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Gilead, Medecins du Monde infectious news

February 16, 2015 8:00 AM UTC

The Delhi High Court issued a ruling that Gilead’s patent application for HCV drug Sovaldi sofosbuvir be “considered afresh along with pre-grant oppositions filed” due to “a complete breach of principles of natural justice” occurring in the Indian Patent Office’s patent application rejection last month. In its petition of the patent rejection, Gilead argued that it did not receive sufficient notice about the extent and scope of objections of the opposition before the hearing by the Indian Patent Office. Additionally, Gilead said the Patent Office’s ruling was biased towards the opposition, citing the Office’s use of direct quotes from pre-grant opposition materials, including typographical errors.

Last month, the Indian Patent Office rejected Gilead’s patent application 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 (see BioCentury, Jan. 19). ...