Court of Appeals denies McNeil Pediatrics' CONCERTA patent appeal

The Court of Appeals for the Federal Circuit has denied an appeal by McNeil Pediatrics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., to overturn a 2009 decision by the U.S. District Court of Delaware that the patent for CONCERTA (methylphenidate HCl) Extended-Release Tablets CII is invalid and not infringed by Andrx Corporation.

In December 2007, McNeil Pediatrics, which markets CONCERTA, and ALZA Corporation, the owner of the CONCERTA patent, sued Andrx Corporation for infringement of the CONCERTA patent that expires in July 2017, with pediatric exclusivity extending until January 2018.

In March 2009, the court ruled on that case in favor of Andrx. McNeil Pediatrics and ALZA Corporation filed an appeal of that decision in the Federal Circuit, which rendered today's decision.

CONCERTA is approved for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 17 and in adults 18 to 65, as part of a total treatment program that may include counseling or other therapies. McNeil Pediatrics will continue to market CONCERTA.