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.