NATIONAL UNIVERSITY OF SINGAPORE

SOCIOLOGY OF LAW LL5037

RESEARCH PAPER

BEHAVIOR IN THE SOCIAL FIELD OF TRIPS COMPLIANT INDIA: A

LOOK THROUGH THE LENS OF LEGAL PLURALISM

SUBMITTED BY:
KRISHNA DEO SINGH CHAUHAN
MATRICULATION NUMBER A0098282
TOTAL NUMBER OF WORDS - 5940

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CHAPTER I - INTRODUCTION
In the past few years, a number of cases have come up before the judicial and administrative
authorities in India concerning patent rights. The reason why these cases form a distinct set is
because India amended its patent law in 2005 in compliance with the Trade Related Aspects of
Intellectual Property Rights (TRIPs).
Although TRIPs was promulgated with a policy of promoting effective and adequate protection
of intellectual property rights, which would largely coincide with enhanced protection of patent
rights, a common theme can be noted in these decisions these decisions have resulted in a
narrower than sought patent right for the patent owner in question.
This paper considers the presence of plurality of normative orderings as an explanation to this
trend in decision making by state authorities in India. In this context it examines two important
cases among these. It also examines their backdrop the Indian experience with imposition of
TRIPs.1
It argues that as an international treaty such as TRIPs attempts to penetrate and restructure the
existing laws of an individual state, the entire state behaves as a social field and resists and
circumvents penetration and capture in the same manner as non state normative orderings in their
own social fields behave in the face of a state law attempting to penetrate them.2 In this process,
the policy considerations which formed the socio-economic basis of the existing laws transform
into a set of normative ordering for the states social field and a parallel source according to

This paper demonstrates that this imposition upon India was in spite of much reluctance on its part. See Infra
Chapter V.
2
22 Law & Society Review 869 1988, Sally Engle, Merry, Legal Pluralism, on page 881

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which, behavior occurs in that state, thereby creating a pluralism of laws.3 It also argues, in the
context of these decisions, that the work of courts is locally shaped and culturally entwined in
place and setting and therefore in a situation as above, may decide cases not only statute law but
also drawing from contradictory policy considerations.4
Under Chapter II, I will briefly discuss the concept of Legal Pluralism. Under Chapter III, in
the context of TRIPs and India, I will set out why in spite of lack of recognition of public
international law as law, it must be taken into account for a proper appreciation of pluralistic
nature of legal system they contribute in creating. Chapter IV will lay down the socio-legal
context of patent laws in India. Under Chapter V, I will discuss how the various actors in the
social field of India behaved in resistance to or for adjustment with TRIPs obligation. Under
Chapter VI, I will analyze two patent related decisions in context of the preceding discussion.
Subsequently, I will conclude by claiming existence of plurality of legal systems pursuant to
incorporation of TRIPs.

3
4

John Griffiths, What is Legal Pluralism?, (1986) 24 Journal of Legal Pluralism 1

Seron, Carroll and Silbey, Susan, Profession, Science And Culture

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CHAPTER II LEGAL PLURALISM

The term Legal Pluralism has metamorphosed enormously from its earliest uses in the
beginning of twentieth century. The term saw its origin in studies of societies under the colonial
rule and how the legal system imposed by the European colonizers co-existed and interacted with
the rules of social ordering indigenous to the former.5
Subsequently, studies in the second half of the century started expanding the concept of legal
pluralism, using it no longer only in colonial and post colonial settings but also in describing
various forms of normative orderings that may exist in all societies. 6 Given the diverse nature of
norms that could be at work as between various constituents of the society, the law and society
scholarship has considered a number of ways in which the pluralistic nature of the legal system
may be defined7 and of interaction between these elements.8
However, legal pluralism can be generally described as a concept belonging specifically to the
social field. According to this concept, in any social field, behavior of the constituents occurs
pursuant to a plurality of legal systems.9 Thus, this concept fundamentally rejects the centralist
approach to law whereby the legal system established by state is the only legal system and
recognizes non state normative orderings as having the same potential effect as state law.

