Teva Pharmaceuticals Usa, Inc. v. Novartis Pharmaceuticals Corporation

482 F.3d 1330 (2007)

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Nature of the Case

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Facts

D holds a New Drug Application (NDA) for three strengths of the drug Famvir (R). D listed five patents in the Food and Drug Administration's (FDA) Orange Book, each of which covers and is directed to various aspects of Famvir (R). P filed an Abbreviated New Drug Application (ANDA) with the FDA for generic famciclovir tablets. P certified that its drug did not infringe any of the five Novartis Famvir (R) patents or that the patents were invalid. Teva's paragraph IV certifications constituted technical infringement under §271(e)(1). D had 45 days to sue on the patents in order to invoke a statutorily mandated 30-month stay to delay immediate FDA approval of P's famciclovir ANDA. D brought an infringement suit against P on the '937 patent alone and did not include in the action the related therapeutic use patents. P then brought this declaratory judgment action on the four remaining method patents under §355(j)(5)(C) and §271(e)(5) to establish 'patent certainty. P argues that by bringing suit on the '937 patent alone, 'D has sought to put P to the hard choice of either launching at risk of massive liability for patent infringement when the '937 patent expires or P prevails in the pending infringement action, or foregoing that opportunity and thereby effectively extending the term of the '937 patent. D moved to dismiss for lack of subject matter jurisdiction, arguing that Teva had no reasonable apprehension that it would be sued by D for infringing the four method patents. P argued that: (1) D had already sued on the underlying composition patent; (2) listing patents in the Orange Book established infringement as a matter of law; (3) D had a history of aggressively suing generic drug companies; and (4) D had declined to give P a covenant not to sue. The district court applied a two-prong 'reasonable-apprehension-of-imminent-suit' test and found that P had failed to establish a reasonable apprehension of imminent suit. The court dismissed the suit. P appealed.