Patenting of life forms

1. CHENNAI
3rd Floor, ‘Creative Enclave’,
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Chennai - 600 004.
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BANGALORE
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PATENTING OF LIFE FORMS
P.ILANANGAI
IP CONSULTANT
PATENT DEPARTMENT

2. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• A life form is an entity or being that is living or alive. A life form can be anything
from a virus or a plant to a human being.
• Traditionally, patents have applied solely to inventions, granted as a reward for
ingenuity and to encourage innovation. Naturally occurring substances, like DNA,
were exempt from such laws.
• Now the issue is should living things be patented?
• Cells from a human spleen … mice that are genetically predisposed to get cancer
… bacteria that can digest oil … an extract from a tree native to India … There are
at least two features that these all have in common:
they are derived from living organisms
they all have been patented as “human inventions”
INTRODUCTION

3. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• First life form to receive a patent: Patenting a living form
• Diamond Vs Ananda Mohan Chakrabarty [1980]
• The Court wrote “The fact that micro-organisms are
alive is without legal significance for the purpose of
Patent law”.
• contd…..
EVOLUTION IN THE UNITED STATES

4. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• Since 1980, life forms were no longer considered
a natural product but a commodity.
• It is now possible to patent entire species of
microorganisms.
• Patents on animal life: Harvard Onco-mouse-
dependable animal cancer model for scientists to employ
as a test subject in experimental cancer treatments. A
white mouse was injected with a gene to make it
more likely to get cancer. The Onco mouse was
good for testing anti cancer drugs.
• contd….

5. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• Patents on human life: DNA that had been altered to produce specific
proteins, such as the insulin.
• Someone else may own your genes, cell lines, or tissues.
• Cell line taken from the spleen of a human, which was valuable for
producing antibacterial and cancer fighting proteins.
• The fact is that human genetic material is unambiguously patentable.
• Patents on food crops: Exchange of certain seeds and plants is no longer
possible because they have been patented.
contd….

6. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• Drawbacks:
• “A patent on a product of Nature would authorize the patent holder to exclude
everyone from observing, characterizing or analyzing, by any means whatsoever,
the product of Nature,”
• One cannot study a product of Nature if one cannot legally possess it.”
• When a company patents a gene, it also patents the rights to what that gene (or any
fragment of its DNA) might tell us about our health, including our chances of
living or dying.
• Ex: A recent high profile case that received extensive media coverage involved
Myriad Genetics Inc., a biotechnology company, and their patents on two genes
linked to ovarian and breast cancer, BRCA1 and BRCA2.
• Granting monopoly on a DNA sequence through gene patenting has direct impact
on various other areas of worldwide medical research such as, drug designing, etc.

7. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
EUROPE
• EP does not prohibit patent on any living beings produced out of
a non-biological process.
• Genentech- I/Polypeptide expression
• Production of vaccines, polypeptides and antibodies through a
biotechnological process which would help fight the Hepatitis C
virus.
• Human H-2 relaxin, a hormone involved in reproduction, and a
DNA sequence coding for the hormone.

8. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
INDIA
• The Patent Act, 1970 states that an invention that satisfies the universally accepted
requirements of patentability such as novelty, inventive step and industrial
application is patentable.
• Amendment in Patent Act in 2002 brought in changes allowing the patenting of
products of chemical, biochemical, biotechnological processes as well as micro-
organism.
• Sec 3 of Indian Patent Act, 1970 which provides exceptions to patentability has
also been amended in the light of Art 27(1) of TRIPS agreement; adding clauses
like an invention with the primary object being commercial exploitation which
would be contrary to public order, morality, or which might cause injury or
prejudice to plant or animal health or environment, the mere discovery of a
naturally occurring living or non-living thing, plants and animals other than
“micro-organisms”.

9. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• The exclusion of “micro-organisms” from Sec 3 or rather the affirmation of
its patentability is an important feature of this amendment.
• The basic fact about genes/gene products being patentable is that when a
genetically engineered gene/DNA/amino acid sequence is novel and holds
an inventive step thereby ensuring its industrial application, the patents can
be claimed as:
– Gene sequence/amino acid sequence.
– A method of expressing the above sequence.
– An antibody against that sequence/protein.
– A kit made from the antibody/sequence.
• Dimminaco A.G v Controller of Patents and Designs and Others
• contd…

10. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
• The Calcutta High Court held that there is no statutory bar to accept a
manner of manufacture as a patentable item, even if the end product of the
manufacture contains living organism. Therefore it can be said with
reasonable certainty that India also recognizes life form patents.
• Indian Patent No. 243373 assigned to Sichuan Biotechnology Research
Center, discloses artificial gene sequence for encoding recombinant super
compound interferon with enhanced activity.

11. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
BIOTECHNOLOGY IN AGRICULTURE
• In India, biotechnology research and development 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:

12. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

13. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
PROS AND CONS
• Pros:
• Genetic research would help developing treatments for diseases and in
discovering new pharmaceuticals for a wider range of diseases.
• Encourages research and development in private industry.
• Provides opportunities for investment in research and development.
• Companies, as well as individuals, can invest in a patented gene.
• Cons:
• Hinders research.
• Leads to monopolization of genes.
• Slows down medical results.
• Patenting and owning genetic materials is often considered by many to
be tantamount to human slavery.

14. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com
CONCLUSION
• New innovations are inevitable in any field of
Technology.
• The monopoly granted to a patent holder over life
form can exorbitantly elevate the costs of research
and further development of new therapies.
• The patenting process should not be neither
prohibitive nor accept loose principles allowing
discrepancy to standards of patentability for making
companies undue profits.
• So, there is need of definite and consistent standards
of patentability for acceleration of technological
advancement and there by the economical
development and scientific progress of the country.

15. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com