IPR Protection Procedure

with reference
Intellectual to
Property Rights
Biotechnology

Bindu Sharma
Origiin IP Solutions LLP
Bindu Sharma Bangalore
Origiin IP Solutions Email: bindu@origiin.com
Bangalore
Phone: 9845693459
Phone: +919845693459, +918025830363
Website: www.origiin.com
Email: bindu@origiin.com, origiin2010@gmail.com
 Constitutional aspect
 The U.S. Constitution authorizes Congress to protect patents (Art. 1, Sec. 8,
clause 8):

“Congress shall have the power … to promote the progress of science and useful
arts, by securing for limited times to … Inventors the exclusive right to their …
Discoveries.”

 Indian constitution has no mention of IP but just the word “property”

 Freedom to acquire, hold and dispose off property - Article 19

 Protection from deprivation of property – Article 31
 Property could be possessed or acquired for public purpose only by law and
only on payment of compensation – Article 32

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 Development of IP in India

●
Known as the land of gurus and gurukuls
A structured ●
World's first university in Takshila in the 8 th century BC,
where over 10,500 students from all over the world
education system studied more than 60 subjects
from ancient times ●
The University of Nalanda, built in the 4th century BC ,
one of the greatest achievements of ancient India

●
The number system
●
Invention of “zero”
The birthplace of ●
Ayurveda earliest schools of medicine known to mankind, invented by
Charaka 2500 years ago
immense ●
Complicated surgeries conducted over 2600 years ago by Sushrata,
regarded as the father of surgery
knowledge ●
The Indus Valley Civilization, or the Harappan Culture, known for its
scientific town planning

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 Hands of 20,000 worker were cut off

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………invented wireless telegraphy a year before Marconi patented his invention

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 In Texas, RiceTec In US, over 150 There are 200
patented patents on medicinal
modified basmati Yoga asanas which plants from our
rice, is used country
traditionally in India for more on which
grown in India than 5000 multinationals
& Pakistan years are trying to take
patents

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 Non-monetization of knowledge
 Monetization of traditional knowledge by countries
 Champagne from Champagne district in France
 Scotch whiskey from Scotland
 Havana cigars from Cuba
 Colombian coffee from Colombia

 Neem, turmeric, basmati

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Patent filings by the Indian applicants in every year are growing only with a rate of
about 11.6%, where as foreign applicant filing growing at a rate of about 31.7%.
The patent filed by the Indian firms lag behind substantially as compared to foreign
counterparts. The trend in patent filing by the Indian companies is not good signal
to12/08/2021
advance our Indian economy. Source : Annual reports of the Indian Patent Office 8
 Why IP is ignored in India?
 Vidya daan is greatest daan

 There was strong funding support by Indian kings to

promote education

 Free education was imparted to students in gurukuls

 There is subsidized higher education even today –

only recently, there has been an attempt by the
government to cut subsidy amidst great opposition
Mr C.N. Rao, former
Director
Of IISc published
1,000 papers but did not
file a single patent

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 Knowing IP is necessary

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 Some facts
 Researchers at the Indian Institute of Science (IISc) missed filing a patent
regarding carbon nanotubes (with potential applications in power generation
equipment), published it in Science

 In Chicago, unauthorized use of Trademark, Nike resulted 43-year old man in

confinement

 Intel to pay AMD $1.25 billion to settle IP disputes

 Apple Computer Inc. resolves its patent squabble with Creative Technology
Ltd. by paying the Singapore-based company $100 million for a license to use
a recently awarded patent.

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 Patent
 A patent is a statutory grant by Govt for
new inventions conferring certain
monopoly rights on the grantee for a
defined period, subject to certain
conditions

 Patent rights are territorial

 Term: 20 years from date of filing

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 Brief history
 In Venice, first patent was granted to a Germen engineer in
1323 for model grain mill, which could cater storage needs of
entire Venice

 In United States the first patent was granted in 1787 for

specially designed grain elevator

 In India first patent statute was passed in 1857

 Patent act, 1970

landmark in industrial development in India
encourage inventions
inventions must be commercialized without undue delay

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A punkah pulling machine (February 28, 1856)

George Alfred DePenning 14

 Common myths

Invention is more complex than the problem merits

Invention is not kept secret until the date of filing

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 The invention isn't new

Inventor hasn't fully considered the problem

An invention is safer if it's kept secret

Inventor has an unrealistic idea on value of invention

No-one wants it

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 Example

 Chester Carlson was a patent agent who tired of having to make multiple copies
of patent applications using the only duplication method available at the time:
Carbon paper

