TITUSVILLE, N.J., Oct. 16 (UPI) -- A U.S. court in New Jersey has upheld a Janssen LP patent for Risperdal, a drug used for treating schizophrenia, bipolar disorder and irritability.
U.S. District Court Judge John C. Lifland's injunction prohibits Mylan Pharmaceuticals Inc. and Dr. Reddy's Laboratories Ltd. from selling their proposed generic risperidone products in the United States until the Janssen patent on Risperdal expires next year, Janssen said Monday.
Lifland's ruling 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 Dec. 29, 2007, Risperdal patent expiration.
The patent infringement complaint was filed by Janssen in December 2003 and claimed that Mylan and Dr. Reddy's generic products infringed the Risperdal patent -- a charge that Mylan and Dr. Reddy did not dispute at trial. Two additional suits against Dr. Reddy's for its orally disintegrating risperidone tablet, filed in February 2005 and November 2005, were consolidated in this trial.