Client and generic pharmaceutical manufacturer Amneal Pharmaceuticals secured a precedential patent law victory in the U.S. Court of Appeals for the Federal Circuit in an outcome that could benefit many more generic drug companies. Procopio IP Litigation Partner Steve Maddox argued the case, supported by Jeremy Edwards, Brett Garrison and Tina Priestly of the Washington, DC office.  The Federal Circuit upheld a lower court decision finding that asthma inhaler device patents held by Teva Pharmaceuticals were improperly listed in the U.S. Food and Drug Administration’s Orange Book, a status that provides the patent holder extensive protections.

Amneal had challenged five listed Teva device patents after being sued for infringement for its generic inhaler. The Federal Circuit agreed they should not be included in the Orange Book, as they covered device components but not the key active ingredient. This decision clears a path for Amneal’s product and also creates opportunities for similar challenges to other Orange Book listed patents.

The U.S. Federal Trade Commission had supported Amneal’s challenge to the FDA’s Orange Book listings, noting a broad use of the Orange Book unnecessarily delays approval of competing generics. The FTC has challenged the listings of more than 300 device patents listed by other pharmaceutical companies, calling them “junk listings.”

Learn more in an article by Ryan Davis in Law360.