INDEX

Sr. No. Particulars Page No.

1. Ch- I: Introduction 05

 Synopsis 06-08

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

6 Bibliography 17

DECLARATION

I Rakshanta Pareek declare the work entitled “Patent Laws in India in

Compliance with TRIPs Agreement – An overview ” being submitted to Nirma

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University for the 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 : Rakshanta Pareek

CERTIFICATE

This is to certify that the project entitled “Patent Laws in India in Compliance

with TRIPs Agreement – An overview” submitted by Ms. Rakshanta Pareek

for the project work in the subject of IPR Law embodies independent and

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original research work carried out by her under my supervision and

guidance.

Date : Mr. Gautam Solanki

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

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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 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

1 www.who.int.pdf
2 www.ipngos.org

4
 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

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

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 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
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.

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 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 Saharay’s 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

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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

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 Organization’s (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

3 www.ipngos.org
4 supra
5 www.ipindia.nic.in
6 www.healthgap.org
7 supra
8 supra

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 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
9 www.planningcommission.in

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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

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 IPR’s 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 subject-

10 www.pfionline.com
11 supra
12 www.planningcommission.in

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matter 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 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
WTO’s 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

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 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.

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 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

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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 India’s 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 Organization’s (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
applicability. It is also required that patents be available and patent rights enjoyable
15 Supra

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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.
 Saharay’s Commentaries on Patent Act, Kamal Law House.

Web – References :-

 www.who.int.pdf
 www.ipngos.org
 www.ipindia.nic.in

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 www.planningcommission.in
 www.pfionline.com
 www.health.org.in

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