Issue 1

November 2015

CELL FOR STUDIES IN INTELLECTUAL PROPERTY RIGHTS

NATIONAL LAW INSTITUTE UNIVERSITY, BHOPAL

ABOUT CSIPR

He has been invited to deliver over 200 lectures in various

programs organized by institutions of national repute, organized
more than 13 workshops and conferences and has participated
in over 30 national and international workshops.

The Cell for Studies in Intellectual Property Rights (CSIPR) was

incorporated under the aegis of Prof. (Dr.) Ghayur Alam at the
National Law Institute University, Bhopal. Pursuant to its
mission of promoting research and the sharing of ideas in the
field of Intellectual Property Laws, the cell has undertaken to
conduct an ever expanding array of activities. The cell publishes
an annual journal titled the NLIU Journal of Intellectual
Property Law and has also been actively involved in the
organising of events in collaboration with the Ministry of
Human Resource Development, Government of India.

He has also authored and co-authored project reports for a

number of agencies of the Government of India and has many
publications to his credit. He is a member of the Subcommittee
of the Copyright Enforcement Advisory Council of the
Government of India. He also held the membership of
American Society of Inter-national Law.

THE e-NEWSLETTER
The Cell for Studies in Intellectual Property Rights presents the
first issue of its e-newsletter in its endeavour to promote the
culture of knowledge creation in India. It aims to create
meaningful debate and discourse to help build a fair and
equitable regime of Intellectual Property Law and to study the
dynamic confluence of the academic and the transactional world
presented by the Intellectual Property Laws.

INSIDE the e-NEWSLETTER

INDIA AND TRIPS A FORK IN THE ROAD
Aditya Goyal .................................................................... 2
DECONSTRUCTING THE ROCHE-CIPLA PATENT
ROW

THE EDITOR
Prof. (Dr.) Ghayur Alam,

Raghavi Vishwanath ........................................................ 4

Ministry of Human Resource Development Chair of

Intellectual Property Law for the Union of India.

TOWARDS A NEW IPR REGIME

Prof. (Dr.) Alam is the first MHRD Chair Professor on IPR at

NLIU, Bhopal. He joined the University in 1998 and has since
introduced, taught, designed and developed courses for a
majority of subjects that form a part of the University
curriculum.

Vaishali Vinod 6

EDITORIAL BOARD
Ashima Gulati
Devyani Gupta

Meher Tandon
Udyan Arya Shrivastava

In case of any queries kindly drop an email at nliu.csipr@gmail.com or contact:

Ashima Gulati, Convenor, CSIPR: +91 9754225292
Devyani Gupta, Co-convenor, CSIPR: +91 9425203277
1

ISSUE 1

NOVEMBER 2015

INDIA AND TRIPS A FORK IN THE ROAD

Aditya Goyal
Introduction

The interpretation adopted by developing countries has

recently received a validation through the Declaration on
Patent Protection released by the Max Planck Institute 2 in
association with the renowned IP scholars of the world.
These IP scholars belonging to both groups of countries
interpreted TRIPS in light of pre-existing principles of
international law3, particularly- Human Rights and the
Doha Declaration on TRIPS and Public Health (Doha
Declaration) and their flexibilities were brought within the
interpretative fold of TRIPS. They then reached a uniform
conclusion that TRIPS maybe interpreted flexibly in light
of special needs of each country. Consistent with its stand,
India supported a strong open source innovation
culture4when the agenda Intellectual Property and
Innovation: Innovation Incubators was tabled by USA and
Taiwan. India portrayed IPR as only one of the means to
achieve technological development and its use dependent
on the countrys socio-economic development. A model
which views IPR as an end in itself will fail to kindle
innovation and create barriers in providing low cost and
affordable healthcare to the public. Indias stand is
consistent with its practice the Indian governments
Science, Technology and Innovation Policy5and also
stresses on the employment of Open Source Models to
foster innovation.

When the president of the United States of America, Mr.

