[Ip-health] A victory for global public health in the Indian Supreme Court

Ellen 't Hoen ellenthoen.ip at gmail.com
Tue May 21 01:21:59 PDT 2013


Dear IP-Health readers, Here is a brief article I wrote on the Indian Supreme Court ruling in the Novartis case. The conclusion might be relevant for the discussion on R&D and the recommendations for changes in the global R&D framework made by the CEWG this week at the World Health Assembly. 
Kind regards, Ellen 't Hoen

Commentary
Journal of Public Health Policy advance online publication 16 May 2013; doi:
10.1057/jphp.2013.21

A victory for global public health in the Indian
Supreme Court
Ellen ‘t Hoen
University of Amsterdam, OZ Achterburgwal 185, Amsterdam, 1012 DK, Netherlands. 

Abstract
On 1 April of this year, the Indian Supreme Court upheld the decision of the Indian Patent
Office to refuse the patent grant for Novartis imatinib mesylate (Gleevec). The patent
application failed to meet the requirements for patentability under Indian law. The global
public health community followed the case closely. Its outcome could affect the Indian
generics industry – an important supplier of low cost medicines to the developing world.

Keywords:
patents; generic drugs; innovation; drug prices

In 2006, the Indian Patent Office rejected a patent application by Novartis for the beta
crystalline form of imatinib mesylate. The drug is used to treat chronic myeloid leukaemia
and is marketed by Novartis as ‘Glivec’ or ‘Gleevec’1. Novartis appealed the decision of the
Indian Patent Office. After a 7-year battle in the Indian courts, the Supreme Court of India, on
1 April 2013, spoke the final word, confirming that the patent application failed to meet the
requirements for patentability under Indian law. Public health advocates over the world had
closely monitored the court case because of its potential effect on the supply of affordable
generic medicines originating in India.

The Patent Office rejected the application for the beta crystalline form of imatinib mesylate
because it was not considered innovative. Indian patent law (section 3(d)) explicitly requires
that patents be granted only for compounds that are truly new and innovative. For new forms
and new uses of known compounds, Indian law requires patent applicants to prove
significantly improved efficacy to be eligible for a patent. The Supreme Court clarified that
this requirement of improved efficacy refers to therapeutic efficacy. India introduced this
requirement to prevent the practice of continually extending or ‘evergreening’ of medicines’
patents by seeking patents for minor alterations to the original molecules or known
compounds. Thus, the Supreme Court ruled that the Novartis application for a patent for
imatinib mesylate did not meet the requirement of section 3(d). The original Gleevec
compound was invented in the period before 1995, when India did not grant product
patents.2 In 2005, India amended its law to comply with requirements of the World Trade
Organization.

Throughout the 7-year court battle, the public health community around the world paid close
attention for at least two reasons:
the expanded supply of low cost generic imatinib mesylate was at stake – as the Indian
generic was priced at US$170 versus $2200 for the Novartis brand (Figure 1); and
the effectiveness of section 3(d) was at stake. Section 3(d) has been the basis for
successful opposition by patient groups to patent grants that protect high prices. For
example, this provision helped to increase generic supply of low cost antiretroviral
medicines to treat HIV/AIDS in the developing world.

Figure 1.
Price of Gleevec and Indian generics.
Source: MSF Access Campaign India.
Full figure and legend (69K)

The Indian generic pharmaceutical industry has been termed the ‘pharmacy of the developing
world’ for its role in supplying low cost generic HIV/AIDS medications to treatment
programmes in developing countries. The Global Fund to fight AIDS, Tuberculosis and
Malaria, UNITAID, and the United States President’s Emergency Plan for AIDS Relief
(PEPFAR) have supported the purchase of Indian generics. When India amended its Patents
Act in 2005 to conform to intellectual property rules of the World Trade Organization, the
head of the HIV programme of the World Health Organization (WHO), Dr Jim Kim, wrote to
the Indian minister of health: "As India is the leader in the global supply of affordable
antiretroviral drugs and other essential medicines, we hope that the Indian government will
take the necessary steps to continue to account for the needs of the poorest nations that
urgently need access to antiretrovirals, without adopting unnecessary restrictions that are not
required under the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement
and that would impede access to medicines.3"
At the time, Indian lawmakers responded to such pleas from the public health community,
and section 3(d) was included in the Patents Act, as part of a series of provisions using TRIPS
flexibilities. (The Journal of Public Health Policy has just published an article that explains
TRIPS and the importance of this decision involving Gleevec to China’s population).4 In its
recent decision, the Supreme Court recognized the importance of Indian patent practices for
health globally. In its ruling, the Court cited letters from WHO and UNAIDS as evidence of
how Indian law makers had been sensitive to the needs of other developing nations.
The public health community has been harshly critical of Novartis for bringing its suit and
emphasized that Novartis erred in challenging a carefully balanced patents act.5
Novartis was quick to point out that the court’s decision will have detrimental effects on its
investments, and those of other pharmaceutical companies, in research and development
(R&D). In this context, it is important to note that the US National Institutes of Health (NIH)
and health charities played an important part in the development of Gleevec. The best
estimates of R&D expenditure by Novartis towards the development of Gleevec are $38–96
million.6

