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Court Temporarily Restrains US Launch of Mylan’s/Biocon’s Eylea® (Aflibercept) Biosimilar

May 17, 2024

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®, were valid and infringed by Mylan and Biocon.  On 17 May 2024, Judge Kleeh granted a temporary restraining order, prohibiting Mylan/Biocon from manufacturing, using, marketing and selling their Yesafili® (aflibercept) biosimilar in, or importing it into, the US without a licence from Regeneron.  The restraining order operates for 14 days, unless otherwise extended.

Regeneron’s proceedings against Mylan and Biocon are one of six US actions brought by Regeneron regarding aflibercept biosimilars, with the other actions involving Amgen, Celltrion, Samsung Bioepis (2 actions) and FormyconAll proceedings are centralised in the Northern District of West Virginia and are ongoing.  A hearing scheduled for 2 May 2024 regarding a motion by Regeneron for a permanent injunction again Mylan/Biocon and motions for preliminary injunctions against Celltrion, Formycon and Samsung Bioepis, was cancelled by order dated 26 April 2024.  A scheduling conference was held on 17 May 2024, the transcript for which is not yet publicly accessible.