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 …

Implied license denied for patents lacking an explicit cross-reference to the non-provisional application from which the licensed patents issued.

  Case: Endo Pharm. Inc. v. Actavis, Inc., No. 2013-1658 (Fed. Cir. Mar. 31, 2014) (precedential). On appeal from S.D.N.Y. Before Newman, Dyk, and Moore. Procedural Posture: Plaintiff patentee appealed district court’s denial of its motions for preliminary injunction. CAFC vacated and remanded. Estoppel: Plaintiff argued that the district court erroneously found …