Oral arguments were presented yesterday to the U.S. Supreme Court in Caraco v. Novo Nordisk. While the case centers “simply” on an issue of statutory interpretation, the Court’s decision will define another chapter in the saga of brand versus generic pharmaceutical manufacturers under the Hatch-Waxman Act.

WHY TO WATCH THIS CASE

The complex regulatory framework of the Hatch-Waxman Act is designed to strike a delicate balance between innovation and competition in the pharmaceutical industry. The Supreme Court’s decision in Caraco v. Novo Nordisk will have an important impact on that balance by either permitting patent holders to expand patent use code narratives in a manner that could impede approval of generic drug applications, or giving generic manufacturers a means by which to challenge the scope of patent use code narratives.