The Indian Patent Office of New Delhi granted Gilead Sciences Inc. (NASDAQ:GILD) a patent covering active metabolites of HCV drug Sovaldi sofosbuvir, reversing an earlier ruling .
In Monday's decision, Deputy Controller of Patents & Designs Rajesh Dixit said the claimed compounds are "novel, inventive and patentable," and that prior art presented by opponents to the application relied on "hypothetical compounds" that a person skilled in the art would not be able to synthesize without the advantage of hindsight. Optimus Pharma Ltd. (Hyderabad, India) and BRD Pharmaceuticals International Pvt. Ltd. (Mumbai, India) argued against awarding the patent, as did the SanKalp Rehabilitation Trust, the India Cares Foundation, Delhi Network of Positive People (DNP+) and the Initiative for Medicines Access & Knowledge (I-MAK).
In a January 2015 decision rejecting Gilead's patent application, the office found that Sovaldi did not offer "significantly enhanced therapeutic efficacy as compared to the nearest prior art molecule which is structurally and functionally close." The High Court of Delhi remanded the decision later that month.
In a statement on Tuesday, Gilead said it "believes that, if used responsibly, IP does not hinder access" to medicines. In September 2014, the company granted non-exclusive rights to seven Indian generics companies to manufacture Sovaldi and Harvoni sofosbuvir/ledipasvir for distribution in 91 developing countries.
Adapted from BioCentury.