New Delhi, March 29: In a judgment that could have far-reaching consequences on marketing of drugs whose manufacturers seek patent protection in the Indian market, the Supreme Court will Monday pronounce its verdict on Swiss pharmaceutical company Novartis AG's claim that its anti-cancer drug Glivec was covered under the patent law.
Novartis AG, in a hearing spread over several months, had told a bench of Justice Aftab Alam and Justice Ranjana Prakash Desai that it was the author of the beta-crystalline form of chemical imatinib mesylate, used in treatment of chronic mycloid leukaemia and thus was entitled to get it patented in India for exclusive marketing rights.
Staking its claim for the invention and for getting the drug patented in India, Novartis AG, represented by senior counsel Gopal Subramanium, contended that that imatinib mesylate was known to chemists the world over but its beta-crystalline form was developed by the Swiss pharma giant.
The firm contended before the court that though the chemical compound was known, its efficacy as an anti-cancer drug was not and this was discovered by Novartis AG.
Novartis AG had challenged before the apex court the decision of the Intellectual Property Appellate Board (IPAB), which it said, while holding that beta crystalline form of imatinib mesylate was an invention but did not agree to grant it a patent.
Novartis AG's anti-cancer drug marketed by the name of Glivec (imatinib mesylate) is used for the treatment of chronic myeloid leukemia and malignant gastrointestinal stromal tumours (MGST).
"Can there be a situation that a product is an innovation under 2(j) and 2(j)(a) of the Patent Act and sought to denuded of invention under 3(d) in terms of pharmaceutical efficacy," the MNC drug manufacturer had told the court.
"Section 3(d) is not intended for invention but discovery of a new form. It deals with a known substance with known efficacy," it said.
The firm had told the ther apex court that there could not be conflicting provisions in a patent statute where one of its provisions recognises innovation in the development of a drug and other provision of the same statute knocks it down.
Novartis argued that once the IPAB has accepted that beta-crystalline form of imatinib mesylate was an innovation under 2(j) and 2(j)(a) of the Patent Act, then it (Novartis) could not be asked to re-establish its patentability under Section 3(d) of the Patent Act.
