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COMMENTARY

Economic & Political Weekly EPW september 10, 2011 vol xlvi no 37
13
‘3(d)’ Effect:
The Novartis-Glivec Case
Rajshree Chandra
The appeal of the multinational
drug major Novartis in the
Supreme Court against denial
of patent protection to its
anti-cancer drug Glivec will
decide whether Indian courts
uphold a “precautionary
principle” with regard to the
right to health and life or the
demands of intellectual property
rights must take priority. Either
way, this case will have major
ramifications for public health
and the ability of sovereign
countries to enact laws to protect
their citizens.
T
he Novartis patent claim for its anti-
cancer drug, Glivec enters round
four with the Swiss pharmaceutical
giant appealing to the Supreme Court
(Appeal No 20539-549 of 2009) against
the decision of the Intellectual Property
Appellate Board (IPAB) to deny its patent
claim over Glivec. The case has been con-
tentious to say the least and Novartis has
fought a long and hard legal battle which
began in 2005 when its patent application
for Glivec came up for review in the
Chennai Patent Office.
The Glivec Case
Glivec (imatinib mesylate) is crucial in
prolonging the life of patients suffering
from chronic myeloid leukemia (CML).
Since imatinib mesylate controls the cel-
lular action that allows the cancer to grow
but does not cure the disease, patients
must take it for the rest of their lives.
While it is produced and marketed inter-
nationally by Novartis, various Indian
g eneric producers like Cipla, Ranbaxy,
Natco and Hetero sell generic versions.
Novartis sells Glivec at approximately
Rs 12 lakh ($26,000) per patient per
year. Generic versions of Glivec in the
I ndian market are priced at approximately
Rs 97,000 ($2,100) per patient per year.
Novartis therefore charges 12 times more
for the same drug.
Novartis’ battle to secure a patent for
Glivec has been long and unprecedented in
patent history. In 2003, Novartis secured
exclusive marketing rights (EMR) for Glivec
under the 1994 Trade-Related Aspects of
Intellectual Property Rights (TRIPS) agree-
ment of the General Agreement on Tariffs
and Trade, forcing Indian generic compa-
nies to withdraw the production and sale
of generic versions of the drug for the
d omestic market and export to other develop-
ing countries. With the consequent massive
price increase of this drug’s generic versions,
the Cancer Patients Aid Association (CPAA)
and some other non-governmental organi-
sations (NGOs), which provided this drug
to cancer patients for treatment, had to
withdraw their medical support. The CPAA
even went to the Supreme Court against
granting of EMR to Novartis.
1

Novartis’ patent application on Glivec
came up for examination in 2005. Armed
with the provisions of Section 3(d) of the
Indian Patent (Amendment) Act, 2005,
pre-grant opposition was filed by Natco
Pharmaceuticals, Alternative Law Forum
(ALF) and Lawyers Collective on behalf of
the CPAA, in September 2005 against
N ovartis’ patent application, claiming that
it was only a modification of an already
existing drug and that it was violative of
the health rights of the CML patients (Writ
petition No 24759 of 2006 in the High
Court of Madras: 12).
These considerations became the back-
ground for the rejection of Novartis’ patent
claim by the Chennai Patent Office (in
2006), the Madras High Court (in 2007)
and the IPAB (in 2009) as Novartis relent-
lessly persisted. The two central and shared
grounds for these three rejections were:
(a) That the patent claim was only for a
tweaked version of a pre-1995 imatinib
mesylate (for which there are no patent
obligations as TRIPS itself came into force
in 1995). The drug did not meet the crite-
rion of inventiveness as laid out in Section
3(d) of the Indian Patent Act.
(b) Because the Novartis drug was priced
beyond the reach of the ordinary citizen
(Rs 1,00,000/month), the non-availability
and non-affordability of any form of
i matinib mesylate to CML patients was
v iolative of their right to life under Article 21
of the Constitution.