Barack Obama was invited as Chief Guest to Indias SixtySixth Republic Day Parade, he and our Prime Minister Mr.
Narendra Modi discussed and debated on an expansive
range of issues including that of Intellectual Property
Rights (IPR) protection in India. The compliance of
Indian IPR laws with the Trade-Related Aspects of
Intellectual Property Rights (TRIPS) has been a long
sticking point in the Indo-US relationship. India still
features in the Priority Watch List of United States Trade
Representatives (USTR) Annual Special 301 Report for
inadequacy and ineffectiveness in its protection and
enforcement of IPR.
The TRIPS is a treaty administered by the World Trade
Organization (WTO) which sets down the minimum
standards of IPR protection for its signatories. Accession
to TRIPS is a pre-requisite to the membership of WTO, 1
which in turn is necessary to participate in the global
market economy. Hence, it is practically impossible for any
country to refrain from acceding to the TRIPS. A strong
enforcement mechanism has been set up in the form of the
WTO Dispute Settlement Board making the TRIPS the
most powerful international agreement governing IPR laws
of the signatory countries.

TRIPS and TRIPS Plus

Interpretation of TRIPS

However, the 10th rounds of the Regional Comprehensive

Economic Partnership (RCEP) negotiations held in
South Korea from October 12-16 may provide a turning
point in the IPR protection provided by India. RCEP is a
proposed Free Trade Agreement (FTA) between the 10
members of the ASEAN (Brunei, Burma, Cambodia,
Indonesia, Laos, Malaysia, Philippines, Singapore,
Thailand, Vietnam) and 6 other countries with which
ASEAN has FTAs (Australia, China, India, Japan, New
Zealand and South Korea). The negotiations began in
November 2012 with the FTA targeted to be concluded by
the end of 2015. Therefore, any further round of
negotiations on the RCEP assumes critical importance.
According to the RCEPs guiding principles,6 it will include

The interpretation of TRIPS has always been a contest

between the developing and developed countries. It is
purported that the developing countries wish to exploit the
flexibilities in the TRIPS (eg. compulsory licensing, parallel
imports etc) and enact weak IPR protection laws. On the
other hand, developed countries like USA and the
European Union that were the main lobbyists behind the
Uruguay Rounds of negotiations which culminated in the
TRIPS, wish to minimize the discretion available in the
flexibilities. In fact, USA had linked its trade policy to the
IPR regime of the country in 1980s itself. Both groups of
countries however concur that the underlying rationale is
to provide adequate incentives to innovate.

Article 31(3)(a), Vienna Convention on the Law of Treaties, 1969

http://keionline.org/node/2019
5 http://www.dst.gov.in/sti-policy-eng.pdf
6 http://www.asean.org/images/2012/documents/Guiding%20Principl
es%20and%20Objectives%20for%20Negotiating%20the%20Regional%
20Comprehensive%20Economic%20Partnership.pdf

The author currently pursuing his B.A.LLB. (Hons.) at National Law

Institute University, Bhopal and is in his fifth year.
1 Article XII, Agreement Establishing the World Trade Organization,
accessible at https://www.wto.org/english/docs_e/legal_e/04-wto.pdf ;
PHOEBE LI, HEALTH TECHNOLOGIES AND INTERNATIONAL
INTELLECTUAL PROPERTY: A PRECAUTIONARY APPROACH 12 (2014)
2 https://www.mpg.de/8132986/Patent-Declaration.pdf

ISSUE 1

NOVEMBER 2015

an IPR chapter to promote cooperation in the utilization,

protection and enforcement of IPR.

put this clause in their negotiating draft. A recent example

of this delay was when the SC admitted the Special Leave
Petition in the Novartis Case lest the appeal be rendered
infructuous due to the expiry of 20 years while the patent
claim was pending in various government departments.
Nonetheless, this proposal is in addition to the term of
protection mandated by TRIPS where the patent applied
for comes to end after 20 years from the date of the
application.

The leaked negotiating text of Japan7 which is supported

by almost every country contains several TRIPS Plus
provisions which has raised alarms in various NGOs and
civil society groups. A few of these provisions which can
have a harmful effect on the Indian industry are as follows:

1.

Patentable subject matter

4.

The Japanese proposal reads, Each Party shall ensure that a

claimed invention is not excluded from the patentable subject matter
solely on the ground that the invention is a new form of a known
substance which does not result in the enhancement of the known
efficacy of that substance or that the invention is a new use for a known
substance.

