Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp.
United States Court of Appeals for the Federal Circuit
482 F.3d 1330 (2007)
Novartis (defendant) listed five patents for its drug Famvir in the FDA's Orange Book, and after Teva (plaintiff) filed an ANDA with a paragraph IV certification of non-infringement (technically triggering infringement liability), Novartis sued only on one patent (the '937 patent covering the active ingredient), triggering a 30-month stay of Teva's ANDA approval while leaving the other four therapeutic-use patents unaddressed; Teva sought a declaratory judgment on those four remaining patents to establish patent certainty, and the district court dismissed under the Federal Circuit's prior reasonable-apprehension-of-imminent-suit test.
Whether a party may pursue a declaratory judgment action so long as a definite and concrete controversy exists between the parties and, under all the circumstances, an actual or imminent injury requires the issuance of a declaratory judgment.