FTC Renews Campaign to Remove ‘Junk’ Inhaler and Device Patents from Orange Book Listings

Yesterday, the Federal Trade Commission (FTC) sent a series of seven warning letters to several pharmaceutical companies renewing the agency’s challenge to dozens of patent listings in the U.S. Food & Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. The FTC’s redoubled effort to improve consumer access to generic drugs by removing patent listings from the FDA’s list of approved New Drug Applications (NDAs), which continues under the FTC’s new Republican leadership, targets inhaler and drug delivery device patents without addressing decades of calls from the pharmaceutical industry seeking clarity on the guidelines for listing device patents in the Orange Book.

The recent spate of warning letters from the FTC targets 200 patent listings in the Orange Book across 17 NDAs held by:

• Covis Pharma for Tudorza Pressair and Duaklir Pressair
• Teva Branded Pharmaceutical Products for ProAir HFA, ProAir DigiHaler, ProAir RespiClick and QVAR 40 & 80
• Teva Pharmaceutical Industries for AirDuo Respiclick, AirDuo Digihaler, ArmonAir Respiclick and ArmonAir Digihaler
• Amphastar Pharmaceuticals for Baqsimi
• Mylan Specialty for Epipen and Epipen Jr.
• Norton (Waterford) Limited for QVAR RediHaler
• Novartis Pharmaceuticals for Seebri and Utibron

Each of the Orange Book patent listings challenged by the FTC’s recent round of warning letters has previously been targeted by the nation’s competition agency since it first began opposing improper Orange Book listings as an unfair method of competition under Section 5 of the FTC Act back in November 2023, during the Biden Administration. Last May, the FTC sent an additional 10 warning letters to pharmaceutical companies, increasing the total number of Orange Book patent listings challenged to about 400.

CAFC’s Teva v. Amneal Ruling Sets Stage for Larger Effort to Delist Orange Book Patents

The FTC’s warning letter campaign, coming under the leadership of current Republican Chairman Andrew Ferguson, recommences about five months after the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Teva v. Amneal last December affirming the District of New Jersey’s ruling ordering Teva to remove several patent listings from its NDA for the ProAir HFA. The Federal Circuit found that Teva’s listed patents were directed to components of a metered inhaler device rather than the ProAir HFA’s active ingredient, albuterol sulfate, and ruled that a patent must claim the active ingredient to be listed with an Orange Book NDA.

The Federal Circuit’s Teva v. Amneal ruling closely followed the FTC’s reasoning in an amicus brief filed by the agency in that case last March, according to the agency’s recent press release. In that brief, the FTC argued that 21 CFR § 314.3, which defines various terms within the Federal Food, Drug, and Cosmetic Act, requires a patent to claim “a finished dosage form… that contains a drug substance” to qualify as a proper Orange Book patent listing for a drug product. Under the terms of the Hatch-Waxman Act, the assertion of Orange Book-listed patents triggers a 30-month stay on Abbreviated New Drug Applications (ANDAs) covering generic versions of branded pharmaceuticals in NDAs already approved by the FDA. Such delays not only prevent consumers from accessing low cost generics for up to two-and-a-half years, but could constitute illegal monopolization under Section 2 of the Sherman Act by foreclosing competition regardless whether the Orange Book-listed patent is valid or infringed.

Although the Federal Circuit’s ruling in Teva primarily deals with the meaning of provisions under the Hatch-Waxman Act and doesn’t reach much of the FTC’s arguments under antitrust law, the FTC lauded the decision as an important step in lowering inhaler product costs for U.S. consumers. The FTC’s statement from last December also noted that the Federal Circuit’s ruling sets the stage for the removal of many “junk listings” on critical medications, an early harbinger of the FTC’s renewed efforts in the Trump Administration.

Despite the FTC’s characterization of its warning letter campaign as improving market access to generic drugs, several industry stakeholders have noted that the FDA’s long inability to clarify listing guidelines is a major contributor to this problem. The FDA’s silence in the face of calls from pharmaceutical companies over 20 years to clarify listing requirements related to delivery device patents was the subject of a letter sent last September to the FDA by Senator Bill Cassidy (R-LA), who denounced the FDA’s inaction as untenable. Representatives from industry groups like the Biotechnology Innovation Organization (BIO) have previously pointed out that these drug delivery patents remain enforceable even when delisted from the Orange Book. As a result, the FTC’s letter campaign could potentially result in protracted infringement litigation in U.S. district court outside the statutory timelines of the Hatch-Waxman Act, increasing costs for generic drugmakers that are ultimately borne by the American consumer.