As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held 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 aflibercept method of treatment patents (11,253,572 and 10,880,601) to be invalid. Regeneron appealed and Mylan and Biocon filed cross-appeals.
On 12 April 2024, the Court of Appeals for the Federal Circuit dismissed the appeal and cross-appeals on the basis that all parties agreed that the Appeals Court lacked jurisdiction pending a decision of all patents in dispute. This was agreed because only three patents out of the 24 asserted by Regeneron had been addressed in the 27 December 2023 decision and the infringement and validity of numerous patent claims are still pending in the proceeding.
A hearing of Regeneron’s motion for a permanent injunction following the Court’s decision that Mylan/Biocon infringe US 11,084,865 is scheduled for 2 May 2024, ahead of a status conference on 13 May 2024.