The Federal Trade Commission announced on November 7, 2023, that it has challenged more than 100 patents held by brand-name drug manufacturers as improperly listed in the FDA's Orange Book, targeting drug delivery devices for critical medications including asthma inhalers and epinephrine autoinjectors. The enforcement action represents the FTC's most aggressive move yet to address what it views as anticompetitive patent listing practices that artificially inflate drug prices.
Scope of FTC Challenge
The Commission sent notice letters to 10 major pharmaceutical companies, including AbbVie, AstraZeneca, Boehringer Ingelberg Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of GlaxoSmithKline and Teva. The challenges implicate 62 unique patents and 18 FDA-approved products, specifically targeting patents for asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors commonly known as EpiPens.
"Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition," said FTC Chair Lina M. Khan. "The FTC's action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens."
Patent Listing Requirements and Disputes
Under the Hatch-Waxman Act, brand manufacturers must submit for Orange Book listing any patent that claims the drug for which they submitted an application, including drug substance patents, drug product patents, or patents claiming methods of using the drug. However, FDA regulations explicitly prohibit submission of process patents, packaging patents, patents claiming metabolites, and patents claiming intermediates.
An independent review of the patents identified in the FTC letters revealed that all challenged patents are related to drug delivery devices, including liquid eye-drop dispensers, inhalers, and injectors. While all patents are indicated in the Orange Book to cover drug products, none have claims that recite the specific drug contained in the product, though some include dependent claims that recite classes of drugs.
Regulatory Response Process
Under FDA's patent listing dispute process, companies receiving FTC notice letters have 30 days to withdraw or amend these listings, or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements. When patent listings are disputed consistent with FDA regulations, the agency sends the statement of dispute to the New Drug Application holder for response.
"The FDA reminds all NDA 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," said FDA Commissioner Robert M. Califf, M.D.
Competitive Impact and Market Access
When a brand pharmaceutical company lists a patent in the Orange Book, it may trigger a statutory stay that generally blocks introduction of competing drug products for 30 months, including lower-cost generic alternatives. According to the FTC's policy statement, costs associated with challenging improperly listed patents can disincentivize investments in developing generic drugs, potentially delaying or preventing competitive generic alternatives.
The FTC noted that delays in generic competition, even if brief, can reduce patient access to more affordable alternatives and increase costs across the entire healthcare system. Last month, the Commission issued a policy statement warning that it would scrutinize improper patent submissions for Orange Book listing, stating that such listings may harm competition from cheaper generic alternatives and keep brand prices artificially high.
Ongoing Regulatory Uncertainty
Despite numerous requests from pharmaceutical companies for FDA guidance on drug delivery device patents, the agency has provided no formal clarification on whether such patents can be properly listed in the Orange Book. Brand manufacturers have submitted multiple requests for Advisory Opinions from FDA explicitly seeking determinations about drug delivery patent listings, but these requests remained pending for years before FDA declined to provide clarity in June 2020.
Following the Orange Book Transparency Act of 2020, FDA solicited public comments on whether drug delivery patents should be included in or removed from the Orange Book. In a recent report to Congress, FDA stated it "will create a multidisciplinary working group" to address these comments in line with existing statutory requirements, but has not published further guidance on the appropriateness of listing drug delivery device patents.
A senior FTC official indicated that the November challenges represent just the beginning of broader enforcement efforts, stating that "the lists we identified in those letters weren't exhaustive" and promising continued review of patent listings across a wide array of products.
