Expanding Jurisdiction over Patent Challenges

Continuing the recent trend of court decisions expanding jurisdiction over declaratory judgment challenges to patents, the Court of Appeals for the Federal Circuit (the “Federal Circuit” or the “court”) opened the door to increased challenges to drug patents in Teva Pharms. USA Inc. v. Novartis Pharms. Corp., 482 F.3d 1330 (Fed. Cir. 2007). The Federal Circuit ruled that a generic drug company could, under the appropriate circumstances, pre-emptively seek a declaratory judgment that certain drug patents listed in the FDA’s Orange Book are invalid or not infringed. Generic drug companies thus can have a court resolve patent infringement issues before undertaking the expense of launching a generic drug under the threat of patent litigation and any resulting injunction or treble damages for willful infringement. The Teva decision is expected to increase declaratory judgment challenges by generic drug companies and help speed generic drugs to market when those challenges are successful.

Background