Shire, Actavis generics, autoimmune news
The U.S. Supreme Court granted a petition from Shire and remanded to a lower court Shire’s patent infringement suit against Actavis for a generic of inflammatory bowel disease (IBD) drug Lialda mesalamine, citing the high court’s decision last month in Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) vs. the Sandoz International GmbH generics unit of Novartis AG (NYSE:NVS; SIX:NOVN, Basel, Switzerland) (see BioCentury, Jan. 26).
Shire asked SCOTUS to review whether the U.S. Court of Appeals for the Federal Circuit (CAFC) overreached by reviewing de novo certain questions of fact in the company’s lawsuit against Actavis rather than deferring to the findings of the U.S. District Court for the Southern District of Florida. Shire alleges Actavis’ ANDA for generic Lialda -- originally submitted by Watson Pharmaceuticals Inc., which merged with Actavis in November 2012 -- infringed on Shire’s U.S. Patent No. 6,773,720, which expires in 2020. Shire received notice of Watson’s ANDA for the ulcerative colitis drug in March 2012, and the district court ruled in Shire’s favor in May 2013. In 2014, the CAFC reviewed the facts of the case and overturned the district court’s ruling. ...