On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®. The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.
The infringement finding was made in relation to the aflibercept biosimilar Yesafili®. Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it. Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US.
On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions. At that time, the detailed reasons remained under seal. Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one.
Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023).