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Special Issue on The GlivecPrecedent, Economic and
Political Weekly, Vol.
XLVIII No.32, pages 4157.
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THE GLIVEC PRECEDENT
Economic & PoliticalWeekly EPW august 10, 2013 vol xlviii no 32 41
Who Invented Glivec?Does It Matter Anyway?
Graham Dutfield
This article looks at Glivecs
journey from its invention to
its patenting and sale while
questioning the concept of credit
for inventions in science and
technology.
In 2003, the then Novartis Chief
Executive Officer Daniel Vasella pub-
lished a book (Vasella and Slater
2003) in praise of Glivec detailing his
firms major role in delivering this un-
commonly effective life-saving medi-
cine. But, who was really responsible? In
the original USpatent,1one single per-
son is named as the inventor: Jrg Zim-
mermann of Ciba Geigy (later Novartis).
In the later USpatent on the beta crystal-
line form, held in India to be unpatentable,
Zimmermann is joined by two Novartis
colleagues.2However, 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, ad-
vanced technical knowledge in one or moredisciplines, 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 to-
gether a whole cast of actors and locations
over broad geographical and chronologi-
cal 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).
Glivec: To Whose Credit?
Which stories are most complete and
accurate depends largely on what Glivec
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 closelyassociated 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 extraordi-
narily 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 theindividual 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 thresh-
olds. Legally, it is immaterial whether
this persons effort or intellectual input
was proportionately significant compared
to anybody elses, and this may not
necessarily be seen as unfair.
None of the numerous scientists who
contributed has publicly challenged
Zimmermanns sole inventorship. Zimmer-
mann 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 (Buch-
dunger and Zimmermann ND).
Competing claims could be made for
Nicholas Lydon or Alex Matter of CibaGeigys programme on kinase inhibitors.
But, if one really can single out the
Graham Dutfield ([email protected])
teaches International Governance at the
School of Law, University of Leeds, UK.
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THE GLIVEC PRECEDENT
august 10, 2013 vol xlv ii i no 32 EPW Economic & PoliticalWeekly42
irreplaceable person without whom
there would have been neither an inven-
tion nor a pharmaceutical product called
Glivec, then it would probably be Brian
Druker, initially of the Dana-Farber Can-
cer Institute, and thereafter at the Ore-
gon 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 com-
mitment to do all that was necessary to
cure leukaemia patients led him to
collaborate with Lydon and Ciba Geigy
to harness the companys biochemical
capacity in kinase inhibition to his
search for a molecule that was able
specifically to block the action of a sin-
gle aberrant enzyme common to the
cells of CMLsufferers. 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 incrediblypersistent 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 Novartiss 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 USFood and
Drug Administration approved Glivec.
Novartis subsequently set a global
patient-per-month price of $2,400. Even
with patient assistance for poorer peo-
ple, which enabled some to get it for
free, the drug proved to be highly profit-
able. Besides, such programmes, bene-
ficial as they obviously are to some
patients, are an excellent way to dis-courage generic market entry where
there are no patents. By 2003, annual
sales had reached $1 billion, and reve-
nues 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 Mye-
loid Leukemia 2013). Such an article
could have been published several yearsago: this is hardly a new problem. But,
one hopes at this late stage that while
the key patents are still in force in sev-
eral countries, and the original USpat-
ent having been extended from its expi-
ry date of 28 May 2013 for 586 addition-
al days, it might make a difference. It is
also worth noting that Druker report-
edly welcomed the Indian Supreme
Court decision.
Brian Drukers 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 US Patent no 5521184, Pyrimidine Derivativesand Processes for the Preparation Thereof,28 May 1996.
2 US States Patent no 6894051, Crystal Modi-fication of a N-phenyl-2-Pyrimidineamine
Derivative, Processes for Its Manufacture andIts Use, 17 May 2005.
References
Brody, H (2007):Hooked: Ethics, the Medical Profes-sion and the Pharmaceutical Industr y (Lanham:Rowman & Littlefield).
Buchdunger, E and J Zimmermann (nd): The
Story of Gleevec, viewed on 2 June 2013,http://www.innovation.org/index.cfm/StoriesofInnovation/InnovatorStories/The_Story_of_Gleevec
Druker, B, S Tamura, E Buchdunger, S Ohno,G M Segal, S Fanning, J Zimmermann andN B Lydon (1996): Effects of a Selective Inhibitorof the Abl Tyrosine Kinase on the Growth ofBcr-Abl Positive Cells, Nature Medicine , 2(5):561-66.
Experts in Chronic Myeloid Leukemia (2013): ThePrice of Drugs for Chronic Myeloid Leukemia(CML) is a Reflection of the UnsustainablePrices of Cancer Drugs: From the Perspective ofa 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 Revolu-tion: How Smart Drugs and Other NewTherapies Are Renewing Our Hope and Chang-ing the Face of Medicine (Hoboken: John Wiley& Sons).
