Republican FTC renews challenges to Orange Book patent listings

The FTC submitted contemporaneous patent listing dispute communications to the FDA regarding the patents identified in each of its warnings.¹  FDA will forward those disputes to the relevant drug manufacturer, which will then have 30 days to withdraw or amend their patent listings, or verify that the listings comply with federal law.²  FDA generally has viewed its patent listing role as ministerial and is not expected to make any substantive determinations regarding the patent listings.

Republican FTC continues to mirror antitrust enforcement policies of its Democratic predecessor 

The renewed challenges pertain to more than 200 patent listings in the “Approved Drug Products with Therapeutic Equivalence Evaluations,” known as the “Orange Book.”³  The relevant patents include claims generally directed to device components of drug-device combination drugs and relate to brand-name asthma, diabetes, epinephrine autoinjector, and COPD drugs.  The FTC’s concern is that allegedly improperly listed patents that are the subject of Hatch-Waxman patent infringement litigation can lead to 30-month stays of approval for generic drugs, and thereby can “delay generic alternatives from entering the market, keeping drug prices artificially high and preventing patients from accessing lower cost drugs.”⁴

The FTC originally challenged the Orange Book listings for this category of patents in November 2023 and April 2024,⁵ which led to the delisting of patents from the Orange Book for 22 brand-name products.  In a May 21, 2025 press release announcing the renewed challenges, the FTC said that the re-issued warning letters relate to “patent listings that remain listed on the FDA’s Orange Book despite the FTC’s previous challenges . . . .”⁶  Notably, while the November 2023 and April 2024 warning letters stated that the FTC had “opted to use the FDA’s regulatory dispute process to address the improper listings” and that the FTC “retain[s] the right to take any further action the public interest may require” including investigating the conduct under Section 5 of FTC Act, the new warning letters refrain from suggesting that the FTC may take other action if the companies do not delist their patents.⁷

Further, the May 2025 warning letters cite to a December 2024 ruling by the U.S. Court of Appeals for the Federal Circuit that affirmed a lower court decision requiring a pharmaceutical company to delist five Orange Book patents generally directed to dose counters and inhaler devices.  In response to patent infringement claims brought against a generic drug company by the brand manufacturer, the generic manufacturer filed antitrust counterclaims, alleging that the brand manufacturer improperly listed patents for these devices in the FDA’s Orange Book as a way to delay generic entry, in addition to counterclaims under the Hatch-Waxman Act seeking delisting of the patents.  

In March 2024, the FTC—under the leadership of former Democratic Chair Lina Khan—filed an amicus brief in the District Court for the District of New Jersey in support of the generic manufacturer’s antitrust claims.  The FTC says that the Federal Circuit’s December 2024 decision “finding that the patents were improperly listed, consistent with [the] amicus brief filed by the FTC” supports the agency’s decision to issue renewed warning letters to the brand manufacturers.  The Federal Circuit’s decision, however, does not address the antitrust counterclaims, which remain pending before the District Court.  Therefore, the FTC’s assertion that the Federal Circuit decision supports its challenges to the Orange Book patent listings is not correct as to whether such listings “may harm competition and delay generic drug entry.”⁸

Looking ahead 

In his statement concerning the renewed challenges, Chair Ferguson cites the harm to “everyday Americans” that the allegedly improper listings pose, echoing themes that have been a hallmark of the second Trump administration.  The original warning letters issued by the Biden FTC represented, at the time, an unprecedented effort by the agency to challenge Orange Book patent listings.  The current FTC’s decision to continue to pursue these challenges demonstrates that the enforcement agenda of the current Republican-led agency will continue to resemble that of its Democratic predecessor, even when it comes to advancing novel theories of harm that we would not expect to see promoted as part of a more traditional conservative enforcement agenda.

Authored by Chuck Loughlin, Gary Vernon, Jason Conaty, Ilana Kattan, Bryan Walsh, and Jill Ottenberg.