The US District Court for the District of Delaware has rendered a decision in the patent litigation between Alza Corporation, McNeil-PPC, Inc and Andrx Pharmaceuticals LLC McNeil Paediatrics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, which markets Concerta (methylphenidate HCI) Extended-Release tablets CII, said the court held that the patent in suit is not valid or infringed by the filing of Andrx's Abbreviated New Drug Application.
Alza and McNeil-PPC are analyzing the court's lengthy opinion and assessing their next steps in this litigation, which may include a request for reconsideration, or an appeal to the Court of Appeals for the Federal Circuit.
Concerta is approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment programme that may include counselling or other therapies.