Nowell, P C and D A Hungerford (1960): A MinuteChromosome in Human Chronic GranulocyticLeukemia, Science, 132(3438): 1497.
Vasella, D and R Slater (2003):Magic Cancer Bullet:How a Tiny Orange Pill Is Rewrit ing MedicalHistory (New York: HarperBusiness).
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Intersections of Gender and Caste Sharmila Rege, J Devika, Kalpana Kannabiran,
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Reflexive, Anti-Caste Agency of Mang
and Mahar Women in Maharashtra Smita M Patil
Caste and Gender in a Mumbai Resettlement Site Varsha AyyarDalit 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 Swathy Margaret
Ruptures and Reproduction in Caste/Gender/Labour Meena Gopal
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THE GLIVEC PRECEDENT
Economic & PoliticalWeekly EPW august 10, 2013 vol xlviii no 32 43
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 thebackdrop of the judgment.
The judgment by the Supreme Court
of India, denying the claim of apatent on the anti-leukaemia drug
Glivec (imatinib) by the Swiss multi-
national 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 enact-
ment 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 negoti-
ations. 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, invest-
ment 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 UScontinued topress for their inclusion. The latters
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 USwas keen to open up the
services sector especially for financial
services. At the same time, the UShad 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. Indias
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 resistanceby developing countries was broken down.
Enormous pressure exerted by the US
resulted in the two main hold-outs
changing their position. India went to
the extent of replacing Indias 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 wasnot 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 NWGPLwas 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 represent-
atives of trade unions in the pharma-
ceutical 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 reso-
nance among a wide range of politicalactors. 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 develop-
ments had their roots in the popular mo-
bilisations between 1990 and 2005.
Tortuous Path
The path towards the final formulation
of Indias Patents Act was also increas-
ingly informed by, from 1991, the formal
introduction of neo-liberal reforms. From
an earlier position that India was forced
to concede to in the GATTnegotiations,
there was now an attempt to argue that
strong IP protection would promote
domestic interests. However, popular
sentiment continued to be hostile.
The TRIPSAgreement provided a three-stage time framework for developing
countries: introduction of a mailbox
Amit Sengupta ([email protected])
is co-convenor of Jan Swasthya Abhiyan
(Peoples Health Movement, India) and is alsoassociated with the All India Peoples Science
Network.
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THE GLIVEC PRECEDENT
august 10, 2013 vol xlv ii i no 32 EPW Economic & PoliticalWeekly44
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, post-1996, meant that further discussions on
amendments to Indias 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 TRIPSAgreement.
After assuming office, the NDAgovern-
ment was clearly subsumed by the neo-
liberal 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 NDAs Third Patents
(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 BJPstarted voicing
opposition to the draft Bill. While this is in
the realm of speculation, BJPs volte-face
had little to do with any opposition to thesubstance 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 UPAgovernment
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 BJPengaged 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 lefts 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 interest-
ed parties to suggest new language. At
the end, several important amendments
were made to the 2004 Ordinance
(ICTSD2005), including the insertion of
Section 3(d), which has been the subjectof much discussion after its use by the
Supreme Court to strike down the
appeal by Novartis.
The negotiations were held in the back-
drop 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 Mdecins Sans Frontires (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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THE GLIVEC PRECEDENT
Economic & PoliticalWeekly EPW august 10, 2013 vol xlviii no 32 45
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 eco-nomic significance or both. It incorpo-
rated 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 forpharma-
ceutical substanceas beinga 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 Manu-facturing Ability: The amendments
clarified that a country could import
from India if it by notification or other-
wise allowed importation of the patent-
ed pharmaceutical product from India.
(4) Continued Manufacture of Drugs
with Applications in Mailbox: The
amendments clarified that Indian com-
panies that were already producing drugs
that were the subjects of mailbox applica-
tions could continue to produce them
after payment of a royalty, even if the
drug was subsequently granted a patent.
(5) Time Period for Considering Com-
pulsory Licence Application: Concerns
that the process of granting compulsory
licences could take too long were ad-
dressed by specifying that the reasonable
time period before the Patents Controller
considers issuance of a compulsory licence
when such a licence is denied by thepatent holder shall not ordinarily exceed
six months.
(6) Export by Indian Companies of
Patented Drugs: The amendments pro-
vided 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 tosafeguard access. In particular, the pre-
grant 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 Manufac-
turers 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 consti-
tuted 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
TRIPSAgreement. 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 ex-
peditiously accepted by the government.
