District Court Upheld Risperdal Patent

Judge John C. Linfland of the U.S. District Court for the District of New Jersey has upheld the validity and enforceability of Janssen key U.S. Patent # 4,804,663 (the ‘663 patent) for Risperdal, generically known as Risperidone, used to treat schizophrenia, bipolar mania, and irritability in autistic children. The Injunction prohibits Mylan Pharmaceuticals Inc. and Dr. Reddy’s Laboratories Ltd. from selling their proposed generic risperidone products in the U.S. until the Janssen patent on Risperdal expires next year. The judge also directs the Food and Drug Administration to change the effective date of Mylan’s tentative approval to market its generic risperidone tablets to no earlier than the December 29, 2007 when the ‘663 patent expires. The lawsuit was result of Janssen patent infringement complaint in 2003, contending that Mylan and DRL proposed generic products infringed the ‘663 patent – a charge that Mylan and DRL did not dispute at trial. Two additional suits against DRL for its orally disintegrating risperidone tablet, filed in February 2005 and November 2005, were consolidated in this trial. Risperdal generated sales of about US $ 3 billion in 2005.