 In 1959 he came up with a new copying system and took it to IBM for
evaluation

 The "experts" at IBM determined potential sales to be only 5,000 units because
people wouldn’t want to use a bulky machine when they had carbon paper

 Carlson’s invention was the xerography process, the company founded on the
system is Xerox

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 Other reasons
 Lack of awareness and don't know how to go about it

 Funds

 Lack of experts around

 Tedious and complex process

 Breaking trend is tough

 Hesitation to approach law firms

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 Simple inventions do get protection
 Gillette Mach 3 is protected by 35 patents, which cover
 Blade design
 Razor design
 Manufacturing processes

 Post-it

 Rubber band

 Over 400 patents for improvements in paper clips have been filed till date

 Thousands of patents on kids toys and household items

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What is an invention?

Invention as defined in Section 2, Indian Patent Act, 1970 -

“A new product or process involving an inventive step and capable of

industrial application”

Novel
Novel Industrial utility Non-obviousness

No prior use/claim/ Capable of

publication being made or Should be non-obvious to a
used in person skilled in the art
industry & -Technical advancement
reproduced
-Economic significance
with the same
characteristics
as many times
as necessary 20
Novelty
Fomento v Mentmore
 Improved nib for ball point pen
 Continuous and uniform flow of ink
 Published
 Novelty was lost

Van Der Lely (c.) N.V. v. Bamfords

 Hay raking machine
 Anticipated by photograph in a journal

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Non-obviousness/inventive step
 Question of law based heavily on underlying issues of fact
 Scope and contents of the prior art
 Level of ordinary skill in the art
 Differences between the claimed invention and the prior art
 Evaluating evidence of secondary considerations
 Final gate keeper of the patent system
 Technical advancement

 Who is "person having ordinary skill in the art“?

Fictional person having the normal skills and knowledge in a

particular technical field, without being a genius. He or she mainly
serves as a reference for determining, or at least evaluating,
whether an invention is non-obvious or not

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 Non-obviousness/inventive step
 Prior failure of other inventors
 Long felt need
 Unexpected results
 Licenses
 Commercial success
 EPO- Problem solution method
 Japanese-identify person having ordinary skill in the art
 Case-laws

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Issues in biotechnology
 All involve biological processes not under the direct control of the
scientist
 May be hazardous to health and biodiversity
 There is no scientific basis to support the patenting of genes and
genomes, which are discoveries at best
 Unethical, 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
 Doctrine of product of nature

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 Novelty and non-obviousness in biotechnology
 Raw material is in public domain

 Usually product of nature

 Research is based on pre-existing biological material

 Example: DNA, genes, tissues etc

NATURE AND EXTENT OF HUMAN INTERVENTION AND

DEGREE OF VALUE BY SUCH INTERVENTION IS USUALLY
RESORTED TO CHECK PATENTIBILITY

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 Novelty in biotechnology inventions
Raw material is in public domain and usually product of nature
 American Fruit Growers v Brogdex
 Patent was denied to oranges coated with preservative on the ground
that oranges are “products of nature”
 Funk Brothers Seed co v Kalo Inoculant Co
 Mixture of non-inhibiting nitrogen fixing bacteria
 Patent was denied as patentee did not create new bacteria as bacteria
in mixed culture are “products of nature”
 Merck & Co v Olin Mathieson Chemical Corp
 Purified Vitamin B12 isolated from fermentation materials which is
cheap, abundant, free from toxins
 Vitamin B12 naturally found in minute quantity in liver of cattle and
certain microbes
 Patent can be granted to products of nature provided it is a “new and
useful composition of matter”
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 Non-obviousness in biotechnology
 Discovery vs invention
 Exparte Erlich, the claim of the applicant was related to the use of
hybridoma technology to produce monoclonal antibodies specific for
human fibroblast inteferon.
 Rejected on the basis that “the ordinary person skilled in the art would
have done it with reasonable expectations of success”

INVENTION WAS CONSIDERED OBVIOUS TO A PERSON SKILLED IN

THE ART

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 Non-obviousness in biotechnology
Amgen Inc v Chugai Pharmaceutical Co Ltd
 Gene and DNA sequence encoding protein
erythropoietin (EPO) and protein itself in a
highly purified state
 Therapeutic potential in treating chronic
anemia
 Cloning of EPO was able to produce
recombinant EPO in quantities exceeding those
of EPO purified from natural sources

