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Court Orders Permanent Injunction Against Biocon in US Aflibercept Dispute

Jun 11, 2024

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.