HONOURS PROJECT

INTELLECTUAL PROPERTY RIGHTS (PATENTS)

ON

BOLAR EXEMPTION FOR

INFRINGEMENT OF PATENT

PROJECT SUBMITTED TO: PROJECT SUBMITTED BY:

Dr. Mohd. Aamir Khan DEVENDRA DHRUW

(FACULTY- Patent Law) SEMESTER- VIII
ROLL NO.: 59
I.P.R. (Patent) Hons.-II
(B.A., L.L.B (Hons.))

(DATE OF SUBMISSION- 04/05/2019)

HIDAYATULLAH NATIONAL LAW UNIVERSITY

UPARWARA, NEW RAIPUR (C.G.)

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 ACKNOWLEDGEMENTS

At the outset, I would like to express my heartfelt gratitude and gratefulness to my teacher
Dr.Mohd.Aamir Khan, for putting his trust in me and giving me a project topic such as this and
for having the faith in me to present my report in the best possible way. I would also like to
thank him for the guidance he provided during the tenure of my working in this project. Sir,
thank you for providing me with an opportunity that helped me to grow.

My gratitude also goes out to the staff and administration of Hidayatullah National Law
University for providing the infrastructural facilities in the form of our library and IT Lab that
was a source of great help for the completion of this project.

.Last but not the least, a heartfelt thanks to my seniors and friends who were there to help me out
even in the oddest of hours. Without you all this project wouldn’t be what it is.

Thanking you all sincerely,

Devendra Dhruw
Roll No.: 59

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 TABLE OF CONTENTS

Sr. No. Chapter Page No.

1. Certificate of Declaration 4

2. Research Methodology 5-6

3. Introduction 7

4. Generic Drugs and Bolar Exemption 8

5. International Patent Regime: Bolar Exemption Around the Globe 9-16

6. Bolar Exemption under Indian Patent Law 16-21

7. Conclusion 22
8. References 23

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 CERTIFICATE OF DECLARATION

The researcher hereby declares that the project work entitled “BOLAR EXEMPTION FOR
INFRINGEMENT OF PATENTS“ submitted to Hidayatullah National Law University, Raipur, is
a record of an original work done by the researcher under the guidance of Dr. Mohd. Aamir
Khan, faculty member of Patent Law, Hidayatullah National Law University, Raipur.

The research done by the researcher is his own original work and wherever excepts from the
works of different authors have been taken, they have been duly acknowledged.

Declared By:

Devendra Dhruw
Roll No. 59
Semester- VIII

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 RESEARCH METHODOLOGY

STATEMENT OF PROBLEM

As the global disease burden expands, the need for new, more effective treatments is greater than
ever. Investing in drug research and development is, however, a costly, high risk endeavor.
Patents are intended to offer some guarantee of a return on investment, but the patent system is
also designed to balance the interests of inventors with those of the public. The Bolar exception
for infringement of patentee’s right, provided under the international patent regime seeks to
balance these conflicting interests and has a tremendous effect in pharmaceutical industry.
However, some problems still exist, especially under the Indian Patent law and there’s a need for
making some changes into it.

AIMS AND OBJECTIVES

The primary aim of this research work is to highlight the Bolar exemptions to infringement of
patent under various legal regimes, around the globe. Research paper will then deal with the
consequences of inclusion of this exception. Further, it emphasises on the persistent problems
under Indian patent law, even after inclusion of the said exception and the need for modification
in law.

SCOPE AND LIMITATIONS

Since patent infringement and defences against it, has noticed tremendous research from
different angles across various jurisdictions round the world, this research work focuses on the
legal framework existing in India. Nevertheless, a comparative study is also done with other
regimes such as Canada, U.S., European Union, for introducing and explaining some concepts
and while making suggestions.

OBJECTIVES

1. To understand the need to introduce exceptions for patent infringement in pharmaceutical

industry.

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 2. To study the “Bolar exemption” and related concepts as understood across different
jurisdictions and trace a legal history of its inclusion in the International Patent regime.
3. To analyse the legislative framework in reference to Bolar exemptions in India.
4. To examine the problems persisting in the Indian and international patent regime, even
after the inclusion of Bolar exceptions to infringement of patent; and
5. To suggest the changes that can be brought about in light of the existing problems.

HYPOTHESIS

It is hypothesized by the researcher that the existing exemption from infringement of

pharmaceutical patent in India is not capable to solve existing problems of the industry due to
inherent lacunas in the present law.

RESEARCH QUESTIONS

1. Why is there a need to exempt, use of certain patented products, especially

pharmaceutical products, from the purview of infringement?
2. What is the Bolar exemption from infringement under the international patent regime?
3. What is the legal framework with respect to Bolar exemptions in India?
4. What are the persisting problems under Indian law after the inclusion and possible
modifications to deal with the same?