The interpretation of TRIPS in light of the pre-existing

body of international law and subsequent state practice was
sanctioned by the Declaration on Patent Protection.
However, the Japanese proposal is silent on the
interpretation and implementation of the rights and
obligations under the RCEP in consonance with the Doha
Declaration.

This is a clear attack on Section 3(d) of the Patents Act,

1970 which prohibits ever-greening of patents a problem
prevalent in the drug industry to extend the royalty term
over blockbuster drugs by making small insignificant
changes in the drug composition. It provides much needed
breathing space to the generic pharmaceutical industry post
the Patents (Amendment) Act, 2005. The constitutionality
of the above provision was upheld by the Supreme Court
of India (SC) in the landmark judgment- Novartis AG v.
Union of India8 (Novartis Case).

2.

It is clear that rather than evolving as a response to the US

led Trans-Pacific Partnership (TPP) and proposing
alternative standards, the RCEP has outdone the TPP
itself. Perhaps, Japan being a key participant in the TPP
agreement is now closely allying with the US in pushing
extremely stringent IPR standards in other countries.
The Road Ahead

Data Exclusivity

The leaked drafts have caused massive public outrage over

the deals because they aim at restricting the ability of
governments to take decisions in the interest of the public
health and delay the availability of low-cost generic
versions of medicines.9The anger was apparent when a slew
of protestors outside the designated site where India was
to host the RCEP necessitated a last minute change of
venue. The Commerce Secretary has expressed some
discomfort over the negotiation journey of the RCEP.10

The Japanese proposal protects data submitted to any

authority for the purpose of trial and marketing approval
for 6 years from the date of approval of that application.
Countries with an innovative pharmaceutical industry have
often sought to incorporate data exclusivity in their FTAs
to ensure that generic companies cannot rely on the
expensive test data produced without paying any costs
associated with it. Neither TRIPS nor the 1970 Act
mandate data exclusivity of test data.

3.

Doha Declaration

However, being party to the RCEP is crucial for India since

it is not a part of the other two mega regional trade deals
TPP and transatlantic trade and investment partnership
(TTIP) because of the high-level of ambitions proposed
for them. RCEP envisages regional economic integration
leading to the creation of the largest regional trading bloc
in the world amounting for almost 45% of the world
population with a combined gross domestic product of
over $21 trillion. Thus, even the Commerce Secretary has

Duration of patent protection

With respect to pharmaceutical products, the Japanese

proposal provides for a compensatory term of protection
for a period during which the patented invention cannot be
worked due to marketing approval process.
The time taken by Patent Officeand the Controller to
process applications and courts to adjudicate disputes with
respect to patents granted might have motivated Japan to
http://keionline.org/sites/default/files/RCEP_WGIP_JP_Revised_D
raft_Text_3Oct2014.pdf
8 AIR 2013 SC 1311
9 http://lists.keionline.org/pipermail/ip-health_lists.keionline.org/2015February/004857.html , http://lists.keionline.org/pipermail/iphealth_lists.keionline.org/2015-February/004856.html

http://www.livemint.com/Politics/3iqdSmkLJYwwVbmas3hF0K/
After-WTO-India-hardens-stand-in-RCEPnegotiations.html?utm_
source=copy

10

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NOVEMBER 2015

acknowledged that it is essential for India to become a part

of the RCEP.11

For the time being it seems that India might be tempted to

give up some of the protective measures in its domestic IP
laws to avail the benefits of RCEP. It will be interesting to
see if India finds a way out by providing other incentives
or if the RCEP reaches the same conclusion as the
proposed India-EU FTA which has proposed India-EU
FTA which has been stalled for years now primarily due to
its IPR provisions.13

It is highly probable that India might be singled out at the

negotiating table. Several RCEP members (Australia,
Brunei, Japan, Malaysia, New Zealand, Singapore and
Vietnam) are also signatories to the TPP with China
expressing hope to join it in future. Moreover, Prime
Minister Modi in his recent trip to Japan, committed to
actively engage in RCEP negotiations and to further
cooperate towards the conclusion of RCEP negotiations. 12

