THE GLIVEC PRECEDENT
The Supreme Court Judgment
‘Lawmaking’ in the South
Dwijen Rangnekar
Bringing together the various
aspects of and issues related
to the recent Supreme Court
judgment rejecting Novartis’s
patent for Glivec, this writeup introduces a set of articles
discussing pharmaceutical
patents and their evergreening,
Section 3(d) of the Indian Patents
Act, as well as the Trade-Related
Aspects of Intellectual Property
Rights Agreement. Even as it does
all of this, the write-up places the
observations in a wider context
that tells a story of lawmaking
in the south.
In getting these articles together, I owe
a special thanks to colleagues at EPW
itself in being supportive of the idea of a
“collaborative” article and patiently navigating
these contributions through to print. It was a
delight to have the desired set of contributors
and to have them respond swiftly.
Dwijen Rangnekar (d.rangnekar@warwick.
ac.uk) teaches Law at the University of
Warwick, UK.
Economic & Political Weekly
EPW
august 10, 2013
T
he idea for this collaborative set of
articles emerged at an impromptu
panel at the Historical Materialism
conference (New Delhi, April 2013).
Occurring soon after the Supreme Court’s
judgment1 rejecting Novartis’s patent for
Glivec (also called Gleevec in some
countries, such as the US), many expressed
a desire to archive the moment, not only
in terms of drawing out how the judgment
illuminates big pharmas’ practices, but
in challenging and correcting narratives
about how the south, in general, and
India, in particular, are navigating their
global intellectual property (IP) obligations. Further, there was a need to testify
to the agency of groups involved, noting
how persistent opposition to the TradeRelated Aspects of Intellectual Propety
Rights (TRIPS) Agreement has never
ceded to its domination.
The articles that follow reflect on
different aspects of the case, from the
problematic discovery of Glivec to the
litigation and the campaign. In this
introduction, I simultaneously highlight
certain overlapping themes across these
contributions while placing the observations in a wider context.
In an immediate sense, the case is
a legacy of the TRIPS Agreement and
its flawed vision for a (high) globally
harmonised minimum standard of IP
protection disconnected from any historical, social, political or economic factors
in a country. In this regard, the inclusion
of IP in the General Agreement on Tariffs
and Trade (GATT) negotiations in Punta
del Este in September 1986 could be an
appropriate starting point.
Yet, this milestone merely escapes
from the shadows of the “most important
international law initiative taken by
the developing world in attempting to
remedy colonial inequities” – the New
International Economic Order (Anghie
vol xlviii no 32
2005: 313). Then again, how can one
forget the revisions to patent law in the
south, such as in India (1970), Brazil (1971)
or the Andean Pact countries (1974)
among others? Essentially, in a roundabout way, the judgment is testimony to
an enduring struggle of postcolonial nations for a humanitarian existence.
Keeping Evergreening at Bay
In seeking to clarify Section 3(d) of the
Patents Act, the Supreme Court notes that
it is “necessary to find out the concerns of
Parliament...What was the mischief [that]
Parliament wanted to check and what
were the objects it intended to achieve
through these amendments?”. This mischief, noted across the contributions,
though with different emphases, is the
big pharma’s practice of evergreening.
Evergreening, while not exclusive to
pharmaceuticals, refers to patenting strategies that result in securing sequential
and overlapping patents on a single object
(qua invention) through trivial changes.
In pharmaceuticals, this may involve
changes in size, colour, dosage, delivery
mechanism and composition. Thus, delaying generic entry with, as Menghaney
(2013) emphasises, devastating implications for the affordability of medicines.
India, as Sengupta (2013) narrates, following the 1970 Patents Act’s changes, has
become a global pharmaceutical powerhouse and effectively the pharmacy for
the developing world. A notable moment,
Menghaney (2013) recalls, is when Indian
generics innovated in producing affordable
triple-combination ARVs, and the World
Health Organization (WHO) was able to
launch their “Treat 3 Million by 2005”
campaign in 2003; a development that
points towards the vast global assemblage of pharmaceuticals.
That Glivec is a notable invention is
little in doubt; for that matter, the
Supreme Court judgment characterises
it as “serious, important and valuable”
research (para 164). In this regard, it is
Dutfield’s (2013) interrogation of the history of Glivec that sheds light on the
“devilishly tricky” job of credit and recognition. Not only does Novartis arrive
grudgingly and late, but their “official”
39
THE GLIVEC PRECEDENT
account silences the role of a number of
scientists and institutions.
Obliged by TRIPS to introduce product
patents for pharmaceuticals by 2005, the
problem facing Indian lawmakers was
potential evergreening, given the several
thousand applications lying in the “mailbox”. While Grover (2013) notes that over
75% of the patented drugs were modifications of known substances, another
study concluded that only 15% of drugs
approved by the US Food and Drug
Authority between 1989 and 2000 were
considered “highly innovative”.
How then to discern within this plethora
of patent applications, and only privilege
(serious) inventions with patent protection? How to secure affordable access to
medicine whilst also being in compliance
with TRIPS obligations? It is to these concerns that Section 3(d) is authored. While
it hints towards text in patent examination
guidelines in the north, Sengupta (2013)
recalls how the Indian Drug Manufacturers’
Association delivered it to the debate.
Yet, the story about 3(d) is more than
this. Was this the only space of residual
flexibility in TRIPS? Was the public debate
on evergreening too narrowly constructed
to miss out the other legal innovations?
It is here that Gopakumar’s (2013) critique
is instructive in noting that 3(d) is an ex
ante and circuitous solution, which could
otherwise have been handled by configuring patentability in terms of new chemical
(or molecule) entities.
In this respect, Sengupta (2013) reminds
us, that following the public debate the
Third Amendment draft was revised to
restore pre-grant opposition, thus, opening
up patent applications to public scrutiny
and wresting interpretative custody of
patent standards from the narrow legalese.
Accounts included here illuminate the
significant role of patient groups and
health/law activists in using pre-grant
oppositions. But, interventions require
resources, and Gopakumar (2013) demonstrates that a number of patents have been
granted, that should have fallen prey to
3(d) had patent examiners been diligent.
Invention vs Patentability
What, then, is 3(d)? In Chapter II of the
Patents Act, 1970 – headlined “Inventions
not Patentable” – Section 3 sets out a
40
number of exclusions from patentability,
such as frivolous inventions, methods of
agriculture, public order and morality,
and traditional knowledge, among others,
where clause (d) seeks to parse out a
distinction between “inventions” and
“patentability”. In rejecting Novartis’s
argument that 3(d) is a trivial standard,
the Supreme Court emphasises “the vital
distinction between the concepts of invention and patentability – a distinction
that was at the heart of the Patents Act
as it was framed in 1970, and which is
reinforced by the 2005 amendment in
section 3(d)” (para 102). The context of
authoring 3(d) warrants “a narrow and
strict interpretation” (para 180).
As Grover (2013) explains, the judgment
steps back from detailing 3(d), but confirms that efficacy in the case of medicines is therapeutic efficacy, which must
necessarily be demonstrated by research
data with in vivo animal models.
It is useful to appreciate the ingenuity of
3(d) and, following Correa’s (2013) account,
its TRIPS-compatibility. Even as TRIPS constrains national sovereignty, there is residual flexibility in giving meaning to the standards of patentability, which the Agreement
itself does not define. Section 3(d) can be
seen to achieve this. Noting a WTO Panel
Report that sustained a distinction between “discrimination” and “differentiation”, Correa (2013) also elaborates how
3(d) is akin to provisions for patent term
extension, which a number of countries
make available only for pharmaceuticals.
Even as these contributions archive
the moment and celebrate the judgment,
they remain aware of the struggle for a
humanitarian IP system. Over the years,
the case has seen rhetorical threats of
departure from India, though none have
materialised. Likewise, there have been
regular threats of a WTO dispute, though
India has successfully fielded questions
about 3(d) at WTO’s Trade Policy Review.
As the accounts of the Uruguay Round
make transparent, it is the use of power
extrinsic to procedural rules that is problematic: unilateral trade sanctions executed by the US. With 3(d) regularly cited in
the US Trade Representative’s annual reports, India remains under watch. For
that matter, at the March 2013 hearing on
“US-India Trade Relations”, Pfizer’s Chief
august 10, 2013
IP Counsel painfully presented a litany
of IP-problems, wherein 3(d) and this
judgment are notable.
In closing, I am reminded of Surendra
Patel’s (1992: 103) reflection of his time at
UNCTAD in the 1970s, when he “felt proud
to receive vicariously compliments from
these countries [in the south] to India on
its new [1970] patent law”. It is a hopeful
turn of events to note that Section 3(d) is
being emulated by a number of countries
including Argentina, Australia, Canada
and Thailand, among others. Tellingly, an
agreement once thought settled is being
chipped away, both, at the periphery
through ingenious jurisprudence, and at
the centre through proposed amendments.
The Patents (Amendment) Act 2005
Section 3(d):2
“the mere discovery of a new form of a known
substance which does not result in the enhancement
of the known effcacy of that substance or the mere
discovery of any new property or new use for a
known substance or of the mere use of a known
process, machine or apparatus unless such known
process results in a new product or employs at least
one new reactant.
Explanation: For the purposes of this clause, 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.”
Notes
1
2
See “Supreme Court of India: Novartis Ag vs
Union of India & Ors on 1 April 2013”, viewed
on 11 July 2013, http://www.indiankanoon.
org/doc/165776436/
“Chapter II: Inventions not Patentable”, viewed
on 11 July 2013, http://ipindia.nic.in/ipr/patent/
manual/HTML%20AND%20PDF/Manual%20of
%20Patent%20Office%20Practice%20and%20
Procedure%20-%20html/Act/Section%203.htm
References
Anghie, A (2005): Imperialism, Sovereignty and the
Making of International Law (Cambridge: Cambridge University Press).
Correa, Carlos M (2013): “Is Section 3(d) Consistent
with TRIPS?”, Economic & Political Weekly, 48(32).
Dutfield, Graham (2013): “Who Invented Glivec?
Does It Matter Anyway?”, Economic & Political
Weekly, 48(32).
Gopakumar, K M (2013): “The Need to Curb Patents
on Known Substances”, Economic & Political
Weekly, 48(32).
Grover, Anand (2013): “Analysing the Supreme Court
Judgment”, Economic & Political Weekly, 48(32).
Menghaney, Leena (2013): “ ‘Drop the Case’: Campaigning against Novartis”, Economic & Political Weekly, 48(32).
Sengupta, Amit (2013): “Two Decades of Struggle”,
Economic & Political Weekly. , 48(32).
Patel, Surendra J (1992): “Statement to the Group
of Ministers on Arthur Dunkel’s Draft of the Final
Act on Uruguay round of GATT Negotiations”,
Social Scientist, 20(1/2): 99-107.
vol xlviii no 32
EPW
Economic & Political Weekly
THE GLIVEC PRECEDENT
Who Invented Glivec?
Does It Matter Anyway?
Graham Dutfield
I
This article looks at Glivec’s
journey from its invention to
its patenting and sale while
questioning the concept of credit
for inventions in science and
technology.
n 2003, the then Novartis Chief
Executive Officer Daniel Vasella published a book (Vasella and Slater
2003) in praise of Glivec detailing his
firm’s major role in delivering this uncommonly effective life-saving medicine. But, who was really responsible? In
the original US patent,1 one single person is named as the inventor: Jürg Zimmermann of Ciba Geigy (later Novartis).
In the later US patent on the beta crystalline form, held in India to be unpatentable,
Zimmermann is joined by two Novartis
colleagues.2 However, contrary to what
this might suggest, chronic myeloid
leukaemia (CML) patients would never
have received a product called Glivec if
they had had to rely solely on Novartis.
Credit in science and technology is a
devilishly tricky matter to be objective
about. Effort, dedication, inspiration, vision,
ambition, intuition, counter-intuition, advanced technical knowledge in one or more
disciplines, skill, serendipity, networking
abilities, and sheer bloody-mindedness,
all help make a creative achievement
possible. But, assessing what contributions
and which people are not just important,
but indispensable, can be a tough task.
The various “Glivec stories” bring together a whole cast of actors and locations
over broad geographical and chronological distances (Brody 2007: 13-18; Keating
and Cambrosio 2012; Mukherjee 2010:
430-43; Nathan 2007: 180-85). Medicines
have histories and Glivec is no exception,
being the final destination of a long and
winding historical learning trail; one
that begins in 1960 with a foundational
discovery by two US-based scientists of a
chromosomal defect, which they suggested
had a “causal relationship” with “chronic
granulocytic leukemia” (Nowell and
Hungerford 1960: 1497).
