Supreme Court Authorizes Federal Court Challenges To Pharmaceutical "Use Codes"

In a closely watched case, the Supreme Court has held that generic drug companies may challenge in federal court the “use codes” that brand-name drug manufacturers submit to FDA. Such codes are used to describe the brand company’s patents on methods of using an approved drug. The new ruling clears the way for generics to contest use codes that they contend are broader than the brand’s actual patent coverage, and that block generics from receiving marketing approval through the filing of so-called “section (viii)” statements.

The new ruling is likely to usher in a new area of Hatch-Waxman practice in cases in which the brand company’s use codes are arguably broader than the method of use patents they purport to describe. We are available to discuss the practical impact of this case on your business and future marketing activities.