Sciele Pharma Inc. v. Lupin Ltd.

Lupin Ltd. submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Fortamet, an extended-release tablet of metaformin hydrochloride. Sciele Pharma Inc., which markets Fortamet, sued Lupin for patent infringement under 35 U.S.C. § 271(e)(2)(A) asserting, among others, U.S. Patent No. 6,866,866 ('866 patent), which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Fortamet. Lupin attempted to launch its generic Fortamet "at risk," i.e., without a final judgment on the merits in the litigation. Sciele moved for a preliminary injunction to stop Lupin from selling its generic Fortamet and the district court granted Sciele's request for injunctive relief. Justice Lourie, speaking for the Federal Circuit Court of Appeals, vacated the preliminary injunction and remanded for further proceedings.