Vindication of Struggle
The Supreme Court judgment in the
Novartis case, thus, needs to be read not
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 incorpo-
rated 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
amend-
ments in clauses (j) and (ja) of section 2(1)
and the amendments in section 3 it is
neces-
sary 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 popu-
lar resistance and mobilisation in
India and across the world that chal-
lenged corporate power. Small victories
such as this become inspirations for
larger battles.
Notes
1 For more informat ion about the formation ofthe NWGPL, see Sen Gupta (2010).
2 See, for example, Arulanantham (2004).
3 Text of final judgment is available at: http://ju-
dis.nic.in/supremecourt/imgs1.aspx? filename=40212 (viewed on 20 June 2013).
References
Arulanantham, David P (2004): The Paradox ofthe BJPs Stance Towards External EconomicLiberalisation: Why a Hindu Nationalist PartyFurthered Globalisation in India, Asia Pro-gramme Working Paper, December, RoyalInstitute of International Affairs, ChathamHouse, London.
ICTSD (2005): Indian Parliament Approves Con-troversial Patent Bill, Bridges Weekly Trade
News Digest, 9(10), International Centre forTrade and Sustainable Development, viewedon 20 June 2013, http://ictsd.org/i/news/
bridges weekly/7294/Khor, Martin (2013): A Victory for Patients Access
to Medicines, Global Trends Series, ThirdWorld Network, 8 April, viewed on 20 June2013, http://www.twnside.org.sg/title2/gtrends/2013/gtrends426.htm
Marcel lin, Sherr y S (2010):The Political Economy ofPharmaceutical Patents: US Sectional Interestsand the African Group at the WTO(Farnham,England: Ashgate Publishing).
Padma, T V (2007): Plagiarised Report on PatentLaws Shames Indian Scientists,Nature Medicine,13(4): 392.
Sen Gupta, Amit (2010): B K Keayla: A PersonalReminiscence, Economic & Political Weekly,45(51): 25-26.
Shukla, S P (2000): From GATT to WTO and Be-yond, Working Papers No 195, United NationsUniversity/World Institute for DevelopmentEconomics Research, Helsinki, Finland.
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Economic & PoliticalWeekly EPW august 10, 2013 vol xlviii no 32 47
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 Indiangeneric companies.9Novartis 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 ad-
ditional affidavits ostensibly to show
that on account of the alleged increased
bioavailability (30%) of the crystalline
form imatinib mesylate, there was a sig-
nificant increase in the efficacy in the
claimed invention.10While there was no
dispute as to the claimed inventions
industrial applicability, the Patent Con-
troller concluded that the claimed in-
vention was neither novel nor inventive
and was also hit by Section 3(d), thus,
rejecting the application.
Against this order, Novartis filed ap-
peals before the Madras High Court.
These were later transferred to the Intel-
lectual Property Appellate Board (IPAB).Both, NovartisAGand Novartis India also
challenged the validity of Section 3(d) on
the grounds that it did not comply with
the TRIPSAgreement and the term effi-
cacy was vague and, therefore, in viola-
tion 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 IPABreversed the
Patent Controller order on two grounds,
and held that the claimed invention was
novel and inventive. However, it agreedwith the Patent Controller that it was hit
by Section 3(d) and rejected the patent
application. It was against this order
that Novartis filed the Special Leave
Petition in the Supreme Court.
In the Supreme Court, the maintain-
ability of Novartiss appeal was dropped
and it was heard on merits.
On MeritsNovartis 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 crystal-
line form of imatinib mesylate.
On the interpretation of Section 2(1)(j)
and (ja) and Section 3, the Court, speak-
ing 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 ap-
plication itself. Moreover, the acid addi-
tion salt forms could be made in a cus-
tomary manner or in the manner knownper 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 UKfrom marketing the mesylate form.
Therefore, the Court observed, that
there was no room for doubt that imat-
inib 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 in-
hibition of tyrosine kinase activity, were
also found in the pharmaceutically
acceptable salt forms, particularly not-
ing that the authors of Cancer Research
had concluded that in respect of proper-
ties no significant difference in results
could be seen between the two forms ofCGP 57148.12 Similar findings were
recorded in an article in the journal,
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 andtherefore 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 inHogan.13The Court found that
Hogan was rendered in very specific
circumstances and later decisions of the
US courts had narrowed that down to
Hogans impact. Additionally, on the basis
that the artificial distinction between
coverage and disclosure negated the fun-
damental rule underlying patents, the
argument was rejected.
The Crystalline Form:
Interpreting 3(d)
For the purposes of argument the Court
accepted that the crystalline form im-
atinib mesylate was new and not obvi-
ous.14Of course, the crucial question be-
fore the Court was, whether in view of
Section 3(d) as amended, Novartis couldbe granted a patent on the claimed in-
vention of the crystalline form of imat-
inib 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 chemicalsubstances and that Section 3(d) had
been enacted to prevent evergreening.