DECONSTRUCTING THE ROCHE-CIPLA PATENT ROW

Raghavi Vishwanath

The dispute between Roche Hoffmann, a multinational

Swiss-based drugs manufacturer and Cipla, a Mumbaibased multinational generic drug-maker, was the first
patents drug trial brought before the Indian courts after the
Patents Act, 20051 and the implementation of the TRIPS
regime.

in the award of injunctions in the eBay case.4 The potential

for misuse of this public interest and the Courts failure to
appreciate the affordability of the drug raised serious
doubts over the reasonableness of the decision.
In its defence, Cipla filed a counterclaim challenging the
validity of Roches IN 774 patent. It contended that the
patent did not improve upon the closest prior art which
was Example 51 of EP 226 and that it was merely a
substitution of an ethyl/methyl group which did not
involve any scientific expertise to configure.5 Mr. Arun
Jaitley, representing Cipla, argued that Roches patent did
not meet the requirements laid down in Section 3(d) of the
Patents Act, according to which derivatives of existing
pharmaceutical products would not be awarded patents
unless it could be proved that they were more efficacious. 6

Roche Hoffmanns claim was centred on the infringement

of its Indian patent 774 for the compound Erlotinib
Hydrochloride. It alleged that Cipla was manufacturing a
generic version of its anti-cancer drug Tarveva using the
patented Erlotinib compound as Ercelop. The
manufacturers therefore approached the Court to restrain
Cipla from selling Ercelop and grant damages for
infringement of Tarceva.
Decision of the Trial Court

Roche responded by explaining that the comparative

efficacy of the two compounds had been evaluated using
inhibitory concentration. In fact, the inhibitory
concentration of Example 51, that Cipla relied on, was not
comparable to these compounds. The Court then
concluded that Cipla had not adequately discharged its duty
of producing positive evidence. Furthermore, it
disregarded the five patent specifications offered by Cipla
on procedural grounds stating that there were beyond
Ciplas knowledge and were filed after the issues had been
framed. Applying the standard of balance of probabilities, the

Usually, the decision of the judiciary is either in favour of

the plaintiff or in that of the defendant, however in the
decision authored by Justice Bhat of the Delhi High Court
in the first instance2, the public interest element had an
integral role to play. The Court refused Roches prayer for
an ad-interim injunction in light of the fact that the public
would be denied access to a low-priced life-saving drug
(Ercelop, manufactured by Cipla, was priced at Rs 1600 as
opposed to the inventors drug which was priced at Rs
48003). Public interest was first considered a deciding factor

Hoffmann-La Roche Ltd. v. Cipla Ltd. 148 (2008) DLT 598.

Patent and Trade Disparities in Developing Countries, Srividya Ragavan,
Oxford University Press, 2012.
4 eBay Inc. v. Mercexchange, LLC 401 F. 3d 1323.
5 Supra, see 4.
6 Roche-Cipla row test case for balancing health issues, patents, Bhuma Srivastava,
Livemint, February 9, 2008.

http://articles.economictimes.indiatimes.com/2015-0824/news/65808614_1_rcep-10-asean-members-trade-agreement
12 http://indiatoday.intoday.in/story/modi-in-japan-shinzo-abe-bullettrains-in-india-tokyo-kyoto/1/380333.html
13 http://www.livemint.com/Politics/vgrNCwTcLpuAyASnEln0LM/
IPR-key-facet-of-IndiaEU-trade-talks-Germany.html

11

The author currently pursuing her B.A.LLB. (Hons.) at National Law

Institute University, Bhopal and is in her third year.
1 Hereinafter Patents Act

ISSUE 1

NOVEMBER 2015

High Court held that Cipla had failed to prove the lack of
innovation and improvement in IN 774 and therefore
Section 3(d) would not be attracted.

applications. It adhered to the precedent established by the

Chemtura Corporation v. Union of India14 which prescribed
stringent measures on grounds of inadequacy of disclosure
as well as non-disclosure to the extent of demanding
revocation of the patent. Despite holding that ...the
plaintiffs as patentee has not disclosed the information as required by
the controller as per Section 8 of the Act which is evident upon from
the examination report dated 22.8.2006 and the responses thereto
which do not record the subsequent patent in US'221 which ought to
have been disclosed. Thus the ground of revocation under Section 64
(1) (m) is made out15, the Court still read into the terms of
Section 64 of the Act and inferred a vested discretion
inherent in the use of the word may. Therefore, it did not
permit revocation of the patent despite Roche failing to
meet the standard of unequivocal disclosure.

