MAHARASHTRA NATIONAL LAW UNIVERSITY, MUMBAI

INTELLECTUAL PROPERTY RIGHTS LAW

GENE PATENTING: MYRIAD CASE ANALYSIS

SYNOPSIS

SUBMITTED TO: PROF SAJID SHEIKH SUBMITTED BY: VINAYA SAIGAONKAR (2016 055)
 1. INTRODUCTION
Patents originated as a mechanism for ensuring the progress of industry, production of
commodities and public access to goods by means of allowing only one individual to produce
an item and excluding all others. 1 the right to exclude, without the right to use, is peculiar to
patent law. 2 A patent is considered to be a contract between the government and the inventor3,
wherein the inventor is promised to benefit from the fruits his invention bears for a limited
period of time, in exchange for the complete disclosure of the invention to the public. 4 It began
with the system of letters patent and today it has reached an age where efforts are being made
to patent life forms.

Technology has progressed to a great extent after the revelation of the structure of the DNA.
Scientists have, since then engaged in identifying the sequences of these molecules, their
function and in manipulating them to achieve desired results. Owing to their close association
with nature and its use to achieve desired results, biotechnology patents often raise issues of
patentability.

The legality of gene patents is a contentious debate. On one hand it may be argued that the
isolation of a gene amounts to ‘discovery’ and not ‘invention’ and hence not patentable, where
as on the other hand, it may be argued that the subject matter is not isolated gene per se but the
purified gene which come under the realm of invention and not discovery.

The Myriad case heralds to be a landmark decision pertaining to gene patenting and its impact
and left many doors open for unanswered questions regarding gene patentability and the
discourse ahead.

The Paper attempts to analyse the Myriad case and scrutinise the IPR regime for gene patents.
The first part of the project discusses Patents in general and the subject matter for eligibility of
patents and the position of gene patents in that context. The second part of the paper shall delve
into the analysis of the Myriad case and its arguments. The third part of the paper shall have
comparative analysis on the position of gene patents in the United Kingdom and the United

1
W. R. Cornish, Intellectual Property: Patents, Copyright, Trade Marks and Allied Rights (Sweet & Maxwell,
1996) at 108.
2
A. Mossoff, Exclusion and exclusive use in patent Law 321, 22 Harv. JI &Tech. (2009) at 5
3
Burge David A, Patent and Trademark Practice (Wiley Publication, 1999) at 27
4
Zekos Georgios I, Patenting Biotechnology, Journal of Information, Law & Technology, (2004)
Sates and that of India. The last part concludes the paper with overall summarisation of the
chapters and suggestions.

2. RESEARCH QUESTION
1. Are Genes Patentable in India?

2. What are the standards applicable for patenting genes?

3. SCOPE OF THE STUDY

This paper will try to do a comparative study of the IPR legal regimes of Gene Patenting of
India, UK and US . The paper will not delve into much of the details of the EU and UK legal
structure and will try to analyse the impact of the myriad case on the Indian IPR regime and
the position of gene patenting in India.

4. METHODOLOGY
The Researcher will use the doctrinal method of research while using the primary and
secondary resources available on IPR law like Books, case laws, foreign articles, research
papers etc.

5. CHAPTERISATION
1. INTRODUCTION
2. PATENTS
2.1 Subject matter of patent eligibility
2.2 Gene Patents
3. MYRIAD CASE ANALYSIS
4. GENE PATENTING LAW: COMPARATIVE ANALYSIS
4.1 United States of America
4.2 United Kingdom
4.3 India
5. CONCLUSION
 BIBLIOGRAPHY

• STATUTES
1. US CONSTITUTION.

2. TITLE 35 OF UNITED STATES CODE.

3. EUROPEAN PATENT CONVENTION 1973.

4. BIOTECHNOLOGY DIRECTIVE 1998.

5. INDIAN PATENTS ACT 1970.

6. TRIPS AGREEMENT.

MAHARASHTRA NATIONAL LAW UNIVERSITY MUMBAI

• CASES
1. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)

2. Mayo v. Prometheus, 566 U.S. 66 (2012)

3. Dimminaco A G v. Controller of Patent Designs, IPLR 255 Cal. H.C (2002)

4. Harvard college v. Canada [2004] 235 F.T.R. 214 (Harvard/Onco mouse)

5. Diamond v. Chakrabarty, 447 U.S 303.

6. LabCorp v. Metabolite, Inc, 410 F. App'x 151 (10th Cir. 2011

7. Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries, AIR 1982 SC 1444.

8. Novartis v. Union of India & Others, (2013) 6 SCC 1

• JOURNAL ARTICLES.
1. Dr. Raju K D, The Debacle of Novartis Patent case in India: Strict interpretation of

patentability criteria under Article 27 of the TRIPS Agreement, Indian Journal of

Intellectual property law, 1 (1) (2008)

2. Ameen Jauhar & Swati Narnaulia, Patenting LIfe the American, European and Indian

way, Journal of Intellectual Property Rights, Vol 15, January 2010.

3. Amelia Rinehart, Myriad Lessons Learned, UC Irvine law review, January 2015

4. Bhavishyavani Ravi, Gene Patents in India: Gauging policy by an analysis of the grants

made by Indian patent office, Journal of Intellectual Property Rights, Vol 18, July 2013.

5. Mathews p George & Akanksha Kaushik, gene patents and right to health, NUJS law

review, 3 NUJS L. REV. 323 (2010)