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Eli Lilly & Co. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2009)

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Donald Zuhn -- The Federal Circuit today 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. Seeking approval to manufacture and market a generic version of Plaintiff-Appellee Eli Lilly and Company's raloxifene hydrochloride formulation, which Lilly markets as Evista® for the treatment and prevention of postmenopausal osteoporosis, Teva filed an ANDA with the FDA in 2006. In response, Lilly filed an...

Full post as published by Patent Docs on February 25, 2009 (boomark / email).