On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entries of preliminary injunction preventing Samsung Bioepis Co., Ltd. (“Samsung”) and Formycon AG (“Formycon”) from marketing their aflibercept biosimilars of EYLEA®.
The district court granted preliminary injunctions against both Samsung and Formycon, finding that both were likely to infringe Regeneron’s U.S. Patent No. 11,084,865, which is directed toward an aflibercept formulation. On appeal, the Federal Circuit addressed whether the district court properly exercised personal jurisdiction over Samsung and Formycon, and whether there existed a substantial question of invalidity due to obviousness-type double patenting (OTDP) or lack of written description under 35 U.S.C. § 112(a).
In affirming the district court’s exercise of personal jurisdiction, the Court relied upon Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016) and stated that the filing of an aBLA, service of a Notice of Commercial Marketing, and establishment of a distribution channel were sufficient to establish minimum contacts. In affirming the grants of preliminary injunction, the Federal Circuit concluded that Samsung and Formycon “had not raised a substantial question of invalidity of the asserted claims of the ’865 patent.” The Court stated that certain limitations rendered the claims at issue patentably distinct.
As we previously reported, the aflibercept BPCIA litigations between Regeneron and competitors continue to progress into 2025. Oral arguments in the Regeneron v. Mylan appeal are scheduled for tomorrow, Friday, January 7, 2025. The argument will likely address similar issues surrounding invalidity and infringement of the ’865 patent.
In a related case, after the Federal Circuit denied Regeneron’s motion for an injunction pending appeal, Amgen became the first company to launch an aflibercept biosimilar in October 2024.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing BPCIA litigations and the biosimilars market.