Many apex courts all over the world
read the right to health as a derivative of
the right to life itself, especially in those
countries where there is no separate con-
stitutional right to health. Thus, a need
was expressed to forestall patent claims for
drugs which are marginally improved or
“evergreened” so that the cheaper generics
remained available in the market. The in-
tellectual property offices and the court
both expressed commitment to the fact
that “the laws of this country have a
Rajshree Chandra (rajshreechandra@yahoo.
com) teaches political science at Janki Devi
Memorial College, University of Delhi.
COMMENTARY
september 10, 2011 vol xlvi no 37 EPW Economic & Political Weekly
14
c onstitutional duty to provide good
healthcare to its citizens by giving them
easy access to life saving drugs”.
What enabled these rulings is a unique but
contested piece of legislation – Section 3(d)
of the Indian Patent (Amendment) Act,
2005. The Act provided for patent protec-
tion for pharmaceutical inventions, instat-
ing the concept of “product patents” in
this category for the first time. Interna-
tional criteria of patentability (novelty,
non-obviousness, utility and adequate dis-
closure) were retained, but the Act had in-
cluded restrictions as to what would be
regarded as patentable inventions by add-
ing clause (d) to Section 3.
The Efficacy Standard
Section 3(d) of the Act stipulates that a
new form of a known substance is exclud-
ed from patent coverage, if it does not
show significantly enhanced efficacy com-
pared to the known substance. The en-
hancement in efficacy was further quali-
fied in the explanation to the subsection.
Explanation to Section 3(d):
Salts, esters, ethers, polymorphs, metabo-
lites, pure form, particle size, isomers, mix-
tures of isomers, complexes, combinations,
and other derivatives of known substance
shall be con sidered to be the same sub-
stance, unless they differ significantly in
properties with regard to efficacy.
Thus, the dividing line between being
an eligible subject matter to be considered
for grant of a patent and not being patent
eligible became its efficacy. Section 3(d)
therefore makes it clear that a number of
technical creations are not inventions, unless
they present a significant increase in efficacy.
This statute of India is therefore relying
on utility to transform non-patentable
i nventions into patentable ones. The criti-
cal part here is that the novelty is derived
from the use, not the product (Colston and
Middleton 2005: 163-64).
Besides serving as a technical require-
ment delineating grounds for patentability
of pharmaceutical drugs, Section 3(d) also
functions as an important public health
safeguard. The objective of the 3(d) pat-
entability criteria is to prevent “evergreen-
ing” and tweaking of old formulations to
e xtend patent claims. These exceptions are
signi ficant, for they seek to make patent
claims for new drugs conditional on the
n ovelty and the efficacy of the new innova-
tion, thereby ensuring that patents for drugs
are not claimed for mere incremental im-
provements over existing drugs. The term
efficacy is being construed in a “drug regula-
tory” sense. In effect 3(d) delimits claims of
patentability thereby ensuring the contin-
ued supplies of generics at cheaper prices.
Article 30 of TRIPS states that members
may provide limited exceptions to the ex-
clusive rights conferred by a patent. Sec-
tion 3(d) can be viewed as providing lim-
ited exceptions to pharmaceutical patents.
The Doha Declaration, 2001 too affirmed
that the TRIPS agreement can and should be
interpreted and implemented in a manner
supportive of World Trade Organisation
(WTO) members’ rights to protect public
health and, in particular, to promote
a ccess to medicines for all.
A second argument, and the one that
needs to be underscored on the eve of the
Supreme Court revaluation of the case,
however, would seek to locate the terms of
the debate outside the legitimating princi-
ples and provisions of TRIPS. This would
mean that we do not conceptualise the
l egitimacy of this legislation in terms of
permitted exceptions by TRIPS. Legisla-
tions and safeguards related to health can-
not be located only within the spaces pro-
vided by TRIPS. If health is recognised in
countries as a right, either as a derivative
of the right to life (India) or as a constitu-
tional right (South Africa) it needs to move
beyond and encompass the many and var-
ied duties that flow from the recognition of
these rights. Health-related duties cannot
expand or contract in relation to the rights
of innovators. Rather, the rights of innova-
tors must be integrated within the frame-
work of these fundamental human rights.
