Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc.

In this amicus brief in support of Teva’s combined petition for rehearing and rehearing en banc, the Commission argues that the court erred in affirming the district court’s dismissal of Teva’s complaint in this Hatch-Waxman Act case. The brief argues that the court applied the wrong test to assess jurisdiction under the Declaratory Judgment Act. The court only considered the likelihood that Teva would face a patent infringement suit, but failed to take account of the injury Teva will suffer. The brief argues that Teva will face injury even in the absence of a patent infringement suit because the FDA cannot approve Teva’s generic sertraline hydrochloride drug unless Teva can obtain a court decision regarding Pfizer’s patent.