This document outlines and discusses issues around the patenting of human genes. It begins with a brief history of genetics and gene patenting. Gene patents are controversial as genes are part of nature but are also seen as innovations that deserve intellectual property protection. The document then examines some of the most controversial gene patents granted, such as for the BRCA1 and BRCA2 genes linked to breast cancer. Both pros and cons of gene patents are presented around whether they encourage research and development or pose ethical issues. Statistics on the large number of human genes patented are also provided. The document concludes that the debate around gene patenting will continue as courts and society discuss the legal and moral implications.

1. “THE FRONTIERS OF
MONOPOLIZATION OF
HUMAN GENES”
BY
Saravanan. A
Ujwal Nandekar,
LL.M-II(IPR),
SLS-PUNE

2. OUTLINE :
• Gene patenting - science and
history.
• Comparative study
• Most controversial Gene
Patent
• Pro’s and Con’s of Gene
Patent
• Statistics of granted Gene
Patent
• Moral and Ethical issues of
Gene Patenting
• Future of Gene Patents
• Conclusion

3. GENE PATENTING - SCIENCE
AND HISTORY:
• Gregory Mendel- Genetics.
• 1953- Double Helix DNA.
• Genes are the medium through which living
organisms transmit genetic information from one
generation to the next.
• Genes are absolutely essential to life.

4. Genesis of Monopolization of
Genes:
• Many diseases today are known to have genetic
origins.
• Fast moving technology- ‘speculative gene
patents’.
• A gene patent is intellectual property-
Monopoly for 20 years

5. Comparative Study:
• Living matter is patentable to varying extent
in different countries.
• It restricts the comparative study of gene
patenting only to USA, Europe and India.
The American Jurisprudence on Life Patents:
i) Four requirements
ii) 35 U.S.C. § 101
iii) Following two cases were changed the entire
patent system of USA and Worldwide

6. Landmark Judgment
1) Funk Bros Seed Co v Kalo Inoculant Co (333 US
127):
• It propounded the doctrine ‘product of nature’
• “These are manifestations of laws of nature, free to all
men and reserved exclusively to none”
2) Diamond Case (447 US 303 (1980) :
• ‘include anything made by man under the sun’
• Impact of this case
• Supreme court expand the functional framework of §
101
• Precedent for patenting living organisms worldwide.
• The current legal position of USPTO on life patents
has very liberal approach

7. The European Jurisprudence on Life
Patents:
• Two primary documents- EPC, Biotechnology
Directives, 1998
1) Harvard-Onco Mouse Patent (1992 O.J. E.P.O.
588 )
2) Relaxinpatent 1995 O.J. E.P.O. 388 (Opp. Div.)
• The patent regime in Europe is ‘all inclusive’ like
America.
• The national IP laws of a majority of the European
nations are still in aberration and pursue a more
rigorous and stringent approach to the grant of life
patents.

8. Life Patents: The Indian
Perspective:
• Dimminaco A G v Controller of Patent
Designs Ors (2002 IPLR 255 Cal. H.C.)
• Calcutta High Court is also seen as concurrent
with the position in US and most EU countries
which allow patentability of biotech
inventions.
• Precedent for patenting living organs in India.
• The legal approach on gene patenting is very
stringent and strict.

9. MOST CONTROVERSIAL GENE
PATENTS:
1) CCR5 Patent:
• USPTO granted a patent to Human Genome
Sciences, Inc. (HGS)
• This receptor is a protein that plays a central
role in the mechanism by which human
immunodeficiency virus (HIV)

10. 2) BRAC- 1 &2 Patent (Myriad
gene patent)
• Cancer is major endemic disease
• Breast Cancer leading cancer death in Britain
and 2nd in USA
• In 1980 scientists identified DNA is linked for
breast cancer
• In 1990 research funded by NIH found that
designated Breast Cancer Susceptibility Gene 1
(BRCA1), was located on a region of
chromosome 17.
• In 1995- BRCA 2, Myriad got patent for both
BRAC 1 & 2

11. Continue…
• Myriad only lab in the world provide
comprehensive BRAC Analysis
Rearrangement Test (BART).
• Cost of single test $3000.
• In 2008, resulting revenues of $222 million.
• Thousand of patients and NGO started
agitation.
• Several oppositions from public

12. Continue…
1. The District Court Southern District of New York
Ruling.
2. Court of Federal Circuit Ruling.
3. Supreme Court Ruling :
• With reference of Mayo v. Prometheus [No. 10-1150
(2012) ]
• Revert back to CAFC
4) CAFC Ruling:
5) On September 25, 2012 BRCA Patent Lawsuit
ACLU and Public Patent Foundation Appeal to
Supreme Court.

