Big Molecule Watch
October 28, 2022

Expedited Trial Ordered in Regeneron Aflibercept BPCIA Case Against Mylan

The court has issued a scheduling order in Regeneron’s aflibercept BPCIA case against Mylan.  The court scheduled a 2-week trial in June 2023, less than a year from Regeneron’s filing of its complaint in August 2022.  The scheduling order requires Regeneron to identify 6 patents from 3 patent families for initial proceedings, and provides that Regeneron will not seek injunctive relief on the other 18 patents asserted in its Complaint.  A claim construction hearing is scheduled for January 6, 2023.

As we previously reported, Regeneron sought an expedited trial in order to gain the benefit of a statutory permanent injunction available under 35 U.S.C. 271(e)(4)(D).  That section of the BPCIA states that “the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the subject of a final court decision, . . . and the biological product has not yet been approved because of section 351(k)(7) of such Act.”  A “final court decision” is defined as one in which “no appeal (other than a petition to the United States Supreme Court for a writ of certiorari) has been or can be taken.”  42 U.S.C. § 262(k)(6)(C)(ii).  As Regeneron pointed out in its motion seeking an expeditated trial, the statutory provision “contains a critical timing limitation” as it provides relief only when the biosimilar product at issue had not yet been approved by FDA.  According to Regeneron, “[b]ecause FDA could approve Mylan’s proposed Eylea® biosimilar in May 2024,” a trial is needed no later than June 2023, “so that Regeneron may avail itself of the relief provided by § 271(e)(4)(D).”

Stay tuned to Big Molecule Watch as we monitor further developments in this case.

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