Supra note 2 at page 869. Termed as Classic Legal Pluralism. It may also be noted that Merry Sally points out to
the difficulty faced by scholars in terming these indigenous rules under one head (pg 875). This difficulty is
indicative of the elusive nature and potentially wide variety of the non-state laws which would attribute the
pluralistic nature to the legal system.
6
Ibid. Termed as New Legal Pluralism.
7
For example, Sally F. Moores Semi-autonomous social fields; Leopold Pospisils Legal levels; M.G. Smiths
Theory of Corporations and Eugen Ehrlichs living law.
8
See supra note 2 on page 879. Importantly, how earlier approaches to legal pluralism considered normative orders
as coexisting and autonomous, then shifting towards focus on state laws dominance and its effect of reshaping other
normative orders. This approach gave way to the opposite where non state laws were shown to be more potent in
shaping social behavior. Later studies became more balanced by taking into consideration the mutually constitutive
effects that state and non state laws had on each other.
9
Supra note 3.

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CHAPTER III - TRIPS AS LAW

The concept of legal pluralism today is not limited to only the state law and the non state
normative orderings within the state. To this has been added a new layer of laws; public
international law governing not private individual but nation states themselves. However, there
has been much debate about the legal nature of international law.10
There are two reasons why TRIPs must be considered as law for an understanding of its role in
the pluralism of law in the member states. To understand these reasons, let us briefly look at the
history and nature of TRIPs.
With the increasing internationalization of trade in the post second world war era, need was felt
by states to reduce barriers and stabilize policies related to trade. 11 Consequently, these states
found themselves negotiating with other states on the international front, mainly evolving from
negotiation of General Agreement on Trades and Tariffs in 1948 to establishment of the World
Trade Organization in 1995 as a result of conclusion of the Uruguay rounds of negotiation. Even
before the commencement of the Uruguay rounds, the trade related aspects of intellectual
property rights had been introduced as a subject of negotiations and were eventually adopted as
an annex to the Treaty establishing the WTO.
TRIPs was subject of much negotiation and criticism, its ratification was nevertheless made
mandatory condition for membership of the World Trade Organization. Thus, in a bid to avoid
isolation from the international avenues of trading, many developing countries, including India,
ratified TRIPs. TRIPs essentially lays down minimum standards that signatory countries must
provide for protection of intellectual property rights.
10
11

Casanovas, Oriol, Unity and Pluralism in Public International Law, M. Nijhoff, 2001
See Understanding the WTO at http://www.wto.org/english/thewto_e/whatis_e/who_we_are_e.htm

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However, a major feature of WTO (and TRIPs) is the dispute settlement provisions. Broadly, the
WTO legal system places emphasis on enforcement of its provisions without which the
objectives will remain unachievable. It provides for compliance and monitoring and any member
of the TRIPs can raise objection against any other member on the ground of non compliance with
TRIPs. The Dispute Settlement Body (DSB) of the WTO will then take up the matter and after
consultation with the parties and examination of the matter, will come up with its
recommendations.12
The instance of non compliance with the recommendation of the DSB can lead to authorization
of retaliation. Retaliation can be done in a number of ways including trade sanctions against the
non compliant country and refusing protection to Intellectual Property from such country.13
What emerges, thus, is that the nature of TRIPs is one of a stronger international law demanding
compliance under threat of retaliation. Although to equate it with the positive state law might not
be correct as it may be distinguished on a number of counts, yet there is an element of
resemblance. 14
Thus, the first reason is the indication that TRIPs acts akin to a state law demanding compliance
from its subjects, which in its case are the states themselves.15

