Judge Rules in Favor of Amgen on PCSK9

A United States District Court judge in Delaware has granted Amgen's request for a permanent injunction prohibiting Sanofi/Regeneron from manufacturing, using, selling, or offering their monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).

According to a statement from Amgen, the injunction will not take effect immediately as the court has delayed its imposition for 30 days to allow Sanofi/Regeneron the opportunity to seek expedited review of the decision.

Officials with Amgen contend Regeneron violated their patents. Both entitites make a PCSK9 inhibitor; Amgen's is evolocumab (Repatha), and Sanofi/Regeneron's is alirocumab (Praluent). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR).

Even though Regeneron's Praluent was the first drug of this kind to get US FDA approval, the court ruled that Amgen has the rights to sell, market, and manufacture its PCSK9 inhibitor and that Sanofi/Regeneron does not.

"Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases," Robert A. Bradway, chairman and chief executive officer at Amgen said in a prepared statement. Bradway continued, "Heart disease is the biggest health care challenge for society today and Repatha aims to help address this challenge by providing a profound reduction in LDL-cholesterol."

"We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position," Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron said in a prepared statement.