U.S. District Court Invalidates Amgen Patent Claims Targeting PCSK9

Regeneron Pharmaceuticals and Sanofi announced the U.S. District Court for the District of Delaware ruled in their favor and found as a matter of law that Amgen's asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid based on lack of enablement.

"Today's decision by the U.S. District Court for the District of Delaware validates our position that Amgen's patents are overly broad and invalid," said Joseph LaRosa, Executive Vice President, General Counsel and Secretary, Regeneron. "Praluent was developed using Regeneron's proprietary science and technology and the judge has confirmed our position by issuing this ruling."

This ruling overturned portions of an earlier jury verdict upholding the validity of three claims. On February 25, 2019, a jury previously found in Regeneron and Sanofi's favor that two other asserted Amgen patent claims are invalid. This means that Regeneron and Sanofi have successfully invalidated all five asserted Amgen patent claims. 

"It has been our longstanding belief that all of Amgen's asserted U.S. PCSK9 patent claims are invalid, and we are pleased today's decision reaffirms this," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Praluent® (alirocumab) inhibits the binding of PCSK9 to the low-density lipoprotein (LDL) receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL cholesterol (LDL-C) levels in the blood. Praluent was developed by Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company's proprietary VelocImmune® technology that yields optimized fully-human monoclonal antibodies.

Praluent is approved in more than 60 countries worldwide, including the U.S., European Union (EU), Japan, Canada, Switzerland, Mexico and Brazil. In the U.S., Praluent is approved to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular disease. Praluent is also approved as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.

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