Regeneron Files Expedited Motion Challenging Mylan’s Designation of Entire aBLA Production as Outside Counsel’s Eyes Only

On Tuesday, December 6, Regeneron filed an expedited motion to compel Mylan’s compliance with the protective order in the parties’ BPCIA litigation concerning Mylan’s proposed aflibercept biosimilar of EYLEA.  Regeneron alleges that Mylan has improperly “designated the entire 1,000,000+ pages of its biosimilar application and regulatory file as ‘Outside Counsel’s Eyes Only’ (‘OCEO’).”  Regeneron states that its in-house counsel previously had access to “a substantial portion of this material” under the terms of a January 2022 “Section 262(l) Confidentiality Agreement” negotiated during the pre-suit patent dance.

Regeneron asks the court to “order Mylan to de-designate its abbreviated Biologics License Application immediately to the level of Confidential, and to engage in a good faith and individualized determination of which additional documents from its November 4, 2022, production qualify for the OCEO level of protection.”  Regeneron asserts that Mylan’s mass designation is hampering Regeneron in-house counsel’s ability to “evaluate the case” and to meaningfully participate in expert witness meetings and imminent fact depositions.  In view of the expedited case schedule, Regeneron requested an abbreviated briefing schedule.

The motion was referred to Magistrate Judge James P. Mazzone.  Mylan’s response to Regeneron’s motion is due on Tuesday, December 13, and a hearing is set for Thursday, December 15, at 10:00 am in person.

UPDATE: On December 12, 2022, Regeneron withdrew its motion to compel.  According to Regeneron, “Mylan agreed to the relief Regeneron sought through its Motion.”

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