Regeneron’s lawsuit, filed earlier this year, alleged more than 30 counts of patent infringement against Amgen and its biosimilar to the blockbuster eye therapy Eylea.
The U.S. District Court for the Northern District of West Virginia on Monday blocked Regeneron’s bid to prevent the sale of Amgen’s biosimilar to its blockbuster eye injection Eylea.
Chief District Judge Thomas Kleeh denied Regeneron’s motion for preliminary injunction, seeking to block Amgen’s biosimilar from the market, which the plaintiff alleges infringed on patent protections for Eylea. The judge’s order, including his justification for rejecting Regeneron’s motion, was issued under seal.
An Amgen spokesperson in a statement to SeekingAlpha said that the company welcomes Kleeh’s ruling, insisting that its biosimilar, dubbed Pavblu, “does not infringe Regeneron’s patent.” The FDA signed off on the biosimilar in August 2024, and the company is currently working toward launching the product.
Meanwhile, a Regeneron spokesperson said that the company is “disappointed” by the decision but pointed out that it was “specific to Amgen.” The spokesperson emphasized that Monday’s verdict “has no effect on previous decisions against other biosimilars manufacturers of Eylea” and “does not impact Eylea HD injection.”
“We continue to believe that Amgen is infringing our patent rights, and today’s decision denying our request for a preliminary injunction is not the final word in this litigation,” the Regeneron spokesperson said. The pharma has quickly appealed the decision.
BMO Capital Markets analyst Even Seigerman in a note to investors called Monday’s ruling “more of a speedbump than a death knell,” Noting that Kleeh has already issued four other injunctions against other biosimilars, all of which will remain in force.
“We underscore that today’s denial of Regeneron’s motion for a preliminary injunction is not a substitute for the case’s final decision,” Seigerman wrote.
Regeneron dipped around 5% in response to the ruling, but Truist Securities analyst Srikripa Devarakonda said in an investor note that the pharma’s portfolio shows formidable strength beyond Eylea. “We believe that the company has an underappreciated pipeline,” Devarakonda wrote, particularly in oncology, immunology and cardiovascular diseases.
Truist analysts “view the pressure on stock as an overreaction,” according to Devarakonda.
Regeneron sued Amgen in January 2024, alleging that it was developing a biosimilar that violated key patent protections for Eylea. Regeneron brought alleged 32 counts of patent infringement, which the pharma claims will “irreparably” harm its business if Amgen is not “enjoined” from violating these protections.
Aside from seeking a preliminary injunction, Regeneron sought to permanently prevent Amgen from marketing “any current or future versions of a product that infringes, or the use or manufacturing of which infringes,” the patents under contention. Regeneron also asked for damages to compensate for lost profits.