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The Court found that as the crystal-
line 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 compari-
son could be made of the crystallineform of imatinib mesylate with a known
substance with known efficacy as
required under Section 3(d). This was re-
jected 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 pub-
lic, 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 sci-
ence or men of commerce or consumers.
In examining the efficacy of the dif-
ferent forms of imatinib, that is imatinib
free base, non-crystalline form of imat-
inib mesylate, and the crystalline form
of imatinib mesylate, the Court noted that
it was Novartiss own case that all the
properties possessed by the imatinib free
base were possessed by the crystalline
form of imatinib mesylate. In the circum-stances the Court queried how there
could be any enhanced efficacy in the
crystalline form of imatinib mesylate?
In this respect, Novartis filed two affi-
davits 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 bio-
availability in the crystalline form of
imatinib mesylate as compared to the
imatinib free base. The Court noted that it
was Novartiss own case that the product
immediately preceding the crystalline
form imatinib mesylate is the non-
crystalline 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 crystalline imatinib mesylate overnon-crystalline imatinib mesylate, which
Novartis had failed to do. Moreover, the
Court opined that the bioavailability
of the 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 in3(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 con-
text 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 medi-
cines, 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 advan-
tageous or beneficial properties are rele-
vant, but only such properties that di-
rectly relate to efficacy, which in case of
medicineis its therapeutic efficacy.
Thus, holding that the physico-
chemical properties of the crystalline
form of imatinib mesylate contended by
Novartis to be properties with regard
to efficacy, namely more beneficialflow 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 CPAAargued that in the pharma-
ceutical 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. Bioavail-
ability, on the other hand, is a pharma-
cokinetic property. It is the term used to
indicate the extent to which a dose of
drug reaches its site of action or a bio-logical fluid from which the drug has
access to its site of action.
Shamnad Basheer, intervenor-cum-
amicus, 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 byitself may or may not result in its efficacy
being affected. In terms of Section 3(d),
it must be claimed and established by re-
search data with in vivo animal models,
which Novartis had not done. Therefore,
the claimed invention,crystalline form
of imatinib mesylate, failed the test of
Section 3(d). Thus, Novartiss appeal
came to be dismissed, and the others by
the CPAAand 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 lobby-
ing by western pharma MNCsto whittle
down Section 3(d) has been repelled.
Notes
1 The unfinished agenda is now being pursuedthrough the free trade agreements.
2 These deliberations included the Tek Chandand Ayyangar Committees and various Parlia-mentary Committees.
3 Earl ier Parliament had refused to introducethis, as a result of which India was taken to theTRIPS Disputes Council where India lost. Indiathen appealed again. It lost again. Parliamenthad no choice but to introduce the interimregime of EMR to avoid trade sanctions.
4 In 1999 the Patent Act was amended to providepatent protection for foods and medicines. The2002 amendments were made to amend Sec-tion 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 83relating to general principles. In 2005 apart
from amending Section 3(d), amendmentswere carried to Section 2(1)(ja) and the provisionof pre-grant opposition under Section 25(1). Asa result of all the amendments India has beenable to use TRIPS flexibilities to the maximum.This includes patentability criteria, pre-grant,post-opposition, revocation procedures, counterclaim in infringement suits to set aside the grantof the patent, provisions for compulsory licences,government use, etc.
5 The World Health Organization (WHO) andthe UNAIDS, amongst others, had appealed toIndian Parliamentarians to keep in mind thatIndia was the pharmacy of the poor in the de-
veloping world while making the final amend-ment (see Sengupta 2013).
6 The Doha Declaration of 11 December 2001
issued by the Inter Ministerial Conference ofthe WTO recognised the gravity of publichealth problems and that the TRIPS Agreementhas to be interpreted to protect public health.
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7 Interestingly the letter from the WHO wassigned by the present president of the WorldBank Jim Young Kim.
8 Thus, in India the MNCs have, with the localindustry formed the US-India Business Coali-tion, which has issued documents aboutthe need to delete Section 3(d) from thePatents Act.
9 Under the Indian Patents Act any person can filea pre-grant opposition on the grounds indicated
in Section 25(1). Post-grant opposition can befiled only by a person interested.
10 The study was conducted on rats, but the com-parison was with the base form of imatinib and
not with the mesylate form of imatinib, whichwas also known at that time.
11 Madras High Court Writ Petition No 24759 and24760 of 2006, at para 19.
12 Referring to the imatinib base and the mesylatesalt form of imatinib.
13 Application of John Paul Hogan and Robert LBanks, 1977 (559 F.2d 595).
14 The Court did go into the issue of novelty ornon-obviousness of the crystalline form imat-
inib mesylate. It dealt with the issue of the ap-plicability of Section 3(d).
