In a recent development, the Federal Trade Commission (FTC) has set its sights on inappropriate listings within the Orange Book – a comprehensive list of FDA approved drugs. The FTC announced in its September 2023 policy statement the intention to “scrutinize improper Orange Book listings” and to employ “its full legal authority” in taking decisive actions against both corporations and individuals who fail to adhere to the statutory listing criteria when registering patents.
Reported by Axinn, Veltrop & Harkrider LLP, this move by the FTC represents a marked shift in focus towards enforcing stricter adherence to Orange Book listing regulations.
Following this policy statement, the latest Orange Book update intriguingly did not involve any voluntarily delistings or disputes. This absence may suggest a heightened awareness and compliance among relevant entities in meeting the Orange Book’s patent listing criteria.
In the face of these developments, corporations – particularly those in the pharmaceutical sector – need to be vigilant about ensuring their patent registrations fall squarely within the stipulated requirements. The FTC, with its clearly articulated commitment to crack down on improper listings, has shown that it is no longer willing to let non-compliant practices slide.
Last but not least, while this is certainly a US-centric issue, the implications stretch far and wide. The fact is, the Orange Book is often used as a reference by international bodies, governments, and corporations alike. Thus, these changes in oversight could potentially reshape international patent listing practices and compliance standards.