Teva Pharms. USA v. Eisai Co., 2009-1593 (Fed. Cir. Oct. 6, 2010)

Teva Pharms. USA v. Eisai Co., 2009-1593 (Fed. Cir. Oct. 6, 2010)

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Teva alleged that as a subsequent filer of a Paragraph IV certification (i.e. not the first filer) to an Orange Book-listed drug, it had a legally cognizable interest in when the first-filer's exclusivity period begins and ends.

Under the Federal Circuit's decision in Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc., 527 F.3d 1278 (Fed. Cir. 2008), Teva alleged a sufficiently concrete injury fairly traceable to Eisai’s actions. Further, the injury can be redressed by the requested relief: a declaratory judgment of noninfringement would trigger the first-filer’s exclusivity period, which currently blocks FDA approval of the Gate ANDA. The district court’s decision is reversed and the case remanded for further proceedings consistent with this opinion.

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Reference Info:Decision | Federal, Federal Circuit, Patent | United States


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