Regeneron CEO: Amgen's disruptive Praluent-blocking patent move hurts patients

Praluent and Repatha
Monday, Regeneron CEO Len Schleifer slammed Amgen for pursuing an injunction on Praluent sales.

SAN FRANCISCO—Last week, a U.S. District Court blocked sales of Sanofi and Regeneron’s PCSK9 med, Praluent, as part of an ongoing patent war with Repatha-maker Amgen. And Monday at the J.P. Morgan Healthcare Conference, Regeneron chief Len Schleifer took his rival to the woodshed.

After Regeneron and Sanofi lost a lower-court fight over Amgen's patents, Schleifer said, the two companies said they wanted to take their dispute to the Federal Circuit Court, the only federal appeals panel that handles patent cases because of their technical nature. But Amgen decided to go ahead and press for an injunction that would push Praluent off the market in the meantime, Schleifer said.

"Now, If you were a company that really cared about patients first, wouldn’t you say, Yeah that sounds reasonable, I can get it fixed later, I can get monetary damages, I’m not going to rip this product from 30,000 people or more who are getting it," Schleifer said during a presentation at the conference.

In a Q&A session afterward, Schleifer said he was “surprised” that Amgen pushed for an injunction on Praluent sales before the circuit court could make its ruling, because pulling the Sanofi/Regeneron drug off the market would be so disruptive.

"To say you can’t wait? Is that putting patients first?" Schleifer asked during his presentation. "Is that what this business is about? It’s no small wonder that our industry isn’t beloved, because we talk a lot about putting patients first, but I don’t think people always do."

It's the second time in recent months that Schleifer has so outspokenly addressed his rival drugmakers. At a Forbes conference late last year, the Regeneron CEO got into a heated argument with Pfizer CEO Ian Read over the industry's pricing policies. Schleifer repeated some of the same points—including a charge that pharma companies raise prices to make up for their failure to innovate—Monday at the conference.

Responding to Schleifer's lecture, Amgen said via email that it believes the best way to serve patients is to preserve a patent system that allows companies to invest in discovering new medicines for serious diseases. Sanofi and Regeneron knew about Amgen's patents long before the lawsuit was filed, Amgen said.

"Sanofi and Regeneron chose to launch a product that they had no right to manufacture or sell," the company said. "Sanofi and Regeneron were afforded a full and fair opportunity to challenge the validity of Amgen’s patents at trial and the jury determined our patents to be valid. The presiding judge reviewed the evidence and found no basis to overturn the jury’s verdict."

The decision, which U.S. District Judge Sue Robinson handed down last Thursday, gave the Regeneron/Sanofi team 30 days to finalize an appeal to the Federal Circuit and request a longer stay from the higher court. Monday, that number climbed to 45 days after the District Court—as expected—denied the pair’s stay request.

Though Robinson did rule in Amgen's favor, she did say that she believed the public interest would be better served with both drugs on the market. In her ruling, she called on the companies “to reach an appropriate business resolution."

Now, Regeneron and Sanofi will ask the Federal Circuit “to quickly review if we can have a stay, and frankly, the merits of the entire case as quickly as possible,” Schleifer said.

Schleifer isn't alone in his criticism. Legal experts have questioned not just the ruling, but Amgen's decision to ask for it. In Harvard Law School's Bill of Health Blog, Rachel Sachs, an associate professor at the Washington University in St. Louis School of Law, echoed Schleifer in pointing out that the injunction, if it takes effect, will push current Praluent patients off the drug, and, given payer exclusives, disrupt insurance coverage.

"Judge Robinson looked at a situation involving two competing, chemically distinct (though similar) drugs for the same condition and opted to kick one of them off the market," Sachs said, "putting Amgen in a monopoly position and taking some number of patients off of the drug they’ve been taking."

Amgen pointed out that its drug is FDA-approved to treat patients now using Praluent. "Based on the FDA-approved labels, Repatha can treat every indication for which patients may be receiving alirocumab (and more), and Amgen is ready to supply Repatha to all appropriate patients," the company said.

But Sachs noted that Amgen had a different option in pursuing Regeneron and Sanofi's drug. "They did not have to ask for an injunction and could have instead asked only for damages," she wrote, citing Merck & Co.'s hepatitis C lawsuit against Gilead Sciences, which did not attempt to force the already-marketed Sovaldi off the market.

Meanwhile, though, a removal of Praluent from the market—which some analysts believe would ultimately be preempted by a settlement anyway—wouldn’t fix the reimbursement problems hampering Amgen’s contender. In a presentation Monday, the Big Biotech’s CEO, Robert Bradway, noted that payers are rejecting three out of every four Repatha prescriptions in the U.S.

“Now, the challenge for us is to see that we achieve the full potential of this class by beginning to increase the rate of approval from payers for these prescriptions,” he said, adding, “In 2017 our focus will be on improving access for patients here in the United States and then expanding this franchise around the globe.”