Graham Dutfield (G.M.Dutfield@leeds.ac.uk)
teaches International Governance at the
School of Law, University of Leeds, UK.
Glivec: To Whose Credit?
Economic & Political Weekly
EPW
august 10, 2013
Which stories are most complete and
accurate depends largely on what “Glivec”
vol xlviii no 32
is. Glivec, the synthetic small molecule,
a pyrimidine derivative generically known
as imatinib, is one thing. If Zimmermann
was the first and only person to make
this molecule, he is rightly the inventor of
it as long as we are unconcerned about
“scientific” credit and merely need to
identify one or a few individuals closely
associated with its first manufacture.
But, Glivec is much more than this or
that pyrimidine derivative in this or that
structural form. It is a pharmaceutical
product of a type known as a tyrosine
kinase inhibitor; one that is extraordinarily effective in the treatment of CML,
and that was made to a specification
well worked out by others. Potentially,
an almost infinite variety of different
molecules can be made in the laboratory.
But, to identify a class of chemicals to be
made for a specific purpose, make them,
analyse them, select a few for testing, test
them in various ways, select the best one,
optimise it, and finally get it approved for
sale, requires the contribution of many
more people than a synthetic chemist
working in a lab, however talented.
One way to look fairly at credit is to
ask which people were the sine qua non,
those without whom there would have
been no Glivec. The importance of the
individual coming up with the actual
chemical cannot be underestimated, but
the inventor named on the patent can
also be seen in such cases as the one who
added the finishing touches, inching the
idea forward over the novelty, inventive
step and industrial applicability thresholds. Legally, it is immaterial whether
this person’s effort or intellectual input
was proportionately significant compared
to anybody else’s, and this may not
necessarily be seen as unfair.
None of the numerous scientists who
contributed has publicly challenged
Zimmermann’s sole inventorship. Zimmermann did spend more than two years in
developing the right molecule and then
preparing it in a form that could be taken
orally. Designing the last piece of the
jigsaw was no quick and easy task (Buchdunger and Zimmermann ND).
Competing claims could be made for
Nicholas Lydon or Alex Matter of Ciba
Geigy’s programme on kinase inhibitors.
But, if one really can single out “the
41
THE GLIVEC PRECEDENT
irreplaceable person” without whom
there would have been neither an invention nor a pharmaceutical product called
Glivec, then it would probably be Brian
Druker, initially of the Dana-Farber Cancer Institute, and thereafter at the Oregon Health Sciences University.
From Brian Druker to Novartis
Druker was not just lead author of the
article that announced Glivec to the
world under the name of CPG57148
(Druker et al 1996). He was relentless in
his determination to find a treatment
for CML and to make it available to as
many patients as possible. This commitment to do all that was necessary to
cure leukaemia patients led him to
collaborate with Lydon and Ciba Geigy
to harness the company’s biochemical
capacity in kinase inhibition to his
search for a molecule that was able
specifically to block the action of a single aberrant enzyme common to the
cells of CML sufferers. His role did not
end when the molecule was discovered
and, largely under his direction, shown
to work.
In an interview with author-medical
scientist Siddhartha Mukherjee (2010:
436), Druker described his incredibly
persistent efforts to talk a reluctant
Novartis, concerned about the small
number of patients and, therefore, the
lack of a market for the drug, into
producing enough for clinical trials.
Ironically, the specificity of Glivec that
made it such an outstanding drug did
not favour it as a commercial product
from Novartis’s perspective: it kept the
patient base small.
In the event, Novartis went ahead
with Glivec, which turned out to be to
its considerable advantage. In May 2001,
in unusually quick time, the US Food and
Drug Administration approved Glivec.
Novartis subsequently set a global
patient-per-month price of $2,400. Even
with patient assistance for poorer people, which enabled some to get it for
free, the drug proved to be highly profitable. Besides, such programmes, beneficial as they obviously are to some
patients, are an excellent way to discourage generic market entry where
there are no patents. By 2003, annual
42
sales had reached $1 billion, and revenues have risen considerably since then.
True to his convictions, Druker was
one of over 100 physicians who recently
publicly criticised the high prices of
drugs for CML (Experts in Chronic Myeloid Leukemia 2013). Such an article
could have been published several years
ago: this is hardly a new problem. But,
one hopes at this late stage that while
the key patents are still in force in several countries, and the original US patent having been extended from its expiry date of 28 May 2013 for 586 additional days, it might make a difference. It is
also worth noting that Druker reportedly welcomed the Indian Supreme
Court decision.
Brian Druker’s name may not be on
any of the patents. But, it would be
hard to name any other individual to
whom leukaemia patients should be
more grateful.
Notes
1
2
US Patent no 5521184, “Pyrimidine Derivatives
and Processes for the Preparation Thereof”,
28 May 1996.
US States Patent no 6894051, “Crystal Modification of a N-phenyl-2-Pyrimidineamine
Derivative, Processes for Its Manufacture and
Its Use”, 17 May 2005.
References
Brody, H (2007): Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry (Lanham:
Rowman & Littlefield).
Buchdunger, E and J Zimmermann (nd): “The
Story of Gleevec”, viewed on 2 June 2013,
http://www.innovation.org/index.cfm/Stories
ofInnovation/InnovatorStories/The_Story_
of_Gleevec
Druker, B, S Tamura, E Buchdunger, S Ohno,
G M Segal, S Fanning, J Zimmermann and
N B Lydon (1996): “Effects of a Selective Inhibitor
of the Abl Tyrosine Kinase on the Growth of
Bcr-Abl Positive Cells”, Nature Medicine, 2(5):
561-66.
Experts in Chronic Myeloid Leukemia (2013): “The
Price of Drugs for Chronic Myeloid Leukemia
(CML) is a Reflection of the Unsustainable
Prices of Cancer Drugs: From the Perspective of
a Large Group of CML Experts”, Blood, 121(22):
4439-42.
Keating, P and A Cambrosio (2012): Cancer on Trial:
Oncology as a New Style of Practice (Chicago:
University of Chicago Press).
Mukherjee, S (2010): The Emperor of All Maladies:
A Biography of Cancer (New York: Scribner).
Nathan, D G (2007): The Cancer Treatment Revolution: How Smart Drugs and Other New
Therapies Are Renewing Our Hope and Changing the Face of Medicine (Hoboken: John Wiley
& Sons).
Nowell, P C and D A Hungerford (1960): “A Minute
Chromosome in Human Chronic Granulocytic
Leukemia”, Science, 132(3438): 1497.
Vasella, D and R Slater (2003): Magic Cancer Bullet:
How a Tiny Orange Pill Is Rewriting Medical
History (New York: HarperBusiness).
REVIEW OF WOMEN’S STUDIES
May 4, 2013
Intersections of Gender and Caste
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Mary E John, Padmini Swaminathan, Samita Sen
Revitalising Dalit Feminism: Towards
Reflexive, Anti-Caste Agency of Mang
and Mahar Women in Maharashtra
– Smita M Patil
Caste and Gender in a Mumbai Resettlement Site
– Varsha Ayyar
Dalit Women as Political Agents: A Kerala Experience
– Rekha Raj
The Mathammas: Gender, Caste and the Politics
of Intersectionality in Rural Tamil Nadu
– Anandhi S
The Concept of Honour: Caste Ideology
and Patriarchy in Rural Maharashtra
– Manisha Gupte
Cultural Gandhism: Casting Out the Dalit Woman
Ruptures and Reproduction in Caste/Gender/Labour
– Swathy Margaret
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august 10, 2013
vol xlviii no 32
EPW
Economic & Political Weekly
THE GLIVEC PRECEDENT
Two Decades of Struggle
Amit Sengupta
The Supreme Court judgment in
the Novartis case is important as
it vindicates the entire process
leading to health safeguards
being incorporated in the Indian
Patents Act. The article discusses
this process, from the General
Agreement on Tariffs and Trade
and popular mobilisation in
India to the enactment of and
amendments to the Act, in the
backdrop of the judgment.
Amit Sengupta (asengupta@phmovement.org)
is co-convenor of Jan Swasthya Abhiyan
(People’s Health Movement, India) and is also
associated with the All India People’s Science
Network.
Economic & Political Weekly
EPW
august 10, 2013
T
he judgment by the Supreme Court
of India, denying the claim of a
patent on the anti-leukaemia drug
Glivec (imatinib) by the Swiss multinational Novartis, is important at many
levels. In this article we discuss, in the
backdrop of the judgment, the long and
protracted course leading to the enactment of the Indian Patents Act of 2005.
The Uruguay Round
In 1986, a new round of negotiations was
initiated under the General Agreement
on Tariffs and Trade (GATT), otherwise
known as the Uruguay Round of negotiations. In the Uruguay Round, developed
countries introduced a number of issues
on the agenda – which were hitherto
not considered trade issues – related to
intellectual property (IP) rights, investment and services.
Initially, developing countries led by
India and Brazil were able to stall the
introduction of these new issues (Shukla
2000: 14-15), while the US continued to
press for their inclusion. The latter’s
position was dictated by the state of the US
economy. Having lost its competitive edge
in the manufacturing sector and with its
own agricultural exports threatened by
state-subsidised agricultural exports from
Europe, the US was keen to open up the
services sector – especially for financial
services. At the same time, the US had an
interest in protecting its IP-dependent
industries where it still had an advantage,
specifically in pharmaceuticals, software
and audiovisual media (ibid: 20-21).
India had a clear interest in not
agreeing to these new demands. India’s
pharmaceutical sector had flourished in
the wake of its 1970 Patents Act, which did
not allow product patents on medicines
and agro-chemicals. India only allowed
process patents on pharmaceuticals, and
had leveraged on this to develop capacity
in process technologies.
By the beginning of 1989, the resistance
by developing countries was broken down.
Enormous pressure exerted by the US
vol xlviii no 32
resulted in the two main hold-outs
changing their position. India went to
the extent of replacing India’s chief
negotiator at GATT, S P Shukla, because
of his strong opposition to the inclusion
of IP issues in the negotiating agenda
(Marcellin 2010: 87).
The significance of the negotiations was
not clear to most popular movements and
civil society groups in different parts of
the world. A key to the development of
the resistance in India was the formation
of the National Working Group on Patent
Laws (NWGPL). In spite of its relatively
small numbers, the NWGPL was hugely
influential in shaping opposition to the
Trade-Related Aspects of Intellectual
Property Rights (TRIPS) Agreement, right
from the late 1980s. It was composed of
a group of former civil servants, lawyers,
scientists, representatives of the domestic
pharmaceutical industry and representatives of trade unions in the pharmaceutical industry.1
The NWGPL, itself not a mass movement,
became a catalyst for advocacy and
mobilisation. It was the principal source of
evidence-based arguments against the
proposed regime on IP. Strong support
from the domestic industry found resonance among a wide range of political
actors. Over the next decade, the NWGPL
organised the “Forum of Parliamentarians”,
which had representation from virtually the
entire political spectrum. Several political
and social movements, non-governmental
organisations and mass organisations in
India formed alliances against the GATT
negotiations. Many subsequent developments had their roots in the popular mobilisations between 1990 and 2005.
Tortuous Path
The path towards the final formulation
of India’s Patents Act was also increasingly informed by, from 1991, the formal
introduction of neo-liberal reforms. From
an earlier position that India was forced
to concede to in the GATT negotiations,
there was now an attempt to argue that
strong IP protection would promote
domestic interests. However, popular
sentiment continued to be hostile.
The TRIPS Agreement provided a threestage time framework for developing
countries: introduction of a “mailbox”
43
THE GLIVEC PRECEDENT
facility and Exclusive Marketing Rights
(EMRs) from 1995; provisions on rights
related to term of patent protection,
compulsory licensing, reversal of burden
of proof, etc, by 2000; and introduction
of product patent protection in all fields
from 1 January 2005.
The political instability in India, post1996, meant that further discussions on
amendments to India’s 1970 Act resumed
only in 1998 after the installation of the
Bharatiya Janata Party (BJP)-led National
Democratic Alliance (NDA) government.
Indian Parliament enacted two legislations
through the Patents (Amendment) Act of
1999 and 2002, which addressed the first
two requirements of the TRIPS Agreement.
