Federal Circuit Clarifies the Scope of On-Sale Bar and Holds that the Absence of Regulatory Approval Before the Critical Date does Not Prevent a Sale and the Completion of Phase III studies and Final FDA Approval are Not Pre-Requisites for the Invention to be Ready for Patenting

HELSINN HEALTHCARE S.A., v. TEVA PHARMS. USA, INC.: May 1, 2017. Before Dyk, Mayer, O’Malley. Takeaway: An agreement contracting the claimed invention for sale contingent on regulatory approval is still a commercial sale, and thus the absence of FDA or other regulatory approval before the critical date does not prevent …

An earlier-expiring patent can qualify as an obviousness-type double patenting reference for a later-expiring patent.

  Case: Gilead Sciences, Inc. v. Natco Pharma Limited, No. 2013-1418 (Fed. Cir. Apr. 22, 2014) (precedential). On appeal from the District of New Jersey. Before Chen, Prost and Rader (dissenting). Procedural Posture: Defendant accused infringers appealed final judgment of infringement. CAFC vacated and remanded for further proceedings. Double Patenting: …

Claims that emerge from reexamination do not in and of themselves create a new cause of action.

  Case: Senju Pharma, Co., Ltd. v. Apotex, Inc., No. 2013-1027 (Fed. Cir. Mar. 31, 2014) (precedential). On appeal from D. Del. Before Newman, Plager, and O’Malley. Procedural Posture: Plaintiff patentee appealed grant of summary judgment finding patent invalidity. CAFC affirmed. Res Judicata: Before that district court’s entry final judgment of invalidity, …

CAFC reverses dismissal of declaratory judgment action for lack of subject matter jurisdiction

  Case: Danisco US Inc. v. Novozymes A/S, No. 2013-1214 (Fed. Cir. Mar. 11, 2014) (precedential). On appeal from N.D. Cal. Before Lourie, Proust, and O’Malley. Procedural Posture: Plaintiff appealed dismissal of declaratory judgment action for lack of subject matter jurisdiction. CAFC reversed and remanded. Subject Matter Jurisdiction: Plaintiff filed …

CAFC reverses judgments of validity, enforceability, and infringement; and orders judgement be entered for defendants

  Case: Pronova BioPharma Norge AS v. Teva Pharmaceuticals USA, Inc., Nos. 2012-1498, -1499 (Fed. Cir. Sept. 12, 2013) (non-precedential). On appeal from D.Del. Before Dyk, O’Malley, and Wallach. Procedural Posture: Defendants appealed judgments of validity, enforceability, and infringement of two asserted patents; CAFC reversed and ordered judgment entered for …