METHODOLOGY

“Non-Doctrinal (Analytical) Method of Research” has been relied upon for conducting the
research. Secondary and electronic resources have been largely used to gather information and
data about the topic. Books, case laws and other reference as guided have been primarily helpful
in giving this project a firm structure. Websites, articles by WIPO and reports have also been
referred. Footnotes have been provided wherever necessary to acknowledge the same.

MODE OF CITATION

The Bluebook (19th Edn.) citation format has been used for footnoting and referencing the
resources referred.

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 INTRODUCTION

Patents are intended to ensure that the patentee’s hard work and knowledge are rewared.
Therefore, the new invention or the process is protected from unauthorized use by public, by
giving monopoly rights to the inventor (patentee) for a limited period. However, in the
pharmaceutical industry, patents can hinder or prevent manufacturers of generic drugs from
entering the market. As with the makers of brand name pharmaceutical products, generics
manufacturers also need to prove the efficacy and safety of their products. In the competitive
generic market, it is important to balance the individual interest (patentee’s rights) and societal
interest (need for better and cheaper access of products to the society).

Many countries have put into place legal exemptions (or research exemptions) from infringement
for certain acts relating to the development and submission of testing data to a regulatory agency.
These exemptions are often referred to as “Bolar” provisions, in reference to a US law enacted to
overturn a prior court ruling holding that the US did not provide for a research exemption.

The Bolar exemption provides an exception from patent infringement to the generic
manufacturers from using and importing patented drugs for research and development, for the
sole purpose of submission of information for regulatory approvals of generic versions of
patented products before the original patents expire. So, after a patent expires, a patented
technology may be freely exploited by anyone; Although care should be taken to ensure that
there are no other IP rights associated with the technology that could impede practicing an
invention in this way.

The instant research project aims to highlight the Bolar exemptions to infringement of patent
under various legal regimes, around the globe. Research paper will then deal with the
consequences of inclusion of this exception. Further, it emphasises on the persistent problems,
especially under Indian patent law, even after inclusion of the said exception, and the need for
modification in law.

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 GENERIC DRUGS AND BOLAR EXEMPTION

GENERIC DRUGS

The generic drug1 is a drug which is identical or bioequivalent to a brand name drug in dosage
form, safety, and strength, route of administration, quality, performance characteristics and
intended use. Although generic drugs are chemically identical to the branded counterparts, they
are sold at a very cheap price. The principal reason for the low price of generic medicine is being
the low cost incurred by companies for manufacturing it. They do not incur the costly process of
discovering the new drug molecule, instead they reverse engineer the present drug molecule that
may or may not be patented. They also do not bear the burden of proving the safety and efficacy
of the drugs through clinical trials.

Before dealing with the analysis of Bolar exceptions around the globe, it is necessary to briefly
explain the concept for basic understanding.

ESTABLISHMENT OF THE CONCEPT

There are certain exceptions to a patentee’s rights to exclude others from making, using, selling
or offering to sell the invention made by him. It has been stated that a patented product or
process is not infringing if the purpose is solely for research and experimentation without any
profit motive.2 The right to use includes a right to make repairs on the product but not to
completely reconstruct a new product from it. A patentee’s exclusive rights may also be limited
for under experimental purpose or de minimis activity.

Bolar provision is an exception under the patent law made for providing a shield from
infringement, mainly in drug research and development of generic medicines. According to this
exemption, despite the patent, research and other tests for preparing for approval from regulators,
does not constitute infringement for a limited term before the end of the patent term. This
provision particularly is advantageous to the generic drugs in advance of the patent expiration. It
can now be discussed how the Bolar provision is applicable to the pharmaceutical industry.

1
http://www.fda.gov/cder/ogd/#Introduction [Accessed on 26th September, 2015]
2
Douglas v. United States, 181 USPQ 170

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 INTERNATIONAL PATENT REGIME: BOLAR EXEMPTION AROUND
THE GLOBE

In patent law, the research exemption or safe harbor exemption is an exemption to the rights
conferred by patents, which is especially relevant to drugs. According to this exemption, despite
the patent rights, performing research and tests for preparing regulatory approval, for instance by
the FDA in the United States, does not constitute infringement for a limited term before the end
of patent term.3 This exemption allows generic manufacturers to prepare generic drugs in
advance of the patent expiration.

HISTORY AND BASIS OF BOLAR EXEMPTION IN PATENT LAW

Bolar exemption was given statutory cognizance for the first time by the Hatch Waxman Act
(Drug Price Competition and Patent Term Restoration Act, 1984). But to understand the
circumstances which led the US Congress to introduce a revolutionary provision like Bolar
exemption, we need to look at the chain of events which resulted into its evolution.