After assuming office, the NDA govern­
ment was clearly subsumed by the neoliberal logic while engaging with public
policy on a range of issues.2 The NDA
government then circulated the draft
Third Patents (Amendment) Bill in 2003,
but it could not be discussed because of
the change of government in 2004.
In 2004, there was a clear consensus
between the two principal parties in ­India
– the Congress and the BJP – and the
United Progressive Alliance (UPA) govern­
ment circulated an almost unchanged
version of the NDA’s Third Patents
NEW
(Amendment) Bill draft. In the then
political spectrum only the left parties
(along with some regional parties) stood
firmly against the draft Bill. But towards
the end of 2004, the BJP started voicing
opposition to the draft Bill. While this is in
the realm of speculation, BJP’s volte-face
had little to do with any opposition to the
substance of the Bill (given that this was
identical to the Bill they had circulated)
and more to do with an ­intent to embarrass
the UPA government. With support for
the bill now unsure, the UPA government
decided to beat the 31 December 2004
deadline by promulgating an ordinance
on 26 December 2004 (The Patents
(Amendment) Ordinance 2004).
Patents Ordinance of 2004
The Ordinance, if ratified by Parliament,
would have made it impossible for Indian
companies to continue producing cheaper
versions of new drugs. In early 2005, with
the BJP engaged in a bitter tussle with the
Congress in Bihar and Jharkhand over
formation of ministries, it became clear
that the Ordinance would be defeated in
Parliament and the Congress was now
forced to seek the left’s support.
In the consequent negotiations bet­ween
the left and the government, the left
largely depended on advice provided by
people associated with the NWGPL. These
negotiations also allowed other interested parties to suggest new language. At
the end, several important amendments
were made to the 2004 Ordinance
(ICTSD 2005), including the insertion of
Section 3(d), which has been the subject
of much discussion after its use by the
Supreme Court to strike down the
appeal by Novartis.
The negotiations were held in the backdrop of protests across the country, as
well as in different parts of the world –
all demanding that the “pharmacy of the
South” should not be jeopardised. By 2005,
the global Access to Medicines campaign
was a powerful force and ­organisations
such as Médecins Sans Frontières (MSF)
and others were able to organise support
across the globe. Protest letters were
sent to the prime ­minister, including one
where the co-signatories included Jim
Yong Kim, the present World Bank chief
(then director, Department of HIV/AIDS,
World Health Organization) (Khor 2013).
Important Amendments
While there has been considerable
focus on Section 3(d) of the amended
Act, many important amendments
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44
august 10, 2013 vol xlviii no 32 EPW Economic & Political Weekly
THE GLIVEC PRECEDENT
to the 2004 Ordinance were adopted,
including:
(1) Restrictions on Patentability: The
amendments clarified that an “inventive
step” means a feature of an invention that
“involves technical advances as compared
to the existing knowledge or having economic significance or both”. It incorporated a new definition for “new invention”:
any invention or technology which has not been
anticipated by publication in any document
or used in the country or elsewhere in the world
before the date of filing of patent application
with complete specification, i e, the subject
matter has not fallen in public domain or that
it does not form part of the state of the art.
It also provided a definition for “pharmaceutical substance” as being “a new entity
involving one or more inventive steps”.
(2) Restoration of Pre-grant Opposition
to Patents: The amendments restored
all the original grounds in the previous
Act for opposing grant of a patent and
also provided that: “the Controller shall,
if requested by such person for being
heard, hear him”. The time for filing
such opposition was extended from
three to six months.
(3) Export to Countries Without Manufacturing Ability: The amendments
clarified that a country could import
from India if it “by notification or otherwise allowed importation of the patented pharmaceutical product from India”.
(4) Continued Manufacture of Drugs
with Applications in Mailbox: The
amendments clarified that Indian companies that were already producing drugs
that were the subjects of mailbox applications could continue to produce them
after payment of a royalty, even if the
drug was subsequently granted a patent.
(5) Time Period for Considering Compulsory Licence Application: Concerns
that the process of granting compulsory
licences could take too long were addressed by specifying that the “reasonable
time period before the Patents Controller
considers issuance of a compulsory licence
when such a licence is denied by the
patent holder shall not ordinarily exceed
six months”.
Economic & Political Weekly
EPW
august 10, 2013
(6) Export by Indian Companies of
Patented Drugs: The amendments provided that when patented drugs are
produced under compulsory licence in
India “the licensee may also export the
patented product”.
Several of the amendments are being
used today by different groups to try to
safeguard access. In particular, the pregrant opposition provisions have been
used extensively by domestic companies
and civil society groups, and combined
with restrictions on patentability, the
provisions have allowed many important
drugs to be kept off patents. Further,
a number of drugs introduced in the
transition phase (1995-2005) were not
patented as the amended Act allowed
generic companies to manufacture and
sell drugs introduced in this period.
The language for Section 3(d) was
provided by the Indian Drug Manufacturers’ Association (IDMA). The left parties
had asked for a more stringent definition
of patentability by limiting grant of patents
for pharmaceutical substances to “new
chemical entities” or to “new medical
entities involving one or more inventive
steps”. Section 3(d) was a compromise
and the government had agreed to refer
the matter to an expert panel.
Subsequently, the government constituted a Technical Expert Group under
the chairmanship of R A Mashelkar,
former director general, Council of
Scientific and Industrial Research. The
Group, in its report in 2007, opined that
restriction of patents to new chemical
entities would be incompatible with the
TRIPS Agreement. Evidence surfaced that
parts of the report had been plagiarised
from a study by the UK-based Intellectual
Property Institute, funded by Interpat,
an association of 29 drug companies
including Novartis (Padma 2007: 392).
The report was withdrawn and press
reports indicated that Mashelkar had
resigned from the committee (ibid). Yet,
the same committee resubmitted a new
version with the same conclusions in
2009. These recommendations were expeditiously accepted by the government.
Vindication of Struggle
The Supreme Court judgment in the
Novartis case, thus, needs to be read not
vol xlviii no 32
just as an instance of the application of
one section (Section 3(d)) of the Indian
Patents Act. The judgment is important
as it vindicates the entire process that
led to health safeguards being incorporated in the Indian Act.
The judgment, in fact, refers clearly to
this process by noting (in para 26):3
…to understand the import of the amendments in clauses (j) and (ja) of section 2(1)
and the amendments in section 3 it is necessary to find out the concerns of Parliament,
based on the history of the patent law in the
country, when it made such basic changes in
the Patents Act. What were the issues the
legislature was trying to address? What was
the mischief Parliament wanted to check
and what were the objects it intended to
achieve through these amendments?
The judgment is a vindication not
just of a legislative process, but of popular resistance and mobilisation – in
India and across the world – that challenged corporate power. Small victories
such as this become inspirations for
larger battles.
Notes
1
2
3
For more information about the formation of
the NWGPL, see Sen Gupta (2010).
See, for example, Arulanantham (2004).
Text of final judgment is available at: http://judis.nic.in/supremecourt/imgs1.aspx? filename
=40212 (viewed on 20 June 2013).
References
Arulanantham, David P (2004): “The Paradox of
the BJP’s Stance Towards External Economic
Liberalisation: Why a Hindu Nationalist Party
Furthered Globalisation in India”, Asia Programme Working Paper, December, Royal
Institute of International Affairs, Chatham
House, London.
ICTSD (2005): “Indian Parliament Approves Controversial Patent Bill”, Bridges Weekly Trade
News Digest, 9(10), International Centre for
Trade and Sustainable Development, viewed
on 20 June 2013, http://ictsd.org/i/news/
bridges weekly/7294/
Khor, Martin (2013): “A Victory for Patients’ Access
to Medicines”, Global Trends Series, Third
World Network, 8 April, viewed on 20 June
2013, http://www.twnside.org.sg/title2/gtren
ds/2013/gtrends426.htm
Marcellin, Sherry S (2010): The Political Economy of
Pharmaceutical Patents: US Sectional Interests
and the African Group at the WTO (Farnham,
England: Ashgate Publishing).
Padma, T V (2007): “Plagiarised Report on Patent
Laws Shames Indian Scientists”, Nature Medicine,
13(4): 392.
Sen Gupta, Amit (2010): “B K Keayla: A Personal
Reminiscence”, Economic & Political Weekly,
45(51): 25-26.
Shukla, S P (2000): “From GATT to WTO and Beyond”, Working Papers No 195, United Nations
University/World Institute for Development
Economics Research, Helsinki, Finland.
45
THE GLIVEC PRECEDENT
Analysing the
Supreme Court Judgment
Anand Grover
A detailed account of the
examination of Section 3(d) of the
Indian Patents Act in the Supreme
Court’s judgment on Novartis’s
patent application for Glivec.
Anand Grover (anandgrover@gmail.com) is
a Senior Advocate practising in the Supreme
Court and the Director of the Lawyers
Collective. He and his team in the Lawyers
Collective represented the Cancer Patients
Aid Association in the Novartis case from the
beginning in the Patent Controller Office to the
end in the Supreme Court.
46
I
n many ways, the Novartis story
starts in the 1980s when western
multinational corporations (MNCs),
notably the pharmaceutical and music
industries in the US, decided that the
whole world should have intellectual
property regimes like the one in the US;
a vision they pursued through their
governments, ultimately leading to the
Trade-Related Aspects of Intellectual
Property Rights (TRIPS) Agreement, and
still being pursued through other means.1
The TRIPS Agreement sets out mandatory minimum standards of intellectual property rights protection and enforcement measures for the World Trade
Organization (WTO) member countries.
Thus, in terms of patent law, in Article 27.1,
the TRIPS Agreement mandates that
member countries have to provide patent
protection for a period of 20 years, for
products and processes that are novel, not
obvious and are industrially applicable.
However, as explained in Correa’s (2013)
accompanying article, it does not stipulate what is “new” or an “inventive
step”, flexibilities that developing countries secured in TRIPS.
In the 1970s, after considerable deliberation,2 which has been reviewed in
Sengupta’s (2013) contribution, India
amended its patent law, notably by removing the protection for product patents and
restricting protection only to processes
in medicines and foods.
This resulted, not only in competition
in the pharmaceutical sector, but gave a
lease of life to the Indian pharmaceutical
industry, making drug prices in India
amongst the lowest in the world. By
1988, India became a net exporter of
high quality affordable drugs, eventually
becoming the “pharmacy of the developing world”. In the late 1990s, the Indian
generic industry was providing over 90%
of quality, safe, efficacious and affordable
antiretrovirals (ARVs) to the developing
world (Waning et al 2010).
august 10, 2013
India had to comply fully with its
obligations under the TRIPS Agreement
by 1 January 2005. Parliament amended
the patent law in 1999 to introduce the
interim Exclusive Market Rights (EMR)
regime required under TRIPS.3 Later,
Parliament amended the Patents Act
in 2002 and had to finally comply
in 2005.4
By the beginning of 2005, when the
final amendments had to be carried out
to the Patents Act, Parliament was not
only mindful of its obligation under
TRIPS, but also of its obligation to protect
the Right to Health for its own citizens
in India, as also for those of the developing world.5 As illustrated by the Novartis
case, it was also conscious of the practice
of evergreening: patents being granted
not only for the New Molecular (or
Chemical) Entities (NMEs or NCEs) with
genuine new therapeutic benefits, but
also for new forms of the same or known
substance. In fact, over 75% of the patented drugs were such forms of known
substances (NIHCM 2002), thus eliminating competition, extending monopolies,
making drugs unaffordable, and adversely affecting the right to health.
The challenge for Parliament, therefore, was to strike a balance to, on the
one hand, comply with the obligations
under the TRIPS Agreement and provide
for patent protection for both product
and processes for 20 years, and on the
other hand, substantially limit evergreening, promote generic competition,
and thereby protect the right to health.
Parliament was guided in its deliberations by the Doha Declaration6 and
several representations from around
the world, including from the World
Health Organization (WHO) and UNAIDS.7
Importantly, several Members of Parliament cutting across party lines voiced
their concerns. And, these hopes were
crystallised in Section 3(d) in the Patents
Act, among other provisions.
It is Section 3(d) that Novartis challenged and, as noted in Correa’s (2013)
contribution, relentlessly campaigned
against.8
In 1997, Novartis had filed the application for its claimed invention, the
drug Glivec, the β crystalline form of
the salt, imatinib mesylate, before the
vol xlviii no 32
EPW
Economic & Political Weekly
THE GLIVEC PRECEDENT
Chennai Patent Controller, and was kept
in the mailbox.
