On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The Commission has notified FDA that it disputes the accuracy or relevance of the listed information for the targeted patents. Once FDA receives the dispute notice, it will send the statement of dispute to the New Drug Application holder, who will then have 30 days to withdraw or amend the listings or certify under penalty of perjury that the listings comply with the applicable statutory and regulatory requirements.

This enforcement action follows the Commission’s release of a policy statement concerning improper listing of patents in the Orange Book in September 2023. There, the Commission stated that improper Orange Book listings harm competition in pharmaceutical markets by delaying generic and follow-on product entry. Specifically, the Commission alleges that by improperly listing a patent in the Orange Book and timely filing an infringement suit, a branded drugmaker can rely on the automatic 30-month stay to block FDA’s approval of a competing drug product regardless of the validity or scope of the patent and regardless of whether the patent meets the statutory listing criteria. The Commission maintains that improper Orange Book listings may constitute an unfair method of competition.

While the Commission’s current enforcement action is limited to disputing the Orange Book listings using FDA’s regulatory dispute process, it also notified the targeted patent holders that it retains the right to pursue additional enforcement actions, including investigation for unfair methods of competition under Section 5 of the FTC Act.

Lina Khan, chair of the FTC, was interviewed by NPR the day following the announcement. Khan stated: “[W]e have found that firms are listing device patents that have absolutely nothing to do with the active ingredient, so patents that are instead covering the dispenser cap on a multidose eye dropper or the cap strap on an inhaler, which just keeps the inhalers in place. And so we've identified patents covering these components of devices that we think are improperly [listed]...”

We are monitoring the FTC’s enforcement actions closely and will provide further updates and insights as they become available.