New Brunswick, NJ (August 17, 2016) – Johnson & Johnson (NYSE: JNJ) today 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 favor of Celltrion and Hospira, holding that U.S. 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 U.S. 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.
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Joseph J. Wolk
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Biotech, Inc. and Johnson & Johnson. Risks and uncertainties include, but are not limited to, the on-going USPTO appeal process related to the ‘471 patent and the current, or any other, litigation challenging the coverage and/or validity of the company's patents related to REMICADE®. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)