Hit by Section 3(d)
After 1 January 2005, the mailbox facility
was opened. Five pre-grant oppositions
were filed, one by the Cancer Patients Aid
Association (CPAA), and four by Indian
generic companies.9 Novartis contended
that the claimed invention was novel,
inventive and industrially applicable. The
oppositionists contended otherwise. They
also argued that the claimed invention
was hit by Section 3(d) of the Patents Act.
In this respect, Novartis had filed additional affidavits ostensibly to show
that on account of the alleged increased
bioavailability (30%) of the β crystalline
form imatinib mesylate, there was a significant increase in the efficacy in the
claimed invention.10 While there was no
dispute as to the claimed invention’s
industrial applicability, the Patent Controller concluded that the claimed invention was neither novel nor inventive
and was also hit by Section 3(d), thus,
rejecting the application.
Against this order, Novartis filed appeals before the Madras High Court.
These were later transferred to the Intellectual Property Appellate Board (IPAB).
Both, Novartis AG and Novartis India also
challenged the validity of Section 3(d) on
the grounds that it did not comply with
the TRIPS Agreement and the term “efficacy” was vague and, therefore, in violation of Article 14 of the Constitution. The
Madras High Court dismissed both the
Writ Petitions on both the grounds. It also
held that Section 3(d) had been enacted,
amongst others reasons, to protect public
health, observing,
We have borne in mind the object which the
amending Act wanted to achieve namely, to
prevent evergreening; to provide easy access
to the citizens of the country to life saving
drugs and to discharge their constitutional
obligation of providing good health care to
its citizens.11
Importantly, Novartis did not challenge
the order of the Madras High Court.
In the appeals, the IPAB reversed the
Patent Controller order on two grounds,
and held that the claimed invention was
novel and inventive. However, it agreed
with the Patent Controller that it was hit
by Section 3(d) and rejected the patent
Economic & Political Weekly
EPW
august 10, 2013
application. It was against this order
that Novartis filed the Special Leave
Petition in the Supreme Court.
In the Supreme Court, the maintainability of Novartis’s appeal was dropped
and it was heard on merits.
On Merits
Novartis had patented imatinib, which
was exemplified in Example 21 of the
Zimmerman patent. Novartis argued
that the claimed invention involved a
twofold step over Zimmerman, firstly
from imatinib to imatinib mesylate, the
salt form, and secondly to the β crystalline form of imatinib mesylate.
On the interpretation of Section 2(1)(j)
and (ja) and Section 3, the Court, speaking through Justice Aftab Alam, held that
if they are read together, even though a
product or a process may satisfy the test
of invention under 2(1)(j) and (ja), it
may still be held not patentable under
Section 3 of the Act.
On Novelty
The Court noted that the salt form was
actually claimed in the Zimmerman application itself. Moreover, the acid addition salt forms could be made in a customary manner or in the manner known
per se. That apart, Novartis itself had
made a Patent Term Extension Application
in the US in the Zimmerman patent, in
respect of the mesylate form. This was
granted for a period of 586 days on the
basis that the Zimmerman patent covered
the mesylate form. Also, Novartis had
sought an injunction against Natco in
the UK from marketing the mesylate form.
Therefore, the Court observed, that
there was no room for doubt that imatinib mesylate, marketed as Glivec, was
submitted for drug approval and was
covered by the Zimmerman patent.
The Court also observed that the
properties of imatinib, namely the inhibition of tyrosine kinase activity, were
also found in the pharmaceutically
acceptable salt forms, particularly noting that the authors of Cancer Research
had concluded that in respect of properties “no significant difference in results
could be seen between the two forms of
CGP 57148”.12 Similar findings were
recorded in an article in the journal,
vol xlviii no 32
Nature. The Court, therefore, concluded
that it was “unable to see how Imatinib
Mesylate can be said to be a new product”,
and was in fact covered by the
Zimmerman patent.
In order to get over this hurdle,
Novartis admitted that though imatinib
mesylate may have been claimed and
therefore covered under the Zimmerman
patent, it was not disclosed, as there was
no enabling disclosure in the Zimmerman
patent. Novartis relied on the decision of
the US court of Customs and Patent
Appeals in Hogan.13 The Court found that
Hogan was rendered in very specific
circumstances and later decisions of the
US courts had narrowed that down to
Hogan’s impact. Additionally, on the basis
that the artificial distinction between
coverage and disclosure negated the fundamental rule underlying patents, the
argument was rejected.
The β Crystalline Form:
Interpreting 3(d)
For the purposes of argument the Court
accepted that the β crystalline form imatinib mesylate was new and not obvious.14 Of course, the crucial question before the Court was, whether in view of
Section 3(d) as amended, Novartis could
be granted a patent on the claimed invention of the β crystalline form of imatinib mesylate.
The Court observed that “in order to
correctly understand the present law it
would be necessary to briefly delve into the
legislative history of the law of patents in
the country”. It noted the parliamentary
debate during the final amendments to
the Patents Act in 2005, with concerns
about evergreening in pharmaceutical
patents. It recalled that Section 3(d) is
directed at these practices.
In interpreting the new provisions,
the Court held that the Act provided for
the duality of the concepts of invention
and patentability. Not all inventions
under the Act were patentable, as is
illustrated by Sections 3 and 4. The Court
rejected the submission by Novartis that
Section 3(d) was trifling change. It held
that different standards are set by the
Act for medicines and other chemical
substances and that Section 3(d) had
been enacted to prevent evergreening.
47
THE GLIVEC PRECEDENT
The Court found that as the β crystalline form imatinib mesylate was a new
form of imatinib mesylate, Section 3(d)
would apply.
However, Novartis argued that neither
imatinib nor imatinib mesylate had
known efficacy. Therefore, no comparison could be made of the β crystalline
form of imatinib mesylate with a “known
substance” with “known efficacy” as
required under Section 3(d). This was rejected by the Court on the grounds that it
is well established by the Supreme Court
itself, as interpreted in Monsanto,15 that
the expression “publicly known” was
held not to mean that it was widely used
to the knowledge of the consumer public, but that it is sufficient if it is “known
to the persons who are engaged in the
pursuit of knowledge of the patented
product or process either as men of science or men of commerce or consumers”.
In examining the efficacy of the different forms of imatinib, that is imatinib
free base, non-crystalline form of imatinib mesylate, and the β crystalline form
of imatinib mesylate, the Court noted that
it was Novartis’s own case that all the
properties possessed by the imatinib free
base were possessed by the β crystalline
form of imatinib mesylate. In the circumstances the Court queried how there
could be any enhanced efficacy in the
β crystalline form of imatinib mesylate?
In this respect, Novartis filed two affidavits to satisfy the requirements of
Section 3(d) for consideration.
One of these affidavits stated that on
conducting experiments it was found
that there was a 30% increase in bioavailability in the β crystalline form of
imatinib mesylate as compared to the
imatinib free base. The Court noted that it
was Novartis’s own case that the product
immediately preceding the β crystalline
form imatinib mesylate is the noncrystalline form of imatinib mesylate.
The non-crystalline form of imatinib
mesylate was thus known. The Court
found that the comparison with imatinib
free base was inappropriate.
The Court therefore held that Novartis
was bound to show enhanced efficacy
of β crystalline imatinib mesylate over
non-crystalline imatinib mesylate, which
Novartis had failed to do. Moreover, the
48
Court opined that the bioavailability
of the β crystalline imatinib mesylate
would be on account of the salt form,
that is the non-crystalline form of
imatinib mesylate.
Efficacy Is Therapeutic Efficacy
The Court held that the term efficacy in
3(d) has to be understood as the ability
to produce the desired or intended
effect. This would differ in the context
of the product, its function, utility or the
purpose under consideration. In the context of medicines that claim to cure a
disease, it has to be therapeutic efficacy.
Considering the context of 3(d), the
Court held that, with respect to medicines, it had to be construed strictly and
narrowly in line with language used in
the Explanation to 3(d), namely, “differ
significantly in properties with regard to
efficacy”, therefore, “that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of
medicine…is its therapeutic efficacy”.
Thus, holding that the physicochemical properties of the β crystalline
form of imatinib mesylate contended by
Novartis to be properties “with regard
to efficacy”, namely more beneficial
flow properties, better thermodynamic
stability, and lower hygroscopicity, may
be otherwise beneficial but cannot be
taken into account for the purpose
of the test of Section 3(d) of the Act.
These properties have nothing to do
with therapeutic efficacy.
That left bioavailability and its role in
efficacy. There were two rival contentions
here. The CPAA argued that in the pharmaceutical field, drug action is explained
by “pharmacokinetics” (effect of the body
on the drug) and “pharmacodynamics”
(effect of the drug on the body). Efficacy
is the capacity of a drug to produce an
effect, an aspect of pharmacodynamics.
The generation of response from the
drug receptor complex is governed by a
property described as efficacy. Bioavailability, on the other hand, is a pharmacokinetic property. It is the term used to
indicate the extent to which a dose of
drug reaches its site of action or a biological fluid from which the drug has
access to its site of action.
august 10, 2013
Shamnad Basheer, intervenor- cumamicus, argued that safety or significantly
reduced toxicity should also be taken
into consideration to judge enhanced
therapeutic efficacy of a pharmaceutical
product in terms of Section 3(d).
While the Court left these submissions
untouched, it held that bioavailability by
itself may or may not result in its efficacy
being affected. In terms of Section 3(d),
it must be claimed and established by research data with in vivo animal models,
which Novartis had not done. Therefore,
the claimed invention, β crystalline form
of imatinib mesylate, failed the test of
Section 3(d). Thus, Novartis’s appeal
came to be dismissed, and the others by
the CPAA and Natco allowed.
The Novartis decision has enormous
significance. It clarifies the meaning of
efficacy in Section 3(d), stating that mere
advantages are insufficient. The applicant
has to show with in vivo animal models
how therapeutic efficacy is significantly
enhanced. Crucially, the relentless lobbying by western pharma MNCs to whittle
down Section 3(d) has been repelled.
Notes
1 The unfinished agenda is now being pursued
through the free trade agreements.
2 These deliberations included the Tek Chand
and Ayyangar Committees and various Parliamentary Committees.
3 Earlier Parliament had refused to introduce
this, as a result of which India was taken to the
TRIPS Disputes Council where India lost. India
then appealed again. It lost again. Parliament
had no choice but to introduce the interim
regime of EMR to avoid trade sanctions.
4 In 1999 the Patent Act was amended to provide
patent protection for foods and medicines. The
2002 amendments were made to amend Section 2(1)(j) relating to invention, add 2(1)(ac)
relating to industrial application and 2(1)(ja)
relating to inventive step, as also Section 83
relating to general principles. In 2005 apart
from amending Section 3(d), amendments
were carried to Section 2(1)(ja) and the provision
of pre-grant opposition under Section 25(1). As
a result of all the amendments India has been
able to use TRIPS flexibilities to the maximum.
This includes patentability criteria, pre-grant,
post-opposition, revocation procedures, counter
claim in infringement suits to set aside the grant
of the patent, provisions for compulsory licences,
government use, etc.
5 The World Health Organization (WHO) and
the UNAIDS, amongst others, had appealed to
Indian Parliamentarians to keep in mind that
India was the pharmacy of the poor in the developing world while making the final amendment (see Sengupta 2013).
6 The Doha Declaration of 11 December 2001
issued by the Inter Ministerial Conference of
the WTO recognised the gravity of public
health problems and that the TRIPS Agreement
has to be interpreted to protect public health.
vol xlviii no 32
EPW
Economic & Political Weekly
THE GLIVEC PRECEDENT
7 Interestingly the letter from the WHO was
signed by the present president of the World
Bank Jim Young Kim.
8 Thus, in India the MNCs have, with the local
industry formed the US-India Business Coalition, which has issued documents about
the need to delete Section 3(d) from the
Patents Act.
9 Under the Indian Patents Act any person can file
a pre-grant opposition on the grounds indicated
in Section 25(1). Post-grant opposition can be
filed only by a person “interested”.
10 The study was conducted on rats, but the comparison was with the base form of imatinib and
Economic & Political Weekly
EPW
august 10, 2013
11
12
13
14
15
not with the mesylate form of imatinib, which
was also known at that time.
