DR RAM MANOHAR LOHIYA NATIONAL LAW UNIVERSITY,

LUCKNOW

2022-2023

INTELLECTUAL PROPERTY RIGHTS II

PROJECT

PATENT LAW IN INDIA AND ITS ADAPTABILITY IN THE CONTEXT

OF PUBLIC WELFARE AND MEDICATION

SUBMITTED BY: SUBMITTED TO:

KISHALAYA PAL DR. VIKAS BHATI
190101083 ASSISTANT PROFESSOR
(LAW)
 ACKNOWLEDGEMENT
I would like to convey my heartfelt gratitude to Dr. Vikas Bhati for her tremendous support and
assistance in the completion of my project and for providing me with this wonderful
opportunity to work on a project with the topic Food Culture during the Pandemic. The
completion of the project would not have been possible without their help and insights.

KISHALAYA PAL
 Introduction

Background

The first known instance of Indian patent law dates back to 1856, when the country passed a
legislation granting inventors exclusive rights for a fourteen-year period. Experts believed that
the Legislative Council of India lacked the jurisdiction to pass the 1856 statute since it did not
have the previous approval of the British Queen. 1

Over the ensuing decades, India's patent law was further evolved and improved. The Patents
and Designs Protection Act and the Protection of Inventions Act were both passed in 1872 and
1883, respectively. 2 Ultimately, the Inventions and Designs Act was created in 1888 by
combining the two laws. The Indian Patents and Designs Act, 1911 (the "1911 Act"), which
was passed by the British, established a system of patent administration in India under the
direction of a Controller of Patents. According to the 1911 Act, a patent's duration was sixteen
years from the date of filing and, in some circumstances, it might be extended by an additional
seven years. Even after India gained independence from Britain in 1947, the 1911 Act
continued to be in effect with a few modifications and governed the Indian patent system.
Finally, the Patents Act of 1970 repealed it. 3 Pharmaceuticals were included in every version
of the British-enacted product patent law that was implemented in India.

Several private sector businesses and state sector organisations, notably Hindustan Antibiotics
Ltd. and Indian Medicines and Pharmaceuticals Ltd., were encouraged to produce vital
pharmaceuticals at reasonable prices under the National Drug Policy of 1978 and the Patents
Act of 1970. Due to a lack of funding at the time, the pharmaceutical industry concentrated on
manufacturing generic drugs rather than doing original research to generate innovative
compounds.4

Globalisation

As India joined the World Trade Organization ("WTO") in 1995, the country's pharmaceutical
patent system started to gradually shift. The WTO membership agreements encompass

1
DENIS JUDD, THE LION AND THE TIGER: THE RISE AND FALL OF THE BRITISH RAJ, 1600-1947, 14-
27 (2004).
2
P. NARAYANAN, PATENT LAW 6 (3d ed. 1998).
3
The Patents Act, No. 39 of 1970, INDIA CODE sec. 162(i) (1998).
4
Santanu Mukherjee, The Journey of Indian Patent Law Towards TRIPs Compliance, 35 INT'L REV. INTELL.
PROP. & COMPETITION L. 125, 128-29 (2004).
products, services, and intellectual property rights ("IPRs"). 5 The Trade-Related Aspects of
Intellectual Property ("TRIPS") Agreement, which requires all WTO members to adopt and
enforce specific minimum standards of IPR protection, is one of the most significant accords
within the WTO. India and other developing nations, including Brazil and Argentina, fiercely
opposed the World Trade Organization when negotiations to establish it began in 1986 on the
grounds that the protection of intellectual property rights fell under the purview of the World
Intellectual Property Organization ("WIPO"). 61 Due to various forceful actions by the United
States by 1989, several developing nations modified their positions, leaving only India to
maintain its opposition.6 India was thus compelled to accept the TRIPS Agreement and join the
WTO in 1995 after being presented with the unworkable alternative of remaining entirely
outside the WTO system. However, India also succeeded in obtaining significant latitude with
regard to patent rules during this process, which limited the impact of the TRIPS-mandated
amendments.7

5
Understanding the WTO: The Agreements, Overview: A National Guide, WORLD TRADE ORG.,
http://www.wto.org/english/thewto-e/whatis-e/tife/
6
Robert C. Bird & Daniel R. Cahoy, The Emerging BRIC Economies: Lessons from Intellectual Property
Negotiation and Enforcement, 5 Nw. J. TECH. & INTELL. PROP. 400, 403-04 (2007).
7
Amy Kapczynski, Harmonization and Its Discontents: A Case Study of TRIPS Implementation in India's
Pharmaceutical Sector, 97 CAL. L. REV. 1571, 1579 (2009).
 Amendments

