Objective Rule Triggering Exclusivity Period for Generic Drug Manufactures Affirmed

In yet another chapter of a long and convoluted history involving generic versions of the drug Pravachol, the U.S. Court of Appeals for the District of Columbia Circuit summarily affirmed a refusal to grant a preliminary injunction forbidding the U.S. Food & Drug Administration (FDA) from allowing a generic drug manufacture to begin exclusive marketing under the Hatch-Waxman Act. The court found that a stipulation and order in the district court stating that the challenged patent holder had no intention of suing and that the complaint should be dismissed for lack of subject matter jurisdiction was insufficient to trigger market exclusivity. Apotex, Inc. v. Food & Drug Admin. and Teva Pharmaceuticals, Case No. No. 06-5105 (Ct App for D.C. Cir. June 6, 2006) (Per Curium).