FTC continues to highlight FDA Orange Book patent listings

FTC’s Amicus Brief

On March 22, 2024, the FTC filed an amicus brief in support of a generic drugmaker that was sued by a brand manufacturer for patent infringement related to an asthma inhaler.2 The generic manufacturer filed antitrust counterclaims alleging that the brand manufacturer improperly listed patents for dose counters and inhaler devices in the FDA’s Orange Book as a way to delay generic entry.

The FTC’s brief reiterates the Commission’s argument that “device patents that do not mention any drug in their claims do not meet the statutory criteria for Orange Book listing, and a device patent that is improperly listed in the Orange Book must be delisted.”3 According to the FTC, improperly listed patents that are the subject of Hatch-Waxman patent infringement litigation can lead to 30-month stays of approval for generic drugs, which allegedly harm patients, hospitals and health plans “both in terms of higher drug prices and patient health.”4 The FTC considers improper Orange Book listings to be part of a “widespread problem, particularly with inhaler device and device components patents.”5

The FTC’s brief follows on the heels of two agency initiatives from late 2023. 

• In September 2023, the agency issued a policy statement to “put market participants on notice” that the FTC would be scrutinizing patents listed in the Orange Book because, in the FTC’s view, improperly listing patents in the Orange Book may constitute illegal monopolization under Section 2 of the Sherman Act as well as an unfair method of competition under Section 5 of the FTC Act. 
• Shortly thereafter, in November 2023, the FTC sent warning letters to ten pharmaceutical companies “challenging more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed” in the Orange Book.  The letters informed the companies that the FTC was disputing certain of their Orange Book patent listings pursuant to the FDA’s administrative process provided in 21 CFR 314.53(f).6

In addition, the FTC’s amicus brief notes that two of the ten warning letters the FTC issued in November 2023 were sent to the brand name manufacturer that is the plaintiff in the subject suit, identifying five of the inhaler patents at issue in the litigation as improperly listed.  The FTC argued that, “[r]ather than heed this warning,” the company recertified the patent listings identified in the warning letters. 

The FDA context

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), the corresponding regulations, 21 CFR 314.53(b) and 21 CFR 314.3, and FDA’s 2003 preamble to the patent listing regulations.  The FTC argues that the statute requires that sponsors list only patents that claim the drug, drug product, or method of using the drug.  According to the FTC, this requirement, in combination with FDA’s regulation defining drug product as the “finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients,” means that a drug product patent must claim the drug substance (i.e., active ingredient) in order to be listed properly in the Orange Book.  The FTC emphasizes a 2003 FDA preamble to a final rule revising the patent listing requirements in 21 CFR 314.53, where FDA explained that a relevant factor in determining whether a drug product patent must be listed is whether it claims the finished dosage form. 

Implications for other pharmaceutical companies

The FTC’s amicus brief suggests that the agency will continue to review Orange Book listings for patents it believes are improperly listed.  In a footnote, the FTC states that the patents identified in its November 2023 warning letters are not “an exclusive or exhaustive list of patents the FTC believes may be wrongfully listed.”  Instead, “all companies have an ongoing responsibility to ensure their listings are lawful.”7 According to the agency, even companies that did not receive a warning letter in November 2023  “should not assume the FTC views their listings as proper.”8

In another footnote, the FTC addresses actions taken by certain recipients of the agency’s warning letters to cap patient out-of-pocket costs for asthma inhalers to $35 per month:  “While the Commission welcomes voluntary reductions in patients’ out-of-pocket costs, doing so is not a substitute for removing improper patent listings, as such listings may delay competition from generics with lower list prices.”9

Most recently, in prepared remarks at a White House event on April 3, 2024, FTC Chair Lina Khan did not mince words regarding the agency’s intention to continue to pursue patents it believes are improperly listed: “ To be clear, we’re not stopping. At the FTC we’re going to keep challenging unlawfully listed patents that block competition from cheaper generic drugs.”10 If you are in need of guidance regarding your Orange Book patent listings, 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.