Regeneron Sues Samsung Bioepis for Proposed Biosimilar of EYLEA in West Virginia District Court

Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 37 patents under the BPCIA based on Bioepis’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA (aflibercept) and Bioepis’s provision of Notice of Commercial Marketing with respect to the same.  This is the third infringement suit under the BPCIA concerning a proposed biosimilar of EYLEA, after Regeneron sued Mylan and Celltrion on August 3, 2022, and Nov 8, 2023, respectively.

Regeneron asserts that (1) use of Bioepis’s SB15 infringes 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) Bioepis’s SB15 formulation infringes four formulation patents, (3) Bioepis’s process for manufacturing SB15 infringes twenty-three patents, and (4) the proposed sterilization methods used for SB15 manufacture infringes two 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.
  • Four formulation patents alleged to be infringed by SB15:  U.S. Patent Nos. 10,464,992; 11,066,458; 11,084,865; and 11,732,024.
  • Twenty-three 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. 7,070,959; 9,222,106; 9,315,281; 9,816,110; 10,415,055; 10,669,594; 10,927,342; 11,053,280; 11,104,715; 11,174,283; 11,299,532; 11,306,135; 11,312,936; 11,332,771; 11,472,861; 11,485,770; 11,535,663; 11,542,317; 11,548,932; 11,555,176; 11,753,459; 11,788,102; and 9,562,238
  • Two patents alleged to be infringed by the sterilization methods used for SB15 manufacture: U.S. Patent Nos. 10,905,786 and 10,918,754.

In its counts for infringement of certain patents, Regeneron has alleged that “between August 29, 2021 and March 28, 2023, Bioepis 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 Bioepis 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.