15 Monsanto Company vs Coramandal IndagProducts (P) Ltd, 1986 (1 SCC 642).
References
Correa, Carlos M (2013): Is Section 3(d) Consistentwith TRIPS?,Economic & Political Weekly, 48(32).
NIHCM (2002): Changing Patterns of Pharmaceuti-cal Innovation(Washington: National Institutefor 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 ofIndian Generic Manufacturers in Supplying Anti-retroviral Medicines to Developing Countries,
Journal of the International AIDS Society, 13: 35.
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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 theIndian Patents Act, which is
compatible with the Trade-Related
Aspects of Intellectual Property
Rights Agreement, but about
which questions can still be raised.
Novartis 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 gov-
ernment did not initiate a case in the
World Trade Organization (WTO) in sup-
port of Novartiss argument regarding
the alleged violation of TRIPS. However,the Supreme Court decision has not
foreclosed the possibility of such com-
plaints 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 (USTR2013: 38) that the Indian
Supreme Court decision
appears to confirm that Indias law creates a
special, additional criterion for select tech-
nologies, like pharmaceuticals, which could
preclude issuance of a patent even if the ap-
plicant demonstrates that the invention is
new, involves an inventive step, and is capa-
ble of industrial application.
This statement suggests the possible
incompatibility of Section 3(d) with two
aspects of Article 27.1 of the TRIPS
Agreement: (a) the non-discriminationclause,2and (b) the obligation to grant
a patent when the three patentability
criteria specified in that article (novelty,
inventive step/non-obviousness, industrial
applicability/utility) are met, without im-
posing 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 proc-
esses3that suggested possible inconsist-
encies with Article 27.1 of the TRIPS
Agreement. Some of those questions
(posed by Japan, the European Union)
specifically addressed the patentabilityof crystalline forms, the subject matter
of Novartis s patent application in India.
Does It Discriminate?
The obligation not to discriminate con-
tained in Article 27.1 applies both to the
availability and enjoyment of patent
rights, meaning that neither the acquisi-
tion of patent rights nor the means
for enforcement can be subject to dis-
crimination. Although the provision is
broad in this respect, it is only applica-
ble 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 prod-
ucts are imported or locally produced
(Correa 2007).
Arguments about the possible incon-
sistency of Section 3(d) with the TRIPS
Agreement allude to the second ground
the field of technology.
A possible conflict with the non-discrimination clause was unsuccessfully
claimed by the European Commission (EC)
Carlos M Correa ([email protected]) teaches at
the University of Buenos Aires and is Advisoron Intellectual Property and Trade, South
Centre, Geneva.
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in its complaint against Canada relating
to the Bolar exception (WTO2000).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 pharma-
ceutical products, but to any chemicalproduct. 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 pharma-
ceutical 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 regula-
tions, 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 pharma-
ceutical inventions in national laws and
policies, including in developed countries.
Thus, several patent offices have adoptedspecific 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 (PartVII, Chapter 3).
Moreover, some national laws contain
provisions specifically related to phar-
maceuticals which have never been chal-
lenged under the WTO rules: the French
industrial property law provides for the
grant of compulsory licences on patents
relating to medicines (Article L613-16);
the Australian USFree Trade Agreement
Implementation Bill 20046 introduced
anAU$10 million penalty for drug patent
litigation in bad faith; under USlegislation
(35 USCSection 156) and in accordance
with the free trade agreements (FTAs)
signed by the USwith a number of coun-
tries,7 special provisions apply for the
extension of the term of pharmaceuticalpatents to compensate for delays in the
marketing approval of medicines.
Another potential objection to Sec-
tion 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 interpreta-
tions 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
IPABconsidered that Novartiss 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 crystalline form of imatinib me-
sylate fails in both the tests of invention
and patentability as provided under
clauses (j), (ja) of Section 2(1) and Sec-
tion 3(d) respectively (para 195).9It has also been suggested that
Section 3(d) relates to the utility require-
ment for patentability: the limited inte-
gration 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
util ity that mars patent regimes (Roderick
and Pollock 2012).
Whether Section 3(d) is part of the defi-
nition of invention (as explicitly stated by
the provision)10or a patentability require-
ment (inventive step and/or utility), is not
essential for an assertion of the provisions
compatibility with Article 27.1 of the
TRIPSAgreement. 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 con-
sidered an invention for the purposes
of patent law. Like most patent laws in
the world, the TRIPSAgreement does notdefine what an invention is. Hence, WTO
members can adopt different concepts,
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 TRIPSAgreement, national laws candistinguish between inventions that
are patentable and other matters that
are not, as many laws actually do.11
The TRIPSAgreement permits diverse
approaches regarding the interpretation
of the obligation to patent any inven-
tions. 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 (WIPOSecretariat 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
WTOmembers to grant patents where the
specified standards are met, it does not
define them. This important flexibilityallowed, for instance, the USto maintain
until recently and defend the TRIPScom-
patibility 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
TRIPSthat in the TRIPSAgreement 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 provi-
sions of the TRIPSAgreement.13
In particular, the TRIPS Agreement
does not define the standard of non-
obviousness 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. Al-
though under most patent laws those
concepts require an enquiry as t0 whetherthe claimed invention is evident or obvi-
ous to a person with skills in the relevant
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technical field, there is in fact no uni-
formity in the way the standard is
defined and applied.