12

A Handbook on the WTO TRIPS Agreement, Edited by Antony Taubman, et al, Cambridge University Press, 2012
Ibid.
14
For example no penalties or retaliation can be done for past actions if recommendations are complied with. See
Pauwelyn, Joost, The Role of Public International
Law in the WTO available online at http://www.ecologic-events.de/sustra/en/documents/JoostPauwelyn.pdf
15
An example of this can be seen when Mr. Kamal Nath (Union Minister of Commerce and Industry in India at the
time of making this statement) while informing about the promulgation of Ordinance pursuant to requirement by
India to pass law in compliance with TRIPs, said: The ordinance is an interim measure to fulfill our legal
obligations
within
the
stipulated
time.
(emphasis
added).
See
http://biospectrumindia.ciol.com/archive/articledetail.asp?arid=65747&
13

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However, there is a second and more important reason. If we note the actual compliance with
TRIPs obligations, we observe that broadly all the developing countries of the world have indeed
complied with them in so far as they have amended there laws after ratifying it. It directs us to
take into account a wider perspective of law including within our vision the sociological
approach.16 With this approach, we may see TRIPs not only as a set of rules of international law
that may or may not be considered law per se, but a phenomenon that has arisen due to mutual
needs of all human beings. These mutual relationships create norms and even obtain compliance
from its subjects.
Thus, we may consider TRIPs as law in this sense. This law of TRIPs is primarily meant to
harmonize state laws around the world. Clearly, all the states have different socio-economic and
cultural settings as well as histories and legal precedents. Do these new imposed centralist laws
become the sole source of social behavior? The answer is a resounding no. Let us proceed to
examine the nature of legal pluralism created by TRIPs in the context India.
CHAPTER IV A SOCIO LEGAL CONTEXT FOR INDIA AND PATENT LAW
The concept of property was recognized in ancient India. 17 However, ownership of property was
not strictly individualistic. Communal ownership of the property has been norm in agrarian
settlements in India and even today, continues to be prevalent in Indian villages.18
On the other hand, the concept of intellectual property does not even receive much recognition in
India traditionally. Whatever knowledge was acquired or received from texts was free to use for

16

Cedillo, Erika, The continuous dialogue among juricultures in International Treaty Law, available online at
http://oppenheimer.mcgill.ca/IMG/pdf/E_Cedillo.pdf
17
Choudhary, Radhakrishna, Studies in ancient Indian law and justice.
18
Mueller, Janice M., The Tiger Awakens: The Tumultuous Transformation Of Indias Patent System And The Rise
Of Indian Pharmaceutical Innovation, 68 University of Pittsburgh Law Review 491 on page 544.

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everybody. The great wealth of traditional knowledge in India including, but not limited to
scriptures, medicines19, yoga and number system, is evidence that any intellectual property was
the property of the entire society and not of any particular individual or group of individuals.
Further evidence is seen from the fact that no laws, customary or otherwise related to patent
rights, are found in Indian history before the advent of British rule in India.20
The Patent Act of 1911, inherited by India post independence, evolved through a number of
previous enactments in this regard done by the British rule in India. However, a system
introduced by the British for the promotion of British interests was not necessarily suited to
India. The legal regimes established under this regime left Indian pharmaceutical industry in
tatters since British policies did not promote innovation and the patents obtained by foreign
companies over drugs did not let these companies manufacture generic drugs.21
Post independence, India faced the task of supporting the health of a huge and growing
population amidst an extremely weak economy. Due to the state of the pharmaceutical industry,
India was still reliant on imported drugs, which were patented and sold by foreign drug
companies at exorbitant prices. The needs of the country dictated a change in the patent
protection policy of India. Within only one year of the independence, the government of India
resolved to make the patent laws in India more conducive the national interest.22

19

Ayurveda is a clearly demarcated branch of medicine owing its roots to thousands of years in history. It is not a
vague set of knowledge for home administered medications but a proper body of knowledge still taught in Indian
universities and practiced by qualified professionals.
20
Bagchi, Amiya Kumar, Indian Patents Act and its relation to Technological Development in India: A Preliminary
Investigation, Economic and Political Weekly, Vol. 19, No. 7 (Feb. 18, 1984), page 287
21
Supra note 18 at page page 508
22
Ibid. page 509-511.

