Regeneron Files BPCIA’s First Complaint Regarding Eylea Biosimilar Against Mylan in West Virginia District Court – Patent


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Regeneron yesterday filed a lawsuit 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 claims that use of Mylan’s M710 infringes seven patents: US Patent Nos. 9,254,338; 9,669,069; 10,130,681; 10,857,205; 10,888,601; 10,973,879; and 11,253,572, all of which generally relate to methods of administering aflibercept according to specified dosage regimens to treat certain angiogenic ocular disorders. Regeneron’s complaint also alleges that Mylan’s M710 formulation infringes three patents: US Patent Nos. 10,464,992; 11,066,458; and 11,084,865, which generally relate to stable formulations of aflibercept. Regeneron further asserts that Mylan’s M710 manufacturing process infringes, or causes the M710 to infringe, fourteen patents: US 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 on which patents to challenge, with Regeneron suggesting twelve patents to Mylan’s twenty-five. Regeneron noted that it was obligated under § 262(/)(6)(B) to sue Mylan on all of its listed patents, except for one that it “no longer asserts against Mylan.” Regeneron’s complaint notes that there “remains[s] lend themselves to approaches to streamline this procedure. »

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

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