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Bristol-Myers’ tactics, and those of its colleagues are increasingly coming under fire. For the past year, the Federal Trade Commission has been investigating whether listing secondary patents with the Food and Drug Administration is anticompetitive. On April 23, the agency announced its first complaint against a drug maker for listing a patent with the FDA with the intention of blocking generic competition. The order prohibits any action by Biovail Corp. that would stop the sale of a generic version of Biovail’s angina and hypertension drug, Tiazac. It also prohibits Biovail from wrongfully listing patents in the Orange Book in the future. Congress is stepping in, too. Last year New York Sen. Charles Schumer and Arizona’s John McCain sponsored The Greater Access to Affordable Pharmaceuticals Act. The proposed law would revise the 1984 Hatch-Waxman law. It eliminates the automatic 30-month stay that goes into effect when a drug company sues a generic for infringement. If a brand name drug manufacturer wanted to keep an allegedly infringing generic from coming onto the market, it would have to go to court for a preliminary injunction. The act also allows generic drug makers to seek declaratory judgments on any patents listed in the Orange Book. Though hearings on the bill have been scheduled, even its advocates concede that passage is a long shot. For now, antitrust lawsuits like Mylan’s seem to be the most promising tactic.

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