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Finally, two expert committee reports and two decades later, India introduced its own Patent
Legislation in 1970.23 The 1970 Act in one of the most important steps, removed pharmaceutical
products from subject matter of patentability. This marked the beginning of a new era in Indian
patent law, and in the pharmaceutical industry, which in subsequent years saw exponential
growth and brought public health costs down by a substantial margin.
It is important to take note of these developments, specially the state policies and the socioeconomic context which led to their formulation. These developments indicate that gradual,
incremental changes occurred in colonial and post colonial India over several decades as a result
of the plurality of laws and not in a revolutionary manner.24 Thus, Indian socio economic needs
were still lagging behind the laws that had been imposed by the British, but not so much as to
force India to go back to pre-British position However, having brought its laws in sync with its
socio economic realities, India was faced with fresh transplant of laws; in the form of TRIPs.
CHAPTER V - BEHAVIOUR IN THE SOCIAL FIELD OF INDIA - TRIPS AND OTHER ORDERINGS25
Faced with a mounting pressure from the WTO, India did not accept the imposition of TRIPs
obligations without resistance. Although resistance existed more prior to its ratification by India,
this resistance gradually took the shape of well thought out adjustments in post-ratification era.
23

The two committees were Chand Committee of 1950 and Ayyangar Committee of 1959. Ayyangar Committee
played a vital role in the formulation of the 1970 Act. It laid down three important strategies, in consonance with the
said policy; (i) identification of the types of inventions for which patent protection should be available; (ii)
determination either to prohibit the granting of Indian patents to foreign entities or to require working of such
patents in India; and (iii) determination to withstand international pressures on India to join international intellectual
property conventions such as the Paris Convention, which required national treatment.
24
This is an example of Classic Legal Pluralism brought about by the transplantation of western legal system of
patenting of inventions that was developed in the context of industrial revolution on the Indian society which was
traditionally neither industrial nor recognized legal protection of rights akin to patent. As noted in The Impact of a
Legal Revolution in Rural Turkey by Starr and Pool, the effect is more gradual and incremental than
revolutionary.
25
As discussed in Chapter I, the status of a social field has been imputed on the entire country in the face of
penetration by a treaty law such as TRIPs. Discussion in this paper will be done by observing the behavior of
various players of this field in this context.

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When India learnt about the proposed negotiations, it was among the foremost countries to
oppose inclusion of TRIPs in the WTO negotiations of the Uruguay round.26 It viewed these
proposed inclusions as potential tools in the hands of developed countries for increasing public
health costs in developing countries and restricting access by the developing countries to the
technologies of the western world. It is clear that historical experience of India as a society was
playing at the back of mind of the Indian policy makers. India had faced the consequences of
being subject to a stronger patent regime imposed by a Western power in the form of a terrible
state of economy and public health. Imposition of the strong patent regime under TRIPs by
Western dominated regime did not go down well with that experience.
Not only on the governmental level, but resistance was shown by the Indian pharmaceutical
companies as well which had emerged and prospered during the patent regime of 1970 Act
hitherto in place. The Indian Drug Manufacturers Association, for example, registered its
concerns by warning against threat to public health posed by stronger patent regime.
However, after most of the other developing countries shifted stand, India too had to give up on
the opposition in the face of skewed bargaining powers. India was facing a turbulent and weak
economy and the negotiators on the other side of the bargain held the channels that would lead
India to a more desirable economic state. Yet, even in agreeing to negotiate on stronger patent
protections, India did not abandon resistance altogether and maintained the stand that the patent
protection in each country should be tailored according to the extent of economic development of
the country keeping in mind access to technology needed.27

