Actavis and Kissei file law suits against Sandoz and Hetero over Rapaflo patent

USA-based Actavis (NYSE: ACT), itself predominantly a generic drug marketer, and Japan’s Kissei Pharmaceutical confirmed that they have filed law suits against Swiss drug major Novartis’ (NOVN: VX) Sandoz unit and India’s Hetero in the US District Court for the District of Delaware for infringement of US Patent No 5,387,603 covering Rapaflo (silodosin), a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH).

Actavis and Kissei's law suits were filed in response to Abbreviated New Drug Applications filed by each of Sandoz and Hetero seeking Food and Drug Administration approval to market a generic version of Actavis' Rapaflo prior to the expiration of the '603 patent. The law suits were filed under the provisions of the Hatch-Waxman Act, accordingly, the FDA must refrain from approving the Sandoz and Hetero ANDAs prior to April 8, 2016, or until a district court decision finding that the '603 patent is invalid or not infringed, whichever occurs earlier, noted Actavis.