Amendment act 1999

Even though India was granted exemptions from implementing pharmaceutical/agrochemical

product patents until 2005, it was nevertheless required to set up a mailbox facility and to
provide each application a filing date for those product patent applications submitted during
the TRIPS transition period. The TRIPS commitment to award EMRs for mailbox applications
that complied with certain requirements throughout the transition period was another
requirement. "India's initial attempt was to use a presidential order to deploy the mailbox
function and give EMRs. 8 The Indian parliament failed to enact the law governing postal
facilities and EMRs for a variety of reasons. As a result, the WTO's dispute settlement process
was used by the United States to address India's inability to pass the mailbox and EMR scheme
into law.9 The WTO's Appellate Board determined in December 1997 that India had violated
Article 70.8(a) of the TRIPS Agreement, which required India to develop "a means" that
sufficiently safeguarded uniqueness and priority of pharmaceutical product patent applications,
by failing to timely alter its patent laws. After the legislation was finally approved by the Indian
parliament in March 1999, India formally adopted the mailbox system for pharmaceutical
product patent applications and made it applicable in the past.

Amendment act 2002

The most notable change brought about by the 2002 amendment was the increase in the patent
period from ten to twenty years. In order to assure that all patents issued in India will expire
twenty years after the date of their application filing, the 2002 Act revised the 1970 statute.
"Prior to this change, the term of all other types of Indian patents was fourteen years from the
date of the patent, whereas the period of Indian process patents awarded in the field of
pharmaceuticals was only five years from sealing, or seven years from the date of the patent,
whichever was less.

India's ratification of the Paris Agreement and the Patent Cooperation Treaty was solidified by
the 2002 amendment. India signed both of the treaties in 1998. The WIPO is in charge of
managing them. This required India to conform its laws to the Paris Convention's national

8
The Patents (Amendment) Ordinance, 1994, No. 13, Acts of Parliament, 1994 (India).
9
Ruth L. Okediji, Public Welfare and the Role of the WTO: Reconsidering the TRIPS Agreement, 17 EMORY
INT'LL. REV. 819, 890-93 (2003).
treatment principle, which forbids the treatment of foreign applicants differently, 10 as well as
its right of priority, which gives foreigners who have already submitted a patent application in
their home countries a 12-month window during which to submit one in India while still
enjoying the advantages of their earlier home country. 11

The 2002 amendment lists three justifications for requesting a mandatory patent licence. In the
case of patented inventions not operating, the law first establishes the broadest grounds for
requesting a forced patent licence. Nevertheless, this licence can only be requested three years
after the sealing of the relevant patent.12 Third, there is a provision for compulsory licences in
the case of certain patents that are necessary for the effective operation of other patented
inventions. This provision is triggered by notifications from the Indian government in cases of
national emergency or extreme urgency, such as the outbreak of epidemics. The Licenses of
Right idea was eliminated by the 2002 amendment."

10
Paris Convention for the Protection of Industrial Property, supra note 101, at art. 2.
11
Id. at art. 4(C)(1).
12
The Patents (Amendment) Act, 2002, No. 38 sec. 3, Acts of Parliament, 2002 (India).
 Flexibilities

This section will deal with the salient features of India's patent law, which is equipped with
several flexibilities that the TRIPS Agreement provides to its member states.

Section 3(d) of the Patents Act

This recently added clause in the patent law has given rise to some well-known patent battles
between multinational corporations and Indian businesses. 13 According to Section 3(d), a
discovery of a new form of a known substance that does not improve upon its known efficacy,
a discovery of a new property or application for a known substance, or a discovery of a new
use for a known process, equipment, or apparatus are not regarded to be inventions. 14