Given this important flexibility under
the TRIPSAgreement, WTOmembers can
adopt patentability criteria that avoid
the evergreening of pharmaceutical
patents, that is, the grant of patents onminor developments whose protection is
sought to delay or block generic com-
petition. Preventing evergreening was the
very purpose of Section 3(d) as extensively
elaborated on by the Indian Supreme
Court in the commented decision.14The
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 ar-
rangements of the molecules in thesolid-
state structure.15Hence, it may be argued
that a polymorph is not an invention, butrather 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 pro-
duction is obvious. For a person with
basic knowledge in organic chemistry, it
is well known, in effect, that one poly-
morph may be more stable and have
better properties than others for manu-
facturing a particular drug (Purohit and
Venugopalan 2009: 890-91).Hence, even
if a particular polymorph showed a
significant enhancement of the drugs
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 likeSection 3(d). The guidelines for the
examination of pharmaceutical patents,
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 onparticular 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 require-
ment. 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 TRIPSAgree-ment. 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
WTOmembers to determine what is the
eligible subject matter for the purposes
of the national patent law. WTO mem-
bers also have policy space to define the
specific contours of the patentability
standards, as the TRIPSAgreement does
enumerate them, but does not provide
specific rules governing their definition
and application.
Section 3(d) is not only compatible
with the TRIPSAgreement. 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 com-petition through the patenting of a broad
range of minor, often trivial developments.
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 inventivestep standard.
Notes
1 On occasion of Indias Trade Policy Review(2011) at WTO, the US questioned whether theGovernment of India considered the require-ment under Section 3(d) to be in line withTRIPS Article 27(1). Indias reply indicated thatthe 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 ofthe said Agreement.
2 Article 27.1: patents shall be available andpatent rights enjoyable without discrimination
as to the place of invention, the field of techno-logy and whether products are imported orlocally produced.
3 Joint Resolution of the Ministry of Industry(118/2012), Ministry of Health (546/2012) andInstituto Nacional de la Propiedad Industrial(107/2012).
4 See WTO (2000), para 92. It is worth notingthat the TRIPS Agreement does differentiatethe treatment given to semiconductor technol-ogies (Article 31(c)). There is also specifictreatment for the textile sector in the area ofindustrial designs (Article 25.2).
5 For instance, the US patent office and courts ap-ply differently the non-obviousness and disclo-sure standards to biotechnological and softwareinventions (Burk and Lemley 2003).
6 Amendment (2), The Senate, The Parliament ofthe Commonwealth of Australia (codified as newSection 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 which-ever way Section 3(d) may be viewed, whetheras setting up the standards of patentability oras an extension of the definition of invention,it must be held that on the basis of the materialsbrought before this Court, the subject product,that is, the beta crystalline form of ImatinibMesylate, fails the test of Section 3(d), too, ofthe Act (para 190).
10 Section 3 (chapeau): What are not inventions.The following are not inventions within themeaning of this Act.
11 See, for instance, Article 52(2) of the EuropeanPatent Convention.
12 The controversy regarding the patentability ofhuman genes in the US is illustrative of the
various views on the matter found even at thenational level (USDJAMP et a l 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 anti-
retroviral), after 18 months of its launch itsmanufacturing company Abbott observed anunexpected occurrence. The final product did notshow dissolution and the drug was precipitating.
After considerable investigations it was revealedthat this was because of a new thermodynamicallymore stable and less soluble polymorph Form-II(Purohit and Venugopalan 2009: 890-91).
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References
Burk, D and M Lemley (2003): Is Patent Law Tech-nology-Specific?, 17Berkeley Tech Law Journal,(1155), 1155-1206.
Correa, C (2006): Guidelines for the Examination ofPharmaceutical Patents: Developing a PublicHealth Perspective(Geneva: WHO, ICTSD andUNCTAD).
(2007): Trade Related Aspects of Intellectual
Property Rights (Volume VI of Commentaries onthe GATT/WTO Agreements) (Oxford: OxfordUniversity Press).