26
27

http://www.sunsonline.org/trade/areas/intellec/07140089.htm
Supra note 18 at 518

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Once India had ratified TRIPs, even more varied group of stakeholders developed. As the
potential implications of TRIPs were realized by several other sections of Indian citizenry, it
stirred up a new set of protests emerging from academics and civil society groups condemning
TRIPs and its impact on issues of public health in India and elsewhere. These concerns were
inspired by an understanding of the socio economic perspective in which India was and grew
stronger over time. They eventually succeeded in pushing Indian delegation at the Doha round of
negotiations at the WTO to demand for an acknowledgement that TRIPs should be subject to the
primacy of the right of countries to take measures for protection of public health and maximize
access to medicine.28 These efforts by India and other developing countries succeeded and a
declaration on the TRIPs and public health was issued.29
Even more striking adjustments were made in the Indian patent law when the time for amending
the Indian Patent Act to conform with the requirements of TRIPs arrived.30 Due to reasons of
political instability, the government could not go through with the parliamentary process of
getting the amendment bill passed in the parliament within the time stipulated under TRIPs.
Therefore, in order

to meet its obligations under TRIPs, the government promulgated a

Presidential Ordinance.31
The provisions under this Ordinance were, however, widely criticized. Even New York Times,
generally vouching in support of the interest of multinational organizations expressed serious
concerns over the intents and potential effects of the new law.
28

Ray, Amit Shovon and Saha, Sabyasachi, Indias Stance At The Wto: Shifting Coordinates, Unaltered Paradigm,
Discussion Paper on Economics, Jawaharlal Nehru University, January 2009, available online at
http://www.jnu.ac.in/Academics/Schools/SchoolOfInternationalStudies/CITD_Oldwebsite/DiscussionPapers/WTO.
pdf
29
Ibid. According to the declaration, the countries have a right to grant compulsory licenses and the freedom to
determine the grounds upon which such licenses are granted. and the right to determine what constitutes a national
emergency or other circumstances of extreme urgency in implementing TRIPS.
30
TRIPs provided India a transitional period of 10 years for this purpose.
31
Supra note 15

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It is interesting to note however, that one of the section of the parties supporting the government
at the centre, the Left parties32, opposed the passage of this law in that form. It considered this
bill as being against the interests of the poor. However, understanding that in the face the kind of
international pressure against India, resistance was futile and that creative ways of adjustments
would bear better results in the interest of India, they pressurized the government into making
several important changes to the law before it was passed and enacted retrospectively in April
2005.33 Important among these changes were a few that made criteria of patentability more
stringent including section 3(d) aimed against evergreening of patents and provision for pregrant opposition of patent applications. These changes, while remaining within the mandate of
TRIPs, paved way for a more self beneficial patent regime in India.34
CHAPTER VI POST 2005 DECISIONS OF COURTS AS ACTIONS IN THE SOCIAL FIELD OF INDIA
Changes that were introduced by the 2005 amendment later became issues of litigation. In this
section, I will discuss two important ones.
NOVARTIS GLEEVEC CASE
The first was introduction of a section 3(d). What this section provides had essentially to do with
a practice in the past undertaken by pharmaceutical companies around the world that had been
termed as ever greening of the patent. What this practice essentially entailed was that the
companies would strategically obtain multiple patents on various aspects of the same product
32

The Communist Party of India, the Communist Party of India (Marxist), the Revolutionary Socialist Party and the
Forward Bloc, called Left parties because of their pro communist/socialist political agenda.
33
See article by CPIM dated 23 March 2005 on its webpage http://cpim.org/content/left-parties-patents-amendment
34
Another possible factor in these actions of the Left parties is that the Left parties in India have been traditionally
strong in particular states, such as the state of West Bengal. They cater to a particular population and it is clear that
by the very ideology, these electorates prefer protectionist policies. Thus, to Left parties, it was important also from
a view to appeasing there electorate to ensure that they did everything in their powers to offset the invasive policies
in the Patents Ordinance as drawn according to the TRIPs.