More specifically, it states that "salts, esters, ethers, polymorphs, metabolites, pure form,
particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of
known substance shall be considered to be the same substance, unless they differ significantly
in properties with regard to efficacy." The purpose of this amendment is to prohibit the issuance
of spurious patents on items that are only truncated variations of already-existing inventions.
Companies frequently strive to increase the length of their patent protection in the
pharmaceutical sector by securing separate patents for various aspects of a single product.
Whilst it's possible that Section 3(d) was the first clause addressing insubstantial changes to
pharmaceutical discoveries to be legislated anywhere in the world, numerous nations, including
the United States, have developed strategies to deal with these patents. The U.S. Court of
Appeals for the Federal Circuit ("CAFC") invalidated a patent on the metabolite of the
antihistamine drug Loratadine because the metabolite "necessarily and inevitably" formed from
ingestion of Loratadine under normal circumstances, demonstrating that U.S. courts rely on the
doctrine of inherent anticipation to deal with such patents.15

According to academics, Section 3(d) is a "bold legislative initiative" that has the potential to
stop the unjustified "evergreening" of patents and might force other nations to follow India's
lead in trying to stop similar activities. 16

13
Raheel Rashad Daureeawo, The Controversy of Section 3(D) of The Indian Patent Act, LEGAL SERVICE
INDIA (Nov. 22, 2009), http://www.legalserviceindia.com/article/1400-Controversy-of-Section-3(D)- of-The-
Indian-Patent-Act.html.
14
The Patents (Amendment) Act, 2005, No. 15 sec. 2, Acts of Parliament, 2005 (India), available at
http://ipindia.nic.inlipr/patent/patent-2005.pdf.
15
Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373 (Fed. Cir. 2003).
16
Rajarshi Sen & Adarsh Ramanujan, Pruning the Evergreen Tree or Tripping up Over TRIPS?- Section 3(d) of
the Indian Patents Act, 1970, 41 INT'L REV. INTELL. PROP. & COMPETITION L. 170, 186 (2010).
Section 3(d)-Novartis Case

Novartis filed a case with the Madras High Court in May 2006, claiming that the Patent
Controller had improperly denied its request for a patent on the medicine imatinib mesylate
beta crystalline under Section 3(d) of the Patents Act. As a result of the patent controller's broad
discretion being granted, Novartis further alleged that the clause violated Article 14 of the
Indian Constitution. The Madras High Court and the Intellectual Property Appellate Board
divided the matter ("IPAB"). The Madras High Court considered the arguments regarding
TRIPS compliance and the legality of Section 3(d), and it rendered a decision against Novartis.
The IPAB heard the patentability argument and found against Novartis as well. 17

Three matters were to be looked at by the High Court. The first was whether Indian courts had
the authority to examine whether Section 3(d) complied with Article 27 of TRIPS and to award
declaratory relief if it did not. The second concern was determining whether Section 3(d)
complied with TRIPS Article 27. The third concern was whether Section 3(d), which gave the
Patent Controller unrestricted power, violated Article 14 of the Indian Constitution. The Court
ruled that it lacked jurisdiction to decide a matter involving the compatibility of an Indian
domestic legislation with an international treaty. The Court declined to address the question of
whether Section 3(d) complied with TRIPS because it determined that it had jurisdiction to
assess whether a domestic legislation violated a treaty. On the third question, the Court
determined that Section 3(d) did not contravene Article 14 of the Indian Constitution, was not
ambiguous or capricious, and did not provide the Patent Controller unrestrained authority. The
Indian government's argument that it had a constitutional obligation to provide its citizens with
appropriate health care by facilitating them access to life-saving medications was accepted by
the court. The Court also concurred that appropriate legal safeguards should be put in place to
prevent patent evergreening, which could have severe effects on the accessibility of affordable
medications. The second concern was determining whether Section 3(d) complied with TRIPS
Article 27. The third concern was whether Section 3(d), which gave the Patent Controller
unrestricted power, violated Article 14 of the Indian Constitution. The Court ruled that it lacked
jurisdiction to decide a matter involving the compatibility of an Indian domestic legislation
with an international treaty. Hence, it did not provide Novartis with any declaratory relief. 18

17
PB Jayakumar, Novartis Loses Battle for Cancer Drug Patent, Bus. STANDARD (July 5, 2009),
http://www.business-standard.com/india/storypage.php?autono=36295 1.
18
Novartis AG, 2007 A.I.R.
The Court declined to address the question of whether Section 3(d) complied with TRIPS
because it determined that it lacked jurisdiction to assess whether a domestic legislation
violated an international treaty.49 On the third question, the Court determined that Section 3(d)
did not contravene Article 14 of the Indian Constitution, was not ambiguous or capricious, and
did not provide the Patent Controller unrestrained authority. The Indian government's argument
that it had a constitutional obligation to provide its citizens with appropriate health care by
facilitating them access to life-saving medications was accepted by the court. The Court also
concurred that appropriate legislative safeguards should be put in place to avoid patent
evergreening.

