The Supreme Court on Wednesday will hear oral arguments about a simmering controversy over a wonky but important topic called skinny labels, which will be closely watched for its implications for the availability of generic medicines.
Skinny labeling refers to moves by generic companies that seek regulatory approval to market a 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 key tool for generic companies ever since the Hatch-Waxman Act was signed into law more than four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling, which amounts to a carve-out tactic, is one way that Congress attempted to foster more competition and benefit consumers.
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