Federal judge denies Amgen's motion to dismiss Regeneron antitrust case
While Amgen and Regeneron’s spat before the Supreme Court goes forward on Amgen’s request to revive patents on its blockbuster Repatha and block the sale of Sanofi and Regeneron’s Praluent, another case is moving forward in federal court — this time Regeneron is pushing a case against Amgen and focusing on antitrust law.
Delaware Circuit Court Judge Richard Andrews overruled a petition from Amgen on Tuesday to dismiss the case (1:22-cv-00697-RGA-JLH), now allowing it to continue. Regeneron filed the case against Amgen last May.
Andrews overruled all of Amgen’s objections, following a recommendation from magistrate judge Jennifer Hall that Andrews deny Amgen’s motion to dismiss the case. Overall, Regeneron’s case accuses Amgen of engaging in an illegal and anti-competitive strategy to force payers to choose Repatha over Praluent.
Amgen’s objections related to submitted contracts related to product bundling, allegations against blockbuster drug Enbrel, and foreclosure.
In Amgen’s response to the magistrate’s filing, it wrote that the filing found Regeneron “plausibly alleged this conduct foreclosed Regeneron from competing for about 22% of the market. But under well-established law in this Circuit, that is not enough. Regeneron must show it has been ‘substantially foreclosed’ from the market, which generally requires foreclosure levels of 40 to 50%.”
However, Andrews noted in his 3-page ruling that Amgen’s main argument on foreclosure is not “all that suitable for a motion to dismiss,” adding that Amgen was mostly relying on cases that were decided after summary judgment or a trial.
“[T]he allegations have to be judged in the context of the entire complaint,” Andrews wrote.
Regeneron’s original complaint detailed what Regeneron described as an effort from Amgen to “eliminate from the market a life-saving medicine that has served thousands of patients” — aka Praluent. Regeneron claimed that Amgen did so because Praluent is the only direct competitor to Amgen’s Repatha.
Further, Regeneron claimed that Amgen started a bundling scheme — where multiple products are sold in a bundle at a cheaper price than buying those items individually — in a bid to leverage sales of other Amgen drugs and raise Praluent’s effective cost.
According to the 100+ page suit, Amgen and Regeneron had competed on formulary positioning with PBMs until 2020, after Amgen spent $13.4 billion to get its hands on Celgene’s Otezla before Bristol Myers Squibb bought out Celgene in 2019.
Regeneron then accused Amgen of threatening to withhold rebates on Otezla and blockbuster Enbrel “unless Payors accept either outright exclusivity for Repatha or else ‘equal’ formulary position,” per the suit.
For context, 2020-2021 sales for Otezla and Enbrel were $12.8 billion compared to Praluent’s 2020-2021 sales of $356 million — only 2.8% of Amgen’s two product sales, according to Regeneron’s complaint.
“Therefore, the threat of paying just 3 percent more for Otezla and Enbrel easily overwhelms the total amount of sales generated by Praluent, leaving Payors trapped and with no viable choice but to exclude Praluent from their formularies,” Regeneron wrote.
That scheme, the biotech added, is keeping Praluent out of enough market share that Praluent is “no longer a financially viable competitor to Repatha.”
Both of these drugs are PCSK9 inhibitor antibodies that reduce LDL cholesterol.
Amgen declined to comment on the development of the case. Regeneron kept it short, telling Endpoints News only that “We are pleased with the court’s decision and look forward to purs[u]ing our case.”
