Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp.

Novartis Pharmaceuticals Corp. (“Novartis”) (defendant) held the New Drug Application (“NDA”) for three strengths of the drug Famvir and listed five patents related to the drug in the U.S. Food and Drug Administration’s (“FDA”) Orange Book. One of the patents, the ‘937 patent, was the active ingredient in Famvir called famciclovir, while remaining four patents detailed the methods of use for Famvir. Teva Pharmaceuticals USA, Inc. (“Teva”) (plaintiff) filed an Abbreviated New Drug Application (“ANDA”) with the FDA for a generic version of Famvir, with an included paragraph IV certification that its drug did not infringe any of Novartis’ five listed Orange Book patents. Teva’s paragraph IV certification constituted technical infringement under 35 U.S.C. § 271(e)(1). Accordingly, Novartis had 45 days in which to file an infringement suit against Teva to invoke a mandatory 30-month stay of approval of Teva’s ANDA. Novartis brought suit against Teva for infringement of only its ‘937 patent in the U.S. District Court for the District of New Jersey. After Novartis filed suit, Teva brought a declaratory judgment action on the four remaining therapeutic use patents under 21 U.S.C. § 355(j)(5)(C) and 35 U.S.C. § 271(e)(5) to establish “patent certainty.” Novartis moved to dismiss Teva’s action for lack of subject matter jurisdiction, arguing that Teva had no reasonable apprehension that it would be sued by Novartis for infringing the remaining four patents. The district court dismissed Teva’s declaratory judgment action after applying the two-prong “reasonable-apprehension-of-imminent-suit” test set forth in Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc., 395 F.3d 1324 (Fed.Cir.2005). Teva appealed.