Month: July 2015

  • By Andrew Williams — As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. — a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for approval of biosimilar drug products.  Unfortunately, the decision was, much like the BPCIA itself, anything…

  • By Kevin E. Noonan — In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz.  In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument).  On…

  • By Kevin E. Noonan — In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz.  In doing so, the Court limited the information available to biologic drug makers regarding a competitor's application for a biosimilar product (adopting Sandoz's argument).  On…

  • By Donald Zuhn — Earlier this month, in Daiichi Sankyo Co. v. Lee, the Federal Circuit affirmed the decision by the District Court for the District of Columbia granting summary judgment to the Director of the U.S. Patent and Trademark Office with respect to Daiichi's challenges to patent term adjustment (PTA) determinations made by the…

  •         By Sherri Oslick — About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases. Alcon Research Ltd. v. Akorn Inc.1:15-cv-00474; filed June 11, 2015 in the District Court of Delaware Infringement of U.S. Patent Nos. 8,268,299 ("Self Preserved Aqueous Pharmaceutical Compositions," issued September 18, 2012), 8,323,630 (same title,…

  • July 20-21, 2015 – Patent Cooperation Treaty Seminar (American Intellectual Property Law Association) – San Francisco, CA July 22, 2015 – "Navigating Ex Parte Reexamination and Reissue Applications — The Mechanics of Preparation and Interplay with AIA Post-Grant Proceedings and Litigation" (American Intellectual Property Law Association) – 12:30 – 2:00 pm (Eastern) July 23, 2015…

  • Strafford will be offering a webinar/teleconference entitled "Advanced Issues for Patent Claim Construction: Leveraging Recent Court Guidance — Navigating New Standard of Review, Interplay With Litigation and Choice of Law, and Continuation Application" on July 30, 2015 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner, Michael A.…

  • Strafford will be offering a webinar/teleconference entitled "Defending Patents in IPR Proceedings — Leveraging Motions to Amend and Preliminary Responses, Weighing Secondary Considerations" on August 13, 2015 from 1:00 to 2:30 pm (EDT).  Michael J. Flibbert of Finnegan Henderson Farabow Garrett & Dunner, John C. Jarosz of Analysis Group, and Maureen D. Queler of Finnegan…

  • By Andrew Williams — As we reported earlier, the Federal Circuit recently affirmed the PTAB's Final Written Decision in the Versata Development Group v. SAP America, Inc. case — the first appeal under the covered business method ("CBM") patent review procedure.  In so doing, the Court made several ancillary determinations, such as whether the PTAB…

  • By Michael Borella — Section 18 of the Leahy-Smith America Invents Act (AIA) established a transitional program through which the USPTO conducts post-grant reviews of covered business method (CBM) patents.  For the most part, § 18 incorporates the procedural aspects of 35 U.S.C. §§ 321–329, which codifies post grant reviews.  The CBM review process is an…