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such that they would extend their monopoly on the drug for far longer than the ordinary patent
protection term. Section 3(d) provided that patent protection will not extend to mere discoveries
of new forms or properties of known products or processes unless it lead to enhancement of
known efficacy.
The case that arose around the interpretation of this provision became subject of a number of
procedural hurdles and challenges. As of now, it is pending at the Supreme Court, at which stage
also, it has been marred by recusals.
Before the 2005 amendment and grant of patents in pursuance thereof, a Swiss company
Novartis was granted Exclusive Marketing Rights (EMR) for its drug Gleevec allowing Novartis
to stop other companies from marketing this drug without having obtained a patent and thereby
raise the price of the drug by almost twenty times.35 When this patent application came to be
examined by the controller of patent office, it was rejected. A leading Indian academic writing
voraciously on Intellectual Property issues in India commented:Not too surprisingly, public interest suits were filed challenging this grant and the
excessive price rise. In this emotionally charged atmosphere, it is no wonder that the
mailbox application that came up for examination was decided the way it was. Of course,
the decision was correct on meritshowever, the speed with which it was decided does
lead one to think that the reasons for rejection went beyond the purely legal The
Gleevec application was clearly fast tracked36

35

The patent application for Gleevec was in pipeline for consideration by patent office in India post 2005 by virtue
of certain transitional provisions of the TRIPs. The EMR too were provided under these provisions (TRIPS Article
70(2)).
36
Basheer, Shamnad, First Mailbox Opposition (Gleevec) Decided In India, posted on 11 March 2007 available at
http://spicyipindia.blogspot.sg/2006/03/first-mailbox-opposition-gleevec.html

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Thus, it is not very difficult to figure that there strong policy consideration in addition to legal
ones in rejection of this application. A number of other instances suggest similarly.
The main ground of rejection was section 3(d). The molecule that Novartis intended to patent
was another form of a molecule that was already known. Novartis however, presented tests that
improvements in the form of 30 % enhancement in bioavailability of former over the latter. In
doing so, it clearly hoped that the requirement of enhancement of efficacy will be fulfilled.
However on this very count, the controller decided otherwise.
It is argued that the requirement of determining whether the new form of the substance has
significant enhancement in efficacy or not clearly leaves scope for discretion. As noted below,
the court held that this discretion was regular and not unconstitutional. However, even if the
discretion is not so broad or arbitrary so as to make it unconstitutional, the court itself agrees (as
discussed below) that such language has to be interpreted in the facts of the case. It is argued that
30% enhancement in bioavailability has been legally scrutinized by court as well as academics,
and has been decided that it does not satisfy section 3(d) requirement. Yet it cannot be said with
any amount certainty exactly what threshold is if it is not 30%. At 40 % the court could say it is
not significant enhancement in efficacy. At 100% it could say that enhancement in
bioavailability does not amount to enhancement in efficacy. What could have the applicant
shown with the assurance that it will fulfill the criteria, unless it was one with inventive leap.
Therefore, scope of discretion and in this situation, of furthering policy objectives cannot
considered absent from this provision.

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Novartis went in appeal against this decision on a number of grounds. First, it argued that section
3(d) was not TRIPs compliant. Second, it argued that it was also unconstitutional since it was in
breach of the Fundamental Right to equality and conferred arbitrary power on the controller.
Against the latter argument, the court said that legislatures commonly use general language and
leave the courts to interpret the language based on the facts of each case. This is clearly
indicative that laws in general and section 3(d) in particular leave gaps to be filled in accordance
with judges own preferences and can be used to further policy imperatives.
The court also said that Novartis was a sophisticated party who should have figured out what this
requirement exactly meant.
In response to the ground that section 3(d) was not in compliance with TRIPs the court took into
account that TRIPs was not part of Indian law directly and therefore the court did not have the
jurisdiction to decide on this question and that it should be taken at the dispute settlement level
of TRIPs. However, by way of opinion, the court observed that section 3(d) is not in breach of
TRIPs since it fell within flexibilities provided under the latter.
The issue of whether controller had substantially erred in refusing patent to Novartis was
bifurcated and sent to Intellectual Property Appellate Board (IPAB), a specialized quasi-judicial
body established to hear appeals from decision of the controller. Here it was opposed by an
Indian generic manufacturer of drugs, Natco and a Nongovernmental Organization37
It was once again suspected by some experts that the reason for shifting part of the case from
High Court to IPAB was more than merely legal. The judge presiding over the proceedings at the
High Court had earlier shown pro Novartis inclination by upholding the validity of the EMR
37