Inventive step

By "a feature of an invention that entails technological advance as compared to the existing
knowledge or having economic relevance or both and that makes the invention not evident to
a person knowledgeable in the art," Indian patent law currently defines inventive step. As a
result, Indian law has attempted to supplement the normal non-obviousness criterion with new
standards like "technical development" and "economic significance." According to academics,
the new, more inclusive definition of inventive step will explicitly require the Patent Office and
courts to take into account the economic impact of a claimed invention. 19

Opposition before the Patent controller

Pre-grant and post-grant objection are the two administrative avenues under Indian law by
which a patent award may be contested before the patent offices." One of the rare systems that
offers both pre-grant and post-grant opposition proceedings is India. 6 It's interesting to note
that most developed nations do not follow pre-grant opposition procedures. In India, however,
anyone may file a pre-grant opposition with the appropriate patent office "has been interpreted
to include social action organisations that advocate for patients with various diseases like
cancer and AIDS as well as potential generic competitors.20 A pre-grant opposition might be
brought on a wide range of grounds as well. The primary grounds for resistance include a lack
of originality, a lack of an inventive step, an inadequate description, and an invention's
ineligibility for a patent under current law. Although there is a dearth of data regarding the
number of pre-grant opposition cases brought before the Controller, some analyses place the
number at 200 as of July 2007.

19
Mueller, supra note 54, at 565.
20
The Patents (Amendment) Act, 2005, Section 25(l).
Mandatory licensing

India's legal system includes fairly extensive requirements for compulsory licencing. The
following requirements must be met in order to invoke compulsory licencing three years after
the patent grant: 1) "reasonable requirements of the public with respect to the patented
innovation have not been satisfied;" (3) The patented innovation is not being used on Indian
soil. (2) "The patented invention is not offered to the public at a reasonable price." 21

Additionally, in cases of urgent national health concerns, the Indian government may issue a
mandatory licence. The law also offers methods for producing and exporting copyrighted
medications to nations without local manufacturing facilities.

Government use

Indian law also has a system that, in some situations, permits the government to employ a
patented invention. This is more or less in line with TRIPS requirements, and the law mandates
that the government notify patentees of the use as soon as is reasonably practical, unless an
emergency arises, and provides adequate compensation to the patentee in each case, taking into
account the economic value of the use of the patent.22 The government is permitted to import
patented drugs or medicines under one more specific clause that deals with medications "for
the sole purpose of its own use or for distribution in any dispensary, hospital, or other medical
institution maintained by or on behalf of the Government" or designated under the Patents Act.

Experimental use

A product, a method, or even an article or product made by a process may be made or used for
"just the purpose of experimentation or research, including the imparting of instructions to
learners," in accordance with Indian law.

According to scholars, this provision is "broad enough to even permit activities like "creating
around" the patented invention or the production of improvements thereto" and appears to be
more lenient than comparable provisions in the majority of other nations. Indian law also
exempts experimental trials carried out on copyrighted medications from the definition of
patent infringement in addition to this broad exclusion for experimental use. 23 This clause is
much more expansive than the corresponding U.S. law because it permits "making, building,

21
The Patents Act, No. 39 of 1970, INDIA CODE (1995) sec. 84(l)-(6).
22
The Patents (Amendment) Act, 2002, No. 38, Acts of Parliament, sec. 41, 2002.
23
The Patents (Amendment) Act, 2002, sec. 58.
using, or selling a 'patented invention' for the purpose of generating regulatory data to comply
with both domestic (Indian) drug regulatory law, and any corresponding foreign law," whereas
U.S. law only exempts activities related to a regulatory submission within the United States.

