The U.S. Supreme Court issued its decision in Caraco v. Novo Nordisk, holding that Hatch-Waxman permits generic drug companies to counterclaim to force correction of a use code that inaccurately describes the brand company’s patent as covering a particular method of using the drug in question. While the case centered on an issue of statutory wording, the Court’s decision depended upon the broader context of the Hatch-Waxman Act. In supporting its decision, the Court emphasized that “[t]he statutory scheme, in other words, contemplates that one patented use will not foreclose marketing a generic drug for other unpatented ones.”

BACKGROUND

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 giving generic manufacturers a means by which to challenge the scope of a brand company’s broadly drafted patent use code narrative designed to impede approval of generic drug applications.