The U.S. Court of Appeals for the Federal Circuit has upheld a district court's decision requiring Teva Pharmaceuticals to remove several asthma inhaler patents from the FDA's Orange Book. This ruling follows a case initiated by Teva against Amneal Pharmaceuticals, which sought FDA approval to market a generic version of ProAir HFA, an asthma inhaler.
The Federal Trade Commission (FTC) had previously submitted amicus briefs in support of delisting these patents, arguing that their presence in the Orange Book was improper and could hinder competition by delaying or preventing the introduction of cheaper generic drugs. The FTC also challenged Teva's inhaler patents through the FDA’s Orange Book dispute process and targeted similar listings by other pharmaceutical companies, including those for epinephrine autoinjectors and diabetes and weight loss medications.
Hannah Garden-Monheit, Director of the FTC’s Office of Policy Planning, expressed satisfaction with the appellate court's decision: “We are pleased the court agreed with the FTC that these improper inhaler patent listings must be wiped from the Orange Book. Removal of junk patent listings is critical to ensuring drugmakers can fairly compete to offer generic drugs at a lower price for consumers. This decision is important not only for lowering asthma inhaler costs, it also sets the stage for removal of junk listings on a range of other critical medications where junk device listings impede competition.”
The Orange Book is an FDA-approved list of safe and effective drug products. When patents are listed here by brand pharmaceutical companies, it can result in a statutory stay that blocks competing drug products' entry into the market for 30 months, including more affordable generics. Improper patent listings can thus negatively impact competitive conditions.
In September 2023, the FTC issued a policy statement indicating its intent to scrutinize improper patent submissions for listing in the Orange Book. The agency warned that such actions could harm competition from less expensive generics and maintain high brand prices artificially.
The Federal Trade Commission continues to develop policies affecting competition, consumers, and the U.S. economy while providing resources like consumer alerts and business blogs.
