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
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