Apotex v. Troy
Executive Summary
FDA Chief Counsel Daniel Troy will argue the agency's case in Apotex v. HHS in federal appeals court Feb. 4. Apotex is appealing a February 2002 D.C. federal court decision that GlaxoSmithKline's late-listed patents for Paxil (paroxetine) should remain in FDA's "Orange Book." A trial on the validity of GSK's hemihydrate patent, which expires in 2006, is scheduled to begin in Chicago federal court Feb. 5...