Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/s — Sotomayor, J., Concurring

Summary

Justice Sotomayor concurred in the judgment and the Court’s judgment, agreeing that the counterclaim provision should be read to allow generic manufacturers to force correction of inaccurate use codes. She reasoned that this interpretation is the most sensible given the regulatory scheme but warned that the counterclaim cannot fully fix delays caused by overly broad codes. She noted the FDA’s guidance is opaque, leading brands to comply with confusing regulations, and emphasized the fix must come from Congress.