US challenge for Glivec "could affect India case"

The US Food and Drug Administration has accepted a generic challenge by India's Sun Pharmaceuticals Industries against Swiss drug major Novartis' oncology drug Glivec/Gleevec (imatinib mesylate), in a move regarded in India as potentially weakening the Swiss firm's appeal against an Indian Patent Office decision to deny a patent for the product.

On November 13, the High Court accepted the approach put forth by the Indian government that the Glivec patent appeal be heard at the Intellectual Property Appellate Board by a two-member bench comprising a Chairman and Vice Chairman, instead of the official three-member panel structure. The Court ruled that the Chairman could also act as a technical member of the Bench. The compromise, which was accepted by Novartis, followed a complaint by the firm that the originally-appointed technical member had a potential conflict of interest in the case (Marketletters passim). A spokeswoman for Novartis told the Marketletter that no dates have been set for IPAB hearings.