The U.S. Court of Appeals for the Federal Circuit has upheld (20 December) a district court ruling requiring Teva Pharmaceuticals to delist several asthma inhaler patents from the FDA’s Orange Book. The decision, tied to a case brought by Teva against Amneal Pharmaceuticals over the generic version of ProAir HFA, aligns with the Federal Trade Commission’s (FTC) efforts to combat improper patent listings that hinder competition and delay lower-cost generics.
FTC’s Role and Response
The FTC actively participated in the case, filing amicus briefs advocating for the delisting of Teva’s patents. It has also challenged similar “junk” patents across various pharmaceutical categories, including inhalers, epinephrine autoinjectors, and diabetes medications.
Hannah Garden-Monheit, FTC Director of Policy Planning, welcomed the decision:
“This ruling ensures fair competition and paves the way for more affordable asthma inhalers and other critical medications.”
The Impact of Orange Book Listings
The FDA’s Orange Book catalogs patents for approved drugs. Improper listings can delay generic alternatives by up to 30 months, keeping prices high for consumers.
In 2023, the FTC issued a policy statement warning against improper patent submissions to the Orange Book, signaling heightened scrutiny on practices that suppress competition and inflate drug costs.
This decision represents a significant step toward removing barriers to generic drug market entry, ensuring more affordable options for consumers.