The Delhi High Court also relied on the crucial principles

of triability of a case- irreparable injury and balance of
convenience, in denying Roche the relief of an interim
injunction. Citing the ratio of the American Cyanamid
case7, the Court elaborated that patents are to be presumed
not valid, especially when the defendant challenges its
validity. Since Roche could not prima facie defend these
claims, it did not fulfil the standard of credibility that merits
protection through the grant of interim injunctions.
Decision of the Appellate Courts
At the appellate stage, the Division Bench of the Delhi
High Court dismissed the appeal and directed Roche to pay
Rs.5 lakhs on grounds of suppression of material
information albeit restraining Cipla from exporting
Roches patented drug.8 Many scholars objected to the illfounded logic of awarding costs at the interim stage even
before the contentious issues are discussed in entirety. 9
Upon further appeal, the Supreme Court redirected the
case to the Trial Court with orders for expedite disposal of
the case.10

Critical Appraisal of the Litigation Process

The Roche-Cipla dispute has expanded the existing
contours of Indias intellectual property law regime in
several ways.
Firstly, the decision of the single judge was the first time
that public interest was considered to be an equally decisive
factor in the grant of injunctions, thereby emulating the
American standard16. Justice Bhat creatively interpreted the
conflicting public interest involved in granting the
injunction during pendency of the infringement suit vis-vis that involved in denying access to the life-saving drug.
Quoting from the judgment, it was held that The damage or
injury that would occur to the plaintiff in such case is capable of
assessment in monetary terms. However, the injury to the public which
would be deprived of the defendants product, which may lead to
shortening of lives of several unknown persons, who are not parties to
the suit, and which damage cannot be restituted in monetary terms, is
not only uncompensable, it is irreparable. Thus, irreparable injury
would be caused if the injunction sought for is granted.17

Analysing the Fresh Trial

While pronouncing the final verdict, Justice Manmohan
Singh of the Delhi High Court offered an unusual
reasoning in upholding the validity of Roches patent
however still acquitting Cipla of the infringement charges. 11
Upon examining whether Tarceva subsumed the
compound manufactured by Cipla, the Court elected to
undertake a purposive interpretation (in this respect, it
relied solely on the test of inventiveness and patentability
laid down in the case of Biswanath Prasad v. Hindustan Metal
Industries12) to determine the real purpose for which the product
was invented13. The judge elucidated that Cipla was
manufacturing Tarceva using the Polymorphic form B of
the Erlotinib compound which was not covered by the IN
774 patent whereas Roches product was an admixture of
the polymorphic forms A and B.

However, there is a flip-side to this as well. Many scholars

have noted that Roche is largely to be blamed for the
verdict in light of the ill-researched and flawed legal
strategy floated by them. Roche operated on the
presumption that merely establishing a prima facie triable
case would merit injunctive relief, disregarding the settled
principles of law laid down in Dalpat Kumar v. Prahlad
Singh.18 In fact, the counsels for Roche even
misrepresented the sale price of the drug before the single

The Court also addressed the issue of validity of the IN 774

patent in respect of Section 8 of the Patents Act which lays
down the disclosure requirements of foreign patent
American Cyanamid v. Ethicon [1975] I All ER 504.
FAO (OS) No.188/2008
9 Patent litigation in India and interim injunctions--an evolving jurisprudence,
Rajashree Sharma and Dinesh Kumar Sharma, Journal of Commercial
Biotechnology, 18.1 (Jan. 2012): p37.
10 Special Leave to Appeal (Civil) No.20111/2009.
11 Hoffmann-La Roche Ltd. v. Cipla Ltd. CS (OS) No.89/2008 and C.C.
52/2008.

AIR 1982 SC 1444.

