Swiss drug major Novartis has approached the Supreme Court against a decision of the country’s apex patent complaint redressal forum, the Intellectual Property Appellate Board (IPAB), to deny patent protection for its cancer medicine, Glivec. The court is expected to take up the case for hearing on August 31.
The special leave petition (SLP) filed by Novartis said the basis for the denial of patent was not applicable in the case of Glivec.
“Novartis believes that Section 3(d), the Indian legal paragraph intended as a hurdle for 'evergreening', is not applicable at all to the breakthrough medicine Glivec. The beta crystal form of Imatinib mesylate is the active ingredient of the genuine breakthrough medicine Glivec. No other drug comprising Imatinib was available anywhere in the world before Glivec was launched,” said a Novartis press release.
Novartis also said it objected to IPAB’s contention, citing Section 3(b), that the price of the drug is “too unaffordable".
The company said the price was irrelevant in the case of Glivec as “99 per cent of all Glivec patients in India — currently more than 11,000 — have been receiving their medicine free of charge through the Glivec International Patient Assistance Program (GIPAP) since 2002”.
Glivec is among the first and most contentious patent battles in pharmaceutical sector after India changed its patent laws to comply with its obligations to the World Trade Organisation in 2005.
In 1998, Novartis filed a patent application in India for a product patent on the beta-crystalline form of imatinib mesylate (Glivec). As India did not recognise product patents for pharmaceuticals, this patent application was to be examined only after 2005. In 2003, Novartis obtained exclusive marketing right for the medicine based on this patent application.