Cancer Patient Aid Association

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granted to it while issuing injunctions against generic drug companies from marketing the drug.
This was done in spite of the fact that another High Court in Mumbai had questioned the very
validity of granting EMR in this case. Thus, it was feared by the government that the same pro
Novartis sentiment in deciding the question of patentability might defeat the purpose of
introducing section 3(d) and hitherto achieved success in demolishing patent over Gleevec.38
However, this gave rise to new issues. The IPAB was formed during pendency of this appeal in
front of the High Court and the technical member appointed to IPAB was the same controller
who had rejected the patent application. After much scrambling between Novartis, Natco and the
courts, a new technical member was appointed and IPAB proceeded to dismiss Novartiss
appeal.
Interestingly, not only did the IPAB in its decision rule that the patent was rejected on the ground
of non satisfaction of section 3(d), it also based its decision on the ground that the drug was
excessively priced. This shows a propensity of the courts to take into account criteria of pure
public policy. Novartis appealed to the Supreme Court, the highest court in the country, where
the matter, as of this date, is pending.
However, even at Supreme Court, the matter has not been without controversies. Over the course
of the proceedings in the last 3 years, two of the judges involved in hearing the case have recused
themselves.
First, Justice Katju recused himself from this case, arguably because in one of his scholarly
writings, he advocated cheaper drugs by observing that "many of the medical drugs available in

38

Basheer, Shamnad, Novartis Moves High Court To Remove Chandrasekharan, posted on 3 August 2007 available
online at http://spicyipindia.blogspot.sg/2007/08/novartis-moves-high-court-to-remove.html

16 | P a g e

the market are too costly for the poor people in India" and "ways and means should therefore be
thought out for making these drugs available to the masses at affordable prices"39
Next, Justice Bhandari, who had taken over from Justice Katju, recused himself, this time for
taking an apparently pro patent right stand when he participated in a couple of conferences in
different parts of the world which had been organized by Associations of owners of intellectual
property rights of which, Novartis was a member. He had also expressed his views about
educating people about importance of IP Rights protection.40
Thus, it cannot be overlooked that role of human actors in the decision making process, there
backgrounds and ideologies have been recognized as important factors. These ideologies may
stem from a plurality of norms that govern the behavior of these actors. As actors in the social
field of the state where policy considerations assume the role of non state normative orderings, it
is only to be expected that they will apply such policy considerations in deciding cases.
Last, but importantly again, allegations have surface that the patent office has come up with a
draft manual for guidance of the examiners with respect to section 3(d) clearly prejudicing
Novartis in this case.41 An important comment about the patent manual in this regard throws
light on the nature of practice in a patent office and discretion available at the administrative
level:it bears reiteration that the patent manual does not have the force of law And indeed, the manual
itself acknowledges this by stating so in the preface. However, as many of you who practice

39

Extracts taken from The Glivec Patent Saga: Its Raining Recusals posted by Shamnad Basheer available online at
http://spicyipindia.blogspot.sg/2011/09/glivec-patent-saga-its-raining-recusals.html
40
Ibid.
41
See The Draft Manual of the Patent Office and SpicyIP's recommendations on Section 3(d) available online at
http://spicyipindia.blogspot.sg/2008/08/draft-manual-of-patent-office-and.html

