On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept. The order is currently sealed.
As previously reported, following a December 2023 judgment that Biocon infringed eight claims of Regeneron’s US patent 11,084,864, a temporary restraining order was granted on 17 May 2024, and extended on 30 May 2024, preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron. The temporary order was made to preserve the status quo until the Court could determine the motion for a permanent injunction.
Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023), Formycon (aBLA for FYB203 accepted by FDA in August 2023) and Samsung Bioepis (Opuviz FDA-approved in May 2024) in respect of alleged infringement of US Patent No. 11,084,855 (ophthalmic formulations of a VEGF antagonist). On 7 June 2023, Regeneron filed a preliminary injunction motion (under seal) against Amgen (aBLA for ABP 938 accepted by FDA in October 2023) in relation to the same patent.