Gilead infectious news
The Indian Patent Office rejected Gilead’s patent application covering HCV product Sovaldi sofosbuvir. The patent office issued a decision saying Sovaldi did not offer “significantly enhanced therapeutic efficacy as compared to the nearest prior art molecule which is structurally and functionally close,” based on data presented to the office. The office did find in favor of Sovaldi’s novelty and inventiveness. Gilead said additional patent applications covering Sovaldi are still pending before the Indian Patent Office and that this particular rejection relates to an application covering the metabolites of Sovaldi. The company said the rejection will not affect Gilead’s generic licensing program with Indian partners. Last September, Gilead signed non-exclusive licensing agreements allowing seven Indian generics companies to manufacture Sovaldi and Harvoni sofosbuvir/ledipasivir for distribution in 91 developing countries. Harvoni is a fixed-dose combination of Sovaldi, a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir, an HCV NS5A protein inhibitor (see BioCentury, Sept. 22, 2014). ...