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# Janssen-Celltrion BPCIA Suit Updated
- URL: https://www.fdaweb.com/janssen-celltrion-bpcia-suit-updated/
- Published: 2016-06-14T12:00:00.000Z
- Updated: 2026-09-14T21:09:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135928

Three Fish & Richardson attorneys say that Janssen’s Massachusetts federal court suit against Celltrion is of interest because it is one of the few currently pending litigations related to biosimilars and the Biologics Price Competition and Innovation Act (BPCIA). Writing in an online blog [post](http://www.lexology.com/library/detail.aspx?g=a07e9fe1-be68-4d44-b281-5f5f57e81130&ref=fdaweb.com), the attorneys says that the litigation has focused on three issues: **(1)** infringement and validity of the patents-in-suit; **(2)** Celltrion’s notice of commercial marketing and the associated timing of its product launch; and **(3)** amendments to the protective order that would allow Janssen to use confidential information obtained from Celltrion to pursue other litigation.

At issue is Celltrion’s aBLA seeking to market Remsima, a biosimilar of Janssen’s Remicade. After FDA accepted the Celltrion application for review, the two parties engaged in the BPCIA “patent dance” provisions, although Janssen argues that Celltrion did not complete the process.

The post updates the legal maneuvering and actions of the two parties for each of the three BPCIA issues being contested.