INDIAN LAW INSTITUTE

SYNOPSIS

DEVELOPMENT OF BIOTECHNOLOGICAL PATENTS IN INDIA:

ISSUES & CHALLENGES

Submitted by:

Sania Aftab
[38/ILI/ L.L.M- 2 Yr. /2014]

Submitted to:

Arya. A Kumar

CONTENTS
1. Introduction
1.1 Statement of Problem
1.2 Scope of the study
1.3 Objective of the study
1.4 Research Question
1.5 Research Methodology
1.6 Review of Literature
2. Chapterisation (Tentative)
2.1 Introduction
2.2 Biotechnology in Agriculture
2.3 Biotechnology in Animals
2.4 Genetic engineering
2.5 Bio patents
3. Patentability of Biotechnology Under the International Patent Regime
4. Issues related to Biotechnology (social ,legal & ethical)
5. Challenges
6. Conclusion and Suggestions
7. Bibliography
7.1 Statutes
7.2 Cases
7.3 Books
7.4 Articles
7.5 Websites

1. Introduction
1.1 Statement of Problem
The term biotechnology is derived from a fusion of biology and technology, it concerns
with the exploitation of biological agents or their components for generating useful
products/ services. Biotechnology is a field of technology of growing importance in
which inventions may have a significant effect on our future, particularly in medicine,
food, agriculture, energy and protection of the environment. The science of biotechnology
concerns living organisms, such as plant, animals, seeds and micro-organisms, as well as
biological material, such as enzymes, proteins and plasmids (which are used in genetic
engineering).

Biotechnological inventions ordinarily fall into three categories. They are the processes
for the creation or modifications of living organisms and biological materials; the results
of such processes; and the use of such results.1
The TRIPs Agreement makes it obligatory for the Member States to protect bio
technological inventions but allows them to exclude plants and animals from
patentability. However, it is obligatory for them to protect micro-organisms and
essentially biological processes for the production of plants and animals. It is also
provided that Members shall also provide protection for plant varieties either by patents
or by an effective sui generic system or by any combination thereof.
In United States, in Diamond v. Chakrabarty,2 Mr. Ananda M. Chakrabarty created a
genetically engineered bacterium capable of breaking down multiple components of crude
oi and applied for patent on the ground that his bacterium possessed a trait not found in
naturally occurring bacteria, and therefore sought patent protection. The Patent and
Trademark office rejected the patent application of Chakraborty on the ground that the
micro-organisms were products of nature and as living things non-patentable per se. On
an appeal to Supreme Court, the Court held that micro- organisms per se were patentable
in the United States. This judgement opened the doors for patenting of animals in the
United States.

Earlier nobody thought that biotechnology could manipulate either plant or animal or
human being and therefore none thought of the need for evolving a comprehensive law on
biotechnology for regulation. However, as biotechnology has progressed in various
generations at different times and this field mandated a comprehensive legal framework
for proper regulation.
The biotech inventions could be patented following the patentability criteria; however there
exists complexity of manipulating of living forms hence need special attention.

1 WIPO, Backgroumd reading material on Intellectual property, Geneva,

1988, p.375
2 447 U.S.303 (1980).

In India, after the amendments made in Patens Act in 2002, micro-organisms were made
patentable. This amendment was made to fulfill our obligations under the TRIPs
Agreement.
This paper will examine and analyze the effectiveness of TRIPS-level patent protection
as an incentive mechanism for enhanced biotechnology innovation in India and how to
enhance patent protection on novel biotechnology products by prosecuting the patent
applications in an articulate manner in the Indian Patent Office

1.1 Scope of the Study

Biotechnology has rapidly emerged as an area of activity having a marked realized as
well as potential impact on virtually all domains of human welfare ranging from food
processing, protecting the environment, to human health.
Scope of the study is limited jurisprudential insight and aspect of patent law related to
biotechnology in India in comparison with the international law on biotechnological
genesis.
1.3 Objective of the study
The objective of the study is to analyze the distinction between inventions and discoveries
to grant patent in biotechnological development with the emerging trends. And what are
the difficulties in granting patent in the field of biotechnology in accordance with the
procedure given in The Indian Patents Act.

1.4 Research Question

How far the patent law is applicable in biotechnological development in India?

How far the patent regime in India has helped in achieving the patent protection to

biotechnological innovation and developments?

How far the Indian Patent Regime in India has balanced the interests of the innovator
and society ?

1.5 Research Methodology

The interdisciplinary nature of the research calls for a comprehensive and analytical
study of the subject matter. The researcher proposes to justify the needs of the research
through extensive study of the issues and challenges in patenting of biotechnology. The
researcher for such study would incorporate Doctrinal method of research.
1.6 Literature Review
For the insight and overview of the complete subject matter researcher has referred to
Indian Patents Act 1970, (2005 Amendment) which will give a detailed analysis of the
present biotechnological patents in India. Articles referred for the same are
biotechnology and the law3, Development of Biotechnology: the legal
challenges.4 For study of the most contentious of the issues in the TRIPs Agreement
was relating to the patents Patenting in Biotechnology inventions in TRIPs. 5 For
detail study biotechnological inventions in the I.P regime Biotechnology and
Intellectual Property Rights (Legal and Social Implications).

Bibliography
Primary sources:
Statutes
1. The Patents Act, 1970 as amended by The Patents (Amendment)
Act, 2005 along with The Patents Rules, 2003 as amended by The
Patent (Amendment ) Rules, 2006.
2. TRIPS Agreement

3 P. M. Bakshi, Biotechnology and the Law The Lawyers Collective (1990).

4 Nik Ahmad Kamal Bin Nik Mahmod, Development of Biotechnology : the legal
challenges Kashmir University Law Review
5 C. Niranjan Rao, Patenting in Biotechnology inventions in TRIPs EPW (2002).

Case Laws
1. Dimminaco Ag v Controller of Patents & Designs and Others, [2001] AID No.1.
2. Diamond v Chakrabarty

Books
1. kshitij Kumar Singh, Biotechnology and intellectual property Rights legal and social
implications (springer,New Delhi, 1st edn., 2014).
2. Warren Freedman, Legal Issues in Biotechnology and Human Reproduction
(Artificial Conception and Mdern Genetics (Quorom Books, U.S.A, 1st edn., 1991).
3. Iver P.Cooper , Biotechnology and the Law (sai Printo Pack(p), New Delhi 1 st edn.,
2014).

Articles

1. P. M. Bakshi, Biotechnology and the Law The Lawyers Collective (1990) .

2. Nik Ahmad Kamal Bin Nik Mahmod , Development of Biotechnology : the legal
challenges Kashmir University Law Review

3. C. Niranjan Rao, Patenting in Biotechnology inventions in TRIPs EPW (2002).

4. R.T. Gahukar, issues relating to patentability of biotechnological subject matter in
Indian Agriculture. JIPR 8 (2003).

5. Prasanta K Ghosh and Terala V Ramanaiah, IPR issues in Biotechnology in the

context of Developing Countries and India JIPR 6 (2001).