Post-Trial Briefing in Regeneron v. Mylan Aflibercept BPCIA Case

Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia.  As we previously reported, the case was expedited, with trial occurring less than a year after Regeneron filed its complaint.  The case was originally filed naming only Mylan as a defendant, but in March 2023, the parties stipulated to add Biocon as a defendant in view of Mylan’s transfer of its rights to the aflibercept biosimilar to Biocon.  The patents-at-issue are directed to dosing regimens for aflibercept, an anti-VEGF treatment for intravitreal injection.  At trial, Regeneron asserted infringement of claims 11 and 19 of U.S. Patent No. 10,888,601 (the “’601 patent”); claims 6 and 25 of U.S. Patent No. 11,084,865 (the “’865 patent”); and claims 4, 7, 9, 11 and 14-17 of U.S. Patent No. 11,253,572 (the “’572 patent”).

Post-trial briefing is now underway.  Regeneron’s opening brief on infringement (filed under seal) and Defendants’ opening brief on invalidity were filed on June 7, 2023.

Defendants’ opening brief sets forth invalidity argument for all asserted claims.  Specifically, Defendants argue that claims 6 and 25 of the ’572 patent, and claims 11 and 19 of the ’601 patent, are both anticipated and obvious.  Defendants further argue that claim 6 of the ’572 patent lacks written description and is not enabled, and that the term “approximately” in claim 6 is indefinite.  Lastly, Defendants argue that claims 4, 7, 9, 11 and 14-17 of the ’865 patent are anticipated, obvious, lack written description, and are not enabled, and that the term “suitable for intravitreal administration” is indefinite.

Responsive briefs and findings of fact and conclusions of law are due July 21, 2023, and reply briefs on July 28.  Closing arguments are currently scheduled for August 3, 2023, and the location for argument has been changed to West Virginia University College of Law, in the Lugar Courtroom.

Stay tuned to Big Molecule Watch for updates on this BPCIA litigation.