The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio" (filgrastim-sndz) is a biosimilar of Amgen's Neupogen® (filgrastim) product), another biosimilar patent dispute is brewing between Janssen Biotech, Inc. and Celltrion Healthcare Co., Ltd. over Remicade® (infliximab). On March 6, 2015, Janssen filed a complaint against Celltrion in the Massachusetts district court, alleging violations of the BCPIA, and infringement of six patents. Like the pending litigation between Amgen and Sandoz, the Remicade biosimilar case highlights how the carefully orchestrated patent dispute resolution processes of the BCPIA can fall apart when the parties cannot even agree on what the law requires.