Novartis has been urged to drop its "persistent legal actions" in India regarding patent coverage for its anticancer drug Glivec and a challenge to the country's patent laws over fears the latter could hinder access to medicines.

In a letter to Novartis chairman Daniel Vasella, Health Action International and other non-governmental organisations (Berne Declaration, Third World Network and Knowledge Ecology International) have urged the Swiss major to put an end to its five-year legal battle concerning Glivec/Gleevec (imatininb), its chronic myeloid leukaemia treatment. The NGOs note that despite three consecutive patent refusals pronounced by the Indian justice authorities since 2006, Novartis, through an appeal to the Supreme Court in August 2009, is "insistent in its attempt to challenge the Indian patent law." The next hearing of the Glivec case is scheduled for April 19.

The letter also notes the establishment of the Glivec International Patient Assistance Programme to counter the problem of high prices, but alleges that it is "nowhere near covering all the public health needs". Compared with the 25-30,000 people newly affected by CML each year in India, according to what the NGOs claim are Novartis figures, the GIPAP has benefited only between 7-11,000 patients. Treatment with Glivec currently costs around $2,500 per month, "a sum that the vast majority of Indians simply cannot afford", whilst local generic versions are available for around 10% of that price.

HAI et al go on to argue in response to the R&D investment argument to justify why Novartis set a single global price for Glivec that "all the basic research and preclinical investigations were done in academic institutions, overwhelmingly funded by taxpayers and other non-profit support". Furthermore, they claim, Glivec was granted orphan drug status in the USA and was therefore eligible for tax rebates "equal to half the cost of clinical testing". The letter adds that Novartis "certainly deserves credit for the development and production of Glivec, but evidence suggests that its R&D investment was below the average costs cited by the originator pharmaceutical industry".

The letter also urges Novartis to "abstain from lobbying the Indian government for more stringent intellectual property regulation". It is argued that "this would have major negative impact on access to medicines for disadvantaged patients and would undermine competition with generics", issues which are currently being negotiated in the framework of bilateral free-trade agreements between India and the European Union, and the European Free Trade Association.

The letter cites comments made by Patrick Durisch, health programme coordinator of Berne Declaration, during Novartis' annual general meeting earlier this week. He said “the stakes go far beyond the granting of the patent for this anticancer drug. This action aims at weakening a public health safeguard clause – section 3(d) of the Indian Patents Act – which limits the multiplication of abusive or useless patents on an already-known substance”.

He added that “without this disposition, access to affordable medicines would be threatened in most developing countries, since India is one of the primary suppliers of generic medicines worldwide, in particular in the field of HIV/AIDS".

Novartis had not immediately responded to an e-mail request for comment concerning the letter by the time PharmaTimes World News was published.