The Patent Trial and Appeal Board (PTAB) in found that Regeneron’s patents 10,130,681 and 10,888,601 relating to methods of treatment using Eylea® (aflibercept) are invalid. The PTAB held in IPR2022-01225 and IPR2022-01226 that all challenged claims of the two patents were anticipated by a journal publication which disclosed aflibercept for age-related macular degeneration (AMD), and disclosed phase I and II data relating to its use in neovascular AMD. The inter partes review (IPR) proceedings were filed by Mylan in July 2022 and instituted in January 2023.
On 23 March 2023, PTAB instituted Celltrion’s IPR challenge to ‘601 and ’681 and Samsung Bioepis’ IPR challenge to ‘601. PTAB also granted Celltrion and Samsung Bioepis’ motions to join the Mylan IPRs. Samsung Bioepis’ IPR2023-00442 challenge to the ‘681 patent is still pending before the PTAB.