Blog Big Molecule Watch January 09, 2020

Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation (UPDATED)

This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed by the 35 U.S.C. § 271(e)(1) safe harbor, and “subject to the terms and conditions of the Stipulation submitted to the Court on December 23, 2019.” The Order, dated January 8, states that the “basis for this Order is the referenced Stipulation.” The referenced Stipulation, however, is not publicly available; it was filed by the parties under seal last month, and entered by the Court under seal on January 6.

Today, the parties filed a letter asking the court to administratively stay the litigation “consistent with the Confidential Stipulation … and entry of the Consent Injunction.” The parties request that “the administrative stay remain in place consistent with paragraph 2 of the Confidential Stipulation previously entered by the Court as D.E. 110 (the ‘Confidential Stipulation’), except that the following shall not be subject to the stay: (1) discovery as set out in Paragraph 6 of the Confidential Stipulation; (2) preliminary injunction proceedings, including discovery and discovery disputes related thereto; and (3) amendment(s) to the First Amended Complaint.”

Stay tuned to Big Molecule Watch for further developments.

UPDATE (Jan. 15, 2020): The district court has endorsed the parties proposed order, administratively staying the case, subject to the provisos of the order.

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