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Mylan Laboratories Inc. was dealt a setback by a federal judge who ruled that the Food and Drug Administration violated no law in rejecting the pharmaceutical giant’s application for a pain medication patch. The announcement by Mylan that it would sue the FDA in late June sent the company’s stock tumbling 7 percent in one day. The company also suspended its annual earnings guidance. Mylan, based outside Pittsburgh, said it would appeal the decision by the U.S. District Court for the District of Columbia. Mylan has a separate appeal pending before the U.S. Court of Appeals for the Federal Circuit. In the ruling, the judge wrote that statutes “do not provide clear answers” and that the court would defer to the FDA’s interpretation. Mylan chief executive Robert Coury said the FDA has diminished the ability of generic companies that want to challenge patents nearing expiration. “We are disappointed with the ruling because we continue to believe, as we said in June, that the FDA acted contrary to several sections of the Food, Drug and Cosmetic Act,” he said. The FDA in June rescinded its approval for the introduction of Mylan’s generic fentanyl transdermal patch, saying that Janssen Pharmaceutica Products LP should maintain exclusive rights to sell its Duragesic patch for another six months. Janssen, based in Titusville, N.J., is a subsidiary of Johnson & Johnson. The FDA had granted approval for Mylan’s patch on Nov. 21, but a federal court in Vermont ruled that Mylan’s version of the drug would violate a patent held by ALZA Corp., another Johnson & Johnson subsidiary. Mylan received the go-ahead from the FDA on Nov. 21 because ALZA did not challenge Mylan’s application within 45 days, which statutes require. The patent would have expired in July, but federal law gives companies another six months of exclusivity if they run pediatric clinical trials on the drug. Mylan is challenging that extended period of exclusivity because ALZA replied to Mylan’s application on the 46th day, one day after the 45-day period allowed by law. Mylan shares were up 11 cents in trading Wednesday to $15.47, but still down sharply from six months ago. The most precipitous decline occurred on July 26, when Mylan announced it was buying King Pharmaceuticals Inc. in an all-stock deal that was worth $4 billion at the time. That price tag has decreased along with Mylan’s shares. Industry analysts said they were not surprised by the court ruling. “The fact that Mylan seemingly found a genuine loophole within the regulations has proved to be of little value,” said Manoj Garg of American Technology Research. Mylan said it expects a hearing on its appeal on the Vermont court ruling as early as October. Copyright 2004 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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