Caraco Pharmaceutical Laboratories, Ltd. has confirmed that the US Federal Court of Appeals for the Federal Circuit in Washington upheld the United States District Court for the Eastern District of Michigan ruling that Caraco does not infringe Ortho-McNeil Pharmaceutical, Inc.'s US Patent No. 5,336,691.
Caraco's Tramadol with Acetaminophen is the generic equivalent of Ortho McNeil's analgesic, Ultracet. The company commenced shipment of Tramadol with Acetaminophen on December 19, 2005, following the FDA's approval to manufacture market and distribute the generic product.
Daniel H Movens, CEO, commented, "We were confident of our position and are gratified that the Federal US court of appeals supported the ruling of the eastern district court of Michigan that we do not infringe. We have continued to market Tramadol with Acetaminophen since the FDA approved our product as a generic version of Ultracet."
On September 22, 2004, Ortho-McNeil filed a complaint in the US district court for the eastern district of Michigan alleging that Caraco's filing of an ANDA seeking approval to market its generic version of Ortho- McNeil's Ultracet infringed Ortho-McNeil's patent, which expires on September 6, 2011. Ortho-McNeil sought an order from the district court which, among other things, directed the FDA not to approve Caraco's ANDA any earlier than the claimed expiration date.
The ANDA filed by Caraco contained a paragraph IV certification challenging the Ortho-McNeil patent. On October 8, 2005, arguments were heard in the US district court for the eastern district of Michigan on the Caraco's motion for summary judgment on the issue of non-infringement. On October 19, 2005 the motion for summary judgment was granted in Caraco's favour.
Although the district court has determined that Caraco does not infringe Ortho-McNeil's original patent, on July 31, 2006, Ortho-McNeil filed a lawsuit against Caraco in the US district court for the district of New Jersey, alleging that Caraco's generic version of Ultracet infringes its reissue patent Number RE39221. On September 26, 2006, Caraco filed an Answer denying, among other things, that its generic product infringes any valid claims of Ortho-McNeil's reissue patent. The Corporation believes that, like its original patent, Ortho- McNeil's reissue patent is invalid and/or is not infringed by Caraco's manufacture, use or sale of the product and the Corporation intends to vigorously defend this action.