[Ip-health] Novartis case_Statement of the Indian Ambassador at the European Parliament

[Alexandra HEUMBER]

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Below the statement of the Indian Ambassador in Belgium at the Exchange of=
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views on Novartis case (Sect 3d) organised by the European Parliament=0D
yesterday in Brussels.=0D
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Statement in the European Parliament on the legal action of Novartis=0D
against the Government of India=0D
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Hon=E2=80=99ble Members of the European Parliament, Ladies and Gentlemen,=
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At the outset let me thank you for inviting me to be present here during=0D
this hearing concerning the litigation launched by the pharmaceutical=0D
company Novartis.  This hearing and its consequences will have significant=
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bearing on millions of patients in the developing world.=0D
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As you know, Imatinib Mesylate (and Gleevec/Glivec, Novartis=E2=80=99 brand=
 name=0D
version of it) is a cancer drug crucial in prolonging the life of patients=
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suffering from Chronic Myeloid Leukemia (Blood Cancer). Since Imatinib=0D
Mesylate controls the cellular action that would cause the cancer to grow=
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but does not cure the disease, patients must take it for the rest of their=
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lives, unless another type of treatment or cure is available. The medicine=
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is produced and marketed internationally by the Swiss pharmaceutical=0D
company Novartis and its generic forms are produced by several Indian=0D
generic-drug manufacturers. Novartis sells Gleevec in India for US$ 26000=
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per patient per year. Generic versions of the drug in the Indian market=0D
are priced at about US$ 2100 per patient per year or less than one-tenth=0D
the price charged by Novartis. Novartis is charging high prices for=0D
Gleevec worldwide: from about 25000 USD to more than 50000 USD per patient=
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per year. This price is well above the financial capacity of most of the=0D
patients. Novartis points out that only a few number of patients in India=
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are paying the higher price since they have established a Gleevec donation=
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programme. In 2006, about 5000 persons in India benefited from this=0D
programme. But India witnesses about 25000 new cases of Chronic Myelloid=0D
Leucemia every year.  Additionally, thousands of people worldwide are=0D
affected by this disease.=0D
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Let me give a brief chronological sequence of events which resulted in the=
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present stalemate.  In conformity with TRIPS Agreement, India amended the=
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Patents Act by the Patents (Amendment) Act 1999 effective from 1995=0D
providing for receipt of product patent applications and for granting=0D
Exclusive Marketing Rights (EMRs) on such applications in the fields of=0D
pharmaceuticals and agricultural chemicals, till patent is granted or=0D
patent application is rejected.  In 1998 Novartis had filed an application=
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in the Chennai Patent Office for a patent on Glivec. Based on this patent=
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application, Novartis was granted EMR in November 2003 till patent was=0D
granted. In case the patent was rejected the EMR would be cancelled.  In=0D
fact, the EMR operated like a patent monopoly preventing Indian=0D
pharmaceutical companies from producing affordable generic versions of the=
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drug Imatinib Mesylate.  Indian generic companies had to withdraw the=0D
production and sale of the generic versions of the drug for the domestic=0D
market and export to other developing countries. With an over 10 fold=0D
increase in the price of the drug, Cancer Patients Aid Association and=0D
some of the NGOs who provided the more affordable generic versions to=0D
patients for their treatment had to withdraw their medical support to=0D
cancer patients. Patients of other developing countries who were importing=
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generic versions of the drug were also seriously affected by the=0D
unavailability of the affordable versions. This situation of=0D
unavailability of affordable generic versions of the drug continued till=0D
2006.=0D
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In 2005 India further amended its patent law to become TRIPS compliant in=
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all fields of technology including pharmaceuticals for which applications=
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had earlier been filed. Novartis=E2=80=99 patent application on Gleevec cam=
e up=0D
for examination. The patent law allows for any person or group to oppose a=
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patent application and accordingly several pre-grant oppositions had been=
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filed against the patent application of Novartis.  As a result of=0D
