Nirma University

Institute of Law
VII Semester B.A.LL.B.(Hons.)Course

Submission of Synopsis
o n t h e Top i c of

Patent Laws in India in compliance with

TRIPs Agreement An overview

In the Course of Intellectual Property Rights

As a part of continuous evaluation scheme.

S u b m i t t e d t o : M r. R o h i t m o o n k a
Submitted by: Rupali Jani (09BAL018)

INDEX
1

Sr. No.
1.

Particulars
Ch- I: Introduction

Page No.
05
06-08

Synopsis

2.

Ch II: Patent (Amendment) Act 2005

09-10

3.

Ch III: Impact of TRIPs upon Indian Patent Law

11-13

4.

Ch IV: Implication of Novartis Case

14-15

5.

Ch V: Conclusion

16

Bibliography

17

DECLARATION

I Rupali Jani declare the work entitled Patent Laws in India in Compliance with
TRIPs Agreement An overview being submitted to Nirma University for the
2

project in the subject of Intellectual Property Right Law is original and where
the text is taken from the authenticated books, articles or web articles,
appropriate reference is given. It is true in my best of knowledge.

Date :

Rupali Jani
Roll No 09 BAL 018
VII Semester, (2012-13)
Institute of Law
Nirma University

CERTIFICATE

This is to certify that the project entitled Patent Laws in India in Compliance
with TRIPs Agreement An overview submitted by Ms. Rupali Jani for the
project work in the subject of IPR Law embodies independent and original
research work carried out by her under my supervision and guidance.
To the best of my knowledge and belief, it is her original work submitted to fulfil
the project assignment for the Semester End Examination of seventh semester
of B.A.LL.B. Programme during the academic year 2012-13.

Date :

Mr. Rohit Moonka

Asst. Professor in Law,
Institute of Law,
Nirma University
Ahmedabad

Chapter I
Introduction

Patent is the exclusive monopoly right granted by Govt to Patentee. Patent is ground in
favour of the inventor conferring on him the right to use his invention to the exclusive of
all others. It is granted for a time i.e 20years. If the investo cannot use or work the
invention by himself, he can do son in association with other or assign it to other or he
can grant licences to other to work the invention for consideration or for fees which is
called Royalty.

The patent system is social policy tool that aims to stimulate innovation. Internationally,
patent protection is governed by the World Trade Organization (WTO) Trade-Related
Aspects of Intellectual Property Rights (TRIPS) Agreement. TRIPS does not establish a
uniform international law, but sets out minimum standards of patent protection that must
be met by all WTO members. Developed countries have already implemented the
agreement, and other countries such as India are implemented in 2005. 1

The Indian patent system has suffered continuous modifications over the past decade,
partly as a reflection of the diverging standpoints and changing priorities of government,
national industry, public health NGOs and other stakeholders. More recently, Indian

1 www.who.int.pdf
5

patent laws have been amended to comply with the World Trade Organisation (WTO)
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). 2

SYNOPSIS:

RESEARCH PROBLEM
Patent is an exclusive monopoly right granted by the Govt. for the invention. An
invention means something new or useful. Therefore patent can be granted only to
such inventions which are new and useful. On the other hand, TRIPs does not
establish a uniform international law, but sets out minimum standards of patent
protection that must be met by all WTO members.
Therefore it is essential to solve the problems and intricacies regarding the Patent
Laws with compliance to TRIPs.
AIMS AND OBJECTIVE
The fundamental objective of the present research is;
To critically examine the various laws relating to Patent.
To critically observe and will have a broad study upon TRIPs Agreement in
relation to Patent.

HYPOTHESIS

2 www.ipngos.org
6

In order to conduct a research work, formulation of Hypothesis is essential. In any

given study or research work, the focal points and assumptions are normally
available through the formulation of hypothesis. The hypothesis developed on the
basis of literature review is that TRIPs is a law that is not yet finally in shape, it is
still to be negotiated.

RESEARCH METHODOLOGY
In order to accomplish the present research work, an attempt has been made to
study the evaluation of term Patent Laws in India.
The material has been collected from the secondary sources, i.e. books, various
websites, articles.

SCOPE OF THE STUDY

The scope of the study is limited to the Patent Laws extending to India.

SCHEME OF THE STUDY

For the sake of convenience, the present work is simplified by chapterisation, and
hence it is divided in V chapters, namely;
o Chapter I : Introduction
o Chapter II : Patent (Amendment) Act 2005
o Chapter III : Impact of TRIPs agreement upon Indian Patent Law
7

o Chapter IV : Conclusion

REVIEW OF LITERATURE

In order to accomplish the research work, the researcher has collected the material
from secondary sources, i.e. books, websites.
The work has been mainly depended on the analysis of Patent Laws in India.
Besides the researcher has visited website of manupatra, indlaw, heinonline, in
order to make an authentic study of the topic.
Moreover, the researcher has read various articles in order to understand the aspect
of Patent Laws in India.
Moreover, the researcher has referred the following book, namely;
o Indian Patents Law- Legal and Business Implications, Ajit Parulekar and
Sarita D,souza, Published by Macmillan India Ltd.
o Patent Law, P. Narayanan, Fourth edition, Eastern Law House.
o Saharays Commentaries on Patent Act, Kamal Law House.

