In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would prevent Amgen from launching PAVBLU (aflibercept-ayyh), Amgen’s biosimilar of Regeneron’s EYLEA®. The FDA approved PAVBLU on August 23, 2024.
The court previously issued preliminary injunctions against Samsung Bioepis, Formycon, and Celltrion, and a permanent injunction against Mylan, preventing each from commercially launching their respective aflibercept biosimilars.
Regeneron immediately appealed the decision to the U.S. Court of Appeals for the Federal Circuit, and asked the Federal Circuit to issue an emergency injunction barring Amgen from launching PAVBLU until resolution of the appeal. According to Regeneron, the district court found that Regeneron was unlikely to prove that Amgen will infringe the ’865 patent. Regeneron also asserts that Amgen has told its customers that it intends to launch PAVBLU on October 1, 2024. Amgen has opposed Regeneron’s request for an emergency injunction.
Stay tuned to Big Molecule Watch for further updates on the pending aflibercept BPCIA litigations.