STAT+: U.S. Supreme Court declines to hear ‘skinny labeling’ case with implications for generic drug access
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.