Chapter II
Patent (Amendment) Act 2005

The Indian patent system, dating as far back as 1856, has suffered several modifications
at different times that have strengthened or relaxed patent rights. The Patents Act, 1970
that came into force in April 20, 1972 was a response to the growing national debate on
how to best strike a balance between patent rights as incentives to innovation and the
need to protect the public interest and to boost industrial development. Up until the 1960s
foreign multinational pharmaceutical companies supplied almost 85 percent of medicines
in India, and prices were among the highest in the world.3
To redress this problem and with a view to make the patent law
compatible with Indian developmental objectives, in the post independence period from
1947 to 1970, the Indian Parliament vehemently debated amendments to the Patents Act.
One of the main changes of the Patents Act, 1970 was that it allowed process patents in
pharmaceutical and agrochemical based products, but not product patents. This allowed
the national pharmaceutical industry to develop technical expertise in reverse engineering
of existing medicines modifying the manufacturing process and thus to become an
efficient producer of generic medicines.4
3 www.ipngos.org
4 supra
9

On March 23, 2005, the Indian Parliament passed the Patent (Amendment) Bill 2005. It
was the third amendment to the Indian Patent Act (1970).5 The amended Patent Act
conforms to requirements set forth by the World Trade Organizations (WTO) Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Since the new law
came into effect on January 1, 2005, there have been serious concerns regarding the role
of the domestic Indian generic industry in the new product patents regime, 6 and the
continued availability of essential medicines at affordable prices.7
The Patents (Amendment) Act of 2005 removed the prohibition of product patents for
pharmaceutical compounds, allowing any company to seek both product and process
patents in India. However, other provisions in the 2005 Amendment could potentially
limit the reach of product patent protection. The Patents (Amendment) Act, 2005, was
passed by the Indian Parliament to comply with the TRIPs obligations leading to the
introduction of the product patent system in India for the first time.8

5 www.ipindia.nic.in
6 www.healthgap.org
7 supra
8 supra
10

Chapter III
Impact of TRIPs agreement upon Indian Patent Law

TRIPs which stands for Trade Related Aspects of Intellectual Property Rights, including
trade in counterfeit goods, is an important agreement. The TRIPs Agreement came into
effect on 1 January 1995, is to date the most comprehensive multilateral agreement on
intellectual property.9 The areas of intellectual property that it covers are copyright and
related rights trademarks, geographical indications, industrial designs, patents, including
the protection of new varieties of plants and undisclosed information including trade
secrets. It is mandatory for all members to comply with the TRIPS agreement. However
the transitional arrangements provided under Article 65 and 66 allowed a grace period of
five years to developing countries and ten years to the least developed countries to
implement the TRIPS provision into their domestic law.10

9 www.planningcommission.in
10 www.pfionline.com
11

The main issues under TRIPS that had to be addressed to make the Indian Patent Act
comply with clauses of TRIPS agreement were:
a. The right of importation and the prohibition of discrimination between local production
and importation,11
b. Broadening patentable subject-matter to include micro-organisms,
c. Limiting compulsory licensing to comply with the conditions set forth in Article 31,
d. Increasing the term of protection to twenty years uniformly for all subject matters,
e. Allowing product patents,
f. Shifting the burden of proof in matters of process-patent infringement proceedings.
The key feature of this agreement is that it takes a major step for harmonization of the
norms and standards of Intellectual Property Protection. It requires members to comply
with a defined set of minimum standards for the protection of IPRs covered in it.
The Three main features of the Agreement are:
Standards12: In respect of each of the main areas of intellectual property covered by
the TRIPS Agreement sets out the minimum standards of protection to be provided by
each Member. Each of the main elements of protection is defined, namely the subjectmatter to be protected, the rights to be conferred and permissible exceptions to those
rights, and the minimum duration of protection.
Enforcement : The second main set of provisions deals with domestic procedures and
remedies for the enforcement of intellectual property rights. The Agreement lays down
11 supra
12 www.planningcommission.in
12

certain general principles applicable to all IPR enforcement procedures. In addition, it

contains provisions on civil an administrative procedures and remedies, provisional
measures, special requirements related to border measures and criminal procedures,
which specify, in a certain amount of detail, the procedures and remedies that must be
available so that right holders can effectively enforce their rights.
Dispute settlement : The Agreement makes settlement procedures of disputes between
WTO members about the respect of the TRIPS obligation subject to the WTOs dispute.
In addition the Agreement provides for certain basic principles, such as national and
most- favoured-nation treatment and some general rules to ensure that procedural
difficulties in acquiring or maintaining IPR do not nullify the substantive benefits that
should flow from the Agreement. The obligations under the Agreement will apply equally
to all member countries, but developing countries will have a longer period to phase them
in. The TRIPS Agreement is a minimum standards agreement, which allows members to
provide more extensive protection of intellectual property if they so wish. Members are
left free to determine the appropriate method of implementing the provisions of the
Agreement within their own legal system and practice.13

