Potential For Delayed Generic Launch Does Not Give Rise To Declaratory Judgment Jurisdiction For Second ANDA Filer

For the second time in three months, the U.S. Court of Appeals for the Federal Circuit held that Apotex lacked declaratory judgment jurisdiction in the context of its Hatch-Waxman litigation for its Abbreviated New Drug Applications (ANDAs). (See IP Update, Vol. 11, No. 8, published August 2008). The Court affirmed a district court's decision that a covenant-not-to-sue, coupled with a stipulation of validity and enforceability, removed any case or controversy required for declaratory judgment jurisdiction. Janssen Pharmaceutica v. Apotex, 540 F.3d 1353 (Fed. Cir., 2008) (Moore, J.).

Janssen is a brand-name drug manufacturer that holds an approved New Drug Application (NDA) for Risperdal, used for anti-psychotic treatments. Janssen originally listed the '663 patent, the '425 patent and the '587 patent in connection with Risperdal's NDA. In a previous case, the '663 patent was found to be infringed, valid and enforceable. While Apotex was not a party to that trial,