Judge in Patent Case Won’t Let J&J Block Caraco Painkiller

By SUSAN DECKER, Bloomberg News

Johnson & Johnson’s Ortho-McNeil Pharmaceutical unit lost a bid to block Caraco Pharmaceutical Laboratories Ltd. from receiving regulatory approval for a generic version of the painkiller Ultracet.

U.S. District Judge George Caram Steeh, sitting in Detroit, ruled Oct. 19 that Caraco’s version of Ultracet doesn’t infringe a Johnson & Johnson patent. Ultracet combines acetaminophen, the main ingredient in Johnson & Johnson’s Tylenol, with tramadol hydrochloride, a compound used in the painkiller Ultram.

Caraco, which still needs U.S. Food and Drug Administration approval before it sells generic Ultracet, would be the third company to enter the market. Par Pharmaceutical Cos. began sales in April without waiting for a court ruling, and J&J signed an agreement to let Ivax Corp. sell an unbranded version of the drug.

“We believe our patent is valid and enforceable and is infringed by Caraco and we intend to appeal the decision,” said Marc Monseau, spokesman for New Brunswick-based J&J.

This is the first time Caraco has filed a patent challenge to a brand-name medicine, said spokesman Mike Marcotte. The Detroit- based company usually makes only generic versions of drugs that have no patent protection.

This is the first ruling on J&J’s patent, he said. Par and Teva Pharmaceutical Industries Ltd., the world’s biggest generic-drug company, are awaiting a ruling on a similar case in New Jersey.

J&J had sought a court ruling to block approval of Caraco’s application until the patent expires in August 2011.