Prior to the 1984 Act, the law exempted the use of a patented product for the purposes of
research or experimentation and not for profit, from infringing the patent. It is called the
“experimental use” doctrine. It was based upon the equitable concept that a court will not redress
a de minimis use of a patent. Therefore, at that time, an act to be considered as an infringement of
a patent should have been of such a nature that it results into some commercial gain to the patent
infringer.

It was a common practice back then for the generic companies to use the patented invention for
the FDA (Food and Drug Administration) approval to market the generic versions of those
patented drugs before the expiry of the patent term. This use, in a literal sense, would amount to
the infringement of the patent as the use of the patent by the generic companies was with the sole
objective of commercial gain.4 However, it seems that such a practice had tacit approval of the

3
“The principle behind the Bolar exemption is that generic companies should be in a position to take the necessary
preparatory measures in order to be able to enter the market without delay once patent protection expires.” In
Decision T 0223/11 dated 22 May 2012 of the Board of Appeal 3.3.02 of the European Patent Office, reasons 2,
fifth paragraph.
4
Section 271(a) of the USC 35 (July 19, 1952) (hereinafter USC); See also Steven J. Grossman, Experimental Use
or Fair Use as a Defence to Patent Infringement, IDEA: THE JOURNAL OF LAW AND TECHNOLOGY243
(1990).

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owners of the patented inventions which could be deduced from the fact that there are no
reported cases in which the patent owner sought to prevent such activities. 5 To the contrary, in
Hoffman La Roche, Inc. v. Zenith Laboratories, Inc.6 decided in 1975, the plaintiff acknowledged
that it “did not seek to interfere with Zenith’s legitimate activities in seeking FDA approval”.
This shows the ignorance of the manufacturers of the patented drugs of the fact that their patent
gave them a right to prevent the generic companies from developing a generic copy during the
lifetime of patent.

In Pfizer, Inc. v. International Rectifier, Inc.7 case, for the first time, the proposition that the
development of a generic drug for the approval of FDA during the life of patent amounts to
patent infringement and does not come under the “experimental use” doctrine was laid down. 8
However, the authority of this judgment on the drug development exemption is questionable as it
basically decided the violation of a preexisting court order.9

BOLAR EXEMPTION IN VARIOUS PATENT REGIMES

Many countries have put into place legal exemptions (or research exemptions) from infringement
for certain acts relating to the development and submission of testing data to a regulatory agency,
but their nature and scope vary significantly from country to country.

 CANADA: The Canadian Patent Act (Section 55.2(1)) notes that “it is not an
infringement of a patent for any person to make, construct, use or sell the patented
invention solely for uses reasonably related to the development and submission of
information required under any law in Canada, a province or a country other than
Canada that regulates the manufacture, construction, use or sale of any product.”
Canadian courts have broadly interpreted this exemption to apply when a patented
invention is used solely for the development and submission of information required by a
regulatory authority.

5
Alfred B. Engelberg, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? – A
Political, Legislative and Legal History of U.S. Law and Observations for the Future, 39 IDEA 389(19981999).
6
No. 752221 (D.N.J. filed Dec. 23, 1975).
7
217 U.S.P.Q. (BNA) 157 (C.D. Cal. 1982).
8
Ibid at pg. 158
9
Supra note 5 at pg. 391.

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 In Canada, this exemption is known as the Bolar provision or Roche-Bolar provision,
named after the case Roche Products v. Bolar Pharmaceutical.10 It was a court case in the
United States related to the manufacturing of generic pharmaceuticals. Bolar was a
generic drug manufacturer. Roche was a brand-name pharmaceutical company which
made and sold Dalmane, the active ingredient of which was protected by patent. Before
patent expiration, Bolar used the patented chemical in experiments to determine if its
generic product was bioequivalent to Dalmane in order to obtain FDA approval for its
generic version of Dalmane. Bolar argued that its use of the patented product was not
infringement under the experimental use exception to the patent law.

The Court of Appeals for the Federal Circuit rejected Bolar’s contention holding that the
experimental use exception did not apply because Bolar intended to sell its generic
product in competition with Roche’s Dalmane after patent expiration and, therefore,
Bolar’s experiments had a business purpose. Bolar also argued that public policy in favor
of availability of generic drugs immediately following patent expiration justified the
experimental use of the patented chemical because denying such use would extend
Roche’s monopoly beyond the date of patent expiration. The court rejected this argument,
stating that such policy decisions should be made by Congress. Likewise, the court
decided that apparent policy conflicts between statutes such as the Food and Drug Act
and the Patent Act should be decided by Congress and not the courts.

