Will The Supreme Court Take The Bait? CVSG Issued And Other Updates In The Amgen v. Sanofi Case

• Published date: 04 May 2022
• Subject Matter: Intellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
• Law Firm: Rothwell, Figg, Ernst & Manbeck, P.C.
• Author: Ms Malissa S. Magiera

On April 18, 2022, the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States in the Amgen, Inc. v. Sanofi, Inc. case, which involves important questions of enablement for genus claims. We have previously covered the Federal Circuit's decision, Amgen's petition for a writ of certiorari, and the multiple amicus curiae briefs submitted in this case. Additionally, on March 14, 2022, Sanofi filed its Opposition to Amgen's cert petition, and on March 22, 2022, Amgen filed its Reply Brief. The Supreme Court's Call for the Views of the Solicitor General ("CVSG") signals the Court's interest in this case. This post provides a summary of Sanofi and Amgen's latest briefing. We will continue to provide updates as this case evolves.

The introduction of Sanofi's Opposition is direct, arguing that Amgen "attempt[ed] to corner the market on PCSK9 inhibitors-and after Respondents developed Praluent-Amgen obtained additional patents that broadly claim all antibodies that bind to certain amino acids on PCSK9 and clock its binding to receptors." Sanofi argues that the Federal Circuit's decision "rightly rejected this gambit, holding that Amgen's broad functional claims are not enabled and thereby invalid under 35 U.S.C. ' 112." It further tried to persuade the Court that the decision does not need to be reviewed, as "in its unanimous decision, the [Federal Circuit] panel merely applied well-established law to the undisputed relevant facts and determined that Amgen's broad functional claims require undue experimentation and thus are not enabled by the particular specification."

In response to Amgen's first argument that the Federal Circuit treated the enablement issue as a question of law while the Supreme Court has treated it as a question of fact, Sanofi alleges that the Supreme Court has consistently held that patent validity issues like enablement are questions of law involving subsidiary findings of fact. Sanofi cites Supreme Court cases framing the issue of patent validity as a question of law, and cites Federal Circuit cases that have followed suit. It argues that Amgen "cites a handful of this Court's decision predating the Civil War." Sanofi discusses parts of Amgen's cited cases to argue that these cases do not actually contradict the Federal Circuit's decision. While Sanofi acknowledges that some of the cases Amgen cites included factual issues for the jury, it argues the issues related to the capabilities of the...