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Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia

Apr 12, 2024

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common questions of fact” and should be centralized in the Northern District of West Virginia.

Regeneron commenced five of its actions in the Northern District of West Virginia but commenced proceedings against Amgen in the Central District of California.  The Amgen case will now be transferred and assigned to Judge Kleeh who is hearing the remainder of the actions.

There are 63 patents in issue across each of the six actions.  In each case, Regeneron alleges infringement of a common set of 13 US patents covering its ophthalmic drug, Eylea® (aflibercept).

Of the common set of 13 patents, one (a formulation patent, US 11,084,865, expiring in June 2027) was held by Judge Kleeh to be valid and infringed in a decision issued in the first-filed Mylan action in December 2023.  Seven of the patents are at issue in preliminary injunction proceedings due to be heard on 2 May 2024 in the Northern District of West Virgina actions against Celltrion, Samsung Bioepis and Formycon.