An appeals court today tossed out a ban on Sanofi’s and Regeneron’s cholesterol drug Praluent and is giving the partners a second chance to prove they didn’t trample on Amgen patents in its development.
The U.S. Court of Appeals today ruled that the judge in the trial over Praluent had made mistakes in what it allowed the jury to hear, denied a permanent injunction against sales of the drug and ordered a new trial. Sanofi and Regeneron had earlier won a stay on the injunction during the appeal so never had to pull Praluent from the market.
“We are pleased with the Federal Circuit’s decision to remand for a new trial that allows us to present our complete evidence to the jury,” Karen Linehan, Sanofi general counsel, said in a statement emailed from the company. “It is our long-standing position that Amgen’s asserted patent claims are invalid, and we remain confident in the long-term availability of Praluent for patients.”
Amgen countered that it was disappointed and pointed out : "The Court, however, also rejected a main argument brought by defendants in seeking to overturn the injunction. We firmly believe in the validity of our patents and we look forward to reasserting our rights in court."
The injunction was ordered, and then stayed, after a jury found that Sanofi and Regeneron’s PCSK9 inhibitor infringed patents on Amgen’s competing drug Repatha. When the court fight was proceeding, analysts figured the two sides would settle on royalties—sizable ones—but so far that hasn’t happened. Still, Sanofi has acknowledged that the question of whether Praluent would be pulled from the market has been a damper on sales of the specialized cholesterol-lowering drug.
This isn’t the only patent battle that Sanofi and Regeneron are fighting with Amgen. They also are fighting over new atopic dermatitis rollout Dupixent, which Amgen claims violates patents on a drug it is developing.
But the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board has declined to institute the first of three inter partes reviews Sanofi and Regeneron had sought, Jefferies analyst Biren Amin wrote in a Thursday note to clients.