Legal Opinion
Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc.
Court of Appeals for the Federal Circuit
Decided February 24, 2009No. 2009-1071PublishedCited by 17 opinions
1Opinion of the Court
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 Abbreviated New Drug Application…
2Cases cited5 opinions
- Cooter & Gell v. Hartmarx Corp.Supreme Court of the United States · 1990
- Cheryl A. Gile v. United Airlines, IncorporatedCourt of Appeals for the Seventh Circuit · 1996
- Rick's Mishroom Service, Inc. v. United StatesCourt of Appeals for the Federal Circuit · 2008
- Allergan, Inc. And Allergan Sales, Inc. v. Alcon Laboratories, Inc., Alcon Research, Ltd., and Alcon Universal, Ltd., and Bausch & Lomb, IncorporatedCourt of Appeals for the Federal Circuit · 2003
- Apotex, Inc. v. ThompsonCourt of Appeals for the Federal Circuit · 2003
3Cited by17 opinions
- BAYER SCHERING PHARMA AG v. Lupin, Ltd.Court of Appeals for the Federal Circuit · 2012
- Wyeth v. Sandoz, Inc.District Court, E.D. North Carolina · 2010
- Bayer Schera Pharma AG v. Sandoz, Inc.District Court, S.D. New York · 2010
- Teva Pharm. United States, Inc. v. AzarCourt of Appeals for the D.C. Circuit · 2019
- Abbott Laboratories, Inc. v. Apotex Inc.District Court, N.D. Illinois · 2010
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