Supra, see 10.
14 CS (OS) No. 930 of 2009.
15 Supra, see 10.
16 Supra, see 3.
17 Supra, see 1.
18 (1992) 1 SCC 719.

12

13

ISSUE 1

NOVEMBER 2015

judge, an error which demolished Roches credibility in the

eyes of the judge and understandably so. Furthermore,
unlike the strategy adopted by Novartis19, Roche did not
emphasize and highlight its global access programs, which
could have made its public interest argument seem more
credible.

product to product comparison and is limited to the scope

of the infringement of the patented compound, criticising
the reasoning offered for its flawed construction.
The Way Forward
Re-affirming its rather unprecedented run in the patent
litigation history, the case was thereafter directed to
mediation despite its jurisprudential significance. 20 This
was the first time that an intellectual property dispute was
attempted to be resolved through mediation. However, no
amicable settlement could be reached21 and the case is now
being heard afresh before the Division Bench of the Delhi
High Court.22 It only remains to be seen whether this
decision would settle the legal ambiguities in respect of
awarding interim injunctions and the threshold to
determine validity of patents (as well as that of
infringement) under Section 3 of the Patents Act.

Secondly, by granting interim damages, the High Court

introduced a novel concept in patent litigation. However,
the modalities of awarding interim damages, considering
that the merits of the issues had not been deliberated by
the Court, were not sufficiently addressed.
Thirdly, Justice Singh deviated from the general standards
of proving patent infringement under Section 3 of the
Patents Act. However, the rationale provided by him did
not augur well with the members of the legal fraternity who
argued that a patent infringement claim does not entail a

TOWARDS A NEW IPR REGIME

Vaishali Vinod

Indias laws on Intellectual Property Rights (IPR) are

currently under severe scrutiny as it remains on the Priority
Watch List of the United States of America.1 The USTR has not
once expressed concerns over copyright & piracy, patents &
regulatory data protection, trade secrets, trademark &
counterfeiting, and localization trends in India. While bilateral
ties with the US have taken significant strides over the last few
years, the pressure on the Indian government to protect the
interests and investments of US pharmaceutical companies has
increased. Interestingly, when the IPR Think Tank drafted the
National IPR Policy,2 inputs were invited from the US. The first
draft of this policy seeks to nurture the IP culture and address all
facets of the IP system including legal, administrative and enforcement
infrastructure, human resources, institutional support system and
international dimensions. Its key objectives include the creation of
IP, reconciliation of legal framework with global developments
and scientific developments, efficient administration and
adjudication, and indigenization.

Creation of Intellectual Property (IP)

The number of patent filings has seen constant growth in India.
However, the number of filings by Indians continues to remain
relatively low. Similar trends can be seen in the areas of
copyright, industrial design, and trademarks, wherein the lag
between the current status and the actual potential of IP
creation is truly lamentable. The IP Policy recognises this
problem and suggests changes that could encourage and explore
the potential of the talent pool available in India.
A notable proposal by the IPR Policy is the introduction of
petty patents which protect innovations that may not satisfy
the criteria of patentability but are novel, utilitarian and
inventive in their own spheres. Moreover, the introduction of a
first-time patent fee waiver for Micro, Small and Medium
Enterprises (MSMEs) and reduction of transaction costs have
been suggested. Such measures are targeted at the MSMEs,
which currently account for 45% of manufacturing output in
the country. The IPR Policy also proposes other incentives such
as tax benefits linked to IPR creation and a sui generis system for

(2013) 6 SCC 1.
Trying mediation, Sagnik Dutta, Frontline, July 25, 2014.
21 Roche-Cipla mediation row fails. Rupali Mukherjee, Times of India,
October 31, 2014
22 Ibid.

19

The author currently pursuing her B.A.LLB. (Hons.) at National Law

Institute University, Bhopal and is in her fourth year.
1 United States Trade Representative Michael B.G. Froman, Special 301
Report, (2015) [hereinafter USTR].
2 IPR Think Tank, National IPR Policy (first draft), (Dec. 19th, 2014)
[hereinafter IPR Policy].

