Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al., Case Nos. 2024‑1965, ‑1966, ‑2082, ‑2083 (Jan. 29, 2025), affirming the district court’s grant of an injunction that prevents the launch of biosimilar versions of EYLEA®, a biologic drug used to treat retinal diseases like wet age-related macular degeneration (AMD).
Regeneron sued Mylan and other biosimilar applicants who had filed abbreviated Biologics License Applications with the FDA, seeking approval to market EYLEA® biosimilars under the Biologics Price Competition and Innovation Act (BPCIA). In two such suits against Samsung Bioepis Co., Ltd. (SB), Regeneron filed motions for a preliminary injunction. The district court issued a confidential opinion granting the requested preliminary-injunctive relief. SB appealed.
The Federal Circuit affirmed. The Court first rejected SB’s assertion that the district court’s exercise of personal jurisdiction over it in West Virginia was improper. Specifically, the Court noted that SB filed an aBLA, served a Notice of Commercial Marketing, failed to deny that it would commercialize the product in West Virginia through its distributor, and had established a robust distribution channel that includes West Virginia. The Court determined these facts sufficed to support personal jurisdiction.
Next the Court rejected SB’s various challenges to the district court’s grant of a preliminary injunction. Specifically, the Court determined that claim differences between the asserted claims and those of a reference patent SB had raised in connection with its obviousness-type double patenting rendered the claims patentably distinct. The Court also rejected SB’s challenges to the district court’s determinations on secondary considerations and on written description. Finally, the Court rejected SB’s assertion that the district court erred in finding a causal nexus between the alleged infringements and irreparable harm that Regeneron would incur without injunctive relief. Although the stability range stated in the aBLA is broader than that set forth in the asserted claims, the record evidence indicated it intended only to sell infringing biosimilar products. The Court further explained that where the infringing product contains no feature relevant to consumers’ purchasing decisions other than what the patent claims, the possibility that a different, nonexistent, noninfringing product might cause the same harm is not relevant to nexus.