Shortly after Roche v Bolar was decided, Congress passed a law permitting use of
patented products in experiments for the purpose of obtaining FDA approval [section-
271(e)(1) of the Drug Price Competition and Patent Term Restoration Act, informally
known as the “Hatch- Waxman Act”, which established the modern system for FDA
approval of generic drugs.]

The Canadian courts have extended the Bolar exemption to encompass material that is
not submitted to a regulatory authority but is subject to potential inspection, including
samples and data stored pursuant to regulatory requirements.

10
733 F.2d 858 (Fed. Cir. 1984)

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  U.S.A.: In the United States, this exemption is also technically called Sec-271(e)(1)
exemption or Hatch-Waxman exemption. In 2005, the U.S. Supreme Court considered
the scope of the Hatch-Waxman exemption in Merck KGaA v. Integra Lifesciences I,
Ltd.11 The Supreme Court held that the statute exempts from infringement all uses of
compounds that are reasonably related to submission of information to the government
under any law regulating the manufacture, use or distribution of drugs.

Despite this seemingly broad scope of protection, the exact contours of the US exemption
remain in flux and any inquiry into its applicability remains highly fact specific. Post
market approval studies intended to monitor patients receiving an approved product, for
example, may not qualify for protection under the exemption if the monitoring is not
expressly required by a regulatory agency, is routine, or continues long after marketing
approval. Similarly, it remains unclear when early testing of a product (such as high
throughput screening of compounds, or in vitro assays) would satisfy the requirement for
testing conducted “for uses reasonably related to the development and submission of
information” to a regulatory agency. Thus, companies relying on the exemption are
advised to exercise caution and to consider alternative protection, such as that afforded by
the common law experimental use exemption.12

 EUROPEAN UNION: The Bolar exemption in European Law is governed by Directive

2004/27/EC.13 Notwithstanding the EU Directive, the exact language, scope and
interpretation of Bolar exemptions vary across Europe. Generally speaking, countries can
be divided into two categories. Those countries where the exemption is limited to
activities relating to marketing approval of generic medicines, bio-equivalents and bio-
similars, such as the UK, Ireland, Netherlands, Sweden, etc. And those countries that
more broadly exempt any act required for marketing approval, as well as acts relating to
innovative medicines, the likes of Austria, the Czech Republic, Finland, France,
Germany, Italy, Portugal, Slovakia, Slovenia, Spain, etc. as well as non EU states
11
545 U.S. 193 (2005)
12
WIPO Magazine, Facilitating Generic Drug Manufacturing: Bolar exemption Worldwide, June 2014, available at
http://www.wipo.int/wipo_magazine/en/2014/03/article_0004.html [Accessed on 25th September, 2015]
13
Article 10(6) of the Directive provides that: “conducting the necessary studies and trials with a view to the
application of paragraphs 1 to 4 [i.e. bioequvalents and biosimilars] and the consequential practical requirements
shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal
products.”

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 Norway and Switzerland. Furthermore, many countries in Europe (such as Austria,
Germany, Denmark and Italy) also exempt acts aimed at marketing authorizations outside
the EU or European Economic Area (EEA).14

However, national legislation in this area differs throughout the EU. For example national
case law in Germany15, has resulted in the exemption of all studies and trials necessary to
obtain marketing approval of any medicinal product in any country, not just generics, and
not just in the EU. Italy has a similar exemption, and French law covers all marketing
authorisations required in the EU. The Netherlands and Spain have narrower
implementations, similar to that of the UK, which only cover approvals required for a
generic drug. These differences are due to a number of factors, including variation in
national court views as to what falls within the scope of the experimental use exception
and how the Directives were implemented in light of national case law. To further
complicate the international context, US case law has evolved since the Directives were
implemented in the EU, resulting in a broader US interpretation. US law now exempts
from infringement all uses of patented inventions reasonably related to the development
and submission of information to the Food and Drug Administration (FDA) or other
regulatory agencies.16

While legal uncertainty about the scope and interpretation of Bolar provisions across the
European Union remains, the establishment of the Unified Patent Court (UPC) suggests
that some degree of additional harmonization across the region may not be far away.
Article 27 of the UPC Agreement includes Bolar provisions and its wording appears to
restrict the exemption to generic medicines, bio-equivalents and bio-similars. Of course,
in non EU states such as Norway and Switzerland, and in non UPC states such as Poland
and Spain, those potential restrictions would not apply.17

In some countries outside the EU, notably, Russia and Ukraine, there are no specific
Bolar like exemptions in national law (although Russian case law may provide some

14
Supra note 12.
15
[1998] RPC 423 and Case Z ZR 68/94 Bundesgerichthof: X. Zivilsenat (Klinische Versuche (Clinical Trials) II).
16
Intellectual Property Office, The Research and Bolar Exceptions (An informal consultation on patent infringement
in pharmaceutical clinical and field trials), 2011.
17
Supra note 14

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 protection). Thus, efforts to obtain market approval, including conducting premarket
clinical trials, may be regarded as patent infringement in those countries.

