We have previously reported on the Amgen v. Sanofi Praulent® litigation, which has been ongoing since late 2014. After the parties stipulated to infringement, a jury in the District of Delaware found in favor of Amgen and the validity of its patents over its biologic drug Repatha® (evolucumab) in March 2016. Judge Robinson denied the motion for a new trial, and on January 6, 2017, she granted Amgen’s motion for a permanent injunction to enjoin Sanofi from selling Praluent® (alirocumab). The Federal Circuit issued a stay of that permanent injunction on February 8, 2017. On appeal, the Court of Appeals for the Federal Circuit vacated the permanent injunction and the district court’s judgment as to written description and enablement, and remanded for a new trial.
On February 25, 2019, a jury in the District of Delaware held that while two of the claims in Amgen’s U.S. Patent No. 8,829,165 covering Repatha® were invalid for lack of written description, Sanofi failed to prove that any of the asserted claims in U.S. Patent Nos. 8,829,165 and 8,859,741 were invalid for lack of enablement. However, on August 28, 2019, Judge Andrews, for the District of Delaware, granted the Sanofi defendants’ motion for judgment as a matter of law for lack of enablement. In the same opinion, the court denied the motion for judgment as a matter of law as to written description. The District of Delaware entered its final judgment on October 3, 2019, after which Amgen appealed to the Federal Circuit.
Amgen filed its opening brief to the Court of Appeals for the Federal Circuit on February 21, 2020. Amgen argues that two separate juries properly rejected Sanofi’s enablement challenge, and that in granting judgment as a matter of law for Sanofi, the judge ignored evidence and departed from Supreme Court and Federal Circuit precedent on enablement. Amgen contends that the jury was reasonably justified in finding that Sanofi failed to clearly and convincingly prove a lack of enablement, and that the judge improperly failed to defer to the jury’s underlying factual determinations. The Federal Circuit granted an extension until June 2, 2020 for Sanofi’s response. Most recently, on March 25, Bristol-Myers Squibb Company and Merck Sharp & Dohme filed an amicus brief in support of Amgen’s position in the case. The amici argue that the district court’s decision “essentially set forth a legal rule that would prevent a patentee from claiming a genus of antibodies unless the patentee has identified with certainty each and every possible antibody within the claims. This rule, if followed in cases going forward, would make it effectively impossible for innovator companies to obtain sufficiently broad patent protection,” and would “hinder innovation to the detriment of patients and physicians.”