As the Indian High Court this week postponed the hearing of the legal challenge by the Swiss drug company Novartis against the Indian government over its refusal to grant the company a patent on imatinib (Glivec), nearly a quarter of a million people from more than 150 countries signed an international petition calling for Novartis to back down.
Unni Karunakara, from the charity Médecins Sans Frontières, said at a press briefing this week in New Delhi: “Over 80% of the medicines we use to treat AIDS patients come from India, and access to affordable and new drugs for HIV is now becoming imperative as drug resistance grows . . . Sixty seven per cent of India's generic drug exports go to the developing world. We cannot stand by and let Novartis turn off the tap.”
Leena Menghaney, a lawyer for the charity, said: “The court case was adjourned today until 15 February to give the Indian government more time to prepare its defence.
“This comes amid growing public and patient opposition to the Novartis challenge. Patient groups have written to the Indian government this week calling for the best legal defence, and the Indian government has taken this very seriously. Many patient groups feel that their right to health under the Constitution of India is now under attack.”
India has been able to produce cheap generic versions of drugs patented in other countries because until 2005 the country did not grant pharmaceutical patents. Novartis has launched two lawsuits against India after the country refused to grant a patent to the company for imatinib, a leukaemia drug (BMJ 2007;334:172, 27 Jan).
Novartis is challenging not just this decision but also a section of India's patent law that restricts patenting of drugs to innovative drugs. The Indian Patent Act was designed to promote cheaper generic drugs for poor patients who cannot afford patented ones.
If Novartis wins, patents would be granted far more widely in India, bringing India's patenting system in line with those in other industrialised countries. This would restrict generic production and keep prices of new drugs high for the lifetime of the patent, usually around 20 years. In the immediate term Novartis's challenge could affect the roughly 9000 patent applications currently waiting to be reviewed by Indian authorities, which could then be off limits to competition from cheap generic versions.
Celine Charveriat, from Oxfam, London, said: “The Novartis challenge comes at a time when the global pharmaceutical industry as a whole is facing difficulties. Patents on many blockbuster drugs are beginning to expire, and not enough new medicines are in the development pipeline.
“Therefore companies are seeking to extend and protect their monopolies around the world in order to curb generic competition and maximise their profits on existing drugs.”
Novartis has dismissed allegations that its actions will have global ramifications. In a statement the company said that the legal challenge against the Indian government is needed to “align this increasingly important industrial country with international standards.” Novartis claims that the patent situation in India is “unique” in comparison with other countries and “discourages both breakthrough and incremental drug innovation.”
Dr Karunakara said, “The pharmaceutical industry is a $600bn [£300bn; €450bn] global industry. Even if you allow different patent systems across different countries, there is still a lot of scope for pharma to make a lot of money.
“The current model of using high drug prices to fund research and development of new drugs is not working, and this case in India raises a number of broader issues around how best to supply drugs to the developing world,” he said.