Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)
On Feb. 24, 2009, the Federal Circuit affirmed a decision by the District Court for the Southern District of Indiana to extend the statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii), thereby preventing the U.S. Food and Drug Administration from approving the Abbreviated New Drug Application (ANDA) filed by Defendant-Appellant Teva Pharmaceuticals USA, Inc.
See Patent Docs for the full case history and analysis.