Chinta & Fratangelo LLP

Donepezil: Teva has standing in declaratory judgement action that it doesn’t infringe listed patents

Teva Pharms. USA Inc. v. Eisai Co., Ltd., No. 2009-1593 (Fed. Cir. 10/6/2010).

Ranbaxy was first-filer (pre-MMA) for donepezil of an ANDA with a “paragraph IV” certification, and Teva was a subsequent filer with a paragraph IV certification. Teva obtained tentative approval for its ANDA, but was prevented from marketing by Ranbaxy’s first-filing. Teva sued under 35 U.S.C. § 271(e)(5), seeking a declaration that its ANDA did not infringe four listed patents for donepezil.  If Teva was to prevail in its DJ action, it wold trigger the first-filer’s exclusivity period.  Eisai did not file suit to enforce the four patents at issue. Eisai moved to dismiss for lack of subject matter jurisdiction, because two of the patents were disclaimed, and Eisai agreed to not sue on the other two.  At the district court, the suit was dismissed for lack of subject matter jurisdiction, that there was no Article III controversy.

The Federal Circuit panel analogizes this case to Caraco Pharm. Labs. Ltd. v. Forest Labs. Ltd., 527  F.3d 1278 (Fed. Cir. 2008), that the injury exists “but for” the listing of the asserted patents in the OB. Slip op. at 11.  Thus, there was an actual controversy that could be redressed by a court. Slip op. at 12.

The panel also held that a district court in general has discretion to dismiss a  suit brought under 35 U.S.C. § 271(e)(5), but in this case the dismissal was an abuse of discretion, because the district court erroneously concluded it lacked subject matter jurisdiction, and because the panel concluded that the district court had factual misunderstandings. Thus, there was no “sound basis” for refusing to adjudicate the case. Reversed and remanded.