Regeneron Sues Formycon AG for Proposed Biosimilar of EYLEA in West Virginia District Court

Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39 patents under the BPCIA based on Formycon’s submission of an aBLA for FYB203, a proposed biosimilar of EYLEA (aflibercept).  This is the fourth infringement suit under the BPCIA concerning a proposed biosimilar of EYLEA, after Regeneron sued Mylan (August 2, 2022), Celltrion (November 8, 2023), and Samsung Bioepis (November 22, 2023).

Regeneron asserts that (1) use of Formycon’s FYB203 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) Formycon’s FYB203 formulation will infringe four patents, which are generally directed to stable formulations of aflibercept, and (3) Formycon’s process for manufacturing FYB203 will infringe, or leads FYB203 to infringe, twenty-seven patents.  Specifically, Regeneron has asserted the following patents.

  • Eight method of treatment patents: 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: U.S. Patent Nos. 10,464,992; 11,066,458; 11,084,865; and 11,732,024.
  • Twenty-seven manufacturing process patents:  U.S. Patent Nos. 7,070,959; 7,771,997; 9,222,106; 9,562,238; 9,816,110; 9,932,605; 10,415,055; 10,669,594; 10,927,342; 11,053,280; 11,104,715; 11,174,283; 11,268,109; 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; 11,549,154; 11,555,176; 11,680,930; 11,753,459 and 11,788,102.

As we previously reported, the ’601 and ’572 dosing patents and the ’865 formulation patent were recently asserted at trial between Regeneron and Mylan, also in the Northern District of West Virginia. 

In its counts for infringement of certain patents, Regeneron has alleged that Formycon imported “at least one shipment of FYB203 into the United States” and the shipment contained a product described as “AFLIBERCEPT (INHIBITOR (GROWTH FACTOR))” (see, e.g., Complaint at ¶ 9).  Regeneron seeks a judgment that Formycon 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.