On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug Administration (FDA) that the Commission is disputing 300 allegedly “improper or inaccurate” patent listings in the FDA Orange Book. The patents in this latest round of warning letters consist of device-directed patents for 20 different brand name drug/device combination products to treat diabetes, weight loss, asthma, and COPD.
FTC touts continued effort to target so-called “bogus” and “junk” Orange Book patent listings
The new warning letters are the latest salvo in the FTC’s expanded “campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents” in the Orange Book. So far, the FTC has not brought a challenge under Section 5 of the FTC Act – as it has threatened – but has disputed certain Orange Book patent listings pursuant to the FDA’s administrative process provided in 21 CFR 314.53(f).1 The campaign was launched with a September 2023 FTC policy statement that “put market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.”
As outlined in a previous alert on this issue, the FTC’s argument that the patents are improperly listed in the Orange Book relies on the language of the statute, 21 USC 355(b)(1)(A)(viii), and the corresponding regulations, 21 CFR 314.53(b) and 21 CFR 314.3. The FTC argues that these, in conjunction with a 2003 FDA preamble to a final rule revising the patent listing requirements in 21 CFR 314.53, make clear that a relevant factor in determining whether a drug product patent must be listed is whether it claims the finished dosage form, which includes – as one component – the drug substance. In turn, the FTC argues that the patent must claim the “active ingredient” in the product in order to be properly listed.
To date, the FTC claims to have disputed more than 400 Orange Book patent listings filed by pharmaceutical companies. Nearly half of the companies had already received warning letters from the agency, as the FTC previous sent warning letters in November 2023 as part of the Commission’s first tranche of disputes (targeting patents listed for specific asthma and other inhaler devices, multidose bottles, and autoinjectors). In a press release announcing the latest tranche of patent listing disputes, the FTC highlighted specifically its disputes of so-called “junk patent listings” for “blockbuster” weight loss medications.
Looking ahead
To date, the FTC’s Orange Book patent disputes have been limited to patents generally directed to a device component of a drug-device combination product, with a focus on inhalers and pens/autoinjectors. The FTC has focused exclusively on patents with a “drug product” claim in particular, and has yet to dispute any other type of Orange Book-listed patent, e.g., a patent that claims an approved “method of use.” Sponsors seeking to conduct an audit of current Orange Book-listed patents should contact any of the authors of this alert or the Hogan Lovells US LLP attorney with whom you typically work.
References
1 Under this process, the 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.
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