Updates on Aflibercept BPCIA Litigation

Regeneron files ex parte application for a preliminary injunction schedule in case against Amgen

On Friday, January 20, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed an ex parte application for a scheduling order setting the schedule for preliminary injunction proceedings or, in the alternative, an emergency status conference.  Regeneron requested that the court “enter a preliminary injunction schedule that tracks the schedule in West Virginia.”  On Saturday, January 21, 2024, Amgen Inc. (“Amgen”) filed an opposition to Regeneron’s application for a scheduling order.  On January 23, 2024, the court issued an order granting in part and denying in part Regeneron’s ex parte application, stating, “The Application is GRANTED in part, to the extent it requires setting a preliminary injunction proceeding schedule, and the Application is DENIED in part, to the extent it requests the specific schedule proposed by Regeneron.”  The court set a scheduling conference on April 5, 2024 to discuss the preliminary injunction proceedings.

Oppositions to Regeneron’s motion to transfer case against Amgen to N.D. WV filed before the Judicial Panel on Multidistrict Litigation

As we previously reported, on January 11, 2024, Regeneron filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in the U.S. District Court for the Northern District of West Virginia and transfer its case against Amgen in the U.S. District Court for the Central District of California for “coordinated pretrial proceedings with five cases filed by Regeneron that are already pending before Chief Judge Kleeh in the Northern District of West Virginia.”  On January 11, 2024, Regeneron also filed a motion before the Judicial Panel on Multidistrict Litigation (“JPML”) seeking to expedite review of its motion to transfer and to establish an MDL.  The JPML denied this request for expedited consideration on January 12, 2024.  See In Re Aflibercept Patent Litig., C. MDL No. 3103 (JPML Jan. 12, 2024).

On February 2, 2024, Samsung Bioepis Co., LTD, Celltrion, Inc., and Formycon AG filed a joint opposition to Regeneron’s motion to transfer pretrial proceedings to an MDL in the Northern District of West Virginia.  The opposition states, “Regeneron’s failure to inform the Panel of the pending motions challenging personal jurisdiction is indicative of its improper purpose in establishing an MDL: to circumvent a possible unfavorable decision on a motion to dismiss for lack of personal jurisdiction.”[1]  Biocon Biologics Inc. and Mylan Pharmaceuticals Inc. also filed a response in opposition to Regeneron’s motion to transfer on February 2, 2024.  The response in opposition provides, “Regeneron has not established that the Section 1407 conditions of common factual questions, efficiencies or judicial economy, or the convenience of parties and witnesses, are satisfied.”  The same day, Amgen filed an opposition to Regeneron’s motion for transfer.  The opposition states, “[T]he specific circumstances of the actions show that Regeneron cannot demonstrate that there are enough efficiencies to be gained through centralization, which is fatal when compared to the risk of prejudice to Amgen and the other defendants.”  Among other things, Amgen pointed to the fact that the Central District of California is contemplating different and later timing for preliminary injunction proceedings against Amgen as compared to the schedule entered in the Northern District of West Virginia for the suits against Samsung Bioepis Co., LTD, Celltrion, Inc., and Formycon AG.

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

[1] As we previously reported, Samsung Bioepis Co., LTD filed a motion to dismiss for lack of personal jurisdiction on January 4, 2024, and the West Virginia court ordered briefing to be complete on the personal jurisdiction challenges by February 26, 2024.