Pharmagossip and Pharmalot below both provide coverage of an avidly watched patent case playing out before India's Supreme Court. Novartis is challenging an Indian patent office ruling that its new crystalline salt form of the cancer drug Gleevec is not patent eligible as it provides "little enhanced efficacy".
The case is important to the innovator Pharma industry, Generic producers, patient advocates and Indian health policy makers as it is effectively establishing the rules for "evergreening" by setting the standard for "enhanced efficacy".
Novartis argues that by not granting a patent for this improvment, it (and other innovators) lose any incentive to create "new" drugs. Patient advocates fear that allowing small changes to result in increased patent protection "up to 20 years", i.e. evergreening, will drive up medicines to unaffordable rates for the poor and gut the generics industry. Novartis' drug is a cancer drug but this same concept might be applied to AIDs medicines for example.
Thus, the case is heavily in the spotlight. For the moment, we'll have to wait on the ruling as one of the Justices recused himself and the hearing schedule for this week was postponed.
Posted by Bruce Lehr Sep 7th 2011.