E-DRUG: Novartis challenges Indian law - MSF Statement
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Today Novartis' challenge against India's patent law will be heard in the
Chennai High Court in India. As you may know in January this year,
the Indian patent office rejected Novartis' request for a patent on the
cancer drug Gleevec on the grounds that it was merely a new form of an old
drug, which meant that under Indian law, it should not be patented
But Novartis is now challenging the patent rejection and a crucial part of
the Indian law that protects patients from the patenting of trivial
improvements of known molecules.
Please find below the press release and a background document we prepared
on the Novartis case.
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Novartis Challenges India's Patent Law,
MSF Warns Access to Medicines is Under Threat
New Delhi/Geneva, 26 September 2006 'A challenge against India's patent
law filed by the Swiss pharmaceutical company Novartis will be heard in
the Chennai High Court in India today. International medical humanitarian
organisation Medecins Sans Frontieres (MSF) warns that this case may have
serious implications for future access to essential drugs worldwide.
Novartis is challenging a crucial part of the Indian law that protects
patients from the patenting of trivial improvements of known molecules.
Novartis is also seeking to have the January 2006 decision to reject its
patent application for the cancer drug Gleevec reversed and is seeking
review by the Chennai High Court.
'If Novartis' challenge against the Indian patent law is successful, a key
safeguard that can protect the production of affordable medicines will be
lost,' said Ellen 't Hoen, Policy Director at MSF's Campaign for Access to
Essential Medicines. 'People the world over who rely on India as a source
of their medicines may be affected if Novartis gets its way.'
India has been a crucial source of affordable generic medicines, and 84%
of the AIDS drugs MSF uses to treat over 60,000 patients in more than 30
countries are generics from India.
India began reviewing pharmaceutical product patent applications in 2005,
when it was required to become fully compliant with World Trade
Organization rules on intellectual property. The Indian patent law has
strict criteria regarding which inventions qualify for patenting, and
allows for any party to oppose a patent before it is granted. In 2005,
cancer groups filed the first ever 'pre-grant opposition', against
Novartis' patent application for Gleevec. MSF has supported similar
oppositions filed by patient groups in India against patent applications
on key AIDS drugs.
'The public health safeguards of the Indian Patent law have given hope to
many who depend on generics manufacture. The Novartis litigation is a
direct challenge to those safeguards,' said Leena Menghaney, MSF
Campaigner in India.
Novartis claims that Section 3(d) of the Indian Patents Act is not
compliant with the WTO rules outlined in the agreement on Trade-related
Aspects of Intellectual Property (TRIPS). Section 3(d) formed a
substantial part of the basis on which the Gleevec patent was originally
denied.
Many public interest and health groups will be watching the case closely,
as the Gleevec patent order set an important precedent for the examination
of other drug patent applications.
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Background
NOVARTIS FILES CASE IN INDIA CHALLENGING PATENT OFFICE ORDER AND PATENT
LAW
CANCER PATIENTS DEMAND WITHRAWAL OF CASES
On 17th May 2006 the Swiss pharmaceutical company Novartis Ltd. filed two
cases, challenging both the Indian patent office's rejection of its
patent application for the cancer drug imatinib mesylate (brand name
Gleevec), and the section of the new Indian patent law which formed the
basis of the patent office decision.
Imatinib mesylate (Gleevec) - A Drug for Cancer Treatment
Imatinib mesylate (Gleevec) is a cancer drug used in the treatment of
Myeloid Leukemia (cancer of the blood). It is produced and marketed
internationally by the Swiss pharmaceutical company Novartis and various
Indian pharmaceutical companies, such as Cipla, Hetero, Natco and Ranbaxy.
Novartis sells Gleevec at Rs. 1,20,000 ($ 2500) per patient per month in
India. Generic versions of the drug are priced at about Rs. 8,000 ($175)
per patient per month on the Indian market.
