Biotechnology Patent Attorney Files Lawsuit Against Pharmaceutical Cos. For Watson Laboritories Under 21 U.S.C. § 355 For ANDA Filed With FDA

Santa Ana, CA – Watson Laboratories, Inc., through its biotechnology patent attorneys, filed suit in Santa Ana District Court seeking declaratory relief of patent non-infringement and patent invalidity against Barr Pharmaceuticals, Inc. and Duramed Pharmaceuticals, Inc. The pharmaceutical companies own U.S. Patent No. 7,320,969, which they listed “with the Food And Drug Administration (FDA) in the Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange Book”), as a patent that could reasonably be asserted against anyone marketing or seeking to market a generic version of [their] SEASONIQUE® female contraceptive product.” Watson “previously filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market a generic form of SEASONIQUE®.” After the patent was filed with the FDA, Watson “filed an amendment to its ANDA containing a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and that the ‘969 patent is unenforceable, invalid and/or not infringed by Watson’s ANDA product.”

Watson has beaten the patent owners to the punch and filed a declaratory judgment action because it believes that it will be sued for patent infringement. Watson seeks a declaration from the Court that the patent is “is invalid, unenforceable and/or not infringed by the commercial manufacture, use or sale of the drub product described in Watson’s ANDA.” The case is titled Watson Laboratories, Inc., v. Duramed Pharmaceuticals, Inc., SACV08-0243 JVS (C.D. California).