 U.K.: In the UK, the experimental use exemption is set out in section 60(5)(b) 18 of the
Patents Act 1977. Its scope has been considered in a number of infringement actions,
with the UK courts following a narrow interpretation. In Monsanto v Stauffer19, it was
held that trials carried out to discover something unknown, to test a hypothesis, or to find
out whether something will work in specific conditions can be regarded as an experiment,
but that trials carried out to demonstrate to a third party that a product works or to amass
information to satisfy a third party that it works as claimed, are not regarded as acts done
for experimental purposes and are therefore not exempted acts under section 60(5)(b) of
the Act. This approach was followed in Auchinloss v Agricultural & Veterinary Supplies
Ltd.20 and has possible implications for field and clinical trials where regulatory approval
is required in order to obtain marketing authorization.

In addition to section 60(5)(b), the UK Patents Act also includes an exemption at section
60(5)(i)21 which implements EU Directives 2004/27/EC and 2004/28/ EC. These
Directives exempt from infringement certain activities performed for the regulatory
approval of generic drugs. The UK fully implemented the Directives, and only those acts
specifically required to obtain marketing authorization of a generic drug are exempt.22

 CHINA: The Patent Law of China does not clearly stipulate whether using patented
technology for SFDA approval constitutes patent infringement. It has stipulated
exceptions to patent infringement in Article 63, according to which using patents solely
for the purposes of scientific research and experimentation shall not constitute patent
infringement (Article 63 Paragraph 1(4)). However, pharmaceutical tests or SFDA
18
UK Patents Act, 1977, S. 60(5)- An act which, apart from this subsection, would constitute an infringement of a
patent for an invention shall not do so if-… (b) it is done for experimental purposes relating to the subject-matter of
the invention.
19
[1985] RPC 515
20
[1999] RPC 397
21
Patents Act, 1977, S. 60(5)- An act which, apart from this subsection, would constitute an infringement of a patent
for an invention shall not do so if-…(i) it consists of:
(1) an act done in conducting a study, test or trial which is necessary for and is conducted with a view to the
application of paragraphs 1 to 5 of article 13 of Directive 2001/82/EC or paragraphs 1 to 4 of article 10 of
Directive 2001/83/EC, or (2) any other act which is required for the purpose of the application of those paragraphs.
22
Supra note 16.

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 approval are not always purely for scientific research, and thus this paragraph cannot be
directly adopted. According to Article 2 of the Administrative Regulations on
Registration of Pharmaceuticals, if the applicant uses patented technology of a third
party to apply for SFDA approval, the applicant can submit the application within two
years before the patent expires. However, this regulation does not have any binding effect
on court cases.23

In practice, Chinese courts have also established some Bolar Exception cases. The first
case was Sangong & Shanghai Sangong Pharmaceutical Ltd. v. Beijing Wansheng
Pharmaceutical Ltd.24 In this case the defendant, Wansheng, used the plaintiff's patented
technology in an application for SFDA approval. However, the court held that the
defendant's production of the pharmaceutical was intended for administrative approval
and for testing the safety and effectiveness of the pharmaceutical, rather than for direct
selling. The defendant's act did not belong to "exploiting the patent for production or
business purposes", and thus did not constitute patent infringement. The plaintiff's claim
was therefore rejected. Nevertheless, as China is not a case law country, whether the
Bolar Exception will be adopted by all Chinese courts remains unclear.

 TRIPS: TRIPs Article 30 allows for limited exceptions to the rights conferred to the
patent holder. These exceptions however can be challenged and subsequently reviewed
by the WTO. In the context of pharmaceuticals, the most common exception to the
exclusive rights of the patent holder is often referred to as the 'Bolar provision'. A Bolar
provision allows interested (generic) manufacturers to start producing test batches of a
product before the patent expires, in order to collect the necessary data for submission to
the registration authorities; this will reduce the delay for generic products to enter the
market after the patent has expired, and thereby enhance competition. The text of the
TRIPs Agreement does not specifically address this issue. However, in a recent WTO
dispute, a WTO Panel25 ruled that a provision in Canadian law, which permits the use of
patented products by generic producers for the purposes of seeking regulatory approval
23
The Bolar Exception in China and the Latest Legislative Developments, July 8, 2008, available at:
http://www.chinalawandpractice.com/Article/1968094/Channel/7576/TheBolarExceptioninChinaandtheLatestLegisl
ativeDevelopments.html [Accessed on 25th Septemver, 2015].
24
http://bjgy.chinacourt.org/public/detail.php?id=42069&kw(2006) er zhong min chu zi No. 04134.
25
The WTO Panel in "Canada - Patent Protection for Pharmaceutical Products".