13 supra
13

Chapter IV
Implication of Novartis case upon Indian Patent Law

In 1993, Novartis filed patents worldwide for the active molecule imatinib. Novartis did
not patent imatinib in India because the 1970 Act did not allow patenting of
pharmaceutical products at that time. After India's entry into the WTO in 1995, Novartis
filed a "mailbox" patent application in the Madras Patent Office for imatinib mesylate, a
beta crystalline form of the free base imatinib.
In 2002, Novartis started its Gleevec donation program in India to provide Gleevec to
patients who were unable to afford the medicine, but halted that program after Indian
drug manufacturers began to produce a generic version of Gleevec. In January 2006, the
Madras Patent Office refused to grant Novartis a patent for imatinib mesylate.

14

The first major ground for rejection was that because imatinib mesylate was a salt form
of the free base imatinib, and Novartis claimed all pharmaceutical salt forms of imatinib
in its 1993 patents, the Indian application therefore lacked novelty and inventiveness.
The second major ground for rejection was based on Section 3(d) of the 2005
Amendment, which required that new forms of a known substance could only be patented
as a product if they demonstrated "enhanced efficacy." Although Novartis disclosed
information that imatinib mesylate had a 30% increase in bioavailability (the percentage
of the drug absorbed into the bloodstream) as compared with imatinib, the Patent Office
found this insufficient to meet the "enhanced efficacy" requirement of Section 3(d). 14
In May 2006, Novartis petitioned the Madras High Court, opposed by the Indian
Government, the Patent Office, several Indian generic drug manufacturers and an Indian
public interest group. Novartis claimed that the Patent Controller erred in rejecting the
Gleevec patent application, that Section 3(d) was not compliant with TRIPS, and that
Section 3(d) was vague, ambiguous and in violation of Article 14 of the Constitution of
India because it was discriminatory against Novartis.
The Madras High Court held that it did not have jurisdiction to decide a case concerning
the compliance of a domestic Indian law with an international treaty. the court held that
Section 3(d) did not confer unlimited discretionary power to the Patent Controller and
was not discriminatory. The court emphasized that discretionary power did not
necessarily mean that it would be discriminatory. The Patent Controller's discretionary
power under Section 3(d) in deciding whether a known substance has enhanced efficacy
did not automatically lead to an arbitrary exercise of discretionary power or
discrimination against Novartis. Furthermore, the court opined that the judiciary should
be more deferential to the legislature in the field of economic regulation.

14 www.pfionline.com

15

When pharmaceutical company Novartis challenged the rejection of its patent application
for the leukemia drug Gleevec in Novartis AG v. Union of India, it became the first major
legal challenge to Indias newly amended patent law. In 2005, India purportedly made the
final changes required to bring its intellectual property laws in compliance with the
Trade-Related Aspects of Intellectual Property Rights (TRIPS), the World Trade
Organizations (WTO) minimum standards for intellectual property protection, but its
patent law is still fraught with a number of controversial provisions. The ability of
pharmaceutical companies such as Novartis to secure patent protection in India not only
is important in creating incentives for pharmaceutical research, but also greatly affects the
Indian generic drug industry, and therefore the price of medicine available to patients. 15

Chapter V
Conclusion

Patent is an exclusive monopoly right granted by the Govt. for the invention. An
invention means something new or useful. Therefore patent can be granted only to such
inventions which are new and useful. On the other hand, TRIPs does not establish a
uniform international law, but sets out minimum standards of patent protection that must
be met by all WTO members.

The TRIPS Agreement requires Members countries to make patents available for any
inventions, whether products or processes, in all fields of technology without
discrimination, subject to the normal tests of novelty, inventiveness and industrial
15 Supra
16

applicability. It is also required that patents be available and patent rights enjoyable
without discrimination as to the place of invention and whether products are imported or
locally produced.

Bibliography

Books : Indian Patents Law- Legal and Business Implications, Ajit Parulekar and Sarita
D,souza, Published by Macmillan India Ltd.
Patent Law, P. Narayanan, Fourth edition, Eastern Law House.
Saharays Commentaries on Patent Act, Kamal Law House.

Web References : www.who.int.pdf

www.ipngos.org
17

 www.ipindia.nic.in
www.planningcommission.in
www.pfionline.com
www.health.org.in

18