Sales for Novartis’ Gleevec in 2012 were $4.675 billion, or $390 million per month. These
sales will not be affected by this recent court decision. Novartis did not need a patent in India
to recoup its investment in the development of the drug and to protect is profits.
Perhaps the key point is that financing R&D primarily through patents poses problems for
public health. In the late nineties, the challenge of providing costly patented antiretroviral
medicines for the developing world focused attention on difficulties caused by patents on
medicines. Today’s concern is drugs for non-communicable diseases.
Responding to the Indian court case, the international president of Médecins sans Frontières
(Doctors without Borders) hit the nail on the head: "At the moment medical innovation is
financed through high drug prices backed up by patent monopolies, at the expense of patients
and governments in developing countries who cannot afford those prices. Instead of seeking
to abuse the patent system by bending the rules and claiming ever longer patent protection on
older medicines, the pharmaceutical industry should focus on real innovation, and
governments should develop a framework that allows for medicines to be developed in a way
that also allows for affordable access.7"

Perhaps an unintended effect of this court case will be much needed dialogue between
industry, the public health community, and government on how to share the burden of
innovation costs and how this can be done in such a way that access to the fruits of innovation
are ensured for all who need them. The World Health Assembly in May of this year will
discuss innovation, intellectual property and public health, and the need for a new medical
R&D framework. The Novartis case shows how timely this is.

References
References and Notes
1. NOVARTIS AG versus UNION OF INDIA & OTHERS, IN THE SUPREME COURT OF
INDIA, CIVIL APPELLATE JURISDICTIONCIVIL APPEAL Nos. 2706-2716 OF 2013,
http://supremecourtofindia.nic.in/outtoday/patent.pdf, accessed 1 April 2013.
2. National Cancer Institute (NCI), US National Institutes of Health, Discoveries Leading
to FDA Approval of STI571/Gleevec: Fact Sheet,
http://www.cancer.gov/newscenter/newsfromnci/2001/gleevectimeline,
accessed 27 April 2013.
3. IN THE SUPREME COURT OF INDIA CIVIL APPELLATE JURISDICTION, CIVIL
APPEAL Nos. 2706-2716 OF 2013,
http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212, accessed 1
April 2013.
4. Chen, J., Nie, X., Peng, Y. and Shi, L. (2013) TRIPS-plus and access to medicines in
China. Journal of Public Health Policy 34(2): 226–238. | Article | PubMed |
5. Rockefeller, Richard 2007 Dead Man Walking 9 March 2007, 12.00 AM IST,
http://timesofindia.indiatimes.com/home/opinion/edit-page/Dead-Man-
Walking/articleshow/1738298.cms?intenttarget=no, accessed 1 April 2013.
6. R&D costs for Gleevec, Knowledge Community International,
http://keionline.org/node/1697, accessed 1 April 2013.
7. Medicines sans Frontiers, Indian Supreme Court Decision on Novartis Case a Victory for
Access to Medicines in Developing Countries, NEW DELHI/GENEVA/NEW YORK, 1
APRIL 2013, http://www.doctorswithoutborders.org/press/release.cfm?
id=6707, accessed 1 April 2013.

About the Authors
Ellen ‘t Hoen, LLM is a member of the Journal’s Editorial Board and a former Senior Advisor
Intellectual Property and Medicines Patent Pool at WHO/UNITAID. She currently holds an
appointment at the University of Amsterdam.





-----------------------------------------
Ellen 't Hoen
phone: +33695048388
e-mail: ellenthoen.ip at gmail.com
twitter:@ellenthoen
skype: efmthoen






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