Praluent to Stay on Market as PCSK9 Patent War Continues in Court

Praluent, the first drug approved in the cholesterol-fighting drug class called PCSK9 inhibitors, won’t be pulled from the shelves while sponsors Sanofi and Regeneron battle in federal court over Amgen’s patent claim for rival Repatha.

A US appellate panel stayed an order late Wednesday from a district judge, who had ruled that Praluent (alirocumab) could not be sold after February 21, 2017. That order came after Amgen won what Sanofi attorneys called an “unprecedented” decision that could have shelved Praluent sales for 12 years.

“We continue to believe that the facts and controlling law support our position,” said Joseph J. LaRosa, senior vice president, general counsel, and secretary for Regeneron, in a statement. In a conference call with reporters today, Sanofi attorneys said the appeal has been expedited, but it could take 6 months to a year for a ruling.

In March 2016, a Delaware jury ruled that Sanofi and Regeneron had violated Amgen’s patents for Repatha (evolocumab). Both Repatha and Praluent target proprotein convertase subtilisin kexin 9 (PCSK9) in liver, dramatically reducing the level of low-density lipoprotein (LDL) or “bad” cholesterol in the bloodstream.

However, attorneys for Sanofi said in a conference call today that the award of a “genus patent” for evolocumab overlooks the fact that alirocumab is “a completely different molecule”—one that Chan Lee, general counsel for Sanofi North America, said has a different product profile, dosing, and approach to LDL management.

“We believe this patent is overly broad and would stifle innovation,” Lee said of Amgen’s patent. He likened the situation to the long-term result if Merck had received a genus patent for all statins when it developed Mevacor and Zocor. “We would not have benefited from the advances of Lipitor and Crestor,” Lee said.

The PCSK9 inhibitor class was highly anticipated by cardiologists and payers alike—physicians were wowed by data that show these drugs can cut LDL cholesterol by up to 60%. But payers and pharmacy benefit managers (PBMs) have balked at the cost; both drugs listed wholesale prices in excess of $14,000 a year. The PCSK9s have not sold as much as hoped, as health plans and PBMs have required a strict protocol in granting access to the drug.

However, Amgen’s recent announcement that Repatha reduced cardiovascular risk in a long-term safety trial could lead the FDA to allow broader access. Full results from that trial will be presented at next month’s meeting of the American College of Cardiology.

Chan said the science on both drugs continues to advance since they were approved in the summer of 2015. He said Praluent works by managing LDL cholesterol to target, while Repatha seeks the “maximum lowering effect” for LDL cholesterol.

Procedurally, it appears the patent dispute will linger for some time. If there is a winner at this level, the losing side could request on “en banc” hearing of the all 9 circuit judges before the case reaches the US Supreme Court. Sanofi Senior Director for Patent Litigation Stephanie Donahue said the circuit court could also remand the matter back to the district court for a new trial.

It is also possible that if Sanofi and Regeneron lose at the appellate level, the court could order them to pay Amgen royalties to keep Praluent on the market and retain patient choice. Sanofi’s John Conway, the vice president and Global Head of Intellectual Property, said despite the jury ruling, the judge at the district court level found there was a public interest in having competition within a drug class. “We think that is going to heavily weigh in our favor throughout these proceedings,” he said.

Conway said there are no settlement talks with Amgen at this time. At press time, Amgen had not responded to a request for comment.