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ARTICLE · 27 NOVEMBER 2023

BPCIA Litigation Related To Proposed Eylea Biosimilar CT-P42 Filed

Venable LLP
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On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia...

United StatesIntellectual Property
Damineh Morsali, Ph.D.
Damineh Morsali, Ph.D.
Robert S. Schwartz, Ph.D.
Robert S. Schwartz, Ph.D.

On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block Celltrion's biosimilar product "CT-P42" – Celltrion's proposed biosimilar of Regeneron's drug Eylea® (aflibercept) – from entering the United States market. Regeneron Pharmaceuticals Inc. v. Celltrion Inc., N.D.W.Va., No. 1:23-cv-00089. In their Complaint, Regeneron alleges that Celltrion infringes 38 patents owned by Regeneron and directed at compositions and methods related to retinal-disease treatment.

42 U.S.C. § 262(l) outlines a framework for applicants and reference product sponsors ("RPS") to resolve patent disputes and engage in the so-called "patent dance". Briefly, Celltrion publicly announced on June 30, 2023 that it had filed an abbreviated Biologics License Application ("aBLA") for CT-P42 with the FDA, followed by serving Regeneron with a copy of the aBLA on

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