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India denies Glivec patent

April 2, 2013 12:09 AM UTC

India's Supreme Court upheld a 2009 ruling by India's Intellectual Property Appellate Board (IPAB) denying a patent for cancer drug Glivec imatinib from Novartis AG (NYSE:NVS; SIX:NOVN). In its (see BioCentury Extra, July 7, 2009).

Section 3(d) of the Indian Patent Act states that the "mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance" is not an invention and not patentable, unless it "results in a new product or employs at least one new reactant." An explanation written into the law notes that salts, polymorphs -- specific crystalline forms of a compound that can crystallize in different forms, isomers and metabolites cannot be patented "unless they differ significantly with regard to efficacy" from the known substance. The Supreme Court noted in its decision that "for a medicine that claims to cure a disease," the new form of the drug must improve therapeutic efficacy over the known form. Novartis had argued the beta crystalline form of imatinib mesylate improved the drug's efficacy by making it easier to process and store. ...