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 …

En Banc Panel of the Federal Circuit Rules That Commercial Benefit and Stockpiling Do Not Alone Trigger the Section 102(B) On-Sale Bar

Authored by Georg Reitboeck, Michael Turner, and Kulsoom Hasan Digest of The Medicines Co. v. Hospira, No. 2014-1469 (Fed. Cir. July 11, 2016) (precedential). On appeal from the United States District Court for the District of Delaware. Before Prost, Newman, Lourie, Dyk, O’Malley, Reyna, Wallach, Taranto, Chen, Hughes, and Stoll (en …

Federal Circuit Invalidates Patent Under On-Sale-Bar

Authored by Georg C. Reitboeck and Dervis Magistre Digest of The Medicines Company v. Hospira, Inc., No. 2014-1469, 2014-1504 (Fed. Cir. July 2, 2015) (precedential). On appeal from D. Del. Before Dyk, Wallach, and Hughes. Procedural Posture: Plaintiff appealed the district court’s claim construction and non-infringement findings. Defendant cross-appealed the district court’s …

Federal Circuit Affirms-in-Part, Reverses-in-Part, Vacates-in-Part and Remands in Snowball Case

Authored by Mark A. Chapman and Michael W. Glynn, Ph.D.  Digest of Southern Snow Manufacturing v. SnoWizard Holdings, Nos. 2013-1586, 2014-1043 (Fed. Cir. Jun. 30, 2014) (nonprecedential). On appeal from E.D. La. Before Prost, Lourie, and Clevenger. Procedural Posture: Alleged infringer appealed final judgment of validity and no unenforceability for inequitable conduct, as well …