We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept biosimilar to Biocon). Now, post-trial briefing is complete.

The parties submitted their responsive briefs on July 24, 2023, along with proposed findings of fact and conclusions of law. Both sides’ papers were filed under seal. The parties submitted their reply briefs on July 28, 2023. Defendants’ reply brief is publicly available.

In their 10-page reply brief, Defendants continued to press their invalidity arguments. Specifically, Defendants argued that the asserted claims of the dosing patents (the ’601 and ’572 patents) are anticipated, obvious, lacking written description, not enabled, and/or indefinite. Likewise for the formulation patent (the ’865 patent), Defendants argued that the asserted claims are anticipated, obvious, lacking written description, not enabled, and/or indefinite. Defendants also attacked Regeneron’s evidence of secondary considerations of non-obviousness for all patents.

This case has developed rapidly, having had a trial less than one year after Regeneron filed its complaint. The case has also been frequently impacted by decisions coming out of the USPTO, where the PTAB has been dealing with numerous petitions for IPR of patents related to aflibercept, including patents asserted in the district court litigation. See our most recent post on aflibercept IPR updates. In their reply brief, Defendants cited to the PTAB’s recent decision granting institution of IPR2023-00462, which was filed by Celltrion and targets the ’992 patent, which is directed to formulations of VEGF antagonists including aflibercept.

Closing arguments in the BPCIA case are currently scheduled for August 3, 2023, in the Lugar Courtroom of the West Virginia University College of Law.

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

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