Janssen Voluntarily Dismisses Infliximab Patent Suit Against Samsung Bioepis

On May 17, 2017, Janssen sued Samsung Bioepis in the District of New Jersey for patent infringement under the BPCIA based on Samsung Bioepis’s filing of its aBLA for Renflexis® (infliximab-abda), a biosimilar of Remicade® that was approved by FDA a month earlier and subsequently launched in July 2017.  Janssen’s complaint include 5 counts: Counts 1 and 2 alleged violations of various provisions of the BPCIA, and Counts 3-5 alleged infringement of three patents.

On September 26, 2017, the court entered a stipulated order dismissing Counts 1 and 2 as moot in view of the Supreme Court’s June 12, 2017 decision in Amgen v. Sandoz.

Today, the parties filed a stipulation of voluntary dismissal of the remaining patent infringement counts of the complaint. The text of the stipulation reads as follows:

All claims and defenses pending between the parties related to the alleged infringement of the ’600 patent, the ’056 patent, and the ’083 patent under 35 U.S.C. § 271(e)(2)(C)(ii) are dismissed, and that dismissal is with prejudice only with respect to all claims and defenses related to the cell culture and downstream purification processes as described in the documents bearing production numbers SB200000001-207.

Given that Samsung Bioepis did not assert any counterclaims, there will be no claims remaining in the case upon entry of the stipulation.