Blog Big Molecule Watch August 03, 2022

Regeneron Files First BPCIA Complaint Regarding Biosimilar Eylea Against Mylan in West Virginia District Court

Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA for M710, a proposed biosimilar of EYLEA (aflibercept).  Regeneron asserts that use of Mylan’s M710 infringes seven patents:  U.S. Patent Nos. 9,254,338; 9,669,069; 10,130,681; 10,857,205; 10,888,601; 10,973,879; and 11,253,572, which are all generally directed to methods of administering aflibercept on specified dosing schedules to treat certain angiogenic eye disorders.  Regeneron’s Complaint also asserts that Mylan’s M710 formulation infringes three patents:  U.S. Patent Nos. 10,464,992; 11,066,458; and 11,084,865, which are generally directed to stable formulations of aflibercept.  Regeneron further asserts that Mylan’s process for manufacturing M710 infringes, or leads M710 to infringe, fourteen patents:  U.S. Patent Nos. 7,070,959; 9,222,106; 9,816,110; 10,406,226; 10,415,055; 10,669,594; 10,927,342; 11,053,280; 11,104,715; 11,174,283; 11,186,625; 11,299,532; 11,306,135; and 11,332,771.

Regeneron states in its complaint that the parties exchanged information under the BPCIA and disagreed regarding which patents to litigate, with Regeneron suggesting twelve patents to Mylan’s twenty five.  Regeneron noted that it was bound under § 262(/)(6)(B) to sue Mylan upon all its listed patents, save one that it “no longer asserts against Mylan.”  Regeneron’s Complaint notes that it “remain[s] amenable to approaches for streamlining this proceeding.”

Regeneron seeks a judgment that Mylan has infringed the asserted patents, monetary damages, and equitable relief including a preliminary and permanent injunction.  This is Regeneron’s first BPCIA litigation against any aflibercept biosimilar developer.  Viatris, Mylan’s parent company, announced in its Q3 2021 earnings call that Mylan’s aflibercept aBLA filing was submitted to FDA “at the end of October” 2021.  According to Regeneron’s Complaint, FDA notified Mylan of acceptance of its aBLA on December 28, 2021.  To date, Mylan is the first and only aflibercept biosimilar developer to have announced submission of its aBLA.

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