Supreme Court May Consider Ruling Invalidating Amgen’s Repatha Patents

Court asks Solicitor General to weigh in on petition challenging Federal Circuit’s standard for determining patent enablement in Amgen’s dispute with PCSK9 inhibitor rivals Sanofi and Regeneron. GlaxoSmithKline, Biogen, Bristol-Myers Squibb, and Merck filed briefs in support of Amgen.

US Supreme Court
US Supreme Court may hear Amgen's PCSK9 patent dispute with Sanofi • Source: Alamy

The US Supreme Court gave Amgen some hope that it might review a court decision that found Amgen, Inc.’s Repatha (evolocumab) patents invalid for lack of enablement. The case is significant for biopharma companies, many of which contend that the US Court of Appeals for the Federal Circuit has established a new enablement standard that does not provide adequate patent protection for their inventions.

In its 18 April orders, the Supreme Court noted that it has asked the US Solicitor General to file a brief in the case, Amgen v. Sanofi. At issue is the standard for determining if a patent claim is enabled, i.e

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