Starting the Conversation: The Need for a Pre-Launch “Skinny Labeling” Dispute Resolution System

Since Congress adopted the Hatch-Waxman Act in 1984, generic drug manufacturers have been able to come to market while certain uses of brand-name drugs are still patented by “carving out” the patented uses from their labeling. For example, suppose a brand-name drug is used to treat both tonsillitis and strep throat, but the drug company has patented only the specific method of using its drug to treat only strep throat. In this scenario, a generic manufacturer can still sell a generic version of the drug, but only for the non-patented use of tonsillitis treatment. To do this, the generic manufacturer would “carve out” all descriptions and references to the patented use of treating strep throat from the drug’s labeling—a process known as “skinny labeling”—and leave only the non-patented use.