Precautionary Principle
Foremost in the minds of the drafters of
S ection 3(d) was not compliance or non-
compliance with TRIPS, although some con-
cerns with TRIPS compatibility were ex-
pressed in the Indian parliamentary debates
in early 2005 (XIV-IV Session – 25 February-
24 March 2005) which took place in the con-
text of Patent Amendment Act 2005.
The parliamentary debates anticipated
the fact that the product patent regime
that India was becoming a part of would
have significant implications for public
health and importantly, for the supply of
affordable drugs to the rest of the world.
The concern was based on the fact that
over a period of time Indian drug compa-
nies would lose the opportunity to develop
processes for patent protected drugs in the
country and therefore would cease to be
suppliers of affordable generic drugs to
millions across the world. Consequently,
the need for safeguards was felt keeping
in mind both India’s pharmaceutical ex-
port potential and public health concerns.
Why did India feel the need to limit the
patentability of incremental innovations?
Are there not already TRIPS criteria which
reserve patentability for “new inventive step”,
for something that is “novel” and “non-
obvious”? The biochemical-pharmaceutical
sector has made it difficult to determine a
clear demarcation for the fulfilment of these
criteria. For example, it has been pointed out
that between 1995 and 2003, only 274 new
chemical entities had been granted market-
ing approval by the United States’ Food and
Drug Administration (USFDA). This implies
that an overwhelming majority of new ap-
plications were for “incrementally modi fied
drugs”. The number of new molecular enti-
ties approved by the USFDA drastically dec-
lined since the mid-1990s (from 53 in 1996
to a minimum of 17 in 2002).
Obviously, there has been a parallel
system devised to beat the criteria of in-
ventiveness either to claim new patents,
or to renew patents when they approach
expiry. Tweaking of drugs to claim novelty
(Novartis’ Glivec, Merck’s Efavirenz,
Gilead Sciences’ Tenofovir and Amprena-
vir, Roche’s hepatitis drug Pegasys) and
combining pre-1995 drugs to create a
“new” drug (Abbott’s Kaletra and Aluvia)
are some examples of the rampant prac-
tice of tweaking novelty itself!
There is therefore a critical need to
expand the interpretative framework of
pharmaceutical patents. Section 3(d) is an
attempt in this direction. The value of 3(d) is
not in settling the debate on what constitutes
invention, what is novel, and what is useful.
If at all, it perhaps complicates the issue by
adding a nebulous dimension, of what could
constitute “novel”. But what 3(d) does, and
what the Glivec judgment based on this
section does, is to incorporate a precau-
tionary principle into the current dialogue
on ways to protect human health.
COMMENTARY
Economic & Political Weekly EPW september 10, 2011 vol xlvi no 37
15
There could indeed emerge more clarity;
“efficacy” and “significant enhancement”
could develop more precise guidelines but
answers can only be successful if we know
the full range of questions that need to be
asked. The questions need to locate the
debate outside the spaces provided by WTO
and TRIPS. As a precautionary principle,
3(d) combines considerations which are
technical in nature as well as those that
locate themselves outside the TRIPS frame-
work in health concerns. This principle,
formalised at the 1992 UN Conference on
Environment and Development, emphasises
that the discipline of precaution be carefully
exercised to avoid potential harm and un-
foreseen and unintended consequences. This
principle requires that precaution should
prevail whenever questions of human and
environmental health are involved. It
mandates restraint until cause and effect
relationships are properly understood.