Madras High Court Writ Petition No 24759 and
24760 of 2006, at para 19.
Referring to the imatinib base and the mesylate
salt form of imatinib.
Application of John Paul Hogan and Robert L
Banks, 1977 (559 F.2d 595).
The Court did go into the issue of novelty or
non-obviousness of the β crystalline form imatinib mesylate. It dealt with the issue of the applicability of Section 3(d).
Monsanto Company vs Coramandal Indag
Products (P) Ltd, 1986 (1 SCC 642).
vol xlviii no 32
References
Correa, Carlos M (2013): “Is Section 3(d) Consistent
with TRIPS?”, Economic & Political Weekly, 48(32).
NIHCM (2002): Changing Patterns of Pharmaceutical Innovation (Washington: National Institute
for Health Care Management).
Sengupta (2013): “Two Decades of Struggle”,
Economic & Political Weekly, 48(32).
Waning, Brenda, Ellen Diedrichsen and Suerie Moon
(2010): “A Lifeline to Treatment: The Role of
Indian Generic Manufacturers in Supplying Antiretroviral Medicines to Developing Countries”,
Journal of the International AIDS Society, 13: 35.
49
THE GLIVEC PRECEDENT
Is Section 3(d) Consistent
with TRIPS?
Carlos M Correa
This article looks at how
inventions are assessed by various
policy regimes in the world and
analyses the Indian regulations
in this light. A well-formulated
and scientific legislation to apply
the inventive step standard could
avoid most of the complications
caused by Section 3(d) of the
Indian Patents Act, which is
compatible with the Trade-Related
Aspects of Intellectual Property
Rights Agreement, but about
which questions can still be raised.
N
ovartis challenged the consistency
of Section 3(d) with regard to
the Agreement on Trade-Related
Aspects of Intellectual Property Rights
(TRIPS) before the Madras High Court.
The high court refused to entertain this
argument. Interestingly, the Swiss government did not initiate a case in the
World Trade Organization (WTO) in support of Novartis’s argument regarding
the alleged violation of TRIPS. However,
the Supreme Court decision has not
foreclosed the possibility of such complaints and an analysis of the subject is
still relevant.
On the one hand, the United States
Trade Representative (USTR) – which
has regularly cited Section 3(d) as
one of the reasons to keep India on its
list of countries whose intellectual
property rights regimes are of “concern”
to the US (Sampat et al 2012: 414)1 –
stated (USTR 2013: 38) that the Indian
Supreme Court decision
appears to confirm that India’s law creates a
special, additional criterion for select technologies, like pharmaceuticals, which could
preclude issuance of a patent even if the applicant demonstrates that the invention is
new, involves an inventive step, and is capable of industrial application.
Carlos M Correa (quiess@gmail.com) teaches at
the University of Buenos Aires and is Advisor
on Intellectual Property and Trade, South
Centre, Geneva.
Economic & Political Weekly
EPW
august 10, 2013
This statement suggests the possible
incompatibility of Section 3(d) with two
aspects of Article 27.1 of the TRIPS
Agreement: (a) the non-discrimination
clause,2 and (b) the obligation to grant
a patent when the three patentability
vol xlviii no 32
criteria specified in that article (novelty,
inventive step/non-obviousness, industrial
applicability/utility) are met, without imposing additional substantive conditions.
On the other hand, other countries,
such as the Philippines, have adopted
measures similar to Section 3(d) or apply
policies that limit the patentability of
certain categories of pharmaceutical
products. For instance, in Argentina's 2013
Trade Policy Review a series of specific
questions were raised regarding recently
adopted guidelines on the patentability
of pharmaceutical products and processes3 that suggested possible inconsistencies with Article 27.1 of the TRIPS
Agreement. Some of those questions
(posed by Japan, the European Union)
specifically addressed the patentability
of crystalline forms, the subject matter
of Novartis’s patent application in India.
Does It Discriminate?
The obligation not to discriminate contained in Article 27.1 applies both to the
availability and enjoyment of patent
rights, meaning that neither the acquisition of patent rights nor the means
for enforcement can be subject to discrimination. Although the provision is
broad in this respect, it is only applicable when discrimination takes place on
the basis of one of the following grounds
– (1) the place of invention, (2) the field
of technology, and (3) whether products are imported or locally produced
(Correa 2007).
Arguments about the possible inconsistency of Section 3(d) with the TRIPS
Agreement allude to the second ground –
the field of technology.
A possible conflict with the nondiscrimination clause was unsuccessfully
claimed by the European Commission (EC)
49
THE GLIVEC PRECEDENT
in its complaint against Canada relating
to the “Bolar exception” (WTO 2000). The
panel rightly made a distinction between
“discrimination” and “differentiation”.4
Section 3(d) is not discriminatory
under the terms of Article 27.1 of TRIPS.
First, it does not apply only to pharmaceutical products, but to any chemical
product. It may be applied, for instance, to
examine the patentability of an isomer of
an agrochemical product. Second, even if
(for the sake of argument) Section 3(d)
applied only to inventions in the pharmaceutical field, it would be justified by the
need to take the specific characteristics
of such products into account in the
examination process. Indeed, special
considerations regarding the type of
claims (compositions, salts, polymorphs,
etc) are unavoidable whether explicitly
contained or not in laws or other regulations, to assess the patentability of any
claimed product in that field. The same
applies to other technological fields, such
as biotechnology and computer software.5
There are, in fact, many examples of
guidelines and legal provisions that
specifically address the case of pharmaceutical inventions in national laws and
policies, including in developed countries.
Thus, several patent offices have adopted
specific criteria to examine chemical
and/or pharmaceutical patents, without
objection from any WTO member. For
example, the Japanese Examination
Guidelines for Patent and Utility Model
contains a specific chapter on “Medicinal
Inventions” (Part VII, Chapter 3).
Moreover, some national laws contain
provisions specifically related to pharmaceuticals which have never been challenged under the WTO rules: the French
industrial property law provides for the
grant of compulsory licences on patents
relating to medicines (Article L 613-16);
the Australian “US Free Trade Agreement
Implementation Bill 2004”6 introduced
an AU$10 million penalty for drug patent
litigation in bad faith; under US legislation
(35 USC Section 156) and in accordance
with the free trade agreements (FTAs)
signed by the US with a number of countries,7 special provisions apply for the
extension of the term of pharmaceutical
patents to compensate for delays in the
marketing approval of medicines.
50
Another potential objection to Section 3(d) under Article 27.1 of the TRIPS
Agreement, as suggested in the USTR
2013 Report quoted above, is that it
imposes an additional standard to obtain
a pharmaceutical patent, not provided
for and in violation to the first sentence
of Article 27.1.
There have been different interpretations in the context of the Novartis
case regarding what type of standard
Section 3(d) actually establishes.
The Intellectual Property Appellate
Board (IPAB) – competent to hear appeals
from the decisions of the Indian patent
office – characterised the efficacy test
imposed by that provision as an enhanced
inventive step requirement. While the
IPAB considered that Novartis’s crystalline
form met the ordinary inventive step
standard, it argued that it failed to meet
the “stricter inventive step” standard
demanded by Section 3(d).8
Invention and Patentability
In the view of the Indian Supreme Court
the β crystalline form of imatinib mesylate “fails in both the tests of invention
and patentability as provided under
clauses (j), (ja) of Section 2(1) and Section 3(d) respectively” (para 195).9
It has also been suggested that
Section 3(d) relates to the utility requirement for patentability: the “limited integration of efficacy considerations, more
traditionally seen in drug-marketing laws,
is a sound and long-overdue attempt to
rectify the low level of proof of real
utility that mars patent regimes” (Roderick
and Pollock 2012).
Whether Section 3(d) is part of the definition of “invention” (as explicitly stated by
the provision)10 or a patentability requirement (inventive step and/or utility), is not
essential for an assertion of the provision’s
compatibility with Article 27.1 of the
TRIPS Agreement. Such compatibility can
be sustained under both interpretations.
In effect, an important flexibility that
WTO members enjoy under the TRIPS
Agreement is to define what is to be considered an “invention” for the purposes
of patent law. Like most patent laws in
the world, the TRIPS Agreement does not
define what an invention is. Hence, WTO
members can adopt different concepts,
august 10, 2013
in accordance with their legal traditions
and national policies, as long as this is
made in good faith and in accordance
with the interpretative criteria codified
by the Vienna Convention on the Law of
the Treaties (Articles 31 and 32).
As a result of the policy space left by
the TRIPS Agreement, national laws can
distinguish between “inventions” that
are patentable and other matters that
are not, as many laws actually do.11
The TRIPS Agreement permits diverse
approaches regarding the interpretation
of the obligation to patent “any inventions”. As noted in a World Intellectual
Property Organization (WIPO) study, “[A]t
the national/regional level, the exclusions
from patentable subject matter provided
for in national/regional legislation vary
significantly” (WIPO Secretariat 2009: 3).
One example is the different treatment
conferred under various national regimes
to substances found in nature such
as genes.12
If Section 3(d) were deemed to define
a patentability requirement (as held by
the IPAB) then similar considerations
would apply. While Article 27.1 obliges
WTO members to grant patents where the
specified standards are met, it does not
define them. This important flexibility
allowed, for instance, the US to maintain
until recently and defend the TRIPS compatibility of a novelty standard (35 USC
Section 102(a)) that combined local and
universal novelty depending on whether
the disclosure of the invention had taken
place within or outside the territory of
the US. The US held at the Council for
TRIPS that in the TRIPS Agreement there
was “no prescription as to how WTO
members define what inventions are to
be considered ‘new’ within their domestic
systems” and, hence, that its legislation
was “perfectly consistent with the provisions of the TRIPS Agreement”.13
In particular, the TRIPS Agreement
does not define the standard of “nonobviousness” or “inventive step”: it does
not limit the WTO members’ right to
choose whether to apply more or less
rigorous criteria to grant a patent. Although under most patent laws those
concepts require an enquiry as t0 whether
the claimed invention is evident or obvious to a person with skills in the relevant
vol xlviii no 32
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Economic & Political Weekly
THE GLIVEC PRECEDENT
technical field, there is in fact no uniformity in the way the standard is
defined and applied.
Given this important flexibility under
the TRIPS Agreement, WTO members can
adopt patentability criteria that avoid
the “evergreening” of pharmaceutical
patents, that is, the grant of patents on
minor developments whose protection is
sought to delay or block generic competition. Preventing evergreening was the
very purpose of Section 3(d) as extensively
elaborated on by the Indian Supreme
Court in the commented decision.14 The
rejected Novartis patent application, as
noted, referred to a crystalline form or
“polymorph” of imatinib mesylate, not
to the drug itself (imatinib), or its
particular salt (mesylate).
Several polymorphs may exist for the
same chemical compound. A polymorph
is not actually “invented”; it is a property
inherent to such a compound which is
found in the process of crystallising a
given substance (depending on solvent,
heating, stirring, and other conditions)
or as the result of the transformation
(without human intervention) of the arrangements of the molecules in the solidstate structure.15 Hence, it may be argued
that a polymorph is not an invention, but
rather the outcome of a discovery.
If, however, a polymorph would be
deemed an invention, it would not meet a
rigorous inventive step/non-obviousness
standard since, for a person working in
the pharmaceutical industry, the need
to try and obtain different polymorphs
and to choose the most suited for production is obvious. For a person with
basic knowledge in organic chemistry, it
is well known, in effect, that one polymorph may be more stable and have
better properties than others for manufacturing a particular drug (Purohit and
Venugopalan 2009: 890-91). Hence, even
if a particular polymorph showed a
significant enhancement of the drug’s
therapeutic effect, a patent office may
consider it as not patentable.
This suggests that the same decision –
to reject a patent application regarding
a crystalline form – may be reached
even in the absence of a provision like
Section 3(d). The guidelines for the
examination of pharmaceutical patents,
Economic & Political Weekly
EPW
august 10, 2013
published by the International Centre
for Trade and Sustainable Development
(ICTSD), World Health Organization
(WHO), United Nations Conference on
Trade and Development (UNCTAD) and
United Nations Development Programme
(UNDP), for instance, recommended patent
offices to refuse patent applications on
particular polymorphs (Correa 2006: 11).
In line with this recommendation, but
with a more rigorous approach, the Joint
Resolution adopted by the Argentine
government in 2012 establishes that, as a
rule, a new crystalline form of a known
substance is not patentable.