Purohit, R and P Venugopalan (2009): Polymor-phism: An Overview, Resonance , September,882-93, viewed on 8 July 2013, http://www.ias.
ac.in/resonance/September2009/p882-893.pdfRoderick, P and A Pollock (2012): Indias Patent
Laws Under Pressure, The Lancet, 380(9846):e2-e4, v iewed on 8 July 2013, http://www.the-lancet.com/journals/lancet/article/PIIS0140-6736(12)61513-X/fulltext
Sampat, B, K Shadlen and T Amin (2012): Chal-lenges to Indias Pharmaceutical Patent Laws,Science, (337): 414-15.
USTR (2013): 2013 Special 301 Report, United
States Trade Representative, viewed on 8 July2013, http://www.ustr.gov/sites/default/files/05012013%202013%20Special%20301%20Re-port.pdf
USDJAMP et al (2010): Brief for the United Statesas Amicus Curiae in Support of Neither Party,
submitted by the US Department of Justice inAssociation for Molecular Pathology, Petitionersvs Myriad Genetics, Inc et al, viewed on 8 July2013, http://graphics8.nytimes.com/packages/pdf/business/genepatents-USamicusbrief.pdf
Vure, P (2011): Polymorph Patents: How StrongThey Are Really?, International Journal of
Intellectual Property Management, 4(4): 297-306.
WIPO Secretariat (2009): Exclusions from PatentableSubject 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 Phar-maceutical Products, Report of the WTO Panel,WT/DS114/R.
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Drop the CaseCampaigning 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 Courts rejection of
Novartiss patent has set in placean important safeguard to ensure
production of affordable generic
medicines from India.
That patents on medicines can
make the difference between life
and death for millions, first hit
home with the AIDS pandemic, when
medicines to treat HIVwere priced way
out of reach of patients and governments
in developing countries.1In 1999, in the
wake of Mdecins Sans Frontires (MSF)
being awarded the Nobel Peace Prize,
MSFlaunched the Access Campaign. At thetime 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 exist-
ing drugs such as those to treat HIV/
AIDS and working to bring prices down
for its medical projects in South Africa
and Thailand.
Evergreening and AIDS Treatment
Evergreening and the issues this practice
of abusive patenting raised were first
highlighted in the late 1990s, when the
HIVepidemic was devastating communi-
ties particularly those in Africa and
the barriers to providing treatment
seemed insurmountable.2
Zidovudine (AZT) (previously Azidothy-
midine), one of the first antiretrovirals
(ARVs) to treat HIV, was a known cancer
product,3but GlaxoSmithKline (GSK) was
granted a patent for its use to treat HIV,4
making it one of the first examples ofan evergreened drug used to treat HIV.
Similarly, GSK filed a secondary patent
in 1997 on a formulation containing
lamivudine andAZT, which was granted
in several countries, including South
Africa.5 Access to these ARVs then be-
came difficult and expensive because of
these patents.
The answer to a sustainable supply of
affordable HIVmedicines 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).6The countrys
generic producers took up the challenge
in 2001 to develop genericARVs, which
they sold for just $1 per day, a fraction of
the price that multinational pharma-
ceutical companies were then charging.
With Indian producers able to manu-facture and export fixed dose combina-
tions ofARVs, the World Health Organi-
zation (WHO) launched the Treat 3 Million
by 2005 initiative in 2003. The same year,
an HIVtreatment 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.
Indias Patents Act: What Future?
In 2005, as the deadline for India to fully
implement the Trade-Related Aspects
of Intellectual Property Rights (TRIPS)
Agreement8approached, 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 Indias patent regime,and a large number including those
for HIV, tuberculosis (TB) and cancer
Leena Menghaney ([email protected]) is Campaign Coordinator (India) for the
Mdecines San Frontires Access Campaign.
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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 dif-
ferent 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 (Sec-
tion 25), and the scope of patentability
under Section 3(d) was restricted toavoid 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 sub-
stance 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 Indias 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 exa-
mination of patent applications on HIVmedicines. More importantly, Section 3(d)
had already demonstrated its importance
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 evergreen-
ing. The Indian Patent Office would haveto apply the same standards of patent-
ability on existing patent applications
covering HIVmedicines and their differ-
ent forms, meaning HIVmedicines could
be easily patented and generic compa-
nies could face expensive infringement
suits. This could ultimately result in hav-
ing a chilling effect on the availability of
affordable generic medicines.
The Campaign
In December 2006, MSFs Access Cam-
paign, 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 theseissues. The message needed to be simple
this case was a direct attack on the safe-
guards in Indias patent law and risked
dismantling Indias 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 interpreta-
tion and application of Section 3(d) tothe countrys Supreme Court. If this
challenge were successful, it could take
much of the substance out of the public
health provision, allowing evergreen-
ing, and, as Correas (2013) accompany-
ing article explains, narrowing the flexi-
bility in TRIPS.