Imports of Patented product

The international "exhaustion of patent rights" principle is put into practise by India's new
Patents Act. The phrase "exhaustion of patent rights" refers to the loss of control over the resale
of an invention by right holders who sell their innovation. 24 In other words, the importation of
a patented product into India after it has been sold outside of India with the patentee's consent
will not constitute an infringement of the Indian patent. "Importation of patented items by any
person from a person who is properly authorised under the law to make, sell, or distribute the
product, must not be considered as an infringement of patent rights," the legislation states. The
developing and least developed nations have incorporated clauses including international
exhaustion of patent rights into their patent laws in order to guarantee their citizens' access to
more affordable medications, but the majority of industrialised countries' patent systems do
not. As Article 6 of the TRIPS Agreement specifies that "nothing in this Agreement shall be
used to address the question of the exhaustion of intellectual property rights," the TRIPS
Agreement is also silent on the topic of international exhaustion. 25

24
Agreement on Trade-Related Aspects of Intellectual Property Rights art. 6, Apr. 15, 1994, Marrakesh Agreement
Establishing the World Trade Organization, Annex IC, 1869 U.N.T.S. 299, available at
http://www.wto.org/english/docs-elegal-e/27-trips.pdf.
25
Agreement on Trade-Related Aspects of Intellectual Property Rights art. 6, Apr. 15, 1994, Marrakesh Agreement
Establishing the World Trade Organization, Annex IC, 1869 U.N.T.S. 299, available at
http://www.wto.org/english/docs-elegal-e/27-trips.pdf.
 Conclusion

Over six years have gone since India's new system for pharmaceutical product patents was put
into place. The number of patent applications filed has significantly increased throughout this
time. The long-term effects of patent protection on medicine pricing in India are still up in the
air. Yet as this article has shown, there are a lot of resources available to the Indian government
to address that issue.

It should be emphasised that Indian generic medication producers have successfully challenged
multinational corporations with pharmaceutical patents, working in tandem with a number of
social action/public interest groups. 182 They are aggressively using the various statutory
flexibilities to challenge pharmaceutical product patents rather than just accepting the situation
as it is.

The new Patent Act's provisions present substantial difficulties for the Indian Patent Office and
courts to understand and apply. Even though India's patent system stands out as a unique
example, there will be growing pressure from stakeholders to increase system transparency.
There have been some substantial moves towards increasing transparency over the last two
years, and it is anticipated that there will be more. Short-term ambiguity in the interpretation
of various articles of the patent law may allow opponents of enhanced patent protection to gain
an advantage. Yet, given a lack of faith in the patent system could negatively affect domestic
innovation to a significant extent and foreign direct investment to a lesser level, this could have
serious long-term ramifications.
 References
 Agreement on Trade-Related Aspects of Intellectual Property Rights art. 6, Apr. 15, 1994,
Marrakesh Agreement Establishing the World Trade Organization, Annex IC, 1869 U.N.T.S.
299
 Novartis AG, 2007
 PB Jayakumar, Novartis Loses Battle for Cancer Drug Patent, Bus. STANDARD
 Rajarshi Sen & Adarsh Ramanujan, Pruning the Evergreen Tree or Tripping up Over TRIPS?-
Section 3(d) of the Indian Patents Act, 1970, 41 INT'L REV. INTELL. PROP. &
COMPETITION L. 170, 186 (2010).
 Schering Corp. v. Geneva Pharm., Inc., 339 F.3d 1373 (Fed. Cir. 2003).
 The Patents (Amendment) Act, 2005, No. 15 sec. 2, Acts of Parliament, 2005
 The Patents (Amendment) Act, 2002
 Paris Convention for the Protection of Industrial Property.
 Ruth L. Okediji, Public Welfare and the Role of the WTO: Reconsidering the TRIPS Agreement,
17 EMORY INT'LL. REV. 819
 The Patents (Amendment) Ordinance, 1994
 Amy Kapczynski, Harmonization and Its Discontents: A Case Study of TRIPS Implementation
in India's Pharmaceutical Sector, 97 CAL. L. REV. 1571, 1579 (2009).
 Robert C. Bird & Daniel R. Cahoy, The Emerging BRIC Economies: Lessons from Intellectual
Property Negotiation and Enforcement, 5 Nw. J. TECH. & INTELL. PROP.
 Understanding the WTO: The Agreements, Overview: A National Guide
 Santanu Mukherjee, The Journey of Indian Patent Law Towards TRIPs Compliance, 35 INT'L
REV. INTELL. PROP. & COMPETITION L. 125, 128-29
 The Patents Act, No. 39 of 1970
 P. NARAYANAN, PATENT LAW 6 (3d ed. 1998).
 DENIS JUDD, THE LION AND THE TIGER: THE RISE AND FALL OF THE BRITISH RAJ,
1600-1947.