13. Patentability?
PRO’s CON’s
Isolated gene sequences are new,
not "part of nature"
Genes are part of nature so should
not be patented
Gene patents do not apply to
natural genes
Gene sequences can be discovered
and mapped, but not invented
Gene patents are non-obvious. Genes can be re-ordered, but not
invented
Gene patents do not give
ownership over others' genes
Uses of genes may be patentable, but
not genes themselves
Gene sequencing can be "useful"
and thus can be patented
Genes cannot be owned practically,
are part of commons
Gene sequencing can be "novel"
and thus can be patented.
No certainty that a patented gene
sequence is unique to a species

14. Do gene patents help or harm
research and development?
PRO’s CON’s
Patents provide incentive for
R&D investment in product
Gene patent monopolies impair
research and development
Little evidence exists that gene
patents hurt research
Gene patents impair research on
diseases
Gene patents do not offer
monopoly power to inventors
Patent licenses are very costly, impair
R and D
Gene patents allow others to use
and profit-from invention
Gene patenting can violate freedom
of thought.
Gene patent are a necessary evil. Gene patenting invites malicious
lawsuits from patent-holders

15. Do gene patents encourage
biotechnological innovation?
PRO’s CON’s
Gene patents are essential to
future of biotech industry
Gene patents do not incentivize
innovation
Gene patents help drive major
economic breakthroughs.
Gene patents imagine R&D only
done by private companies
Gene patents are perverse
commercial exploitation of nature.
Gene Patents lead to Human Beings
becoming merely properties.
Gene patents are on a road to
duplicity.

16. Can gene patents maintain
public health and safety?
PRO’s CON’s
Many major biotech products
have come from patented genes
Gene patents can harm patient care
and pricing
Gene patents impair rapid study of
spreading diseases
Gene patents harm efforts to tailor
medicine to individuals
Gene patents and bio-engineering
may harm environment/society.
Gene patents and research could do
harm to the environment.

17. General: General statements in
support and against gene
patents
PRO’s CON’s
General statements
and rulings against
gene patents

18. Statistics
• 20% of human genes are explicitly claimed in
US patents
• 4,382 of the 23,688 genes in the NCBI’s gene
data base in 2005
• 4,270 patents owned by over 115 different
assignees
• April 2009, more than 50, 000 US patents

19. Continue…
• Australia: 400 gene patents: In 2010, 10 gene
patents.
• 2002: USPTO: 8000 patents on genes and
genetic materials
• 1500 covered human genetic material
• 605 patents: human /Animal DNA sequences
• 2000 patents applications have been filed
worldwide
• 500 applications refer to embryonic stem cells
• 22,000 genes waiting…….

20. IMPACT OF GENE
PATENING
• Positive Impact:
• Negative Impact:

21. MORAL AND ETHICAL
ISSUES:
• As respect for God, species integrity, or the
value of human life.
• Human gene patents are considered to be the
moral equivalent of slavery
• It prevent people from using their genes to
live or to reproduce
• Co modification and propitiation of parts of
the human genome.

22. Human Dignity and Human Value
Analysis:
• Should prevent from ownership on a
human being
• Possibly from transmitting the cells to
third parties for non-commercial
purposes

23. FUTURE OF GENE
PATENTING
• Researchers should be free to use genes in their
research, without fear of infringement
• More than 2,000 human genes—including several
associated with Alzheimer’s disease, colon cancer,
and asthma— have been patented.
• This debate is not likely to end in the foreseeable
future, and human life will continue to be the
benefactor and victim of both sides of this debate.
• As the courts debate the law and scope of gene
patentability, society debates the morality of gene
patents

24. Gene Exploitation:
• The conflicts between science
and the law prevails from
centuries-technologies make
our lives more efficient.
• KIM gene- Biogen
• TCP-1,2 & 3- University of
California.
• Bones - Sumimo Metal
Industries.
• (Homo economicus) ?

25. Continue…
• Whole world is waiting for the judgment of
BRAC 1 & 2 gene from US Supreme court.
• Granting gene patent have both positive and
negative impacts
• So, Government should make effective
policies orchestrate to a harmonious tune
the cries of both the patients and the big
pharmaceutical players.