After months of anticipation, the U.S. Supreme Court declined to hear an appeal of a lower court ruling that throws into question whether generic companies can “carve out” uses for their medicines and supply Americans with cheaper alternatives to brand-name drugs.
At issue is skinny labeling, which happens when 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 the Hatch-Waxman Act went into effect nearly four decades ago. The federal law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.