Novartis files patent application in India temporary monopoly granted
In 1998, Novartis filed an application in the Chennai Patent Office for a
patent on imatinib mesylate (Gleevec). At that time, India did not yet
grant patents on medicines but in November 2003, Novartis was still able
to obtain exclusive marketing rights (EMR) for a period of five years,
based on a temporary provision of the previous Indian Patents Act. The
granting of EMR was a TRIPS obligation for countries like India, which did
not grant patents for pharmaceutical products before 2005 (subject to a
number of conditions). After 2005, when the Indian patent office began
examining pharmaceutical product patent applications, EMRs would either be
replaced by patents (if granted) or cancelled (if patents were rejected).
The latter scenario applies to the Gleevec patent application.
Cancer patient's access to generic Gleevec affected
The EMR operated like a patent monopoly, preventing Indian pharmaceutical
companies from producing affordable generic versions of imatinib mesylate.
Producers of generics were forced to withdraw the production and sale of
generic versions of the drug in India and other developing countries.
Cancer Patient Group files Patent Opposition
In 2005, India changed its patent law to become fully TRIPS compliant and
Novartis' patent application on Gleevec came up for examination by the
Indian patent office of Chennai. The Indian Patents Act allows for any
person or group to oppose a patent application before it is granted and
the Cancer Patients Aid Association filed an opposition on behalf of
cancer patients in the Chennai patent office.
Chennai Patent Office rejects Gleevec patent application
In January 2006, the Chennai Patent office rejected Novartis' patent
application on the grounds that the application claimed 'only a new form
of a known substance.' This order of the Chennai patent office brought
relief to thousands of cancer patients as it not only prevented a patent
monopoly until 2018, but also automatically cancelled the EMR Affordable
versions of imatinib mesylate became unavailable after Novartis was
granted the EMR. The Gleevec patent order rejecting a 'new form of a
known substance' also set an important precedent for the examination of
other patent applications claiming only improvements of known molecules,
including antiretroviral medicines to treat AIDS.
Novartis challenges Patent Order and Indian Patent Law
On 17 May 2006, Novartis filed two sets of cases in the Chennai High
Court.
The first case challenges the order of the Chennai Patent office, which
rejected the Gleevec patent application of Novartis, following a pre-grant
opposition by the Cancer Patients Aid Association. Legal representatives
of the Cancer Patients Aid Association will appear on their behalf before
the Chennai High Court. Novartis' constant litigation renews fears about
the future availability of drugs if the patent case of Gleevec is
reopened. Further, it has raised serious concerns among other patient
groups, as the Gleevec patent order set an important precedent for the
examination of crucial drug patent applications including those for AIDS
treatment.
The second case filed by Novartis challenges the constitutionality of
section 3(d) of the 2005 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 is claiming that the
section is not in compliance with the TRIPS Agreement and hence should be
declared unconstitutional.
Section 3 (d) of the Indian Patent Law - an important public health
safeguard
The section is aimed at preventing pharmaceutical companies from obtaining
patents on trivial improvements or new medical uses of known molecules.
When India became fully compliant with the TRIPS Agreement and introduced
a product patent regime in 2005, it coupled its law with a critical
safeguard of refusing patents on discoveries of new forms or new uses of
known substances. The Indian patent law does not consider such discoveries
as inventions, unless an enhancement in efficacy is proven, and therefore
patents should not be granted. This is in accordance with the TRIPS
Agreement which does not define what an invention is and allows WTO
countries to freely 'determine the appropriate method of implementing the
provisions' TRIPS Article 1. of TRIPS. Indeed the Doha declaration
requires that the TRIPS Agreement is implemented in such a manner that it
allows for measures to ensure access to medicines for all. Section 3 (d)
is an example of such a provision.
For more information contact:
Leena Menghaney, MSF Campaign for Access to Essential Medicines: +
91.98.1136.5412
Anand Grover, Director, Lawyers Collective HIV/AIDS Unit, Phone:
+91.22.2287.5482 aidslaw@lawyerscollective.org
Ellen 't Hoen, MSF Campaign for Access to Essential Medicines: + 33 6 223
758 71