Updates on Aflibercept BPCIA Litigation

Emergency Motion for Entry of a PI Schedule Against Celltrion, Formcyon, and Samsung Bioepis

On December 28, Regeneron filed emergency motions for entry of a PI schedule in its aflibercept BPCIA cases against Celltrion, Inc., Formycon AG, and Samsung Bioepis (“Samsung”).  Regeneron seeks a PI schedule to “ensure an orderly process that will result in resolution of its forthcoming motion for PI before May 17, 2024,” when its regulatory exclusivity period ends.  According to Regeneron’s proposed schedule, its motion for preliminary injunction would be filed on February 22, 2024, briefing would be completed on April 18, 2024, and a hearing to take place the week of April 29, 2024.  The proposed schedule also provides dates for document discovery and depositions.

A status conference took place today January 5, 2024 in relation to Regeneron’s emergency motion.

Regeneron Filed Second Complaint Against Samsung

On December 27th, Regeneron filed a second complaint against Samsung in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 51 patents under the BPCIA based on Samsung’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA (aflibercept).  The Complaint identifies the case as related to Regeneron’s prior pending aflibercept BPCIA case against Samsung, filed on November 22, 2023.

Regeneron asserts that (1) use of Samsung’s SB15 will infringe eight patents which are generally directed to methods of administering aflibercept on specified dosing schedules to treat certain angiogenic eye disorders and/or to patients who have been determined to have certain polymorphisms, (2) Samsung’s SB15 formulation will infringe ten patents, which are generally directed to stable formulations of aflibercept, (3) Samsung’s process for manufacturing SB15 will infringe, or leads SB15 to infringe, twenty patents, (4) Samsung’s method for detecting biological contaminants in the SB15 production process will infringe one patent, (5) Samsung’s SB15 delivery devices will infringe four patents, and (6) Samsung’s SB15 packaging and packaging/syringe cap design will infringe eight utility and design patents.

Specifically, Regeneron has asserted the following patents.

  • Eight method of treatment patents alleged to be infringed by use of SB15: U.S. Patent Nos. 9,254,338; 10,130,681; 10,828,345; 10,888,601; 11,253,572; 11,559,564; 11,707,506; and 11,769,597.
  • Ten formulation patents alleged to be infringed by SB15: U.S. Patent Nos. 10,464,992; 11,066,458; 11,084,865; 11,306,135; 11,485,770; 11,542,317; 11,732,024; 11,753,459; 11,103,552; 11,505,593.
  • Twenty patents alleged to be infringed by the process for SB15 manufacture or by SB15 as a result of the process for its manufacture:  U.S. Patent Nos. 9,222,106; 9,315,281; 9,562,238; 9,816,110; 10,415,055; 10,905,786; 10,918,754; 10,927,342; 11,053,280; 11,104,715; 11,174,283; 11,299,532; 11,312,936; 11,332,771; 11,472,861; 11,535,663; 11,548,932; 11,555,176; 11,788,102; and 11,459,374.
  • One patent alleged to be infringed by the process for detecting biological contaminants in the SB15 production process: U.S. Patent No. 10,669,594.
  • Four patents alleged to be infringed by SB15 delivery devices: U.S. Patent Nos. 10,182,969; 11,433,186; 11,439,758; and 11,478,588.
  • Three utility patents and five design patents alleged to be infringed by SB15 packaging and syringe cap: U.S. Patent Nos. 11,160,918; 11,793,926; 11,577,025; and U.S. Design Patent Nos. D858,753; D906,102; D934,069; D961,376; and D961,377.

In its counts for infringement of certain patents, Regeneron has alleged that “between August 29, 2021 and March 28, 2023, Samsung imported 17 shipments of SB15 into the United States. Each of these shipments contained product described as “AFLIBERCEPT (INHIBITOR (GROWTH FACTOR)).”  See, e.g., Complaint at ¶ 10.  Regeneron seeks a judgment that Samsung 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.

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