented. The second
dimension is the patentability criteria. Article 27(1) provides that patents shall be available for
any inventions provided that they are new, involve an inventive step and are capable of industrial
application. Thus the criteria of novelty, non-obviousness and usefulness have to be satisfied
before the grant of the patents. The third dimension is the coverage of microorganisms under this
Article which requires patenting of microorganisms, non-biological and microbiological
processes. This would mean that perhaps a microorganism which is manmade, genetically-
engineered bacterium, would meet the test of patentability.

In the field of microorganisms, TRIPS does not advocate the heightened standard of Budapest
Treaty system for patent protection of microorganism; however through bilateral treaties,
countries have still entered into this administrative standard. Under bilateral agreements, member
countries must implement their own substantive provisions. These obligations go beyond TRIPS
standards because the Budapest Treaty obliges parties to recognize the physical deposit of

17
Patenting of Microorganisms, TIFAC, Patent Facilitating Centre, 1999.

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microorganisms’ samples with an international depository authority instead of full written

disclosure of invention.

POSITION UNDER CONVENTION ON BIOLOGICAL DIVERSITY

Microbial Patents laws have to be framed in accordance with the TRIPS Agreement, Budapest
Treaty and the Convention on Biodiversity Diversity (CBD). The CBD was first presented at the
United Nations Conference on Environment and Development (UNCED), which took place in
Rio de Janeiro in June 1992. It came into force in 1993 and has 182 contracting parties. 18 The
main objective of CBD is the conservation of biological diversity, its endurable use, and fair
sharing of the benefits arising out of utilization of genetic resources from the country of origin. It
gives every nation-state the sovereign right over its own biological resources. This means that
each state has right to control access to genetic resources within its territory and to determine the
conditions under which this will be allowed.19

CBD recognizes the sovereign rights of States over their resources in Articles 3 through 15.
Article 3 recognizes that, “states have the sovereign right to exploit their own resources,”
including under Article 2, biological and genetic resources of actual and potential value. Article
15 specifically discusses the details of regulating access to genetic resources through increased
transparency in patent applications. Paragraph 5 of Article 16 asserts that IPRs must conflict with
the conservation and sustainable use of biodiversity. Therefore, the CBD not only gives right to
provider States but also regulates the transfer and interaction between provider and recipient
20
states.21

It is the task of each state and the international community as a whole to interpret the
aforementioned CBD principles in a manner harmonious with Article 27 of TRIPS.

18
Pillai, M., Kumar, S., Kumar, R. and Agrawal, P., J. Intellect. Property Rights, 2006
19
Mae-Wan Ho, J. Intellect. Property Rights, 2002, 7, 151–165.

21
H. L., Nat. Biotechnol., 2010, 28, 925–926.

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RELATIONSHIP BETWEEN TRIPS AND CBD

While WTO Members States incorporate TRIPS within their national laws, access to genetic
resources from which genetically engineered product are developed is becoming one of the most
critical areas of debate between industrialized and developing countries.

Many developing countries regard the relationship between TRIPS and CBD as one of the
opposing principles. On one side stands the principle of economic growth purported by the
TRIPS Agreement. On the other side is the principle of sustainable development served by CBD.
Industrialized countries justify globalizing and harmonizing IPRs because such rights will
strengthen the innovation and it was also argued that economic growth will result from
improving dynamic efficiency through strong IPRs. Some countries argue that there is inherent
conflict between the both, and therefore, TRIPS should be amended to remove such conflict.
Many less developed countries have held this position.22 Proponents of this view argue that
patentability of generic material under TRIPS leads to appropriation of natural sources and
materials by private parties and that it is inconsistent with the sovereign rights of countries
supported by CBD. They also argue that TRIPS does not require prior informed consent and
benefit-sharing, as provided for in CBD and their suggestion is the amendments to exclude
patentability of life forms or inventions based on traditional or indigenous knowledge from
TRIPS. On the contrary, developed countries including U.S. argue that these two does not
conflict with each other. Proponents of this view argue that the objectives and purposes of
TRIPS and CBD are different and granting patent rights over genetic material does not conflict
with provisions of CBD regarding the sovereign rights of countries over their genetic material.23

