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Samsung Bioepis Successfully Invalidates Regeneron Aflibercept Patent

Jun 14, 2024

On 14 June 2024, the Patent Trial and Appeal Board (PTAB) issued a final decision[Marketing to link to PDF document] in Samsung Bioepis’ Inter Partes Review Proceeding (IPR2023-00442) relating to Regeneron’s US Patent No. 10,130,681 (‘681 patent) covering methods of treatment involving Eylea® (aflibercept).  PTAB invalidated claims 1, 3–11, 13, 14, 16– 24, and 26 of the patent for obviousness.  Samsung Bioepis filed its IPR petition in January 2023. 

As previously reported, in January 2024, the PTAB found the same claims of the ‘681 patent to be anticipated by a prior art journal publication, in  IPR2022-01225 commenced by Mylan in July 2022.  On 12 March 2024, Regeneron filed a notice of appeal in the United States Court of Appeals for the Federal Circuit challenging the PTAB’s findings in relation to the ‘681 patent (and a second Regeneron patent). 

Samsung Bioepis’ Opuviz and Biocon’s Yesafili® were both approved as biosimilars to Eylea® with interchangeability in May 2024. In BPCIA patent litigation brought by Regeneron against  Samsung Bioepis and Biocon/Mylan (amongst others), a preliminary injunction was issued in relation to Samsung Bioepis’ aflibercept biosimilar on 14 June 2024, while a permanent injunction was granted against Biocon/Mylan on 11 June 2024.