FTC Statement on Appellate Court Decision Ordering Delisting of Teva Inhaler Patents

Today, the U.S. Court of Appeals for the Federal Circuit affirmed a lower district court order against pharmaceutical maker Teva requiring the drugmaker to delist several asthma inhaler patents from the Food and Drug Administration’s (FDA) Orange Book.

The appellate court order stems from a case brought by Teva against drugmaker Amneal after Amneal sought FDA approval to bring a generic version of the asthma inhaler ProAir HFA to market. The FTC had previously submitted amicus briefs in this case, with both the appellate and district courts, urging the delisting of Teva’s patents because they are improperly listed in the FDA’s Orange Book, which can ultimately harm competition by delaying or deterring the entry of cheaper generic products. The FTC also previously challenged Teva’s inhaler patents via the FDA’s Orange Book dispute process, as well as hundreds of other similar device patent listings by major pharmaceutical manufacturers—including other companies’ inhaler listings as well as listings on epinephrine autoinjectors and diabetes and weight loss drugs.

In response to the appellate court’s decision ordering the delisting, Hannah Garden-Monheit, Director of the FTC’s Office of Policy Planning, issued the following statement:

“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 a list of drug products approved by the FDA as safe and effective. When a brand pharmaceutical company lists a patent in the Orange Book, it may lead to a statutory stay that generally blocks the introduction of competing drug products for 30 months, including lower-cost generic alternatives. Listing patents in the Orange Book may negatively affect competitive conditions if listings are improper, as defined by law.

In September 2023, the FTC also issued a policy statement that warned that the agency would be scrutinizing the improper submission of patents for listing in the Orange Book. The Commission said improper listings in the Orange Book may harm competition from cheaper generic alternatives and keep brand prices artificially high.