Skinny Labels at the Supreme Court—Generic Competition, Patent Inducement, and Affordable Medicines

The skinny label pathway, which allows generic manufacturers to enter the market by omitting patented indications from their labels, is under threat following Federal Circuit decisions in GlaxoSmithKline v. Teva and Amarin v. Hikma, which expanded induced infringement liability to include truthful, FDA-aligned statements and contributed to a sharp drop in skinny labeled generic entries. With Amarin now before the Supreme Court, the authors recommend ways the Court can clarify the skinny label safe harbor, warning that failure to do so risks undermining a cornerstone of the Hatch-Waxman Act and prolonging brand-name drug monopolies.