Big Molecule Watch
June 13, 2024

Update on Aflibercept BPCIA Litigation

In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation.  The Court’s ruling on the permanent injunction follows a nine-day bench trial, held in June 2023, after which the Court held on December 27, 2023 that YESAFILI (Mylan/Biocon’s aflibercept biosimilar) infringes U.S. Patent No. 11,084,865 (“’865 patent”) and that Mylan/Biocon had not demonstrated that the infringed claims were invalid.

FDA approved YESAFILI on May 20, 2024, but the Court had previously entered a temporary restraining order against Mylan/Biocon, enjoining them from “manufacturing, using, offering to sell, or offering to sell, or selling within the United States, or importing into the United States without a license from Regeneron any product that is the subject of BLA No. 761274, including YESAFILI.”  The TRO was extended to June 14, 2024, to preserve the status quo until the Court could decide about the permanent injunction motion.  A public version of the Court’s permanent injunction order is not yet available.

On June 11, the Court also issued a partial Final Judgment, pursuant to Fed. R. Civ. P. 54(b), for Counts 12, 17, and 21 of Regeneron’s Complaint.  These counts correspond to Regeneron’s allegations of infringement of U.S. Patent No. 10,888,601 (Count 12), the ‘865 patent (Count 17), and U.S. Patent No. 11,253,572 (Count 21).  In the Court’s judgment that issued on December 27, 2023, the Court ruled that Mylan/Biocon infringed claims 4, 7, 9, 11, and 14-17 of the ‘865 patent, and that the same claims were not invalid; and that Mylan/Biocon will induce infringement of claims 6 and 25 of the ‘572 patent and claims 11 and 19 of the ’601 patent, but Mylan/Biocon had proven that these claims of the ’572 and ’601 patents are invalid.  On January 26, 2024, both Regeneron and Mylan/Biocon had filed notices of appeal to the Federal Circuit.  The parties each asserted that the December 27 judgment was not a final, appealable judgment, as a Partial Final Judgment pursuant to Fed. R. Civ. P. 54(b) was necessary before an appeal could be taken, but “in an abundance of caution,” the parties filed their respective notices of appeal.  On April 12, 2024, the Federal Circuit dismissed the appeal, on grounds that the “December 27, 2023 decision resolv[ed] fewer than all claims at issue.”   In view of the Court’s issuance of a Partial Final Judgment yesterday, it is expected that the parties will likely renew their appeals to the Federal Circuit.

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

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