20

protection of traditional knowledge, in order to encourage all

sections of the industry to generate IPRs.

that for pharmaceuticals if the product for which patent

protection is claimed is a new form of a known substance with
known efficacy, then the subject product must pass, the
additional test of enhanced efficacy as provided in section 3(d). 8
This has received strong criticism from the US, which fervently
argues that such a requirement would limit the patentability of
potentially beneficial innovations.

Reconciliation of Legal Framework

There is a pressing need to constantly review IPR laws to keep
pace with global developments and scientific advancements. In
the field of copyright, immediate measures are required to be
taken to curb the massive boom in online piracy. India is one of
the biggest hubs for online piracy, which is the unauthorized
reproduction, importing or distribution either of the whole or
of a substantial part of works protected by copyright.3 While the
Indian film industry alone suffered a loss of USD 959 million in
2008,4 it has a grave impact on foreign industries too. The states
of Tamil Nadu, Kerala, Andhra Pradesh and Maharashtra have
included video piracy as an offence in their laws to deal with
prevention of dangerous activities. But, besides the protection
of technological protection measures of copyright owners, 5 no
efficacious mechanism exists to curb online piracy. Similarly,
counterfeiting poses a huge threat to the IP owners, consumers
and the exchequer, while also discouraging innovation. The IPR
Policy seeks to take active measures to keep a check on such
issues and to curb their deleterious effects on the industry.

Indigenization
The new government has initiated the Make in India and
Digital India initiatives that seek to foster innovation and
creativity by generating, protecting and utilizing intellectual
property assets. In retrospect, the country has always adopted a
protectionist approach towards the local market.
An example of this is its take on compulsory licensing, which is
also the most controversial aspect of the Indian IPR regime.
Section 84 of the Indian Patent Act, 1970 provides for
compulsory licensing after the expiration of three years from
the date of the grant of a patent on grounds of reasonable
requirements of the public, availability at reasonably affordable
price or that the patented invention is not worked in the
territory of India. In a landmark ruling, the Intellectual Property
Appellate Board upheld the compulsory licence granted to
Natco Pharma Limited, an Indian manufacturer, for the
production of an oncological drug and categorically stated that
the grant is not to favour the licensee, but to make the medicine
reasonably affordable and accessible to the public. 9 This has
been widely criticised and has increased pressure on the Indian
government from the US to water down its stance on
compulsory licensing. The recent initiatives as well as the
proposals in the IPR Policy to encourage domestic innovation
create concerns for foreign investors.

Moreover, the laws protecting trade secrets in India are largely

contractual6 and based on non-disclosure agreements or noncompete clauses. There is no comprehensive law to protect the
same and Indian courts rely mainly on principles of equity and
common law remedies.7 In such an environment, it becomes a
challenge to obtain sufficient damages upon the disclosure of
trade secrets. Hence, there is a need to legislate on the
protection of trade secrets and the IPR Policy does promise to
fill gaps in the protective regime of IPRs such as Utility Models and Trade
Secrets.
Furthermore, according to the definition of patentability in
India under Section 3(d) of the Patents Act, 1970, mere
discovery of a new form of a known substance which does not
result in the enhancement of the known efficacy of that
substance, is not patentable. In the Novartis case, it was stated

However, what remains to be seen is whether the government

successfully amends and consolidates the legal framework on
IPR to remedy the issues identified, and yet does so without
appearing to have succumbed to international pressure.

Capital Records Inc. v. Erickson, 2 Cal. App. 3d 526, 82 Cal. Rptr. 798 (1969).
US India Business Council Ernst & Young, The Effects of Counterfeiting and
Piracy on Indias Entertainment Industry (2008).
5 Copyright (Amendment) Act, 2012, Sections 65A, 65B.
6 Sonia Baldia, Offshoring to India: Are Your Trade Secrets and Confidential
Information Adequately Protected?, MAYER BROWN BUS. & TECH. SOURCING REV.
(Mar. 1, 2008).

Saltman Engineering Co. Ltd. v. Campbell Engineering Co. Ltd., 1948 (65) RPC.
203.
8 Novartis AG v. Union of India & Others, (2013) 6 SCC 1, 103, 104, and 192.
9 Bayer Corporation v. Union of India, The Controller of Patents and Natco Pharma
Limited, MIPR 2013 (2) 97.

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