As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation. Pursuant to that order, Regeneron’s case against Amgen, Inc. (“Amgen”) was transferred from the Central District of California to the Northern District of West Virginia (“N.D.W.V.”) and consolidated for pretrial proceedings with Regeneron’s actions pending there against Mylan/Biocon, Celltrion, Formycon, and Samsung Bioepis, with Chief Judge Thomas S. Kleeh presiding.
On April 24, 2024, after the MDL was instituted and the Amgen case was transferred, Judge Kleeh cancelled the hearings regarding Regeneron’s motion for a permanent injunction against Mylan and motions for preliminary injunctions against Celltrion, Formycon, and Samsung Bioepis, which had been scheduled for May 2, 2024. Two days later, Judge Kleeh also cancelled status conferences that had been scheduled for May 13, 2024, in each of the original N.D.W.V. cases. In their place, Judge Kleeh set an initial scheduling conference in the MDL for May 17, 2024. Regeneron’s FDA exclusivity for Eylea® is set to expire the following day, on May 18, 2024. According to the order, hearings regarding Regeneron’s motions for permanent and preliminary injunctions will be rescheduled, “if necessary, by separate order.” No separate order has yet issued.
On May 3, 2024, Regeneron filed a “Motion for Guidance Regarding Temporary Restraining Orders in View of the May 18, 2024 Expiration of Regulatory Exclusivity for Eylea.” In that motion, Regeneron stated that FDA may begin approving biosimilars on May 18, 2024, and that none of the defendants have “confirm[ed] that they will not launch their infringing products until this Court has had time to decide the pending motions for injunctive relief.” Regeneron stated its intention to move for temporary restraining orders (“TRO”) against Mylan, Celltrion, Formycon, and Samsung Bioepis on May 14, 2024, unless the court sets a different schedule.
On Sunday, May 5, 2024, Samsung Bioepis filed a response to Regeneron’s Motion for Guidance. Samsung argued that because Regeneron’s motions for preliminary injunctions are already fully briefed, the court should decide those motions without need for TRO motions, that Regeneron has failed to prove entitlement to a preliminary injunction, and that if the court chooses to entertain a motion for a TRO, it should set a schedule that allows Samsung Bioepis to respond to the motion before May 18, 2024. On May 6, 2024, Regeneron responded to Samsung Bioepis’s filing, stating that it agrees that the court should decide the motions for preliminary injunctions if possible, but if the court is unable to do so before May 18, when FDA may begin approving biosimilars for sale in the United States, then a TRO may be necessary to maintain the status quo until a decision can be reached.
Stay tuned for further developments.