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 from the authorities for the marketing of their generic version soon after the patent
expires, is allowed under TRIPs. However, the Panel also decided that manufacturing and
stockpiling of patented medicines by generic producers during the six months prior to the
expiry of the patent term (which was also permitted under Canadian law) is not allowed.

With this decision, the Panel effectively has decided that a 'Bolar type' provision is
'TRIPs compliant', provided certain conditions are met 14. Moreover, there is no
requirement to provide for a patent term extension of the original product, as
compensation, in order to legitimize a Bolar exception (as is done in the US). Another
useful exemption is an experimentation clause, which allows companies, universities and
other research institutions to experiment with patented inventions. Such experimentation
may lead to new innovations, to improvement of existing inventions or to the realization
that the granting of a patent was not justified and that it should be revoked.

BOLAR EXEMPTION UNDER INDIAN PATENT LAW

The Indian Patent Act, 1970 (hereinafter Patent Act) provides an exclusive right to the patent
holder to make, use, exercise, sell or distribute the invention in order to protect harm to his
commercial interest. Section 48 of Patent Act26 confers such a monopolistic right to the patent
holder. But such right conferred is not absolute and there are few exemptions laid down in the act
itself. Bolar exemption is one such statutory exemption laid down under section 107A of the act.
This chapter will briefly describe the Bolar exemption under the Indian law and its present status
in light of TRIPS.
AMENDMENT IN THE PATENT ACT, 1970

In May 2002, when India’s Patent Act was amended, a new section 107A was introduced as an
effort by the Government to continue the supply of life saving drugs at a reasonable price. This
provision provides for a research exemption as an exception to the general rules of patent
26
Sec-48: “Rights of patentees, Subject to the other provisions contained in this Act and the conditions specified in
section 47, a patent granted under this Act shall confer upon the patentee – (a) where the subject matter of the
patent is a product, the exclusive right to prevent third parties, who do not have his consent, from the act of making,
using, offering for sale, selling or importing for those purposes that product in India; (b) where the subject matter of
the patent is a process, the exclusive right to prevent third parties, who do not have his consent, from the act of
using that process, and from the act of using, offering for sale, selling or importing for those purposes the product
obtained directly by that process in India.”

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infringement. This amendment was passed under BJP Government with a huge pressure from
many groups such as various NGO’s, human rights activists etc. The bill was passed by the
Government in order to meet the mandates posed by ratification of TRIPS.27

The Amendment Act aimed to balance the competing interests of a variety of stakeholders,
including domestic generic medicine producers, the domestic research and development
community, foreign multinational pharmaceutical companies, civil society groups concerned
with access to medicines and intellectual property lawyers. 28 Hence, this amendment no doubt
made efforts to help generic manufacturers, who were exploring all possible means to help
mitigate the adverse consequences of a pharmaceutical patent regime. Later on, the 2005 Act
expanded this provision to bring even the act of ‘importing’ within its ambit and since then, the
law has remained untouched.

Thus, the Indian law for Bolar exemption is in consonance with TRIPS by virtue of Article 30
which allows the member nations to impose certain restrictions on exclusive patent right of a
patentee.29 The Indian law is almost similar to the Canadian law providing for Bolar exemption
or it can be said that Indian law is borrowed from Canada.

But, the contrasting observation regarding this provision comes when issue of use for
commercial purposes is raised. In this regard idea can be borrowed from the US decisions where
Court disallowed the defence of Bolar exemption where the soul motive was to earn profit and
not to satisfy curiosity or intellect demand.30 Already the heat around this provision can be seen
from the judgment of Delhi HC in Bayer v. Cipla31, in which the Court has ordered Cipla to seek
the High Court’s permission before market launch of the generic version of Bayer’s patented
product. Hence, very soon a settled Bolar exemption can be anticipated in India which will come
by way of judicial decision.

