On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia's entry of a preliminary injunction preventing Celltrion, Inc. ("Celltrion") from launching CT-P42, its aflibercept biosimilar of EYLEA®.
As we have previously reported, the Federal Circuit recently affirmed a similar preliminary injunction against Samsung and Formycon. In that opinion, issued on Jan. 29, 2025, the Federal Circuit affirmed the district court's exercise of personal jurisdiction over Samsung and Formycon, holding that the filing of an aBLA, service of a Notice of Commercial marketing, and establishment of a nationwide distribution channel were sufficient to establish minimum contacts. The Federal Circuit also concluded that Samsung and Formycon had not raised a substantial question of invalidity of the asserted claims of U.S. Patent No. 11,085,865 ("'865 patent").
On June 24, 2024, the district court granted Regeneron's motion for a preliminary injunction against Celltrion. On appeal, the Federal Circuit referenced its Samsung and Formycon opinions, concluding that Celltrion's conduct also satisfied the minimum-contacts requirement for personal jurisdiction for the same reasons. 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.
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