Judge Hands PCSK9 Victory to Amgen

In a dramatic decision on a long-running patent dispute over alirocumab vs. evolocumab, a federal court judge ruled that Amgen's patents were violated and that rivals Sanofi/Regeneron can no longer distribute their product.

A US Federal Court judge in the District of Delaware has ruled that Amgen has the rights to sell, market, and manufacture its PCSK9 inhibitor and that Sanofi/Regeneron does not.

Judge Sue Robinson issued an injunction forbidding Sanofi/Regeneron from selling, marketing, or manufacturing its product, an action the companies immediately vowed to appeal.

At issue was whether Regeneron violated Amgen's patents. Both entities make a PCSK9 inhibitor. Amgen's is evolocumab, marketed as Repatha. Sanofi/Regeneron's is alirocumab, marketed as Praluent.

On Thursday night, the court declared that Amgen got there first, though Regeneron's Praluent was the first such drug to get US Food and Drug Administration (FDA) approval. Alirocumab and evolocimab are both cholesterol-lowering agents administered by injection.

The drug is expensive and used for people who are either resistant to statins or cannot tolerate them.

The court did grant Sanofi/Regeneron a 30-day stay of the injunction, so Praluent is currently still available.

"We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position," Regeneron said in a statement from its lawyer Joseph LaRosa.

The developments in the case were reported by The Street.

The case is Amgen Inc. v. Sanofi Inc., 14-1317, US District Court, District of Delaware (Wilmington).