“THE FRONTIERS OF

MONOPOLIZATION

OF HUMAN GENES”

BYSaravanan. A

Ujwal Nandekar,LL.M-II(IPR),

SLS-PUNE

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

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.

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

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

Landmark Judgment1) 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

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) Relaxin patent 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.

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.

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)

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

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

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.

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

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

Do gene patents encourage biotechnological innovation?

PRO’s CON’sGene 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.

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.

General: General statements in support and

against gene patents

PRO’s CON’s

  General statements and rulings against gene patents

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

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…….

IMPACT OF GENE PATENING

• Positive Impact:

• Negative Impact:

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.

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

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

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) ?

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.

Thank

You

ANY QUESTIONS ?