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February 26, 2019

Sanofi, Regeneron lose patent dispute with Amgen over cholesterol drug

US District Court for the District of Delaware has upheld Amgen’s patent on cholesterol drug Repatha, rejecting a challenge filed by Sanofi and Regeneron.

US District Court for the District of Delaware has upheld Amgen’s patent on cholesterol drug Repatha, rejecting a challenge filed by Sanofi and Regeneron.

The jury upheld the validity of three of the total five claims asserted by Sanofi and Regeneron for two Amgen patents associated with proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies.

Repatha is a human monoclonal antibody designed to inhibit PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR). The drug holds approval in more than 60 countries, including the US, Japan, Canada and European Union members.

Sanofi and Regeneron make a similar drug called Praluent that prevents PCSK9 binding to LDLR.

In March 2016, Sanofi and Regeneron admitted to infringement of Amgen’s patents. The previous jury partially reversed their decision on appeal and sent the case to the district court.

The latest court verdict said that Amgen patents are in line with the legal requirements of written description and enablement.

“Today’s decision protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases.”

These patents are related to antibodies that bind to a specific PCSK9 region and decrease LDL-C levels.

Amgen chairman and CEO Robert Bradway said: “Today’s decision protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases.

“We are thankful that the jury weighed the evidence carefully and recognized the validity of Amgen’s patents.”

Commenting on the verdict, Sanofi and Regeneron said that they “strongly disagree” with some aspects of the jury’s decision and intend to file post-trial motions to overturn the verdict and request a new trial.

Sanofi executive vice-president and general counsel Karen Linehan said: “We are disappointed in today’s verdict. It is our long standing belief that all of Amgen’s asserted US patent claims are invalid and we believe the law and the facts support our positions.”

In October last year, Amgen said that it would cut the price of Repatha by 60%. Sanofi and Regeneron also reduced Praluent’s list price by approximately the same proportion.

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