Thursday, March 28, 2013

Supreme Court’s Decision On Patent Rights Of Novartis AG's Cancer Treatment Drug Glivec In India to Be Pronounced Soon

The patent law of India is incorporate as the Indian Patents Act, 1970. As on date, we do not provide any utility models protection in India. A utility model protection provides a protection akin to patent but the duration of such protection is lesser as compared to a regular patent.

Similarly, the prerequisites for acquiring a utility model are less stringent as compared to patents. In utility models although the requirement of novelty must be duly met yet the burden to prove inventive step and non-obviousness can be easily discharged. 

This practically means that the protection for utility models is generally sought for innovations of incremental character which may not meet the patentability criteria. This also means that cosmetic improvements of already existing and publically known inventions would not be protected by granting a patent.

When it comes to pharmaceuticals there are many more complexities involved. From Doha Declaration to compulsory licenses, pharmaceutical patents are subject to many tests. The pharmaceutical giant Bayer AG's is also facing threes challenges in India.

The Intellectual Property Appellate Board has already rejected Bayer AG's plea to stop Natco Pharma from producing a cheaper generic version of its patented cancer drug Glivec. The matter finally reached the Supreme Court of India and it is going to pronounce its judgment on 1st April, 2013.

The concerned patent case before Supreme Court would decide the fate of patent protection of the Glivec drug in India. It would also clarify what drug is patentable in India and many more definitional and other issues. 

The patent office of India has refused patent protection for Glivec on the grounds that it is not a new medicine but an amended version of a known compound - a decision consistent with domestic patent law which sets tight restrictions on multiple patents for a drug.

India last year also allowed local drug maker Natco Pharma to sell cheaper copies of Bayer AG's cancer drug Nexavar through the mechanism of compulsory licensing. Also last year, India revoked patents granted to Pfizer Inc's cancer drug Sutent, Roche Holding AG's hepatitis C drug Pegasys, and Merck & Co's asthma treatment aerosol suspension formulation. They were all revoked on grounds that included lack of innovation.

We at Perry4Law believe that the decision of Supreme Court should definitely consider the aspects of Doha Declaration, TRIPS Agreement, Public Health and Public Interest, Compulsory License Requirements, etc.  We would cover the decision of Supreme Court once it is given.