SCOTUS Rules Against Amgen in PCSK9 Patent Dispute with Sanofi, Regeneron

Pictured: Supreme Court/philip, Adobe Stock

Pictured: U.S. Supreme Court/philip, Adobe Stock

The U.S. Supreme Court unanimously sided with pharmaceutical companies Sanofi and Regeneron, ruling in their favor in a decade-long patent dispute with Amgen over the PCSK9 cholesterol drug, Repatha, in an opinion released Thursday.

The Supreme Court’s ruling against Amgen in its protracted dispute with Sanofi and Regeneron affirmed a lower court’s decision that Amgen’s rivals did not infringe on patents the company held on its cholesterol-lowering PCSK9 inhibitor Repatha.

“Amgen seeks to monopolize an entire class of things defined by their function—every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors,” Justice Neil Gorsuch wrote for the unanimous opinion. “The record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a ‘vast’ number of additional antibodies that it has not.”

The long-running legal battle centered around the validity of Amgen's patents for Repatha. Sanofi and Regeneron, makers of rival drug Praluent, had been embroiled in a fierce legal clash with Amgen, seeking to overturn the patents and gain market access for their competing product.

The Supreme Court's ruling declared Amgen's patents invalid due to a “lack of enablement,” confirming a lower court's decision. The unanimous decision represents a significant blow to Amgen, which had been defending the exclusivity of its PCSK9 inhibitor against the growing competition for years.

Justice Gorsuch wrote that Amgen’s offering to skilled individuals in the field, as a legal sticking point in patent suits, was nothing more than vague guidance to rely on “trial and error,” according to a report by Endpoints News.

The decision is potentially significant for others in the biopharma space, particularly regarding the tenuous balance between protecting intellectual property rights and fostering competition. The ruling is expected to pave the way for increased market competition and potentially lower prices for PCSK9 inhibitors, benefiting patients and healthcare systems.

Sanofi and Regeneron celebrated the ruling as a victory for innovation and competition in the field of cholesterol-lowering drugs. They contend that the decision will allow them to expand patient access to Praluent, providing an alternative treatment option for people with high cholesterol.

Amgen expressed disappointment with the outcome, stating that it disagreed with the court's interpretation of the patents and believed they met the legal requirements for enablement in an email statement cited by Endpoints.

BioSpace reached out to Amgen for comment but did not immediately receive a response.

Lisa Munger is a senior editor at BioSpace. You can reach her at Follow her on LinkedIn.

Back to news