On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea®. The petition challenges claims 1-17, 19-42, 44-50 as invalid for lack of novelty and claims 1-50 as obvious.
The US ‘865 patent is being hotly contested with Samsung Bioepis and Formycon also having filed IPR petitions challenging it in November 2024 and December 2024, respectively. Those petitions remain pending, awaiting an institution decision.
The US District Court for the Northern District of West Virginia granted preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (US ‘865). Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively). Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. Those appeals are all pending.
Celltrion filed an NDA with the FDA in June 2023 for its aflibercept biosimilar, CT-P42/Eydenzelt™. Eydenzelt™ was approved in Korea in May 2024 and received a positive CHMP opinion from the European Medicines Agency in December 2024.