Federal Circuit Affirms injunction against Celltrion in Aflibercept BPCIA litigation
As we reported previously, the Federal Circuit recently affirmed a similarly preliminary injunction against Samsung & Formycon. In its opinion, dated Jan. 29, 2025 the Federal Circuit affirmed that the district court had exercised personal jurisdiction over Samsung & Formycon. The court held that the filing of aBLAs, service of a notice of commercial marketing, and the establishment of a national distribution channel were enough to establish minimum contact. The Federal Circuit concluded that Samsung and Formycon did not raise a substantial issue of invalidity with respect to the asserted U.S. Patent No. The district court granted Regeneron’s motion for a preliminarily injunction against Celltrion on June 24, 2024. The Federal Circuit cited its Samsung and Formycon decisions on appeal to conclude that Celltrion’s actions also met the minimum-contacts requirements for personal jurisdiction. Additionally, the Federal Circuit held that Celltrion had not raised a substantial question of invalidity of the ‘865 patent based on obviousness-type double patenting.
Celltrion’s aflibercept biosimilar, CT-P42, has not yet been approved by the FDA.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing BPCIA litigations and the biosimilars market.
