The Supreme Court agreed on Friday, November 4, 2022, to review the standard for enablement of genus claims after the Federal Circuit’s decision in Amgen, Inc. v. Sanofi. We have previously covered Amgen’s petition for a writ of certiorari and the multiple amicus curiae briefs submitted in the case. As detailed below, the Supreme

As we have previously discussed, on February 11, 2021, the Federal Circuit decided Amgen Inc. et al.  v. Sanofi, Aventisub LLC, et al. The Federal Circuit affirmed the district court’s grant of JMOL that Amgen’s Repatha® patents (U.S. Patent Nos. 8,829,165 and 8,859,741) were invalid for lack of enablement. The claims at issue

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

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

As previously reported, the FDA had yet to approve any biosimilars in 2020 as of June 9, despite a growing pipeline. Since then, the FDA has approved two biosimilar products.

On June 11, Pfizer Inc. announced the FDA’s approval of Nyvepria™ (pegfilgrastim-apgf), a biosimilar of Amgen’s Neulasta™. Nyvepria is indicated “to decrease the incidence of

On January 15, 2020, Hospira filed a petition for rehearing en banc asking the full Federal Circuit to reconsider a prior panel’s analysis of the Safe Harbor provision and reverse the finding of infringement. In December 2019, the Federal Circuit affirmed the District of Delaware’s decision denying Hospira’s motion for judgment as a matter of