Sanofi and Regeneron Pharmaceuticals, which co-market the PCSK9 inhibitor Praluent (alirocumab), announced Thursday that the European Patent Office (EPO) Technical Boards of Appeal has invalidated certain claims related to Amgen's patent directed to PCSK9 antibodies. "We are pleased with today's decision…which upholds the rigorous standard for pharmaceutical patents that we argued for in this case, affirming that Amgen's asserted claims against Sanofi in Europe are invalid," remarked Karen Linehan, general counsel at Sanofi.
The news follows a US district court ruling in August 2019 that overturned portions of an earlier verdict, which had upheld the validity of three of five claims asserted by Amgen on two of its US patents for the PCSK9 inhibitor Repatha (evolocumab).
Sanofi and Regeneron noted that Praluent will continue to be available in European countries where it is approved for sale, with the exception of Germany following an injunction imposed there in July last year, and which Sanofi said it has appealed. A hearing in that case is scheduled for November 5.
Sanofi and Regeneron restructured their antibody collaboration for Praluent earlier this year into a royalty-based agreement, and as of April, Regeneron has had exclusive responsibility for Praluent in the US, while Sanofi is solely responsible for the drug outside the country.
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