Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

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The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021.  As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL.  The case had been administratively stayed since January 2020.

Judgment was entered, in line with a prior consent injunction order, in favor of Plaintiffs Immunex and Roche, and against Defendant Samsung Bioepis, on each of Plaintiffs’ claims for infringement of U.S. Patent No. 8,063,182 (the “’182 Patent”) and U.S. Patent No. 8,163,522 (the “’522 Patent”).  Samsung Bioepis is permanently enjoined from “making, using, offering to sell, or selling within the United States, or importing into the United States any product containing etanercept,” except as allowed by the 35 U.S.C. § 271(e)(1) safe harbor, and Samsung Bioepis “shall immediately destroy any remaining Bioepis etanercept product that has been imported into the United States.”  The permanent injunction will terminate upon the expirations of both the ’182 Patent and ’522 Patent on April 24, 2029.  There are currently no etanercept biosimilars available in the United States.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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