On February 23, 2021, a Federal Circuit panel of Chief Judge Prost, Judge Newman, and Judge Moore reheard oral argument in GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. As discussed in our previous post, on February 9, 2021, the panel issued an order granting Teva’s petition for rehearing, vacating the prior October 2,
In a precedential opinion in Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., No. 20-1074 (Fed. Cir. 2021) issued on February 11, 2021, the Federal Circuit affirmed the decision of the United States District Court for the District of Delaware granting JMOL that Amgen’s Repatha® patents (U.S. Patent Nos. 8,829,165 and 8,859,741)
A panel of the Federal Circuit agreed on February 9, 2021, to rehear arguments in a case between GlaxoSmithKline LLC (“GSK”) and Teva Pharmaceuticals USA, Inc (“Teva”) regarding Teva’s generic to GSK’s carvedilol product, Coreg®. As discussed below and in our previous post, the three-judge panel previously held in a 2-1 decision in October
On December 9, 2020, the Federal Circuit heard oral arguments on the validity of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) on cholesterol-lowering drug Repatha. Specifically, the question came down to whether the patents, claiming a genus of antibodies by their functional properties, are enabled under 35 U.S.C § 112. The panel consisted of
Mark your calendars – on December 9th, the Federal Circuit is slated to hear oral arguments as to whether two Amgen patents claiming a genus of antibodies meet the enablement requirement of 35 U.S.C. § 112. The court’s decision may have a considerable impact on antibody-based drug development and the scope of patent
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent infringement cases. Section 1400(b) provides that an action for patent infringement may be brought in the judicial district where the
In the context of Immunex’s patent on IL-4 antibodies, the Federal Circuit says yes.
On October 13, 2020, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (the “Board”) final written decision in IPR2017-01884, holding invalid all claims of U.S. Patent No. 8,679,487 (“the ’487 patent”) assigned to Immunex. The ‘487 patent is drawn
The Federal Circuit recently held[1] in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic version of carvedilol.
The case concerned GSK’s United States Patent No. 4,503,067 (“the ’067 patent”) and Reissue
Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®.
As explained in the petition, Immunex was the first to make etanercept, the tumor necrosis factor (TNF) receptor fusion protein that is the active ingredient in Enbrel® (used
We have previously covered various aspects of a legal battle between Genentech and Amgen regarding Amgen’s efforts to market Mvasi, a biosimilar to Genentech’s bevacizumab product, Avastin. These aspects include Genentech’s quickly-dismissed February 2017 action contending Amgen was in violation of the Biologics Price Competition and Innovation Act (“BPCIA”) (covered here and here), and