Theses two treaties operate in manner that has generated much conflict and uncertainty. Indeed,
portions of TRIPS clash with the concept and principles provided by the CBD. Granting IPRs to
modified, unauthorized appropriations of plant and animal genetic resources frustrates provider
countries trying to implement the concept and principles provided by CBD of control over their
genetic resources. The CBD is far more favorable to conservation of biodiversity and
preservation of rights for developing countries while TRIPS is far more aggressive about

22
Patenting of Microorganisms, TIFAC, Patent Facilitating Centre, 1999.
23
ibid

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facilitating biological patentability and promoting private ownership and exploitation of such
resources. Nevertheless, the two aims are not necessarily mutually exclusive. Most of the
conflict between these two is spurred by moral and rhetorical assumptions. One assumption
claims that the patent regime is a western form of IPR, which is totally unsuitable to the
majorities of the societies in the south that have accepted TRIPS by acceding to the WTO.
Another assumption asserts that private rights are completely alien to indigenous communities
because the vast majority of their farmers, who manage biodiversity at the local level, are
accustomed to collective rights.24

Legally speaking, inconsistencies between IPRs applied to life forms under TRIPS and the
obligations of CBD are multifaceted. The inconsistencies particularly reveal themselves in
following fields: the access to and fair and equitable sharing of benefits from the utilization of
genetic resources, the respect of traditional knowledge held by the indigenous communities, and
the transfer of technology.

24
Braga Primo, C. A., Fink, C. and Sepulveda, C. P., World Bank Discussion papers, 1999

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CONCLUSION AND SUGGESTION

Patenting of life forms may have at least two dimensions. Firstly, there is an ethical question of
extent of private ownership that could be extended to life forms but ethical issues are not
connected with patent laws. Unlike economic arguments against patents on life forms, ethics do
not have place in disputes over patent policy. The question of ethics might be legitimate in
principle but are not matter of law and it is put forward that they cannot be a break to scientific
research. The second dimension related to the use of IPRs concept as understood in the
industrialized world and its appropriateness in the face of the larger dimension of right on
knowledge, their ownership, use and transfer and dissemination. The TRIPS Agreement makes it
mandatory to provide patent protection to microorganisms but does not provide its definition.

We need to define ‘microorganism, The broad categorization as biological materials as used in

European union is preferable. However microorganism under the umbrella of biological
materials should be treated individually. This is because microorganisms are distinct from other
life forms and the intricacies in treating them along with other life forms or their molecules like
DNA cannot be predicted now.

The concerns against patentability of microorganisms can be addressed by; firstly, striking the
right balance between the discovery versus invention debate and this can only be done by
granting patents to those which involve substantial human intervention, for example, genetically-
engineered microorganisms. So, it ensures that mere isolation or purification of it through known
procedure should not be patented. It is essential to develop a system of classification and
products. This will enable to identify the items suitable for patenting with a view to safeguard the
interest of the nation. This will also be helpful for the patent examiner to identify whether the
patent filed is eligible for patenting or not. We should also think of documenting and protecting
our traditional knowledge on the use of microbes.

The most important difference between the Indian Patent Law 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 the section 3(d)25 and therefore, not

25
Indian Patent Act, Sec 3(d), 1970

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patentable but genetically modified versions of the same microorganisms that result in
enhancement of its known efficacies are patentable. At last it can be concluded that human
intervention is necessary for patenting of microorganisms.

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BIBLIOGRAPHY

1. Adelman; J., Martin; Reader, Randal R.; Thomas, John R.; and Wagnar, Harald C.,
Cases and Materials on Patent Law, American Case Book Series, Minnesota, USA, 2nd
ed., 2003

2. Altman, Arie and Hasegawa, Plant Biotechnology and Agriculture: Prospects for the 21st
century, Elsevier Inc., UK, 1st ed., 2012

3. Apte, Tejaswani, A simple guide to IPRs, Biodiversity and Traditional Knowledge,

Kalpavriksh- Environmental Action Group Publications, Pune, 2006

4. Mittal DP, Indian Patent Law

5. Bhushan, Shanta, A Guide to the Biodiversity Act 2002, Kalpavriksh- Environmental

Action Group Publications, Pune, 2007

Websites

1. www.bch.cbd.int
2. www.biodiv.org
3. www.bricwallblog.com
4. www.cbd.int
5. www.dbtindia.nic.in
6. www.documents.epo.org
7. www.epo.org
8. www.fbae.org
9. www.geacindia.gov.in

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