“Naturally occurring genes are not patentable and mere identification of same is just
discovery. But “purified and isolated” gene sequences are different from those occurring in
nature and hence patentable”

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Diamond v Chakrabarty
1980, USPTO:
Genetic engineering techniques to construct
bacteria that could digest oil

It involved a process by which four different

plasmids could be transferred by genetic
engineering techniques and be maintained stably
by Pseudomonas bacterium

By breaking down multiple components of oil,

microbe promised efficient and rapid oil-spill
treatment

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 Proceedings
Patent claimed:

[1] process of producing a bacterial organism (inoculum and

medium)
[2] method of using a bacterial organism
[3] the bacterial organism itself
Examiner allowed [1] and [2] but not [3] because:

Micro-organisms are “products of nature” and living

organisms and hence are not patentable

Whether genetically modified organism is product of nature

or human-made invention??

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US Supreme Court judgment
Invention was considered Human-made invention by 5 out of a bench
of 9 judges and Court made a classic judgment:

“anything under sun made by man is patentable”

This decision opened the door for patenting living organisms for the
first time

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 Indian scenario
 Microorganisms are patentable provided criteria of
patentability is fulfilled
 “Budapest treaty on the international recognition of the deposit of
microorganisms” – 1980
 31 International deposit authorities in 19 countries
 Institute of microbial technology (IMTech), Chandigarh
 Patent application has to specify the conditions necessary for
the cultivation, storage and testing for the availability of
microorganisms

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 Rights of patent owner
 If the patent is for a product, the right to prevent others from
 Making, using, offering for sale, selling, importing the patented product

 If the patent is for a process, the right to prevent others from

 Using the process, offering for sale, selling the product, importing the
product using the process
 Infringement of patent rights
 Civil remedies - Injunction, Damages, Account of
profit
 Criminal remedies - Imprisonment (upto 6 months),
Fine (1 to 5 lakh rupees) or Both
 Top damages awarded
 Polaroid V Kodak – US $ 873,200,200
 Cordis V Boston Scientific –US $ 324,400,000
 Cordis V Medtronic AVE – US $ 271,100,000
 3M V Johnson & Johnson – US $ 107,300,000
 Stac V Microsoft - $ 43,000,000 + $ 40,000,000 as
investment settlement after $ 130,000,000 jury
award
 Procedure of patent filing

Provisional/C
omplete

Pre-grant
Priority Post-grant
opposition
date opposition

Filing Publication Examination Grant

Revocation
18 months

48 months

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Patent Cooperation Treaty (PCT) filing

Filing at
IB Geneva Report on
national ISA IPEA
patentability
office

National Offices

International Phase National Phase

 Precautions
 Patenting Dos:
 Keep accurate records and logbooks.
 Determine if the invention is patentable.
 Determine the value of the invention.
 Determine its alternative embodiments/applications.
 Disclose ALL information while patenting.

 Patenting Don'ts:
 Disclose invention to third parties before filing the patent.
 Offer the invention for sale before filing.
 Delay the patenting process, thereby allowing others to file an
application for the same invention.

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 Challenges: bioinformatics patents
 Uses computers to manage biological
information

 Large investments of time and money

 Multidisciplinary nature of the technology

involved

 Diversity of patent claim types that may be

necessary to ensure maximum patent
protection

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 Products of bioinformatics

Data Tools
 Genomics  Software/hardware
 Proteomics  Collection
 Clinical  Analysis
 High-throughput assays  Visualization
 Pattern recognition
 Molecular modeling
 Predictive

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 Position in US
 AT &T Case - declared that algorithms are patentable, if it has a
“practical approach to produce a useful result”

 Excel Case - all step by step processes whether they are electronic,
chemical or mechanical, which involves an algorithm and if the
algorithm is an integral part of a machine or a process which as a whole
produced a useful result, then the invention might be patentable.

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 Examples
 The U.S. Patent No. 6,772,069, granted to the University of California -
Los Angeles, for a software which determines protein function and
interaction by genome analysis

 Incyte Genomics, Inc., has been granted U.S. Patent No. 6,611,82 which
is for to a graphical user interface for displaying biomolecular sequence
data

 U.S. Patent No. 6,510,391 is for a computer software for analyzing gene
expression data

 A study conducted by London-based firm Silico Research found that

only 50 software related patents had been issued by the USPTO
between 1996 and 2001 to companies operating in the the
pharmaceutical, biotechnology, and genomics research.