NEED AND RELEVANCE OF BOLAR EXEMPTION IN INDIA

27
Agreement on Trade Related Aspects of Intellectual Property Rights, Marrakesh Agreement Establishing the
World Trade Organization, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (Apr. 15, 1994) (hereinafter TRIPS Agreement).
28
F.M. Abbott, Beginning of a New Policy Chapter: A Hopeful Way Forward in Addressing Public Health Needs,
FIN. EXPRESS– NEW DELHI (Apr. 6, 2005).
29
Chaudhari Sudip, TRIPS Agreement and Amendment of Patents Act in India, 37(32) ECONOMIC AND
POLITICAL WEEKLY 3357 (Aug., 2002).
30
Madey v. Duke University, 307 F.3d 1351.
31
F. Hoffmann La Roche Ltd. & Anr. v. Cipla Ltd., WP ( C ) No. 7833/2008

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India being a developing country with low per capita income is highly market sensitive, that is,
people are highly depended upon market conditions for their survival. Since patent law also deals
and affects the market, it can be said that a patent right is market oriented right or market
monopolistic right. Therefore, in a market sensitive country like India, critical issues of patent
law such as Bolar exemption gain critical importance for the public at large.

1. Bolar Exemption is necessary for promoting competition in the market - The purpose of
the Bolar exemption is not to subsidize new research at the expense of the patentee, but
rather to allow research when market forces prevent it. Since competition in market has
already suffered substantial loss during the patent term, so such an implied extension of
monopoly and curtailment of competition results in further considerable harms. Since
lack of competition is detrimental to the consumer interest, is harmful for the market in
long run and is against national interest and economy, the Bolar exemption is necessary
in a country like India. Therefore, public interest here is heavily outweighing the
individual interest of the patentee.
2. Bolar Exemption is essential in pharmaceutical industry to provide cheap access to life
saving drugs to citizens- The introduction of product patent for pharmaceutical products
resulted in sudden increase in price of life saving drugs. Consequently, the generic
industry declined, directly affecting the population having low per capita income, with
respect to access to medicines. Thus, Bolar exemption is significantly relevant in such a
scenario because it helps in progress of the generic industry, which further results in
availability of cheaper lifesaving medicines for the consumers. In other words, the
9999“Bolar” exception in the Indian patent law, would allow Indian generic
manufacturers to compete among themselves, ensuring the continuous availability of
medicines at low prices for domestic, as well as international, consumers
3. Bolar Exemption promotes and enables further Research and Development - It has been
regarded by most of the patent law theorists that research leads to further innovation, but
due to patents sometimes research gets prohibited, thus exceptions such as Bolar
exemption enables research at an earlier stage than it would have taken place in its
absence.

PROBLEMS AND ISSUES ASSOCIATED WITH BOLAR EXEMPTION IN INDIA

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In India there are still problems emerging in law providing for Bolar exemption. Apart from
enforcement difficulties that may arise in future, there is an inherent problem present in the
statue itself, which is a concern relating to data exclusivity. Data exclusivity, in effect, extends
the term of the monopoly rights that a patentee enjoys. It becomes important because the most
innovative, truly revolutionary products involving new chemical entities ordinarily take a very
long time to come to market because of extensive premarketing product development, clinical
trials and delays in regulatory approvals.32

In such a case, the patentee does not get to utilize the whole of its patent term to exercise its
monopoly rights and reap out the cost of developing that product and the subsequent benefits
emerging from it. In such a case, extension of patent term becomes vital for the patentee and
thus, the patentee is left with the following options:

(i) Patent term extensions designed to compensate for product development and
regulatory delays help companies to recapture some of their rights to exclude, but
extension provisions are subject to stringent upper limits, meaning that patent terms
are often too short to secure market exclusivity during the entire period of the
medicine’s therapeutic advantage.33
(ii) Ever-greening strategies, that is, efforts to extend the period of patent protection
through incremental modifications to the product, could be resorted to by the patentee
to get an indirect extension of patent but many a times such a modification may not
even fulfill the criteria of novelty or inventive step or utility.

Due to these reasons, data exclusivity becomes the only way to ensure market exclusivity of such
products. However, in India, the Patent Act does not provide for a period of data exclusivity.
Section-107A of the Patent Act, which inculcates the Bolar provision, is silent about this aspect.
Therefore, it addresses only one side of the issue. It is a statutory gap which may result in
discouraging the Indian pharmaceutical industry to invest in the research and development of
drugs. The absence of data exclusivity legislation in India results in clash between research-

32
Rebecca S. Eisenberg, The Role of the FDA in Innovation Policy, 13 MICH. TELECOMM.& TECH. L. REV. 345
(2007).
33
Brook K. Baker, Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage,
34 AM. J.L. & MED. 303 (2008).

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based pharmaceutical companies and local generic companies.34 The law in India, therefore,
which absolutely excludes the protection for data exclusivity, is highly volatile and subjected to
criticism.

