Fitzpatrick Case Update
September 24, 2015
On September 24, 2015, the Federal Circuit issued an opinion addressing infringement liability for active pharmaceutical ingredient (“API”) suppliers in Hatch-Waxman cases. In particular, the Court held that API supplier Johnson Matthey’s activities are protected by the safe harbor provision of 35 U.S.C. § 271(e)(1), and that it did not induce infringement under 35 U.S.C. § 271(b) by providing API to abbreviated new drug application (“ANDA”) applicants for use obtaining FDA approval.