US District Court rules against Watson in generic Fentora patent suit

Mar 25 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI), today confirmed that the United States District Court for the District of Delaware has ruled that Watson's generic version of Fentora® (fentanyl buccal tablets C-II) infringes United States Patent No. 6,264,981 (the '981 Patent).  The Company said that it was reviewing the court's decision and would evaluate all available options, including an appeal.

Watson's Abbreviated New Drug Application ("ANDA") for its generic version of Fentora® has been approved by the FDA.  

In 2008, Cephalon sued Watson for patent infringement related to its generic version of Fentora®.  On March 11, 2011, the United States District Court for the District of Delaware ruled that Watson's product does not infringe United States Patent Nos. 6,200,604 and 6,974,590 (the '604 and '590 Patents) and that the '604 and '590 Patents are invalid.