Johnson & Johnson announced that the District of Massachusetts Federal Court has issued a ruling on a summary judgment motion filed by Celltrion Healthcare Co. Ltd. and Celltrion Inc. (together, Celltrion) and Hospira Healthcare Corporation (Hospira) in the infringement lawsuits related to Remicade (infliximab) filed by the company's subsidiary, Janssen Biotech, Inc. (Janssen).
The court issued a ruling in favour of Celltrion and Hospira, holding that US Patent No. 6,284,471 for Remicade ('471 patent) is invalid. Janssen is disappointed with the court's ruling and plans to appeal the decision to the Court of Appeals for the Federal Circuit. Janssen is also continuing the appeal process in the proceedings related to the '471 patent before the US Patent & Trademark Office, and is awaiting a date to be set for an oral hearing in the appeal.
Janssen will continue to defend its intellectual property rights relating to its innovative medicines. A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch.
The company reaffirms its sales guidance for operational sales growth for the full-year 2016 of 3-4%, notwithstanding the possibility of a biosimilar launch on or after October 3, 2016.