Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s

Summary

The Supreme Court reversed the Federal Circuit, holding that a generic drug manufacturer can use a statutory counterclaim to compel a brand-name manufacturer to correct an inaccurate use code that improperly indicates a patent covers methods of use it does not claim. The Court interpreted the Hatch-Waxman Amendments to allow this correction even when the patent covers at least one approved method of use, provided the generic seeks to market for other methods. Justice Sotomayor concurred, noting the remedy may not fully restore the statutory scheme's efficiency.