pre-grant opposition filed by civil society groups and Indian drug=0D
companies who contested the novelty and inventiveness of Gleevec, the=0D
patent application was rejected under Section 3(d) of the Indian Patent=0D
Law in January 2006 on the ground that the drug was only a new form of an=
=0D
old drug.  Section 3(d) states that =E2=80=9Cthe mere discovery of a new fo=
rm of a=0D
known substance which does not result in the enhancement of the known=0D
efficacy of that substance or the mere discovery of any new property or=0D
new use for a known substance or of the mere use of a known process,=0D
machine or apparatus unless such known process results in a new product or=
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employs at least one new reactant=E2=80=9D is not an invention within the m=
eaning=0D
of the Patents Act.  Consequently the EMR stood automatically terminated.=
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Rejection of the patent brought relief to thousands of cancer patients as=
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it prevented a patent monopoly till 2018. The Gleevec patent order=0D
rejecting a 'new form of an old drug' also set an important precedent for=
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the examination of patent applications related to essential drugs=0D
including AIDS medicines.=0D
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Novartis filed cases in the Chennai High Court. challenging the order of=0D
rejecting the Gleevec patent as well as challenging the constitutional=0D
validity of the Indian Patent Law. Novartis' litigation has raised=0D
concerns among other patient groups as the Gleevec patent order set a=0D
precedent for the examination of crucial drugs patent applications=0D
including those for AIDS treatment.=0D
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Moreover, Novartis challenged the constitutionality of section 3(d) of the=
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Indian Patents Act, which was specifically introduced by the Indian=0D
parliament as a safeguard against the misuse of the product patent regime.=
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Novartis, in its petition, claimed that the section is not in compliance=0D
with the TRIPS agreement and hence should be declared unconstitutional.=0D
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Section 3(d) is aimed at preventing pharmaceutical companies from=0D
obtaining patents on old medicines which would prevent trivial patenting=0D
and new use patents. India, while complying with the TRIPS agreement and=0D
introducing a product patent regime for 'new drugs that were invented',=0D
also coupled its law with a safeguard of refusing patents on discovery of=
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new forms or new uses of older drugs to prevent =E2=80=9Cevergreening=E2=80=
=9D. This=0D
provision is in conformity with TRIPS agreement. This is also in keeping=0D
with the 2001 Doha Declaration on the TRIPS Agreement and public health.=0D
The Doha Declaration on Trade-Related Aspects of Intellectual Property=0D
Rights (TRIPS) and Public Health states that "the Agreement can and should=
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be interpreted and implemented in a manner supportive of WTO members'=0D
right to protect public health and, in particular, to promote access to=0D
medicines for all".=0D
Further, the TRIPS compliance of any law can be and should be challenged=0D
by a government in the Disputes Settlement Body of the WTO and not by a=0D
company in an Indian court.  The right course for Novartis would be to=0D
file an appeal before the Intellectual Property Appellate Board which is=0D
headed by a judge and has already been constituted.=0D
The EU has endorsed WTO rules allowing compulsory licensing of patented=0D
products and processes to ensure access to affordable medicines for poor=0D
countries. We are glad that the European Parliament has taken a very=0D
proactive role in urging Novartis to drop its litigation.  It has=0D
recognised the importance of India with regard to access to medicine for=0D
developing countries and called on the EU to support India in further=0D
implementing its intellectual property laws in a manner that will create=0D
an environment that will continue to encourage and facilitate investment=0D
by the Indian generic manufacturing industry in providing affordable=0D
essential medicines for developing countries.=0D
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###################################=0D
SIGN MSF'S 'DROP THE CASE' PETITION=0D
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Millions of people around the world today rely on affordable medicines=0D
produced in India.  Pharmaceutical company Novartis is taking the Indian=0D
government to court to force a change in the country's patent law.  If=0D
Novartis wins, a major source of affordable medicines for millions of=0D
people across the globe could dry up.=0D
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MSF is urging Novartis to DROP THE CASE.=0D
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Find out more and sign up to our petition:=0D
http://www.msf.org/petition_india/international.html=0D
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Alexandra Heumber=0D
EU Advocacy Liaison Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Access to Essential Medicines Campaign=0D
Rue Dupr=C3=A9, 94. 1090 Brussels=0D
++32 (0) 2 474 75 09 (Dir off)=0D
++ 32 (0) 479 514 900 (Mob)=0D
++ 32 (0) 2 474 75 75 (Fax)=0D
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