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Novartis Challenges Indian safeguards

MSF & Lawyers Collective, India

28 September 2006
A patent for the cancer drug Gleevec was rejected based on the grounds that it was merely a new form of an old drug, which according to the Indian law, cannot be patented. But Novartis is now challenging the patent rejection, and the Indian law that protects thousands of cancer sufferers and their families.

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.
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 grantedIn 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
safeguardThe 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: +
Anand Grover, Director, Lawyers Collective HIV/AIDS Unit, Phone:
+91.22.2287.5482 [email protected]
Ellen 't Hoen, MSF Campaign for Access to Essential Medicines: + 33 6 223 758 71

MSF & Lawyers Collective, India
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