On 23 July 2024, the Patent Trial and Appeal Board (PTAB) issued judgment against Regeneron in relation to the inter partes review (IPR2023-00884) commenced by Samsung Bioepis, Celltrion (IPR2024-00260) and Biocon (IPR2024-00298) challenging the validity of all claims of Regeneron’s US Patent No. 11253572 (Eylea® (aflibercept) method of treatment). The adverse judgment was ordered at Regeneron’s request after it disclaimed all claims of the 572 patent, so that there were no challenged claims of the patent remaining.
Other Regeneron patents relating to Eylea® recently invalidated in IPRs include:
- 10,130,681 (method of treatment): PTAB final decision (14 June 2024) in IPR2023-00442, commenced by Samsung Bioepis in January 2023, and PTAB decision (9 January 2024) in IPR2022-01225, commenced by Mylan in July 2022.
- 10,464,992 (formulation): PTAB adverse decision (21 February 2024) in IPR2023-00462 following Regeneron’s disclaimer of the 992 patent on 17 January 2024. The IPR was commenced by Celltrion and Samsung Bioepis.
- 10,888,601 (method of treatment): PTAB final decision (9 January 2024) in IPR2022-01226, commenced by Mylan in July 2022
On 12 March 2024, Regeneron filed notices of appeal in the United States Court of Appeals for the Federal Circuit challenging the PTAB decisions in relation to 10,130,681 and 10,888,601.
In the US, aflibercept biosimilars have been approved for Samsung Bioepis’ Opuviz™ (May 2024), Biocon’s Yesafili™ (May 2024) and Formycon/Klinge’s FYB203/Ahzantive® (June 2024). These and other aflibercept biosimilars are the subject of BPCIA litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Biocon/Mylan.