17 May 2006 — 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
matinib 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. 120,000 ($ 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 . 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” 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.