On 17^th May 2006 Swiss pharma company Novartis Ltd. filed two cases challenging the rejection of the Gleevec® (or Glivec®) patent application and the Indian Patent Law.

Imatinib Mesylate (Gleevec®) – A Crucial Drug for Cancer Treatment
Imatinib Mesylate (Gleevec®) 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 allows the cancer to grow but does not cure the disease, this means that patients must take it for the rest of their lives, unless another type of treatment or cure is available. Gleevec® is produced and marketed internationally by the Swiss pharmaceutical company Novartis and various Indian generic producers like Cipla, Ranbaxy, Natco, and Hetero. Novartis sells Gleevec® at Rs. 1.44 million (US$ 26'000) per patient per year. Generic versions of the drug Gleevec® in the Indian market are priced at about Rs. 96'000 (US$ 2100) per patient per year.

Novartis policy: high price worldwide and donations
Novartis is charging high prices for Gleevec® worldwide: from about 25'000 USD to more than 50'000 USD per patient per year (50'000 CHF per patient per year in Switzerland). Gleevec® grossed 2.17 billion USD global sales to the company in 2005. This price is well above the financial capacity of the major part of the patients. Novartis recognizes that only a few number of patients in India are paying the price. Novartis has established a Gleevec® donation programme^[1]. In 2006, about 5000 persons in India are benefiting from this programme. There are 25'000 new cases of Chronic Myelloid Leucemia arising every year in India.

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®). Based on the patent application and a particular provision of the Indian Patents Act, Novartis in November 2003 obtained exclusive marketing rights (EMR) till patent was granted—incase the patent was rejected the EMR would be cancelled.

Cancer patient’s access to generic Imatinib Mesylate affected
The EMR operated like a patent monopoly preventing Indian pharmaceutical companies from producing affordable generic versions of the drug Imatinib Mesylate (Gleevec®). Indian generic companies had to withdraw the production and sale of the generic versions of the drug for the domestic market and the exportation to other developing countries.

With an over 10 fold increase in the price of the drug, Cancer Patients Aid Association (CPAA)^[2] and other cancer groups who provided the more affordable generic versions of Gleevec® to Myeloid Leukemia 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 of Gleevec®.

Cancer Patient Group filed Patent Opposition
This situation of unavailability of affordable generic versions of the drug continued till 2006. In 2005 India changed its patent law to become TRIPS compliant and Novartis’ patent application on Gleevec® came up for examination. The Indian patent law allows for any person or group to oppose a patent application and the Cancer Patients Aid Association (in addition to an already pending Supreme Court challenge to the EMR) filed an opposition on behalf of cancer patients in the Chennai patent office where the application of Novartis was pending.

Chennai Patent Office rejects Gleevec® patent application
In January 2006 the Chennai Patent office rejected Novartis’ patent application on the ground that the application claimed 'only a new form of an old drug'. This order of the Chennai patent office brought relief to thousands of cancer patients as it not only prevented a patent monopoly till 2018 but also automatically cancelled the EMR. 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 challenges Patent Order and Indian Patent Law
In May 2006 Novartis filed two sets of cases in the Chennai High Court.

The first case challenges the patent order of the Chennai Patent office rejecting the Gleevec® patent application filed by Novartis. The first hearing took place on 23^rd August 2006. Legal representatives of the Cancer Patients Aid Association appeared on their behalf before the Chennai High Court. Novartis' constant litigation threatens the lives of cancer patients and renews fears about the future availability of drugs if the patent case of Gleevec® is reopened. Further it has raised concerns among other patient groups as the Gleevec® patent order set a good precedent for the examination of crucial drugs patent applications including those for AIDS treatment.

The second case filed by Novartis challenges 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 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 old medicines i.e. trivial patenting and new use patents etc. In the 1990s, pharmaceutical companies obtained additional patents on cancer drugs like Zidovudine for a new use (e.g. use of anticancer medicine Zidovudine for the treatment of HIV/AIDS). The patent granted on Zidovudine prolonged the market monolpoly of Glaxo and contributed to deprive millions in the developing world from accessing AIDS treatment till Indian manufacturers produced generic versions in the absence of product patents in India.

Therefore 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 (i.e. to prevent evergreening). This provision is considered by experts to be in conformity with TRIPS^[3]. Each country can introduce a patent regime that is more suited to its socio-economic context. This is also in keeping with the 2001 Doha Declaration on the TRIPS Agreement and public health.

Cancer Patients, public interest and health groups demand withdrawal of cases
The Constitution of Indian guarantees the right to life and health and the reopening of the Gleevec® patent order or a review of Section 3 (d) by the Chennai High Court, patient groups feel, threatens future access to affordable medicines. Indian cancer patients groups as well as other Indian public interest and health groups protested in Mumbai on 23^rd August 2006 and 13^th September 2006 against Novartis policy and requested Novartis to withdraw its case.

The Berne Declaration supports the Indian patients and public interest groups demands
The Berne Declaration is very concerned that the changes in the Indian Patent Law requested by Novartis would have consequence on access to affordable essential generic medicines (in particular HIV/AIDS medicines) not only in India but also in all developing countries that import Indian generic medicine. India is today the main provider of affordable generic medicines against HIV/AIDS in the developing countries. The Berne Declaration is shocked that Novartis wants to limit the recognized flexibilities left to the Indian Government under the TRIPS agreement and to undermine its ability to fulfil the right to health.

For more information contact:
Julien Reinhard (Berne Declaration): Phone: +41 21 620 03 06

^[1]This programme itself has been criticized: "Novartis: un anticancéreux coûteux." Solidaire n°180, avril 2005; pp. 12-14 (in French) (accessible at: www.evb.ch/fr/p25003505.html); S. Strom & M. Flesicher-Black. "Company's Pledge to Donate a Cancer Drug is Falling Short", New York Times, 5 June 2003 ( lists.essential.org/pipermail/ip-health/2003-June/004854.html)
^[2]CPAA is a Mumbai based cancer patients group working for over 35 years, providing services to needy cancer patients from all over India, and even neighbouring Bangladesh, Bhutan, Nepal and Pakistan.
^[3]Regarding the compatibility of the exclusion of patentability for new forms or new uses of known products with the TRIPs agreement, see for instance: Report of the Commission on Intellectual Property Rights, Innovation and Health. Public Health, Innovation and Intellectual Property Rights, Geneva: April 2006 ( www.who.int/intellectualproperty/documents/thereport/en/index.html) // Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy. London: CIPR, September 2002 ( www.iprcommission.org) // Carlos CORREA. Integrating Public Health Concerns into Patent Legislation in Developing Countries. Geneva: South Centre, 2000 // UNCTAD-ICTSD. Ressource Book on TRIPS and Development. Cambridge University Press, 2005 // Sisule MUSUNGU (South Centre) and Cecilia Oh (World Health Organization). The Use of Flexibilities in TRIPS by Developing Countries: Can they Promote Access to Medicines? Study 4C for the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva: August 2005.