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ELI LILLY AND CO. v. TEVA PHARMACEUTICALS USA

No. 2009-1071.

557 F.3d 1346 (2009)

ELI LILLY AND COMPANY, Plaintiff-Appellee, v. TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant.

United States Court of Appeals, Federal Circuit.

February 24, 2009.

Attorney(s) appearing for the Case

Charles E. Lipsey, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Reston, VA, argued for plaintiff-appellee. With him on the brief were David S. Forman, Howard W. Levine, Laura P. Masurovsky, Jennifer A. Johnson, and J. Derek McCorquindale, of Washington, DC. Of counsel on the brief were James P. Leeds and Gilbert T. Voy, Eli Lilly and Company, of Indianapolis, IN.

Jordan A. Sigale, Loeb & Loeb LLP, of Chicago, IL, argued for defendant-appellant. With him on the brief were Edward H. Rice and Marina N. Saito.

Opinion for the court filed by Circuit Judge RADER. Dissenting opinion filed by Circuit Judge PROST.

RADER, Circuit Judge.

Finding that Teva Pharmaceuticals USA, Inc., ("Teva") "recast its product more than eighteen months after it provided the original sample to Lilly and only eight months before trial is set to commence," the United States District Court for the Southern District of Indiana extended the statutory thirty-month stay of 21 U.S.C. § 355(j)(5)(B)(iii) (2003), preventing the U.S. Food and Drug Administration ("FDA") from finally approving Teva's...

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