Novartis has challenged patent denial for Glivec.
The Supreme Court today issued notice to the central government, drug majors Cipla, Ranbaxy Lab, Hetero Drugs, Natco Pharma and others on an appeal filed by Swiss firm Novartis, challenging the denial of patent for Glivec, its blood cancer drug in beta crystal form.
A Bench headed by Justice Dalveer Bhandari did not pass a stay order against the order of the Intellectual Property Appellate Board (IPAB), against which Novartis approached the Supreme Court. IPAB had rejected the Novartis’ appeal against the Chennai patent office order denying patent to the multinational firm.
The court sought replies from the Ministry of Industry and Commerce, the Comptroller General of Patent and Design, the Cancer Patients Aid Association (CPAA) and the four pharma companies.
IPAB in July had denied the plea for patent mainly under Sections 3(d) and 3(b) of the Indian Patents Act. Section 3(d) restricts patents for already known drugs unless the new claims are superior in terms of efficacy. Section 3(b) restricts patents for products that are against public interest and do not demonstrate enhanced efficacy over existing products.
The SLP filed by Novartis said that Section 3(d) was not applicable at all to their “breakthrough medicine Glivec”. Novartis also said it objected to IPAB’s contention, citing Section 3(b), that the price of the drug is “too unaffordable” as 99 per cent of all Glivec patients in India — currently more than 11,000 patients — have been receiving their medicine free of charge through the Glivec International Patient Assistance Program (GIPAP) since 2002”.
Petitioners such as CPAA have opposed the Novartis view by stating that a patent on the drug will indeed affect its availability.
The battle for Glivec’s patent rights is the longest and the most controversial intellectual property debate on medicines after India changed its patent rules to align itself with the TRIPS (Trade Related Aspects of Intellectual Property Rights) of the World Trade Organisation in 2005.