This Joint Resolution illustrates that
an outcome similar to that emerging from
the Novartis decision can be obtained
through the application by patent offices,
in a rigorous manner, of the conventional
inventive step/non-obviousness requirement. In many instances, patents on
polymorphs have been held invalid or
not infringed; even in the US it has
become more difficult to get a patent
granted on a polymorph and to defend it
if challenged in courts (Vure 2011).
Conclusions
Section 3(d) is not discriminatory in
terms of Article 27.1 of the TRIPS Agreement. It does creates neither additional
nor different requirements of patentability
other than those specified in said article.
With the adoption of Section 3(d) India
has made use of the flexibility allowed to
WTO members to determine what is the
eligible subject matter for the purposes
of the national patent law. WTO members also have policy space to define the
specific contours of the patentability
standards, as the TRIPS Agreement does
enumerate them, but does not provide
specific rules governing their definition
and application.
Section 3(d) is not only compatible
with the TRIPS Agreement. As interpreted
in the Novartis decision commented
above, it also enshrines the right policy
approach in dealing with pharmaceutical
patents: protection should be granted
when genuine inventions are claimed,
but rejected when patent applicants just
aim at creating barriers for generic competition through the patenting of a broad
range of minor, often trivial developments.
vol xlviii no 32
While some countries may be rightly
encouraged by the outcome of the Novartis
case to adopt a provision similar to
Section 3(d) through legislative reform,
regulations or patent offices’ guidelines,
it is worth noting that an equivalent result
may be obtained through a rigorous and
scientific application of the inventive
step standard.
Notes
1 On occasion of India’s Trade Policy Review
(2011) at WTO, the US questioned whether the
Government of India considered the requirement under Section 3(d) “to be in line with
TRIPS Article 27(1)”. India’s reply indicated that
the “provisions of Section 3(d) of the Patents
Act, 1970 are fully compliant with Article 27(1)
of the TRIPS Agreement read with Article 8 of
the said Agreement”.
2 Article 27.1: “…patents shall be available and
patent rights enjoyable without discrimination
as to the place of invention, the field of technology and whether products are imported or
locally produced”.
3 Joint Resolution of the Ministry of Industry
(118/2012), Ministry of Health (546/2012) and
Instituto Nacional de la Propiedad Industrial
(107/2012).
4 See WTO (2000), para 92. It is worth noting
that the TRIPS Agreement does differentiate
the treatment given to semiconductor technologies (Article 31(c)). There is also specific
treatment for the textile sector in the area of
industrial designs (Article 25.2).
5 For instance, the US patent office and courts apply differently the non-obviousness and disclosure standards to biotechnological and software
inventions (Burk and Lemley 2003).
6 Amendment (2), The Senate, The Parliament of
the Commonwealth of Australia (codified as new
Section 26C of the Therapeutic Goods Act 1989).
7 See Singapore FTA, Article 16.8.4(a); Chile FTA,
Article 17.10.2(a); Morocco FTA, Article 15.10.3;
Bahrain FTA, Article 14.8.6(b)(i); CAFTA,
Article 15.9.6(b).
8 See the IPAB decision of 26 June 2009, p 189.
9 The Court, however, emphasised that “in whichever way Section 3(d) may be viewed, whether
as setting up the standards of “patentability” or
as an extension of the definition of “invention”,
it must be held that on the basis of the materials
brought before this Court, the subject product,
that is, the beta crystalline form of Imatinib
Mesylate, fails the test of Section 3(d), too, of
the Act” (para 190).
10 Section 3 (chapeau): “What are not inventions.
The following are not inventions within the
meaning of this Act…”.
11 See, for instance, Article 52(2) of the European
Patent Convention.
12 The controversy regarding the patentability of
human genes in the US is illustrative of the
various views on the matter found even at the
national level (USDJAMP et al 2010).
13 See WTO document IP/Q3/USA/1, 1 May 1998.
14 See, e g, para 100-102.
15 For instance, in the case of ritonavir (an antiretroviral), after 18 months of its launch “its
manufacturing company Abbott observed an
unexpected occurrence. The final product did not
show dissolution and the drug was precipitating.
After considerable investigations it was revealed
that this was because of a new thermodynamically
more stable and less soluble polymorph Form-II”
(Purohit and Venugopalan 2009: 890-91).
51
THE GLIVEC PRECEDENT
References
Burk, D and M Lemley (2003): “Is Patent Law Technology-Specific?”, 17 Berkeley Tech Law Journal,
(1155), 1155-1206.
Correa, C (2006): Guidelines for the Examination of
Pharmaceutical Patents: Developing a Public
Health Perspective (Geneva: WHO, ICTSD and
UNCTAD).
– (2007): Trade Related Aspects of Intellectual
Property Rights (Volume VI of Commentaries on
the GATT/WTO Agreements) (Oxford: Oxford
University Press).
Purohit, R and P Venugopalan (2009): “Polymorphism: An Overview”, Resonance, September,
882-93, viewed on 8 July 2013, http://www.ias.
52
ac.in/resonance/September2009/p882-893.pdf
Roderick, P and A Pollock (2012): “India’s Patent
Laws Under Pressure”, The Lancet, 380(9846):
e2-e4, viewed on 8 July 2013, http://www.thelancet.com/journals/lancet/article/PIIS01406736(12)61513-X/fulltext
Sampat, B, K Shadlen and T Amin (2012): “Challenges to India’s Pharmaceutical Patent Laws”,
Science, (337): 414-15.
USTR (2013): “2013 Special 301 Report”, United
States Trade Representative, viewed on 8 July
2013, http://www.ustr.gov/sites/default/files/
05012013%202013%20Special%20301%20Report.pdf
USDJAMP et al (2010): “Brief for the United States
as Amicus Curiae in Support of Neither Party”,
august 10, 2013
submitted by the US Department of Justice in
Association for Molecular Pathology, Petitioners
vs Myriad Genetics, Inc et al, viewed on 8 July
2013, http://graphics8.nytimes.com/packages/
pdf/business/genepatents-USamicusbrief.pdf
Vure, P (2011): “Polymorph Patents: How Strong
They Are Really?”, International Journal of
Intellectual Property Management, 4(4): 297-306.
WIPO Secretariat (2009): “Exclusions from Patentable
Subject Matter and Exceptions and Limitations
to the Rights”, SCP/13/3,F, viewed on 8 July 2013,
http://www.wipo.int/edocs/mdocs/scp/en/scp_
13/scp_13_3.pdf
WTO (2000): “Canada – Patent Protection for Pharmaceutical Products”, Report of the WTO Panel,
WT/DS114/R.
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THE GLIVEC PRECEDENT
‘Drop the Case’
Campaigning against Novartis
Leena Menghaney
Evergreening and the issues this
practice of abusive patenting
raised were first highlighted
in the late 1990s with the HIV
epidemic, when medicines were
priced way out of reach. The
Supreme Court’s rejection of
Novartis’s patent has set in place
an important safeguard to ensure
production of affordable generic
medicines from India.
T
hat patents on medicines can
make the difference between life
and death for millions, first hit
home with the AIDS pandemic, when
medicines to treat HIV were priced way
out of reach of patients and governments
in developing countries.1 In 1999, in the
wake of Médecins Sans Frontières (MSF)
being awarded the Nobel Peace Prize,
MSF launched the Access Campaign. At the
time patented HIV treatment cost more
than $10,000 per patient per year. One
of the first tasks of the Access Campaign
was to challenge the high costs of existing drugs – such as those to treat HIV/
AIDS – and working to bring prices down
for its medical projects in South Africa
and Thailand.
in 1997 on a formulation containing
lamivudine and AZT, which was granted
in several countries, including South
Africa.5 Access to these ARVs then became difficult and expensive because of
these patents.
The answer to a sustainable supply of
affordable HIV medicines lay in India,
where policies that fostered production
of and access to affordable generics had
taken hold in the absence of product
patents (Sengupta 2013).6 The country’s
generic producers took up the challenge
in 2001 to develop generic ARVs, which
they sold for just $1 per day, a fraction of
the price that multinational pharmaceutical companies were then charging.
With Indian producers able to manufacture and export fixed dose combinations of ARVs, the World Health Organization (WHO) launched the “Treat 3 Million
by 2005” initiative in 2003. The same year,
an HIV treatment programme was set up
in South Africa – the country with the
highest burden of HIV/AIDS7 – through
the public health system, with India
following in 2004.
Evergreening and AIDS Treatment
Leena Menghaney (leenamenghaney@gmail.
com) is Campaign Coordinator (India) for the
Médecines San Frontières Access Campaign.
52
Evergreening and the issues this practice
of abusive patenting raised were first
highlighted in the late 1990s, when the
HIV epidemic was devastating communities – particularly those in Africa – and
the barriers to providing treatment
seemed insurmountable.2
Zidovudine (AZT) (previously Azidothymidine), one of the first antiretrovirals
(ARVs) to treat HIV, was a known cancer
product,3 but GlaxoSmithKline (GSK) was
granted a patent for its use to treat HIV,4
making it one of the first examples of
an evergreened drug used to treat HIV.
Similarly, GSK filed a secondary patent
august 10, 2013
India’s Patents Act: What Future?
In 2005, as the deadline for India to fully
implement the Trade-Related Aspects
of Intellectual Property Rights (TRIPS)
Agreement8 approached, the country was
obliged to introduce product patents for
medicines. Until then, generic producers
had supplied medicines without fear of
facing protracted and expensive patent
infringement suits. Thousands of patent
applications on medicines had been
filed since 1995 in anticipation of the
amendments in India’s patent regime,
and a large number – including those
for HIV, tuberculosis (TB) and cancer –
vol xlviii no 32
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THE GLIVEC PRECEDENT
could be considered as evergreening
patent claims.
As a result, a single medicine had many
secondary patent applications pending
in the Indian patent office covering one
or more specific features, including
“formulation” (e g, heat stable tablets
and capsules, syrups, etc), combinations
(e g, a fixed-dose combination when different HIV medicines are combined in
the same pill), and derivatives (salts,
prodrugs, crystals and polymorphs).
Concerned about the impact on access
to medicines, MSF, UNAIDS, WHO and
even the French Prime Minister Jacques
Chirac, stepped in to warn the Indian
government to find the right balance
between protecting production and access
to affordable generics, and coming into
compliance with TRIPS.
In the midst of civil society protests,
big pharma lobbying, and international
media attention, Parliament passed the
new Patents Act in March 2005 to allow
for pharmaceutical product patents –
something the country had not done
since 1970. Although not perfect,9 the
law crucially allowed for any party to
oppose a patent before it is granted (Section 25), and the scope of patentability
under Section 3(d) was restricted to
avoid “evergreening”, the practice of
granting multiple secondary patents on
an existing medicine.
Novartis vs Union of India
A Novartis patent application on the
anti-cancer drug imatinib mesylate10
was one of the first to be examined,
opposed and rejected by an Indian
patent office on grounds that it claims
covered a new form of a known substance – Section 3(d) of the new law –
and lack of an inventive step. Angered
by this decision, Novartis went to court
in May 2006 alleging, among other
things, that India’s Section 3(d) was
contrary to the TRIPS Agreement and
was unconstitutional.
The patent rejection order – obtained
after Cancer Patients Aid Association
and others filed a pre-grant opposition –
set an important precedent for the examination of patent applications on HIV
medicines. More importantly, Section 3(d)
had already demonstrated its importance
Economic & Political Weekly
EPW
august 10, 2013
in upholding the rejection of the patent
on imatinib.
If Novartis succeeded in weakening
the interpretation of Section 3(d) in
order to obtain a patent on imatinib
mesylate, this would defeat its purpose
in forestalling the practice of evergreening. The Indian Patent Office would have
to apply the same standards of patentability on existing patent applications
covering HIV medicines and their different forms, meaning HIV medicines could
be easily patented and generic companies could face expensive infringement
suits. This could ultimately result in having a chilling effect on the availability of
affordable generic medicines.
The Campaign
In December 2006, MSF’s Access Campaign, in partnership with Oxfam and
Delhi Network of Positive People (DNP+),
launched a petition appealing to people
to urge Novartis to “Drop The Case” in
order to protect the “pharmacy of the
developing world” (Doctors Without
Borders 2006).
The campaigners faced the daunting
task of educating ordinary people about
access to medicines, pharmaceutical
patents and the impact of the case on these
issues. The message needed to be simple –
this case was a direct attack on the safeguards in India’s patent law and risked
dismantling India’s capacity to produce
quality, affordable generic medicines.