So the contention here is that the poten-
tial harm of patents on incremental drugs
could be so tremendous that a precautionary
measure needs be employed to prevent the
damages before they occur. As a precaution-
ary principle 3(d) is expected to prevent a
health emergency, which could arise out of
removal of affordable, life-saving generic
drugs from the market and thereby, limiting
access to these drugs. This is where this prin-
ciple scores over the compulsory licensing
provision implied in Article 31C of TRIPS
which provides measure of addressing health
emergencies and not preventing them.
Implications for Drug Access
At stake in the Glivec case is not just the
fate of the Indian generic drug industry
but the life and well-being of hundreds of
millions of users of generic drugs the
world over. “We have opposed patent ap-
plications for crucial AIDS drugs”, says
Elango Ramchandar, president of Indian
Network for People with HIV/AIDS. “Our
survival depends greatly on winning
these patent oppositions. Novartis is a test
case for us” (Bidwai 2007). This case also
has huge implications for the supply of
a ffordable medicines not just in India but
in African countries and other parts of the
developing world that rely on medicines
exported from India. The ramifications of
this case are wide and multidimensional.
It is for this reason that it has become the
face of the global campaign to save generic
production of drugs in India.
2
Ninety-
one organisations and personalities from
around the world also made a call to
N ovartis to drop the case in an open letter
in October 2006 to Daniel Vasella, chair-
man and CEO.
3

India has, over the years, become a very
large player in the production and exports
of generic medicines the world over, justi-
fiably earning the designation of “the
pharmacy of the developing world”. Some
figures compiled by Médecins Sans Fron-
tières (MSF) on India’s role show that, while
67% of medicines produced in India are
exported to developing countries, 70% of
the drugs for treatment for patients in 87
developing countries, purchased by UNICEF,
International Dispensary Association, the
Global Fund (GFATM) and the Clinton
Foundation since July 2005 has come from
Indian suppliers (Chandra 2010: 218).
By excluding generics, essential drug
patents have the potential to undermine
access to medicines for HIV/AIDS, for heart
disease, for diabetes, in fact for every
“new” medicine needed by the poor in
d eveloping and poor countries. In every
case generic prices present an opportunity
for cost savings.
Conclusions
Pharmaceuticals ought to constitute a dif-
ferent field within the larger domain of
intellectual property rights. Incrementally
improved drugs, tweaked or evergreened
to beat the nebulous criterion of novelty,
threaten to infringe upon the access rights
of millions. While the world today is not at
liberty to discard pharmaceutical patents
there is an urgent need and a space, as
Section 3(d) has demonstrated, to devise
more stringent criteria to prevent ever-
greening of drugs and to induce a measure
of balance between the intellectual prop-
erty rights of the innovators and human
rights like the right to health.
With Novartis appealing to the Supreme
Court, the case is critically poised. If an
i nterpretative ambiguity of Section 3(d) is
exploited, or Article 14 comes into play,
Novartis may well have the last laugh. But
that will be disastrous for the supply of
a ffordable generic life saving drugs the world
over and for national legislations to assert
their sovereign right to protect critical
health concerns that override TRIPS. Sec- Sec-
tion 3(d) of the Indian Patent Act, there-
fore, should not be assessed in terms of its
compatibility with TRIPS, for TRIPS does
not have the normative core which can
benchmark the realisation of core funda-
mental rights like the right to health.
Notes
1 CPAA also contested the fact that there were only
around 7,000 CML patients, 99% of who were
covered by Novartis’ drug donation (GIPAP) and
provided Glivec free of charge. According to
CPAA there are 30,000 CML patients detected
every year most of who are not covered by No-
vartis drug donation program.
2 Ed Sliverman, “India’s Glivec Ruling Is Bad News
for Other Drugmakers Too”, Pharmalot, http://www.
pharmalot.com/2007/08/indias-Glivec-ruling-is-
bad-news-for-other-drugmakers-too/. Also see,
Lawyers Collective and their AMTC campaign
r eports at http://www.lawyerscollective.org/
^amtc/^Patent_Oppositions/introduction.asp
3 Available at http://www.evb.ch/en/p25011413.html
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