J&J Wins Appeal Reviving Patent on Ultracet Drug

Johnson & Johnson won an appeals court ruling that it can try to use its patent on the Ultracet painkiller to block generic-drug makers including Teva Pharmaceutical Industries Ltd. from selling copies of the drug.

The U.S. Court of Appeals for the Federal Circuit in Washington overturned a finding that the patent was invalid and sent the case back to a lower court for trial. The court did affirm that one aspect of the patent was invalid.

Teva’s Barr unit and Caraco Pharmaceutical Laboratories Ltd. have been selling copies of the medicine for more than three years. New Brunswick, New Jersey-based J&J, the world’s largest health-products company, was trying to get the generic medicines pulled from the market.

Ultracet combines acetaminophen, the main ingredient in Johnson & Johnson’s Tylenol, with tramadol hydrochloride, a compound used in the painkiller Ultram. The patent, which expires in August 2011, covers the ratio between the two components.

The Federal Circuit, in a 2-1 ruling, said there were “material questions of fact” as to whether the combination would have been obvious to researchers. Circuit Judge Haldane Robert Mayer disagreed, saying the patent “does nothing more than combine two well-known pain relievers” into a single tablet.

‘Pleased With Decision’

Johnson & Johnson is “pleased with the decision and looks forward to the additional court proceedings,” said Greg Panico, a spokesman for the company.

Teva spokeswoman Denise Bradley declined to comment, and a representative for Caraco didn’t immediately return a call seeking comment.

Detroit-based Caraco is owned by Sun Pharmaceutical Industries Ltd. of Mumbai. Teva, based in Petah Tikva, Israel, is the world’s biggest generic-drug maker.

The case is Ortho-McNeil Pharmaceutical Inc. v. Teva Pharmaceutical Industries Ltd., 2008-1549 and 2008-1550, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Ortho-McNeil Pharmaceutical Inc. v. Kali Laboratories Inc., 6cv3533, U.S. District Court for the District of New Jersey