On 9 July 2024, Regeneron, Mylan, Celltrion and Apotex agreed to the dismissal of Regeneron’s appeals in the US Court of Appeal for the Federal Circuit from PTAB decisions finding US Patent Nos. 9,254,338 and 9,669,069 invalid. The patents encompass Regeneron’s Eylea® (aflibercept) methods of treatment. The PTAB decisions were issued on 9 November 2022 in IPR2021-00881 and IPR2021-00880. With the dismissal of Regeneron’s appeals, the PTAB invalidity decisions stand
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.