US appeals court sides with Sanofi, Regeneron in PCSK9 patent case against Amgen

Regeneron Pharmaceuticals said that a US appeals court upheld an earlier decision that Amgen's asserted patent claims directed toward PCSK9 antibodies are invalid based on lack of enablement. The latest ruling from the Court of Appeals for the Federal Circuit means that Regeneron and its partner Sanofi, which market the PCSK9 inhibitor Praluent (alirocumab), have successfully invalidated all five claims asserted by Amgen on two of its US patents for its own PCSK9 inhibitor Repatha (evolocumab).

Joseph LaRosa, Regeneron's general counsel, remarked "Praluent was developed using Regeneron's proprietary technology, and the Federal Circuit validated that Amgen has no claim to Praluent or its development, helping to provide closure on this matter." The two Amgen patents at the centre of the latest case were due to expire in 2028.

Amgen initially brought the patent infringement case against Sanofi and Regeneron in 2014 after the partners announced plans to seek FDA approval of Praluent. The agency cleared Praluent in 2015 for certain patients with high cholesterol, followed by Repatha a few weeks later. Last October, the European Patent Office (EPO) Technical Boards of Appeal also invalidated certain claims related to Amgen's patent directed to PCSK9 antibodies.

Sanofi and Regeneron restructured their antibody collaboration for Praluent last year into a royalty-based agreement, with Regeneron now having exclusive responsibility in the US, while Sanofi is solely responsible for the drug outside the country. Regeneron recently said Praluent generated US revenues of $55.2 million in the fourth quarter of 2020, while Sanofi reported quarterly sales of €65 million ($79 million) for the drug.

Separately, Regeneron announced the FDA approval of its ANGPTL3 inhibitor Evkeeza (evinacumab-dgnb) for patients with homozygous familial hypercholesterolaemia, with the drug to carry a list price of around $450,000 per year.

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