BPCIA Aflibercept Litigation: Mylan Seeks Leave to Add a Declaratory Judgment Counterclaim of No Lost Profits or Injunctive Relief

As we previously reported, the Northern District of West Virginia ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan.  Regeneron had asserted 24 patents in its complaint.  As required by the court’s scheduling order, on October 28, Regeneron identified six patents for the first phase of the litigation.  Regeneron also had previously stated that it would further reduce the number of patents down to three for trial.  Last week, Mylan filed a motion to amend its Answer, Defenses, and Counterclaims to add a declaratory judgment counterclaim of no lost profits or injunctive relief for the remaining 18 patents not asserted by Regeneron in the first phase.

Mylan argues that “[u]nder the current schedule, the start of any litigation with respect to these unselected patents will occur after the 30-day statutory window to commence litigation under 42 U.S.C. § 262(l)(6).”  According to Mylan, “[i]n view of Regeneron’s actions to deprive Mylan of a full and fair opportunity to immediately litigate or otherwise resolve all of the patents-in-suit, Mylan . . . seeks leave to amend its responsive pleading to limit any relief with respect to infringement of these unselected patents that have been effectively dismissed without prejudice and/or not prosecuted to judgment in good faith under the Biologics Price Competition and Innovation Act.”

In its new counterclaim, Mylan alleges that “Regeneron’s voluntary, unilateral reduction of the (l)(5) Patent List down to an eventual three (3) patents, while reserving the right to litigate the remain[ing] 18 Patents, at its own discretion, at some unknown time, and depending on the outcome of trial, effectively dismisses those patents without prejudice from the (l)(6) suit.”  Mylan also alleges that Regeneron’s “sole and exclusive remedy” for the remaining 18 patents is a reasonable royalty.

Stay tuned to Big Molecule Watch for further developments on this BPCIA case.