The U.S. solicitor general urged the U.S. Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs.
Skinny labeling refers to a process in which a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem, but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
This tactic has been a linchpin among generic companies ever since a federal law known as the Hatch-Waxman Act went into effect nearly four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. Skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.
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