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 Patent-databases
 Databases are not themselves patentable

 Patent protection may be available for database-related inventions

which put a sort of functional utility on the data-base itself, such as new
applications for databases, algorithms for extracting or mining data,
and systems which include databases

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 Under Section 3 (l) of Indian Patents act, following are not patentable:

Literary work such as a book, periodical, compilation of data or computer

program code
Dramatic work such as stage shows
Musical work such a song and its graphical notation
Artistic work such as work of sculpture or architecture
Any other aesthetic creation whatsoever including cinematographic works and
television productions

However all these categories are subject matter of copyright protection

and can be protected under various classes of Copyright Act.

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 Copyright law

Obviously, the highest type of efficiency is that which can

utilize existing material to the best advantage.
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 Copyright

 Inherent

 Statutory rights

 20th century- printing technology

[prohibit the unauthorized copying and
distribution of works ]

 Original/creative works of authorship

 Copyright notice is necessary

 © 2007, Sony Music Entertainment (India)

Limited. All Rights Reserved. Unauthorized
copying, reproduction, hiring, lending,
public performance and broadcasting
prohibited.
 Legislations
 Copyright Act, 1957

 Compliant with most international conventions and treaties in the field of

copyrights

 Berne Convention of 1886 (as modified at Paris in 1971)

 Universal Copyright Convention of 1951

 Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)

Agreement of 1995 

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 Expres
I Origin sion
E
D al X
E P
Fixed
A R
E
S
COPYRIGHT S
I
O
N
 Literary Books, periodicals, computer programs,
databases, tables & compilation
Dramatic Recitation, scenic arrangement & work
capable of being performed by action
Musical Work consisting of music & graphical
notation of such work
Cinematographic Soundtrack in a film, video tapes
film and Sound
recording
Artistic Painting, sculpture, drawing, photograph,
work of architecture & artistic craftsmanship
 Literary Books, periodicals, computer programs,
databases, tables & compilation
Dramatic Recitation, scenic arrangement & work
capable of being performed by action
Musical Work consisting of music & graphical
notation of such work
Cinematographic Soundtrack in a film, video tapes
film and Sound
recording
Artistic Painting, sculpture, drawing, photograph,
work of architecture & artistic craftsmanship
 Literary Books, periodicals, computer programs,
databases, tables & compilation
Dramatic Recitation, scenic arrangement & work
capable of being performed by action
Musical Work consisting of music & graphical
notation of such work
Cinematographic Soundtrack in a film, video tapes
film and Sound
recording
Artistic Painting, sculpture, drawing, photograph,
work of architecture & artistic craftsmanship
 Literary Books, periodicals, computer programs,
databases, tables & compilation
Dramatic Recitation, scenic arrangement & work
capable of being performed by action
Musical Work consisting of music & graphical
notation of such work
Cinematographic Soundtrack in a film, video tapes
film and Sound
recording
Artistic Painting, sculpture, drawing, photograph,
work of architecture & artistic craftsmanship
 Literary Books, periodicals, computer programs,
databases, tables & compilation
Dramatic Recitation, scenic arrangement & work
capable of being performed by action
Musical Work consisting of music & graphical
notation of such work
Cinematographic Soundtrack in a film, video tapes
film and Sound
recording
Artistic Painting, sculpture, drawing, photograph,
work of architecture & artistic craftsmanship
 Computer program – ©

 Copyright Registry, New Delhi

 Source code: Literary work [Printed code, CD –

3 copies]

 Look and Feel: Artistic work [Screen shots, CD –

3 copies]

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 Conclusion
 Understanding and awareness of IPR is essential for research/
innovation based organizations

 Registration and commercialization of IPR can fetch you revenues, it’s a

powerful tool

 Awareness of IPR can prevent you from infringing other’s right:

Remember that litigations result in huge loss of time n money.

 It’s right time to start thinking about it…..

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“We should do something when people say it’s crazy. If
people say something is “good”, it means that someone
else is already doing it”

Contact Information:
Bindu Sharma
Origiin IP Solution, Bangalore
bindu@origiin.com
9845693459, 080-9880213204

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