The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.
A U.S. federal appeals court on Friday handed Regeneron another legal loss in its patent fight against Amgen over the latter’s biosimilar to Regeneron’s blockbuster eye injection Eylea.
The ruling, though expected, could still be a “headwind that could be difficult to overcome” for Regeneron, BMO Capital Markets analysts wrote to investors on Friday afternoon. “This decision adds incremental risk to the Eylea story,” which is already running into other difficulties.
Regeneron sued in January 2024, claiming that by developing and marketing its VEGF blocker Pavblu, Amgen was violating more than 30 Eylea patents. Regeneron at the time asked the court to permanently block Amgen from commercializing “any current or future versions of a product that infringes, or the use or manufacturing of which infringes” the Eylea patents in the suit.
A West Virginia court in September 2024 ruled against Regeneron, though the order was issued and remains under seal.
Writing for the United States Court of Appeals for the Federal Circuit, Judge Alan David Lourie affirmed the lower court’s ruling, noting that Regeneron had failed to sufficiently make its case that Pavblu’s specific formulation clearly violates Eylea’s patents.
“There is at least a substantial question of noninfringement,” Lourie wrote of Amgen’s Pavblu, noting a distinct difference in its formulation to Eylea. “Regeneron has therefore not established a likelihood of success on the merits of its infringement allegations.”
As noted by BMO, it has not been smooth sailing of late for Eylea.
As per Regeneron’s full-year business report last month, for instance, sales of the therapy dipped 11% year-on-year in the fourth quarter, capping off a year of disappointing sales and mounting competition from other biosimilars. Hoping to shore up revenues for the franchise, Regeneron is developing a high-dose formulation of Eylea, though its rollout has been rough. In the fourth quarter of 2024, the high-dose injection made $305 million, missing the analyst expectation of $336 million.
Still, BMO appears to be optimistic about Regeneron overall, pointing to its “catalyst-filled 2025.” Foremost of these is the launch of its prefilled syringes for high-dose Eylea by midyear. Additionally, the BMO analysts pointed to readouts for the biologic itepekimab in chronic obstructive pulmonary disease (COPD) and for the LAG-3 therapy fianlimab in non-small cell lung cancer and melanoma.
Also helping boost Regeneron’s business is the recent approval of its Sanofi-partnered Dupixent in COPD, making the IL4 and IL13 blocker the first-ever biologic cleared for this indication.
