Arnold & Porter Achieves Significant Patent Enablement Supreme Court Victory

Arnold & Porter recently achieved a significant victory at the U.S. Supreme Court for pharmaceutical companies Sanofi-Aventis US and Regeneron Pharmaceuticals Inc. in a closely watched biotechnology case related to the scope and validity of antibody patents and the proper enablement test.

On May 18, 2023, Justice Neil Gorsuch authored a 9-0 unanimous opinion upholding the Federal Circuit’s application of the enablement requirement. This is the first decision in nearly a century to consider how much a patent must teach the public to enable practicing of the claimed invention.

In 2014, another biotechnology company sought billions of dollars in damages and a permanent injunction against the sale of Sanofi and Regeneron's lifesaving and cholesterol-reducing drug Praluent over patent disputes. In 2017, the Federal Circuit reversed a jury verdict for that company and remanded for a new trial on written description and enablement, concluding that a lower court had wrongly excluded evidence and issued an erroneous jury instruction. The Federal Circuit also vacated a permanent injunction in favor of that company.

During the February 2019 re-trial, the jury found two of the five patent claims asserted were invalid, with the other three being held valid. The Arnold & Porter team secured a victory on its post-trial motion for judgment as a matter of law, which found the other three claims invalid for lack of enablement, thus completing the win for Sanofi and Regeneron. On February 11, 2021, the Federal Circuit affirmed this victory.

Amgen’s petition for rehearing en banc was denied and the company subsequently filed a petition for certiorari to the Supreme Court in November 2021. In November 2022, the Supreme Court granted Amgen’s petition to consider the proper test for enablement, marking the first time the Supreme Court has addressed enablement since enactment of the 1952 Patent Act.

The Arnold & Porter team was led by Intellectual Property practice co-chair Matthew Wolf, partners Daniel Reisner and Deborah Fishman, and senior associate Victoria Reines. The team also included partner Abigail Struthers, counsel Paul Margulies, Michael Lynn, and Katie Scott, and senior associates Michael Sapiro, Matt Wilk, and Josh McCollum.