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Watson Wins Ruling Over Reckitt’s Patent Claims on Mucinex

Watson Pharmaceuticals Inc. won an appeals court ruling that clears a hurdle in the company’s effort to sell a generic version of Reckitt Benckiser Group Plc’s Mucinex cough medicine.

Watson’s version of the drug wouldn’t infringe a patent owned by Reckitt, the U.S. Court of Appeals for the Federal Circuit in Washington said today. The court upheld a trial judge’s ruling, saying Reckitt’s patent requires multiple layers of the sustained-release formula for Mucinex tablets, while Watson’s version is made with a single layer.

“We are carefully reviewing the decision to determine our next steps,” said Caroline Hey, a spokeswoman for Reckitt.

Watson still needs U.S. Food and Drug Administration approval to sell a copy of Mucinex, Mucinex D and Mucinex DM. The medicines generated about $500 million in U.S. sales last year for Slough, England-based Reckitt, Watson said in February, citing researcher IMS Health Inc.

“We’re pleased with the decision and are awaiting final approval from the FDA,” said Charlie Mayr, a spokesman for Parsippany, New Jersey-based Watson.

The active ingredient in Mucinex, guaifenesin, has been on the market since 1952. The Reckitt patent is for an extended release formula of the chemical compound. Reckitt got Mucinex as part of its 2008 purchase of Adams Respiratory Therapeutics Inc.

The case is Reckitt Benckiser Inc. v. Watson Laboratories Inc. Florida, 2011-1231, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Reckitt Benckiser Inc. v. Watson Laboratories Inc., 09cv60609, U.S. District Court for the Southern District of Florida (Ft. Lauderdale)

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