Watson Pharmaceuticals, Inc. , today announced 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) does not infringe United States Patent Nos. 6,200,604 or 6,974,590 (the '604 and '590 Patents) and that the '604 and '590 Patents are invalid. A decision on United States Patent No. 6,264,981 remains outstanding and Watson remains enjoined from launching its generic version of Fentora®. Watson's Abbreviated New Drug Application for its generic version of Fentora® has been approved by the FDA.
Thus, a decision on one patent (the '981) remains to be made in this Hatch-Waxman case.