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 …

Federal Circuit Affirms the PTAB’s Decision Finding the Patent Claims Unpatentable as Obvious Where the Patent Owner Did Not Demonstrate that the Board Violated the Administrative Procedure Act Requirements of Notice and an Opportunity to Respond

NOVARTIS AG, MITSUBISHI PHARMA CORP., v. TORRENT PHARM. LTD.:  April 12, 2017. Before Taranto, Chen, and Stoll. (precedential). Takeaways: The Patent Trial and Appeal Board did not violate the requirements of notice and an opportunity to respond found in the Administrative Procedure Act when it relied on a prior art …

Summary Judgment of Infringement is Vacated Because the Defendant’s ANDA Did Not Meet the “Efficient Mixing” of the Asserted Claims

THE MEDICINES COMPANY v. MYLAN: Apr. 6, 2017. Before Dyk, Wallach, Hughes Takeaways: In ANDA case, the CAFC interprets batching limitation to require specific efficient mixing conditions, and reverses the district court’s finding of infringement based on this claim construction. Procedural Posture: The N.D. Ill. Held on summary judgment that …

Board’s Finding of Obviousness Upheld Despite that Prior District Court Found the Claims Non-Obvious

NOVARTIS AG, LTS LOHMANN THERAPIESYSTEME AG, v. NOVEN PHARMACEUTICALS INC.,: Apr. 4, 2017. Before Prost, Wallach, and Stoll Takeaways: Because of the different burdens, the PTAB may properly reach a different IPR conclusion than a prior district court based on the same evidence. Chemical claims are obvious where a skilled …

Octane Fitness Does Not Provide a Set Formula For Determining Whether to Grant Attorney Fees.

UNIV. OF UTAH v. MAX-PLANCK-GESELLSCHAFT: March 23, 2017. Before O’Malley, Reyna, Wallach. Takeaway: Octane Fitness does not provide a precise framework for a finding that a case is exceptional and warrants an award of fees, only several suggestions that might guide a district court’s discretionary decision. In ruling on a …