Category: Claim Construction

  • By Kevin E. Noonan – The provisions of U.S. regulatory law regarding FDA approval for less than all the indications for which an innovator drug was approved under 21 U.S.C. § 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past raised something of a kerfuffle before the Federal Circuit (see "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA…

  • By Kevin E. Noonan – Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal Circuit opinions, perhaps the most notable being in Warner-Jenkinson v. Hilton Davis Chemical (1997), which revitalized the…

  • By Kevin E. Noonan – It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement requirement under 35 US.C. § 112(a).  After all, the decision is a rare affirmance of Federal Circuit…

  • By Kevin E. Noonan — The Federal Circuit today affirmed determinations by the Patent Trial and Appeal Board (PTAB) in an inter partes review in American National Manufacturing v. Sleep Number Corp., in an opinion by Judge Cunningham.  The opinion was not Judge Cunningham's first Federal Circuit opinion but it is likely to be her…

  • By Kevin E. Noonan — In reviewing (and reversing) the District Court's claim construction in University of Massachusetts v. L'Oreal S.A., the Federal Circuit availed itself of both the disclosure in the specification and the prosecution history to construe a limitation in a wherein clause, based on its determination that the term did not have…

  • By Donald Zuhn –- Earlier today, the Federal Circuit reversed the Final Written Decision, and reconsideration of that decision, by the U.S. Patent and Trademark Office Patent Trial and Appeal Board, which determined that claims 1-24 of U.S. Patent No. 8,952,138 were unpatentable under 35 U.S.C. § 103(a). The '138 patent is directed to methods…

  • By Kevin E. Noonan — The Federal Circuit issued three decisions on Monday relating to Eli Lilly & Co's. challenge in separate inter partes review proceedings on obviousness grounds of nine patents licensed by Teva Pharmaceuticals Int'l, with disparate results. The patents were related to humanized monoclonal antibodies immunologically specific for calcitonin gene-related peptide (CGRP),…

  • By Kevin E. Noonan — Last week, the Federal Circuit affirmed imposition of an exclusion order under 19 U.S.C. § 1337 (Section 337 of the Tariff Act of 1930) by the Federal Trade Commission against 10X Genomyx (an intervenor in this appeal) over importation of patented microfluidic chips, in Bio-Rad Laboratories, Inc. v. International Trade…

  • By Kevin E. Noonan — Last month, the Federal Circuit affirmed an exclusion order imposed by the International Trade Commission against Bio-Rad for importing infringing microfluidic systems and components used for gene sequencing or related analyses, in Bio-Rad Laboratories, Inc. v. Int'l. Trade Comm. The ITC's decision followed a complaint by 10X Genomics, an intervenor…

  • By Kevin E. Noonan — Last week, the Federal Circuit affirmed a jury verdict against Baxalta Inc., Baxalta US Inc., and Nektar Therapeutics for infringing Bayer Healthcare's patent to human blood clotting factor conjugates in Bayer Healthcare LLC v. Baxalta Inc. Bayer Healthcare sued Defendants on U.S. Patent No. 9,364,520, alleging willful infringement by Baxalta's…