MSF relaunched the Drop The Case
campaign, this time rebranded as Stop
Novartis, in February 2012. While theinitial campaign took the form of a peti-
tion, 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 companys @Novartis pro-
file and the hashtag of #STOPNovartis.
The new campaign almost immediately
goaded Novartis into responding, with a
series of tweets defending the companys
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 com-
mon misconceptions on the subject of
pharmaceutical patents.
These included Novartiss statementthat as imatinib mesylate had been
granted a patent in 40 countries, includ-
ing 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 sys-
tems 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 recoupedthrough the drugs high cost (Ghose 2013).
The company which claims patent
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rights in 40 countries, reaping huge
profits in return deliberately under-
played 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&Dcost
(Love 2013).
Throughout the court challenges andin the wake of the Supreme Courts
decision, which Grovers (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 sys-
tem, 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 pat-ent 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 safe-
guard 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 pat-
ents. 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
peoples access to medicines and preventabusive patenting practices by the pharma-
ceutical industry can be taken.
Notes
1 In March 2000, the daily dose (400 mg) of flu-conazole needed to treat cryptococcal menin-gitis cost $17.84, more than two t imes the daily
wage of an average employed South Africanwho earned just $7.69. In Thai land, however,the daily dose of fluconazole costs just $1.20(Doctors Without Borders 2000).
2 A common patenting practice in the pharma-
ceutical industry aimed at filing and thenobtaining separate (and sequential) patents re-lating to different aspects of the same medi-cine, such as different dosages, formulations,fixed dose combinations and different forms ofthe active ingredient, among others.
3 In September 1986, early clinical tests showedthat Azidothymidine (AZT), a drug first syn-thesised in 1964 to be used as chemotherapyfor leukemia, slowed down the progress of thedisease. In 1987, AZT became the first anti-HIVdrug 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%2FPTO%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 on30 June 2013, http://apps.who.int/medicine-docs/en/d/Js4913e/7.html
6 Under the 1970 Patents Act, India did not grantproduct patents on medicines.
7 On 19 November 2003, the South AfricanNational Department of Health announced anOperational Plan for the rollout of ARV medi-cines in the public health system. UNAIDS/WHO statistics from 2004 suggested that of theapproximately 5.3 million people living withHIV/AIDS in the country, 7,50,000 were inneed of ARV treatment.
8 The TRIPS Agreement came into effect on 1
January 1995, setting out minimum standardsfor the protection of intellectual property,including patents on pharmaceuticals. Underthat agreement, since 2005 new drugs may besubject to at least 20 years of patent protect ionin all, apart from in the least-developed coun-tries and a few non-World Trade Organizationmembers, such as Somalia.
9 See Gopakumars (2013) accompanying article.
10 Marketed as Glivec.
11 See Dutfields (2013) article for a discussion.
References
Correa, Carlos M (2013): Is Section 3(d) Consist-ent with TRIPS?,Economic & Political Weekly,48(32).
Doctors Without Borders (2000): One World, OnePrice Means Death for People With AIDS inPoor Countries, 13 March, viewed on 30 June2013, http://www.doctorswithoutborders.org/press/release.cfm?id=536
(2006): MSF Urges Novartis to Drop CaseAgainst Indian Government, 20 December,viewed on 30 June 2013, http://www.doctor-swithoutborders.org/press/release.cfm?id=3715&cat=press-release
Dutfield, Graham (2013): Who Invented Glivec?Does It Matter Anyway?,Economic & Polit icalWeekly, 48(32).
Ghose, Sagarika (2013): FTN: SC Ruling onNovartis: 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-can-cer-drugs-be-cheaply-available.html
Grover, Anand (2013): Analysing the SupremeCourt 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 GlivecPatent Clarifies Limited Intellectual PropertyProtection and Discourages Future Innovationin India, 1 April, viewed on 30 June 2013,http://www.novartis.com/newsroom/media-releases/1689290.shtml
Menghaney, L (2013): R&D: What Novartis Says...and Why Its Wrong,Livemint, 12 April, viewedon 30 June 2013, http://www.livemint.com/Opinion/ 3KaBPvulUVkRSoDh8xkVRJ/RD-What-Novartis-says-and-why-its-wrong.html
Sengupta, Amit (2013): Two Decades of Struggle,Economic & Political Weekly, 48(32).
SurveyAugust 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.
For copies write to:
Circulation Manager,
Economic and Political Weekly,
320-321, A to Z Industrial Estate,
Ganpatrao Kadam Marg, Lower Parel,
Mumbai 400 013.email: [email protected]
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Economic & PoliticalWeekly EPW august 10, 2013 vol xlviii no 32 55
The Need to Curb Patentson 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.
Legally speaking, the most impor-
tant implication of the judgment is
that the Supreme Court has bro-
ught a great degree of clarity with re-
gard to the interpretatio