Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia.  On December 27, 2023, the court entered judgment in the litigation finding certain claims of Regeneron’s U.S. Patent No. 11,084,865 valid and infringed and other patent claims invalid.  On January 26, 2024, both Regeneron and the Biocon Defendants filed notices of appeal from the court’s judgment.  Regeneron and the Biocon Defendants asserted that the December 27 judgment was not a final, appealable judgment, as it resolved fewer than all claims in Regeneron’s complaint, but “in an abundance of caution,” the parties filed their respective notices of appeal.

On April 12, 2024, the Federal Circuit dismissed the appeals (CAFC Appeal No, 24-1402 and Cross-Appeal No, 24-1405) for lack of jurisdiction.  The dismissal order states, “Following this court’s February 22, 2024 show cause order, the parties agree that the court lacks jurisdiction over both the appeal and cross-appeal from the district court’s December 27, 2023 decision resolving fewer than all claims at issue. Under the circumstances, we agree and conclude that dismissal is appropriate.”