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before the patent office are aware, the manual pretty mush assumes a sacrosanct /biblical
position with patent examiners. Therefore, any proposition included in the manual is likely to be
religiously adhered to--unless challenged and struck down by a court of law. And therein lies the
danger. (interestingly, the patent office has had a history of "secret internal circulars" that were
religiously adhered to as well. Such circulars were famously used for rejecting biotech
applications containing living subject matter42
BAYER NATCO CASE
The Indian Patent Act 1970 (the Act) provides for granting of compulsory license for any
patented product. Under these provisions, Natco, a drug manufacturing company in India, in
August 2011, filed an application asking for a compulsory license for the drug called Nexavar. 43
The owner of the patent for this drug was an American pharmaceutical company called Bayer,
which had received patent on this drug in India in 2008. The application was heard and granted
by the Controller of the Patent.
This was the first case of compulsory licensing after the 2005 amendments and therefore
important to set the tone of the much debated issue of compulsory licensing around the world.
The Controller found the facts of the case satisfying all three requirements, any of which if
satisfied, is sufficient ground for grant of the license.
Subsequently, an appeal filed against the grant with the IPAB asking for stay was also dismissed.
In addition to its reasoning on legal points, the IPAB also observed that staying the grant of

42

Patent Office Manual: Pre-judging the Novartis-Glivec Case? Basheer, Shamnad available online at
http://spicyipindia.blogspot.sg/2008/08/patent-office-manual-pre-judging.html. Also see, Basheer, Shamnad, Policy
Style' Reasoning at the Indian Patent Office Intellectual Property Quarterly, Vol. 3, pp. 309-323, 2005
43
http://articles.economictimes.indiatimes.com/2011-08-02/news/29842834_1_compulsory-licence-sorafenibtosylate-natco-pharma

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license would affect the right of the patients to dignity which in the case lay in the right to access
to medicines. The Chairperson of this Board is Justice Sridevan, who has in the past ruled that
business methods are not patentable in India.
Although at one glance it could be said that by granting compulsory license, the controller has
aggregated the policy consideration of access to affordable drugs, yet it will not be entirely
correct to say this because the legal issues in at least two of the three requirements found to have
been fulfilled in this case were quite clear and no substantial pushing of policy considerations
through discretionary interpretation was needed.
The third requirement is what has often been referred to as the working requirement, providing
that where a patented invention has not been worked in the territory of India, compulsory license
could be granted.
Another provision of the Act, section 83, which embodies old school principles of Indian patent
law adopted in the Ayyangar Committee Report44, provides that patents in India are not granted
for the mere purpose of importation in India. The patented products need to manufactured in
India, as this will enhance dissemination of technology and technical know-how.
Taking this into account, the controller held that since Bayer had only imported the patented drug
in India and never actually manufactured and thus worked the patent in India, this requirement
was fulfilled.

44

Supra note 23

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However, with reference to this requirement, concerns have been raised about this part of the
judgment not being in compliance with TRIPs.45 It is argued that on interpretation of the
provisions of TRIPs, working requirement is satisfied even where the working entails import
instead of manufacture.
Whether or not these arguments have force, it becomes clear that at least with respect to the third
requirement, we can say that imposition of TRIPs does not fully prevent Indian decision making
bodies from employing rules which favor the national policy.
CONCLUSION
Thus it is firmly established the TRIPs has created a pluralistic legal regime in India where
courts and other actors are constantly deriving authority for their behavior from both the TRIPsincorporated-state law and the policy considerations that have become part of the normative
social ordering. It also sets base of an assumption that treaty obligations similar to TRIPs when
incorporated by the municipal laws of countries to socio-economic condition of which, such
obligations do not suit, it will generally lead to a situation where both previous and new laws will
coexist in some manner resulting into pluralism of laws.
It should also open avenue for further inquiry into how the two systems of law may interact over
a period of time and thereby discovery of most benevolent balanced approach to be taken in
formulations of treaty obligations.

45

Bonadio, Enrico, Compulsory Licensing of Patents: the Bayer/Natco case, (2012) European Intellectual Property
Review (Issue 10), page. 719

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