An appellate court sided with Regeneron versus Novartis on Monday, agreeing that anti-VEGF pre-filled syringes constitute a distinct market than those sold in vials. The case involves Regeneron’s Eylea and Novartis’ Lucentis eye treatments.
Pictured: Sign above the entrance of a U.S. courthouse/iStock, Mariakray
The U.S. Court of Appeals for the Second Circuit on Monday overturned a lower court’s decision on the antitrust case between Regeneron and Novartis regarding their respective anti-VEGF eye treatments Eylea (aflibercept) and Lucentis (ranibizumab).
The appellate court sided with Regeneron, agreeing with the pharma that a district court had wrongly dismissed its antitrust claims against Novartis because anti-VEGF therapies sold in pre-filled syringes (PFS) constitute their own and distinct market versus therapies sold in vials.
The lower court approached the case believing that vials and PFSs operated in the same market and therefore applied the wrong legal standard, Circuit Judge Barrington Parker wrote in Monday’s decision.
“The district court focused on the functional similarities between the PFS and vial versions of Regeneron’s and Novartis’s respective anti-VEGF treatments and concluded that, because of those similarities, both versions compete in the same relevant market,” Barrington wrote.
“The pivotal issue in this appeal is whether anti-VEGF medications in vials and PFSs compete in the same or different product market,” Barrington wrote, adding that the court agrees with Regeneron’s assertion that anti-VEGF therapies administered through PSFs “constitute their own product market—distinct from the market for vials.”
A Regeneron spokesperson in a statement to Reuters said that the company is “encouraged by the Second Circuit’s decision.” Novartis, meanwhile, said it was “disappointed with the court’s ruling,” adding that it continues “to believe Regeneron’s claims lack merit.”
Regeneron’s Eylea and Novartis’ Lucentis are anti-VEGF therapies that work by slowing the growth of abnormal blood vessels in the eye, targeting several ophthalmic diseases such as wet age-related macular degeneration and retinal vein occlusion.
Originally, anti-VEGF therapies were dispensed in vials and would be administered via an injection. According to Monday’s court document, this process was “cumbersome” and could aggravate the risk of complications when done incorrectly.
Regeneron in 2005 collaborated with contract manufacturing company Vetter to develop a PFS syringe of Eylea, which would make administration safer and more convenient. However, the pharma alleges that Vetter “confidentially entered into a similar agreement with Novartis” in 2009, which eventually culminated in a patent covering a PFS product containing an anti-VEGF therapy.
Novartis and Vetter then allegedly engaged in other “anti-competitive steps” to “keep Regeneron out of the anti-VEGF PFS market,” which pushed back the launch of Eylea’s PFS product to 2019. Regeneron sued Novartis in July 2020 based on these allegations, according to the court document on Monday.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