The launch of the campaign turned
what otherwise promised to be a complex
patent dispute followed by just a few
technical organisations and patient groups
into a global outcry against the greedy
practices of pharmaceutical companies.
The petition received a groundswell of
support from MSF field workers, HIV
organisations, and ordinary people from
around the world, resulting in close to
half a million signatures by August 2007 –
when Novartis lost its case at the Madras
High Court – fuelled by protests before
Novartis’s offices worldwide.
In the wake of two failed appeals,
Novartis took its final bid for a patent –
and now a challenge on the interpretation and application of Section 3(d) – to
the country’s Supreme Court. If this
challenge were successful, it could take
vol xlviii no 32
much of the substance out of the public
health provision, allowing evergreening, and, as Correa’s (2013) accompanying article explains, narrowing the flexibility in TRIPS.
MSF relaunched the Drop The Case
campaign, this time rebranded as “Stop
Novartis”, in February 2012. While the
initial campaign took the form of a petition, the Stop Novartis campaign took
advantage of the global reach of Twitter.
The social media platform was used to ask
people to target the company directly,
through the company’s @Novartis profile and the hashtag of #STOPNovartis.
The new campaign almost immediately
goaded Novartis into responding, with a
series of tweets defending the company’s
record and documents that attempted to
set the record straight on its actions
from its own perspective.
Novartis: What They Had to Say
Over a period of seven years, civil society
and MSF received thousands of media
queries from journalists who had picked
up on the campaign. Public statements
from Novartis covered the most common misconceptions on the subject of
pharmaceutical patents.
These included Novartis’s statement
that as imatinib mesylate had been
granted a patent in 40 countries, including Switzerland and the US, India should
simply follow suit. In using this tactic,
Novartis conveniently glossed over the
fact that countries have at their disposal
TRIPS flexibilities to adopt different
standards in designing their patent systems to best suit their own needs – a
point well elaborated in Correa (2013).
Accordingly, it is crucial that developing
countries, in particular, make a careful
decision in what should be allowed a
patent and what should not.
MSF was clear in its response: India
must stand firm, applying a patentability
standard that weeded out evergreened
patent claims. Its generic production of
medicines saved millions of lives.
Novartis also tried – predictably – to
justify its patent claims in India by
stating its research and development
(R&D) costs needed to be recouped
through the drug’s high cost (Ghose 2013).
The company – which claims patent
53
THE GLIVEC PRECEDENT
rights in 40 countries, reaping huge
profits in return – deliberately underplayed the significant contribution made
by the public sector and philanthropic
sources in the US11 meaning it actually
spent just a fraction of the total R&D cost
(Love 2013).
Throughout the court challenges and
in the wake of the Supreme Court’s
decision, which Grover’s (2013) article
discusses, Novartis was quick to raise
fears about the future of innovation in
India if patents were rejected by the
patent office (Novartis 2013). This was a
lazy argument, in that the case was not
about India refusing to grant patents on
new medicines, but stemmed from
whether a salt form of an existing drug
deserved a patent in India. It further
opened the debate on the current system, that despite patent protection, the
diseases and health issues of developing
countries are neglected by companies
(Menghaney 2013).
What Worked?
The Supreme Court decision on 1 April
was the final act in a legal battle that
stretched back to 2004. The verdict,
when read with the law, sets a high
standard for the various tests in the patent legislation, particularly the “efficacy”
test of Section 3(d) and the inventive
step requirement. In the future, this will
lead to fewer patents on new forms of
known medicines, an important safeguard to ensure production of affordable
generic medicines from India.
While the campaign ultimately failed
to convince Novartis to “Drop The Case”, it
effectively forged alliances in civil society
in creating an international debate on
the abusive practice of evergreening patents. This groundswell of support and
the local and international outcry on the
daring tactics pharmaceutical companies
will stoop to in order to secure profit, set
the tone of the campaign and formed the
backdrop to the legal case.
Ultimately, the campaign showed that
there is no reason for developing countries
to have a system that blindly hands out
patents when clear measures to protect
people’s access to medicines and prevent
abusive patenting practices by the pharmaceutical industry can be taken.
54
9 See Gopakumar’s (2013) accompanying article.
10 Marketed as Glivec.
11 See Dutfield’s (2013) article for a discussion.
Notes
1 In March 2000, the daily dose (400 mg) of fluconazole needed to treat cryptococcal meningitis cost $17.84, more than two times the daily
wage of an average employed South African
who earned just $7.69. In Thailand, however,
the daily dose of fluconazole costs just $1.20
(Doctors Without Borders 2000).
2 A common patenting practice in the pharmaceutical industry aimed at filing and then
obtaining separate (and sequential) patents relating to different aspects of the same medicine, such as different dosages, formulations,
fixed dose combinations and different forms of
the active ingredient, among others.
3 In September 1986, early clinical tests showed
that Azidothymidine (AZT), a drug first synthesised in 1964 to be used as chemotherapy
for leukemia, slowed down the progress of the
disease. In 1987, AZT became the first anti-HIV
drug to be approved by the US FDA.
4 US4724232, Glaxo Wellcome, February 1988,
viewed on 30 June 2013, http://patft.uspto.
gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=
HITOFF&d=PALL&p=1&u=%2Fnetahtml%2F
PTO%2Fsrchnum.htm&r= 1&f=G&l= 50& s1=
47 24 32.PN. &OS=PN/ 4724232& RS= PN/
4724232
5 ZA9709726, Glaxo Wellcome, 1997, viewed on
30 June 2013, http://apps.who.int/medicinedocs/en/d/Js4913e/7.html
6 Under the 1970 Patents Act, India did not grant
product patents on medicines.
7 On 19 November 2003, the South African
National Department of Health announced an
“Operational Plan” for the rollout of ARV medicines in the public health system. UNAIDS/
WHO statistics from 2004 suggested that of the
approximately 5.3 million people living with
HIV/AIDS in the country, 7,50,000 were in
need of ARV treatment.
8 The TRIPS Agreement came into effect on 1
January 1995, setting out minimum standards
for the protection of intellectual property,
including patents on pharmaceuticals. Under
that agreement, since 2005 new drugs may be
subject to at least 20 years of patent protection
in all, apart from in the least-developed countries and a few non-World Trade Organization
members, such as Somalia.
References
Correa, Carlos M (2013): “Is Section 3(d) Consistent with TRIPS?”, Economic & Political Weekly,
48(32).
Doctors Without Borders (2000): “‘One World, One
Price’ Means Death for People With AIDS in
Poor Countries”, 13 March, viewed on 30 June
2013, http://www.doctorswithoutborders.org/
press/release.cfm?id=536
– (2006): “MSF Urges Novartis to Drop Case
Against Indian Government”, 20 December,
viewed on 30 June 2013, http://www.doctorswithoutborders.org/press/release.cfm?id=37
15&cat=press-release
Dutfield, Graham (2013): “Who Invented Glivec?
Does It Matter Anyway?”, Economic & Political
Weekly, 48(32).
Ghose, Sagarika (2013): “FTN: SC Ruling on
Novartis: Should Cancer Drugs be Cheaply
Available?”, IBN Live, 2 April, viewed on
30 June 2013, http://ibnlive.in.com/videos/
382785/ftn-sc-ruling-on-novartis-should-cancer-drugs-be-cheaply-available.html
Grover, Anand (2013): “Analysing the Supreme
Court Judgment”, Economic & Political Weekly,
48(32).
Love, James (2013): “R&D Costs for Gleevec”,
Knowledge Ecology International, 3 April,
viewed on 30 June 2013, http://lists.keionline.
org/pipermail/ip-health_lists.keionline.org/
2013-April/003005.html
Novartis (2013): “Supreme Court Denial of Glivec
Patent Clarifies Limited Intellectual Property
Protection and Discourages Future Innovation
in India”, 1 April, viewed on 30 June 2013,
http://www.novartis.com/newsroom/mediareleases/1689290.shtml
Menghaney, L (2013): “R&D: What Novartis Says...
and Why It’s Wrong”, Livemint, 12 April, viewed
on 30 June 2013, http://www.livemint.com/
Opinion/ 3KaBPvulUVkRSoDh8xkVRJ/RDWhat-Novartis-says-and-why-its-wrong.html
Sengupta, Amit (2013): “Two Decades of Struggle”,
Economic & Political Weekly, 48(32).
Survey
August 27, 2011
Experimental Economics: A Survey
by
Sujoy Chakravarty, Daniel Friedman, Gautam Gupta, Neeraj Hatekar, Santanu Mitra, Shyam Sunder
Over the past few decades, experimental methods have given economists access to new sources
of data and enlarged the set of economic propositions that can be validated. This field has
grown exponentially in the past few decades, but is still relatively new to the average Indian
academic. The objective of this survey is to familiarise the Indian audience with some aspects
of experimental economics.
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august 10, 2013
vol xlviii no 32
EPW
Economic & Political Weekly
THE GLIVEC PRECEDENT
The Need to Curb Patents
on Known Substances
K M Gopakumar
Despite a progressive judgment
by the Supreme Court of India
on Section 3(d) of the Indian
Patents Act, the processes of
legislation and implementation
are not equipped to uphold the
spirit of the Novartis judgment.
This article explains the various
loopholes that plague the system
of patents in India, and suggests
possible solutions.
L
egally speaking, the most important implication of the judgment is
that the Supreme Court has brought a great degree of clarity with regard to the interpretation of Section 3(d)
of the Indian Patents Act. Section 3(d) is
a legislative innovation to address the issue of extension of patent monopoly to
secure multiple patents on a known substance. This article suggests additional
measures for Indian law and policy to
make Section 3(d) effective in the postNovartis context.
Assessing Section 3(d)
K M Gopakumar (kumargopakm@gmail.com)
is Legal Advisor and Senior Researcher with
the Third World Network.
Economic & Political Weekly
EPW
august 10, 2013
It is important to understand the policy
concerns behind Section 3(d) to assess
the implication of the Supreme Court
judgment. As explained in Sengupta’s
(2013) accompanying article, the objective
of Section 3(d) was to prevent the evergreening of patents on known substances
which also delayed generic entry.1
Instead of an ex ante exclusion of the
patents for known substances, India
opted for the more circuitous route of
Section 3(d).2 Unfortunately, Section 3(d)
does not shut the door on serial patenting of known substances as it allows
such patents if the claimed invention on
known substance differs significantly in
properties with regard to efficacy. This
small opening of serial patenting of
known substances is further complicated
by the absence of any definition for
the term “efficacy”.3
The patent office continues to grant
patents on known substances even after
the verdict of the Madras High Court,
which limited the efficacy requirement
under Section 3(d), with respect to
pharmaceutical products, to therapeutic efficacy.4 Over the last eight years,
the patent office has failed to provide an
effective filtering mechanism to translate the legislative intent into practice.
As Grover’s (2013) accompanying article
explains, the Supreme Court judgment
vol xlviii no 32
is significant in concurring with the
interpretation proposed by the Madras
High Court; thus, reading “efficacy” as
“therapeutic efficacy”. Pointedly, the
Supreme Court rejected rendering efficacy claims with regard to the physical
and/or presentational properties, without any corresponding enhancement in
therapeutic efficacy.
Supreme Court’s Understanding
The Supreme Court clearly held that
What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly
relate to efficacy, which in case of medicine,
as seen above, is its therapeutic efficacy.
Further, the Court held that
...Hence, the mere change of form with properties inherent to that form would not qualify
as ‘enhancement of efficacy’ of a known substance. In other words, the explanation is
meant to indicate what is not to be considered as therapeutic efficacy.
However, the Supreme Court does not
rule out the patent protection of known
substances while it narrows down the
scope of the efficacy criteria. The Supreme
Court does not answer nor explain what
types of elements can fall under therapeutic efficacy. For instance, it does not
deal with the question of whether the
reduction in toxicity or enhanced bioavailability can be considered as therapeutic efficacy. Hence, the patent applicant may argue that these elements constitute an enhanced therapeutic efficacy
in the absence of clear criteria on “therapeutic efficacy”. Another round of litigation may clarify the constituent elements
of the therapeutic criteria.
Further, the Court does not examine
whether the conversion of a molecule from
its free base form to its salt or crystalline
form satisfies the inventive step criterion.
