FTC challenges around 100 FDA Orange Book patent listings

The U.S. Federal Trade Commission (FTC) announced that it issued warning letters to 10 drug manufacturers and challenged the Orange Book listings for around 100 patents under the U.S. Food and Drug Administration's (FDA) administrative dispute process. The patents challenged by the FTC generally are directed to inhaler devices, multidose ophthalmic bottles, and autoinjectors. Under the FDA process, companies named in the letters will have 30 days after FDA sends them the dispute-complaint to withdraw or amend their patent listings, or verify that the listings comply with the law. In September, the FTC issued a policy statement warning that the FTC would be scrutinizing patents listed in the Orange Book. In light of this recent activity, companies should review their Orange Book patent listings, particularly patents covering delivery devices, to determine if any action is needed.

A New Drug Application (NDA) must include patents that claim the drug substance (active ingredient), drug product (formulation or composition), or a method of using the drug for which approval is sought or has been granted, and for which a claim of patent infringement could reasonably be asserted. FDA then lists the patents in the Orange Book for the approved product. Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications must certify to each patent listed for the drug relied upon for approval. The patent certification process, which can result in patent litigation, is linked to the timing of approval of ANDAs and 505(b)(2) applications.

In an unprecedented move, FTC has notified 10 companies that FTC is disputing the listings for more than 100 patents in the Orange Book under FDA’s administrative process as provided in 21 CFR 314.53(f). Under that process, FDA will forward the disputes to the companies, which will have 30 days to withdraw or amend their patent listings, or verify that the listings comply with federal law. FDA views its patent listing role as ministerial and will not make any substantive determinations regarding the patent listings.

Despite its “purely ministerial” role, FDA Commissioner Robert M. Califf has expressed some support for the challenges, saying “FDA reminds all [New Drug Application] holders they are obligated to ensure that patent listings comply with statutory and regulatory requirements and to substantively respond to statements of dispute provided under the FDA’s patent listing dispute process.”

This dramatic new FTC involvement follows a long period of debate, in the courts, and among FDA officials and industry stakeholders, over what types of patents must be listed in the Orange Book, as we recently discussed online here. Center for Drug Evaluation and Research (CDER) regulatory council Jay Sitlani said in October that an internal FDA working group is currently trying to find a way forward on the issue. Sitlani also said FDA does not intend to get involved in substantive patent issues and the responsibility to submit accurate statements that comply with regulatory requirements rests with drug sponsors. In 2020, FDA requested comments from industry regarding what factors the Agency should take into account when determining whether certain drug product patents must be listed in the Orange Book. FDA submitted a report to Congress summarizing the various comments without opining on the substance or outlining objective standards moving forward.

FTC’s warnings come two months after FTC issued a Policy Statement, warning that the agency intended to crack down on "improper" patents listed in the Orange Book. In the September policy statement, FTC raised concerns that some brand drug companies have improperly listed patents in the Orange Book in hopes of thwarting competition from lower-cost generic medicines, and that the FTC has a number of potential legal authorities it could use to challenge those improper listings.

This may be only the first round of FTC warnings and patent challenges. Please do not hesitate to reach out to any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work if you are in need of guidance regarding your Orange Book patent listings.


Authored by Gary Veron, Ilana Kattan, Jason Conaty, and Bryan Walsh


This website is operated by Hogan Lovells International LLP, whose registered office is at Atlantic House, Holborn Viaduct, London, EC1A 2FG. For further details of Hogan Lovells International LLP and the international legal practice that comprises Hogan Lovells International LLP, Hogan Lovells US LLP and their affiliated businesses ("Hogan Lovells"), please see our Legal Notices page. © 2024 Hogan Lovells.

Attorney advertising. Prior results do not guarantee a similar outcome.