Further, there are few subjective approaches laid down under section 107A(a) that again lead to
several issues concerning pharmaceutical market and are likely to be judicially scrutinized in the
near future. For instance, the term used under Section-107A (a), ‘uses reasonably related to the
development’, is a subjective term not defined by any statute. Therefore, several questions arise
in this regard as to what constitutes reasonable use? How much quantity of drug may be required
for ‘uses reasonably related to development’ and for the submission of information? Can
manufacture or import of excessive quantity of drugs and subsequent stock piling be allowed
under the pretext of ‘uses reasonably related to development’ in the Indian scenario?35
“Stockpiling” of drugs in anticipation of patent expiration are NOT considered as valid practices
under a 2000 WTO ruling involving the Canadian Bolar provision. Canadian law in question
allowed a “stockpiling exception” 6 months prior to the expiration of the patent. This was ruled
by WTO as contrary to TRIPS.36

Moreover, another valid question that arises in the present context is whether a regulatory
approval can be granted for a drug which is still having 10 to 15 years of patent term left? Often
it has been the case that the generic company after receiving the marketing approval eventually
launches the product in market in contravention of patentee’s right.

Thus, the Indian law still is highly arguable and still suffers several shortcomings which are
likely to be exposed in the near future.

34
Verkey Elizabeth, Law Of Patents (2nd ed., 2012) at pg. 574.
35
Patents and More, India: Patent Linkage with Regulatory Approval, available at:
http://patentsnmore.wordpress.com/2010/01/18/indiapatentlinkagewithregulatoryapproval/ [Accessed on 26th
September 2015].
36
Supra note 30.

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 CONCLUSION

In patent law, the Bolar Exemption (named after the Roche-Bolar case) is an exemption to the
rights conferred by patents, which is especially relevant to drugs. According to this exemption,
despite the patent rights, performing research and tests for preparing regulatory approval, for
instance by the FDA in the United States, does not constitute infringement for a limited term
before the end of patent term. This exemption allows generic manufacturers to prepare generic
drugs in advance of the patent expiration. Many countries have put into place legal exemptions
(or research exemptions) from infringement for certain acts relating to the development and
submission of testing data to a regulatory agency, but their nature and scope vary significantly
from country to country. Practitioners and companies intending to rely on the Bolar exemption
should take these nuances in protection into account when undertaking research and testing
activities in different jurisdictions.

It is fair to evaluate, from the analysis in the research project, that Bolar exemption is highly
relevant in the Indian scenario. This exemption is essential to protect lifeline of considerable
amount of population of the country suffering from deadly diseases. Already, the Bolar
exemption has started to serve needs of the pharmaceutical industry and it is serving as a blessing
for generic drugs producers. But the lack of judicial interpretation in this regard is posing several
questions that bring Indian patent law under light of various criticisms.

Some problems that need to be reformed in the existing law are such as recognition of data
exclusivity period, prohibition of over stockpiling of drugs etc. As regards the data exclusivity, it
can be regarded as one of the major threats to the patent regime in India because its absence is
leaving branded pharmaceutical industry unprotected, which in turn is resulting in reduction in
presence of genuine drug companies. Thus, for meeting the international requirements, a need
persists to adequately amend the law so as to ensure that the patent rights are respected, resulting
in encouragement for research and development, and increase in presence of these genuine drug
industries in the pharmaceutical market. These amendments are essential, so that the Indian law
at a later stage is protected from penalties by the WTO settlement body for violation of TRIPS
provisions.

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 REFERENCES

 ARTICLES
 Anthony Tridico, et al., Facilitating generic drug manufacturing: Bolar exemptions
worldwide, WIPO Magazine, June 2014.
 Bansal Akshita, Critical Evaluation Of Bolar Exemption In Indian Patent Law,
September 2013

 Intellectual Property Office, The Research and Bolar Exceptions (An informal
consultation on patent infringement in pharmaceutical clinical and field trials), June
2011.
 Patra Soumya Prakash, Critical Appraisal of Bolar Exemption with respect to Indian
Patent Act, 1970, SSRN (September, 2014)
 The TRIPS Agreement and Pharmaceuticals, Report of an ASEAN Workshop on the
TRIPs Agreement and its Impact on Pharmaceuticals, Jakarta (Indonesia), 2-4 May 2000,
at pg 34.

 WEBLIOGRAPHY

 http://lawmantra.co.in/criticalevaluationofbolarexemptioninindianpatentlaw/ [Accessed
on September 25, 2015]
 http://www.chinalawandpractice.com/Article/1968094/Channel/7576/
TheBolarExceptioninChinaandtheLatestLegislativeDevelopments.html [Accessed on
25th September, 2015].
 http://www.wipo.int/wipo_magazine/en/2014/03/article_0004.html [Accessed on 25th
September, 2015]

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