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This article was originally published in The Tan Sheet

Executive Summary

Drug patents should not be listed in Orange Book by FDA if they claim unapproved aspects of a drug, commission suggests in May 16 citizen petition to agency. "Any patent claiming only an unapproved component, an unapproved formulation or an unapproved use of a drug product" should not be allowed in Orange Book, FTC says. Petition comes in response to complaints from generic drug manufacturers that innovator companies are filing large numbers of late-listed patents to thwart private label competition. FTC is conducting an inquiry into this and other anticompetitive practices in drug industry (1"The Tan Sheet" Oct. 16, 2000, p. 13)
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