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[e-drug] Novartis case statement by India


  • From: "Alexandra HEUMBER" <Alexandra.HEUMBER@brussels.msf.org>
  • Date: Thu, 12 Apr 2007 16:20:45 +0200

E-DRUG: Novartis case statement by India
----------------------------------------
[This statement clearly explains the position of the Indian government in the Novartis case. WB]

Novartis case Statement of the Indian Ambassador at the European Parliament

Below the statement of the Indian Ambassador in Belgium at the Exchange of
views on Novartis case (Sect 3d) organised by the European Parliament
yesterday in Brussels.

Statement in the European Parliament on the legal action of Novartis
against the Government of India

Hon’ble Members of the European Parliament, Ladies and Gentlemen,

At the outset let me thank you for inviting me to be present here during
this hearing concerning the litigation launched by the pharmaceutical
company Novartis. This hearing and its consequences will have significant
bearing on millions of patients in the developing world.

As you know, Imatinib Mesylate (and Gleevec/Glivec, Novartis’ brand name
version of it) is a cancer drug crucial in prolonging the life of patients
suffering from Chronic Myeloid Leukemia (Blood Cancer). Since Imatinib
Mesylate controls the cellular action that would cause the cancer to grow
but does not cure the disease, patients must take it for the rest of their
lives, unless another type of treatment or cure is available. The medicine
is produced and marketed internationally by the Swiss pharmaceutical
company Novartis and its generic forms are produced by several Indian
generic-drug manufacturers. Novartis sells Gleevec in India for US$ 26000
per patient per year. Generic versions of the drug in the Indian market
are priced at about US$ 2100 per patient per year or less than one-tenth
the price charged by Novartis. Novartis is charging high prices for
Gleevec worldwide: from about 25000 USD to more than 50000 USD per patient
per year. This price is well above the financial capacity of most of the
patients. Novartis points out that only a few number of patients in India
are paying the higher price since they have established a Gleevec donation
programme. In 2006, about 5000 persons in India benefited from this
programme. But India witnesses about 25000 new cases of Chronic Myelloid
Leucemia every year. Additionally, thousands of people worldwide are
affected by this disease.

Let me give a brief chronological sequence of events which resulted in the
present stalemate. In conformity with TRIPS Agreement, India amended the
Patents Act by the Patents (Amendment) Act 1999 effective from 1995
providing for receipt of product patent applications and for granting
Exclusive Marketing Rights (EMRs) on such applications in the fields of
pharmaceuticals and agricultural chemicals, till patent is granted or
patent application is rejected. In 1998 Novartis had filed an application
in the Chennai Patent Office for a patent on Glivec. Based on this patent
application, Novartis was granted EMR in November 2003 till patent was
granted. In case the patent was rejected the EMR would be cancelled. In
fact, the EMR operated like a patent monopoly preventing Indian
pharmaceutical companies from producing affordable generic versions of the
drug Imatinib Mesylate. Indian generic companies had to withdraw the
production and sale of the generic versions of the drug for the domestic
market and export to other developing countries. With an over 10 fold
increase in the price of the drug, Cancer Patients Aid Association and
some of the NGOs who provided the more affordable generic versions to
patients for their treatment had to withdraw their medical support to
cancer patients. Patients of other developing countries who were importing
generic versions of the drug were also seriously affected by the
unavailability of the affordable versions. This situation of
unavailability of affordable generic versions of the drug continued till
2006.

In 2005 India further amended its patent law to become TRIPS compliant in
all fields of technology including pharmaceuticals for which applications
had earlier been filed. Novartis’ patent application on Gleevec came up
for examination. The patent law allows for any person or group to oppose a
patent application and accordingly several pre-grant oppositions had been
filed against the patent application of Novartis. As a result of
pre-grant opposition filed by civil society groups and Indian drug
companies who contested the novelty and inventiveness of Gleevec, the
patent application was rejected under Section 3(d) of the Indian Patent
Law in January 2006 on the ground that the drug was only a new form of an
old drug. Section 3(d) states that “the mere discovery of a new form of a
known substance which does not result in the enhancement of the known
efficacy of that substance or the mere discovery of any new property or
new use for a known substance or of the mere use of a known process,
machine or apparatus unless such known process results in a new product or
employs at least one new reactant” is not an invention within the meaning
of the Patents Act. Consequently the EMR stood automatically terminated.
Rejection of the patent brought relief to thousands of cancer patients as
it prevented a patent monopoly till 2018. The Gleevec patent order
rejecting a 'new form of an old drug' also set an important precedent for
the examination of patent applications related to essential drugs
including AIDS medicines.

Novartis filed cases in the Chennai High Court. challenging the order of
rejecting the Gleevec patent as well as challenging the constitutional
validity of the Indian Patent Law. Novartis' litigation has raised
concerns among other patient groups as the Gleevec patent order set a
precedent for the examination of crucial drugs patent applications
including those for AIDS treatment.

Moreover, Novartis challenged the constitutionality of section 3(d) of the
Indian Patents Act, which was specifically introduced by the Indian
parliament as a safeguard against the misuse of the product patent regime.
Novartis, in its petition, claimed that the section is not in compliance
with the TRIPS agreement and hence should be declared unconstitutional.

Section 3(d) is aimed at preventing pharmaceutical companies from
obtaining patents on old medicines which would prevent trivial patenting
and new use patents. India, while complying with the TRIPS agreement and
introducing a product patent regime for 'new drugs that were invented',
also coupled its law with a safeguard of refusing patents on discovery of
new forms or new uses of older drugs to prevent “evergreening”. This
provision is in conformity with TRIPS agreement. This is also in keeping
with the 2001 Doha Declaration on the TRIPS Agreement and public health.
The Doha Declaration on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) and Public Health states that "the Agreement can and should
be interpreted and implemented in a manner supportive of WTO members'
right to protect public health and, in particular, to promote access to
medicines for all".

Further, the TRIPS compliance of any law can be and should be challenged
by a government in the Disputes Settlement Body of the WTO and not by a
company in an Indian court. The right course for Novartis would be to
file an appeal before the Intellectual Property Appellate Board which is
headed by a judge and has already been constituted.

The EU has endorsed WTO rules allowing compulsory licensing of patented
products and processes to ensure access to affordable medicines for poor
countries. We are glad that the European Parliament has taken a very
proactive role in urging Novartis to drop its litigation. It has
recognised the importance of India with regard to access to medicine for
developing countries and called on the EU to support India in further
implementing its intellectual property laws in a manner that will create
an environment that will continue to encourage and facilitate investment
by the Indian generic manufacturing industry in providing affordable
essential medicines for developing countries.

---

Alexandra Heumber
EU Advocacy Liaison Officer
Médecins Sans Frontières
Access to Essential Medicines Campaign
Rue Dupré, 94. 1090 Brussels
++32 (0) 2 474 75 09 (Dir off)
++ 32 (0) 479 514 900 (Mob)
++ 32 (0) 2 474 75 75 (Fax)

SIGN MSF'S 'DROP THE CASE' PETITION

Millions of people around the world today rely on affordable medicines
produced in India. Pharmaceutical company Novartis is taking the Indian
government to court to force a change in the country's patent law. If
Novartis wins, a major source of affordable medicines for millions of
people across the globe could dry up.

MSF is urging Novartis to DROP THE CASE.

Find out more and sign up to our petition:
http://www.msf.org/petition_india/international.html