Shire v. Amneal: API Supplier Does Not Induce Infringement by Supplying Material for Use in Obtaining FDA Approval

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.

View Attachment (PDF)