In a way, the Court reassured pro-patent
advocates by stating that: “the beta crystalline form of Imatinib Mesylate does not
qualify the test of Section 3(d) of the Act
but that is not to say that Section 3(d)
bars patent protection for all incremental
inventions of chemical and pharmaceutical substances”. The application of the
Supreme Court judgment on the ground
is in the hands of the patent office, which
is to examine patent applications by
55
THE GLIVEC PRECEDENT
using the therapeutic criteria laid down
in the judgment.
Curbing Serial Patents
The above discussion clearly shows that
the Supreme Court judgment does not rule
out the patenting of known substances,
but has significantly narrowed down the
scope of Section 3(d). Patents for known
substances are now only limited to those
inventions, that can prove the enhancement of known therapeutic efficacy. The
practice of the Patent Office clearly
shows that it fails to translate the policy
objective in its day-to-day business.
Hence, a very pragmatic option at this
stage would be for an amendment to
limit “efficacy” to “therapeutic efficacy”,
as mentioned in the Supreme Court
judgment along with certain clear criteria to judge therapeutic efficacy.5 This is
essential to consolidate the policy objective against patents on known substances.
The following suggestions would help
curb patenting of known substances.
Review of Existing Patents
Since the introduction of product patents for pharmaceuticals in 2005, the
Patent Office has granted around 6,000
to 7,000 of them. The Patent Office itself
revealed that between 2007 and March
2010, it has granted 3,470 product patents.
As mentioned above, many of these patents are likely to have been granted in
violation of Section 3(d). Therefore, it is
important to review these grants in the
light of the Supreme Court judgment,
and, in instances, revoke any wrongfully
granted patents under Section 66 of the
Patents Act, which states:
Where the central government is of opinion
that a patent or the mode in which it is exercised is mischievous to the State or generally
prejudicial to the public, it may, after giving
the patentee an opportunity to be heard,
make a declaration to that effect in the
Official Gazette and thereupon the patent
shall be deemed to be revoked.
Many of the patents on known substances may not be of any consequence
for generic entry. However, some of these
patents delay the entry of generics, like
in the case of Trastuzumab, which is a drug
used for the treatment of HER2 Positive
breast cancer. This is an important
medicine and has proved effective in the
56
treatment of breast cancer. It is marketed
in India by Roche, which owns the patent
through its subsidiary Genentech. Roche
sells this medicine in India under two
brand names at different prices. The first
brand, i e, a global brand known as
Herceptine is sold at a maximum retail
price (MRP) of Rs 1,34,000. The second
brand has an MRP of Rs 75,000. According to news reports, the Ministry of
Health is considering to issue a notification under Section 92 of the Indian
Patents Act to expedite the issuance of a
compulsory licence (Livemint 2013).
The original molecule, a pre-1995 one,
is not under patent protection in India.
However, there is another patent, Patent
No 205534, granted on 5 April 2007 by
the Kolkata Patent Office. This patent
claims priority on 6 May 1998. The drug
obtained marketing approval on 25 September 1998.
This patent contains seven claims.
The first claim states: A composition
comprising a mixture of anti-HER2 antibody and one or more acidic variants
thereof, wherein the amount of the acidic
variant(s) is less than 25%. One cannot
find any claim of therapeutic efficacy
even in the subsequent claims. However,
a patent has been granted on this application and it is blocking the generic
entry of Trastuzumab in India.
Disclosure of INN
Another important step to curb the patenting of known substances is through the
mandatory disclosure of the International
Nonproprietary Names (INN) as recommended by the East African Community
(EAC) Regional Policy on Utilistaion of
Public Health WTO Related TRIPS Flexibilities (EAC 2013). The disclosure of INN
clearly provides evidence as to whether
the substance is known or not. This
would further make the examination
procedure easy through the identification
of the literature on known substances in
pharmacology and to gauge the claims
of enhanced therapeutic efficacy. To
strengthen this obligation to disclose,
the INN includes the threat of revoking a
patent on the grounds of intentional
non-disclosure or wrong disclosure. In
the case of new chemical entities (NCEs),
there should be an obligation on the part
august 10, 2013
of the applicant to disclose the INN
immediately after the allocation of INN.
Amendment of Procedure
The patent office should incorporate the
Supreme Court judgment in the examination manual and apply therapeutic efficacy
as the sole criteria to apply Section 3(d).
The current draft manual even bypasses
the legislative intent behind Section 3(d).
This draft manual still contains the decision of the Madras High Court, but does
not contain clear instructions to implement the therapeutic efficacy criteria.
Further, it contains instructions contrary
to the criteria. For instance, it states that
“Isomers having the same empirical formula but having structural differences
may be considered novel and may not
normally offend ‘obviousness’ as they are
structurally different” (Patent Office 2008).
This statement instructs the examiner to
ignore the legislative requirement on efficacy and to accept claims on an isomer
with structural differences, making it
eligible for patent protection. Hence, it is
important to amend the manual to incorporate the Supreme Court decision on the
requirement of “therapeutic efficacy”.
Curbing Divisional Applications
Another important step is to check the
practice of filing divisional applications.
A divisional patent application is allowed
to help the applicant claim the priority
date of the original application and file
subsequent improvements in the invention. However, transnational pharmaceutical companies often use divisional applications to discourage generic manufactures. These pending applications with
the patent office delay the introduction of
a generic version. At the moment, there is
no restriction on the number of divisional
applications one can file. At times, divisional applications are filed even after
the rejection of the original patent application. Gilled Life Sciences used divisional applications on Tenofovir to issue
a voluntary license to Indian generic companies with restrictive conditions.
Training Required
It is important to train the officers in the
patent office and the judiciary regarding
the Supreme Court’s interpretation of
vol xlviii no 32
EPW
Economic & Political Weekly
THE GLIVEC PRECEDENT
Section 3(d) and on the measures to be
taken on how a public health-oriented
jurisprudence should be used to interpret
the therapeutic efficacy criteria. Further,
the training should ensure that both the
judiciary and the officers in the patent
office should reflect the legislative intent
while interpreting Section 3(d), i e, while
deciding on the patentability of known
substances. Towards this purpose, the
government should review its memorandum of understanding (MoU) with developed country patent offices and remove
clauses on capacity building. Further, there
should be clear norms and standards for
the interaction of judicial officers with
their foreign counterparts, as well as their
participation in the conferences and other
meetings organised by academic institutions, non-governmental organisations
(NGOs), industry lobbies and law firms.
Policy Coherence
There is a need to ensure policy coherence
across sectors. While the government
welcomes the Novartis judgment and
supports the non-patenting of known
substances, such a policy should be implemented across the board. However, this
approach is currently missing. A concrete
case is the exemption rules under the
Drug Price Control Order (DPCO). DPCO
contains a rule which excludes Indian
companies from drug pricing rules if the
company obtain patents on medicines,
provided the company’s research and
development is done indigenously. It is
very clear that such patents can be
obtained only on known substances.
Similarly, India should not negotiate
intellectual property (IP) as part of its
free trade agreement (FTA) engagements.
Developed countries often push for strong
IP protection and enforcement standards
through FTA. India is currently negotiating
with the European Union (EU), Canada,
Australia and New Zealand. Some of the
developing countries are demanding for
patents on known substances through the
FTA. For instance, US FTA contains provisions for extension of patents for new use.
Bilateral Investment Treaties
Lastly, India’s obligations under various
Bilateral Investment Treaties (BITs) may
prevent the taking of effective measures
Economic & Political Weekly
EPW
august 10, 2013
to curb patents on known substances.
The current definition of investment includes IP rights including patents, and
therefore the proposed review of BITs
should also aim at removing IP rights
from the definition of investments. This is
relevant, especially in light of the revocation of Eli Lilly’s patents by the Canadian
Court. The Canadian court revoked the
patents citing failure to deliver the benefits Eli Lilly claimed while obtaining the
patents (Public Citizen 2013). The current
BIT provisions threaten the post-grant
revocation of patents by the patent office,
the Intellectual Property Appellate
Board and the courts.
Conclusions
The above discussion clearly shows that
while the Supreme Court narrowed the
possibilities of obtaining patents on
known substances, it does not rule out
the possibilities. There is still an element
of uncertainty with regard to the interpretation of “therapeutic efficacy”. In the
absence of a shared understanding on
the meaning of the term “therapeutic
efficacy”, there is the threat of diluting
the policy concerns on patenting of known
substances through judicial interpretation or the practices of the patent offices.
Therefore, a long-term solution is required
to further strengthen law to reflect the
policy concerns. This article also suggests certain measures to effectively
implement the Supreme Court judgment
and limit patent protection of known
substances on the sole criteria of enhanced therapeutic efficacy.
Notes
1
2
A study by the author shows that by analysing
the patent expiry data provided in the USFDA
Orange Book and further research to trace the
patent history of new chemical entities (NCEs)
reveal that out of 301 new molecular entities
(NMEs) approved by the USFDA between
1995 and 2004, 291 were invented prior to
1995. An explicit exclusion of inventions prior
to 1995 would have put many NCEs approved
by USFDA till 2004 out of the patent protection in India (Chaudhuri et al 2010: 114).
Section 3(d) itself was a proposal from the
government during its negotiation with the left
parties, which proposed limiting of patent
protection only to new chemical entities. Government of India obtained the language from a
letter of Justice V R Krishna Iyer, who is believed to have obtained the language from
Veda Raman, the former Controller General of
Patents. Late B K Keyla, Convener of National
Working Groups on Patent Laws (1989-2010)
disclosed this to the author in August 2005.
vol xlviii no 32
3
4
5
Sharing the concern, the Parliamentary Standing Committee on Commerce in its report in
2008 recommended, “The government should
clarify the usage of terms ‘significantly’ and ‘efficacy’, which form parts of Section 3(d), to
clear the ambiguities involved in the interpretation of the said section” (Parliamentary
Standing Committee on Commerce 2008).
A study by the National Intellectual Property
Organisation (NIPO) identifies at least 86
patents granted on known substances or combinations of substances bypassing Section 3(d)
(James 2010).
Ideally a country like India should curb the patenting of known substances by amending its
patent law to explicitly exclude patents for
known substances. The easiest way to do this
is by deleting the three-qualifications from
Section 3 (d). First, the word “mere”, second,
“which does not result in the enhancement of
the known efficacy of that substance”, third,
“unless they differ significantly in properties
with regard to efficacy”.
References
Chaudhuri, S, C Park and K M Gopakumar (2010):
“Five Years Into The Product Patent Regime:
India’s Response”, United Nations Development Programme, viewed on 3 July 2013,
http://www.undp.org/content/india/en/home/
knowledge-and-solutions/discussion-papers/
five_ years_into_ theproduct patentregimeindiasresponse.html
EAC (2013): Regional Intellectual Property Policy on
the Utilisation of Public Health-Related WTO-TRIPS
Flexibilities and the Approximation of National
Intellectual Property Legislation (Arusha: East
African Community), viewed on 3 July, http://
www.cehurd.org/wp-content/up loads/downloads/2013/05/EAC-TRIPS-Policy.pdf
James, T C (2010): Patent Protection and Innovation: Section 3(d) of the Patents Act and Indian
Pharmaceutical Industry (National Intellectual
Property Organization).
Livemint (2013): “Health Ministry Recommends
Compulsory Licensing of Three Anti-Cancer
Drugs”, 16 January, viewed on 3 July, http://
www.livemint.com/Companies/F3Rn5jCkKjCJNYzh tuQseO/Health-ministry-recommendscompulsory-licensing-of-three-ant.html
Parliamentary Standing Committee on Commerce
(2008): 88th Report on Patents and Trade Marks
Systems in India (New Delhi: Rajya Sabha),
viewed on 3 July 2013, http://164.100.47.5/
newcommittee/reports/EnglishCommittees/
Committee%20on%20Commerce/88th%20
Report.htm
Patent Office (2008): Draft Manual of Patent Practice
and Procedure (Mumbai: Controller General
of Patents, Designs & Trade Marks), viewed on
3 July 2013, http://ipindia.nic.in/ipr/patent/
DraftPatent_Manual_2008.pdf
Public Citizen (2013): “Elli Lilly Investor State Dispute
Fact Sheet”, Public Citizen, viewed on 3 July 2013,
http://www.citizen.org/documents/eli-lillyinvestor-state-factsheet.pdf
Sengupta, Amit (2013): “Two Decades of Struggle”,
Economic & Political Weekly, 48(32).
available at
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