Delaware jury rules in favor of Amgen in PCSK9 patent legislation

A Delaware jury ruled in favor of Amgen on March 16 in a patent infringement trial pertaining to monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). 

Amgen brought the suit against Sanofi and Regeneron Pharmaceuticals in October 2014 for infringing upon two Amgen patents. Amgen said in a news release that Sanofi and Regeneron acknowledged the infringement of seven patent claims.

However, Sanofi and Regeneron announced in a news release that they plan to appeal the judgment and that they believe Amgen’s patent claims are invalid.

This past summer, the FDA approved the first two PCSK9 inhibitors: alirocumab (Praluent, Regeneron and Sanofi) in July and evolocumab (Repatha, Amgen) in August.

“This is a complex area of law and science, and we believe the facts and controlling law support our position,” Regeneron senior vice president, general counsel and secretary Joseph LaRosa said in a news release. “We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals. Praluent was developed with Regeneron’s proprietary science and technology and represents an important medical advance for patients.”

After the PCSK9 inhibitors were approved, the costs of the medications were hot topics. The annual wholesale acquisition cost is $14,600 for alirocumab and $14,100 for evolocumab.

Clinical trials showed that the PCSK9 inhibitors significantly reduced low-density lipoprotein cholesterol. However, experts expressed concern that the medications have not been shown to prevent or delay major adverse cardiovascular events such as MI, ischemic stroke and death due to cardiovascular disease.

Sanofi and Regeneron said they would continue to sell alirocumab despite the legislation. Still, Reuters reported that the companies may owe Amgen royalties if Amgen wins the lawsuit.

“A permanent injunction is unlikely,” Deutsche Bank analyst Tim Race said in a research note, according to Reuters. “However, the likelihood of settlement has now increased substantially with Sanofi and its partner Regeneron potentially forced to pay royalties.”