Drugmakers Support Sanofi and Regeneron in Supreme Court Case

Multiple drugmakers have filed amicus briefs to the U.S. Supreme Court refuting a broad patent claim by Amgen that — if upheld — could have sweeping implications in drug development.

The case dates back to October 2014 when Amgen sued Sanofi and Regeneron, alleging the companies’ anticholesterol therapy Praluent (alirocumab) violated Amgen’s patents covering antibodies that target PCSK9, a protein that controls the number of low-density lipoprotein receptors, which play a critical role in regulating blood cholesterol levels.

In the ensuing years, both sides have had court rulings in their favor, with the U.S. Supreme Court in November 2022 agreeing to hear Amgen’s petition following its February 2021 loss in the U.S. Court of Appeals for the Federal Circuit.

One brief co-filed by AstraZeneca, Bayer, Genentech, Gilead, and Johnson & Johnson describes Amgen’s attempt to exert a genus claim on the entire PCSK9 protein sequence as an attempt to block scientific invention and innovation.

A decision upholding Amgen’s goal of patenting the PCSK9 protein sequence “would vastly over-reward the first entity to secure patent rights within an unpredictable field of research, preempting innovation in that area,” the co-filed brief argued.

The case is due to be heard on March 27.