US jury upholds Amgen's PCSK9 inhibitor patents in ongoing litigation with Sanofi, Regeneron

A US federal jury on Wednesday upheld two patents protecting Amgen's Repatha (evolocumab), concluding that the patents were infringed by Sanofi and Regeneron Pharmaceuticals' similar PCSK9 inhibitor Praluent (alirocumab). Sanofi and Regeneron, which stated they "strongly disagree" with the ruling, plan to appeal the decision.

In the case, Amgen filed a lawsuit against Sanofi and Regeneron in October 2014 alleging that Praluent infringed several of its patents after the latter companies announced plans to submit their PCSK9 therapy for FDA approval. Sanofi general counsel Karen Linehan remarked "it has always been and remains our position that Amgen’s asserted patent claims in this matter are invalid."

Meanwhile, a follow-up hearing on Amgen's request for a permanent injunction against Sanofi and Regeneron is scheduled for later this month.

Praluent was approved by the FDA in July last year for the treatment of high cholesterol in certain patients. Repatha was cleared by the agency the following month for use in adults with heterozygous familial hypercholesterolaemia, homozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.

For related analysis on the PCSK9 inhibitor class, see ViewPoints: A slow start for the PCSK9 inhibitors; can Pfizer – and payers – benefit? See also Physician Views Poll Results: Taking an early look at the competing anti-PCSK9 mAb launches.

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