Amgen has kicked back at Sanofi and Regeneron’s attempt to keep their cholesterol drug Praluent on the market while an appeals court sorts out a patent dispute between the companies.
In court documents filed late last week, the California-based Big Biotech reasserted its patent rights in the PCSK9 field and claimed that its rivals are “admitted infringers” that launched Praluent ahead of a patent trial that could have settled the IP tug-of-war.
The two sides are locked in that fight after a U.S. district court granted Amgen’s request for an injunction that would push Praluent off the market. At the trial court level, a jury sided with Amgen, saying Praluent stepped on the company’s patents. The two companies admitted their drug infringed particular patents, but challenged those patents’ validity and then lost that argument in court, the filing claims.
“Defendants stipulated to infringement and had a full and fair opportunity to prove their invalidity case,” Amgen’s filing states. “Both the jury and the court rejected them. It is time Defendants stop infringing.”
Amgen markets a PCSK9 cholesterol-fighting med, Repatha, that made its debut the same month as Sanofi and Regeneron’s Praluent. Pegged as probable blockbusters as they made their way through the FDA, the two drugs have struggled to gain traction in a market where payers are kicking back against pricey drugs; both carry list prices above $14,000. Both drugs are in trials testing whether they deliver real reductions in cardiovascular risks, in addition to dramatic cholesterol-lowering, and payers and many physicians say they’re waiting for that data to commit to using them.
If Praluent is removed from the market and Sanofi and Regeneron later win their appeal, the Amgen med would have had months to solidify a lead in the marketplace.
But it’s only fair, Amgen’s latest filing argues. Some other companies dropped their PCSK9 development programs because of Amgen’s patents, the document says. Sanofi and Regeneron not only did not, they used an FDA mechanism to get ahead.
“Instead, Defendants rushed forward,” the filing states. “After realizing they were behind Amgen in filing with the FDA, and after the filing of this lawsuit, Defendants used a priority-review voucher so they could jump the queue and get FDA approval before Amgen.”
The patent fight has been fierce, with both sides claiming the high ground. Amgen said protecting patents is the best way to serve patients, because it preserves incentives for drugmakers to spend the time and money necessary to develop new treatments. Regeneron and Sanofi, on the other hand, said two drugs are better for patients than one because they give physicians options when prescribing—Praluent is available at a lower dose than Repatha, for instance.
Regeneron CEO Len Schleifer has been particularly virulent in his Praluent defense. At the J.P. Morgan Healthcare Conference this month, Schleifer said he was “surprised” that Amgen had pushed for an injunction on Praluent sales before the appeals court could make its ruling, because pulling the Sanofi/Regeneron drug off the market would be so disruptive.
“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.
But Amgen said Sanofi and Regeneron are using drama to make their case, rather than relying on the law. “In arguing for a stay [of the injunction], Defendants resort to hyperbole, misstatements, reliance on self-inflicted injuries, and scare tactics regarding the ‘public interest,’” Amgen’s filing stated, calling out Sanofi and Regeneron’s contention that removing Praluent from the market would hurt patients.
Analysts are split on the prospects of Sanofi and Regeneron’s success in fighting the injunction. In a recent note, Leerink Partners analyst Geoffrey Porges said his firm’s patent specialists were “quite pessimistic” about the partners’ prospects for extending the stay of the injunction past the current 45 days.
The upshot of that? “[R]egardless of the ultimate merits of Regeneron and Sanofi’s case, they will face an unprecedented (and probably first) branded pharmaceutical product withdrawal in the middle of this quarter,” Porges said.
But Bernstein analyst Ronny Gal was more sanguine on Praluent’s behalf. In a note earlier this week, Gal said he found Regeneron’s arguments persuasive: “From experience we learned never to try calling court decisions before seeing both sides, but we have to say the Regeneron arguments resonated with us.”