Updates on Aflibercept BPCIA Litigation

Regeneron Filed Complaint Against Amgen in C.D. Cal. Over ABP 938 Biosimilar to EYLEA

On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s submission of an aBLA for ABP 938, a proposed biosimilar of EYLEA (aflibercept).  On October 31, 2023, Amgen announced that the FDA accepted its aBLA for ABP 938.

Regeneron has asserted the following patents against Amgen:

  • Fourteen patents related to manufacturing processes: S. Patent Nos. 9,222,106, 9,315,281, 9,816,110, 10,415,055, 10,905,786, 10,918,754, 11,104,715, 11,459,374, 11,472,861, 11,535,663, 11,548,932, 11,555,176, 11,680,930, 11,788,102.
  • Nine method of treatment patents: S. Patent Nos. 9,254,338, 10,130,681, 10,828,345, 10,888,601, 11,253,572, 11,542,317, 11,559,564, 11,707,506, 11,769,597.
  • Eight formulation patents: S. Patent Nos. 10,464,992, 11,066,458, 11,084,865, 11,160,918, 11,306,135, 11,505,593, 11,542,317, 11,753,459.
  • One patent directed to a process for detecting biological contaminants: S. Patent No. 10,669,594.
  • One patent related to packaging: S. Patent No. 11,793,926.

Regeneron seeks a judgment that Amgen has infringed the asserted patents, monetary damages, fees and costs, a declaration that the case is exceptional, a judgment of willful infringement and enhanced damages, an award for an accounting of damages, and equitable relief including a preliminary and permanent injunction.

On January 11, 2024, Regeneron filed a Motion, pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Judicial Panel on Multidistrict Litigation, seeking to transfer the case to the U.S. District Court for the Northern District of West Virginia 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.”

Court Sets Briefing Schedule On Preliminary Injunction Proceedings in West Virginia Litigations

On January 9, 2024, following Regeneron’s emergency motions for entry of a PI schedule, the U.S. District Court for the Northern District of West Virginia set a schedule for PI proceedings in Regeneron’s aflibercept BPCIA litigations against Celltrion (No. 23-CV-89), Samsung Bioepis (No. 23-CV-94 and No. 23-CV-106), and Formycon (No. 23-CV-97).  The Court ordered the PI schedule concurrently with a schedule regarding the pending motions to dismiss, noting the “unique timeline.”

Regarding the motions to dismiss, the Court ordered that Regeneron’s responses are due on February 19, 2024, and that any replies are due on February 26, 2024.

Regarding the PI proceedings, the Court ordered that Regeneron’s opening motions are due on February 22, 2024, oppositions are due on March 21, 2024, replies are due on April 18, 2024, and a hearing is scheduled for May 2, 2024.  Regulatory exclusivity is set to expire on May 18, 2024.

Stay tuned to Big Molecule Watch for more updates on these litigations.