The Federal Trade Commission's ambitious campaign to challenge pharmaceutical patent listings in the FDA's Orange Book has yielded limited results nearly a year after its launch, with the overwhelming majority of targeted patents remaining listed despite agency warnings about anticompetitive practices.
FTC Policy Statement Targets "Improper" Listings
In September 2023, the FTC issued a policy statement declaring that improper pharmaceutical patent listings in the Orange Book may constitute unfair methods of competition under Section 5 of the FTC Act. The agency argued that inappropriate listings could prevent generic manufacturers from launching competing products due to automatic stays that block FDA approval during patent disputes.
The Orange Book, formally known as FDA Approved Drug Products with Therapeutic Equivalence Evaluations, serves as the official registry of approved drugs and their associated patent protections. Under the Hatch-Waxman Act framework, generic manufacturers must navigate these listings when seeking to challenge patents through Paragraph IV certifications, which can trigger 30-month regulatory stays if brand manufacturers file infringement suits.
Scope of FTC Challenges Expands
Following its initial policy statement, the FTC announced challenges to more than 100 Orange Book listings in November 2023, followed by an additional 300 listings in April 2024. The agency has primarily targeted device patents that do not mention specific drug substances in their claims, arguing these fail to meet statutory criteria for Orange Book inclusion.
The FTC's focus has centered on respiratory medications, diabetes treatments, and weight loss drugs, with particular attention to inhaler device patents. The agency contends that patents covering delivery devices rather than drug formulations themselves should not receive Orange Book protection.
Limited Voluntary Compliance
Despite the FTC's warnings, only three pharmaceutical companies have voluntarily delisted patents in response to the challenges. GlaxoSmithKline removed patents related to Anoro Ellipta, Trelegy Ellipta, Arnuity Ellipta, and Ventolin HFA. Glaxo Group delisted patents for Advair HFA, Flovent HFA, Incruse Ellipta, and Breo Ellipta. Kaléo voluntarily removed listings for its AUVI-Q and naloxone products.
The financial implications of these delistings are substantial. The GSK products subject to voluntary delisting generated approximately $2.5 billion in North American revenue in 2023, with Trelegy Ellipta alone accounting for $1.756 billion. Glaxo Group's affected products contributed an additional $1.24 billion in regional sales.
Court Victory Provides Template
The FTC achieved its most significant success through amicus participation in private litigation against Teva Pharmaceuticals. A New Jersey federal court found five Teva patents for ProAir HFA inhalers improperly listed and ordered their removal from the Orange Book. The court concluded that the patents did not claim the "finished dosage form" of the approved drug product as required by statute.
However, Teva has appealed the decision, and the patents remain listed pending resolution. The FTC has since opened its own investigation into these Teva listings, though no formal enforcement action has been announced.
Industry Response and Regulatory Questions
Some companies have responded commercially rather than through delisting. Boehringer Ingelheim capped out-of-pocket costs for its inhaler products at $35 monthly, potentially addressing pricing concerns without removing patent protections.
The FTC's approach has raised questions about regulatory authority, given that patent validity traditionally falls under USPTO jurisdiction while Orange Book disputes have established FDA mechanisms for resolution. Private parties, including economically motivated generic competitors, already possess tools to challenge listing propriety through existing regulatory channels.
Broader Antitrust Implications
The FTC's Orange Book initiative has coincided with increased private antitrust litigation alleging improper patent listings and monopolization. These lawsuits seek damages for alleged overcharges during periods when generic competition was delayed by questionable patent protections.
The agency's actions align with broader Biden administration efforts to reduce prescription drug prices, as outlined in the Inflation Reduction Act Initiative. However, the mixed results to date suggest that voluntary compliance may be limited without formal enforcement proceedings.
Uncertain Enforcement Future
Nearly a year after the initial policy statement, the FTC has not brought formal enforcement actions against any Orange Book listings. The agency's success may ultimately depend on its willingness to pursue litigated challenges that could establish precedent for appropriate listing standards.
For pharmaceutical companies, the FTC's scrutiny has created new compliance considerations for Orange Book submissions. NDA holders must now weigh the risk of FTC action against the competitive advantages of patent listing, particularly for device-related intellectual property that may face heightened scrutiny.
The practical impact of patent delisting varies significantly based on factors including the presence of other listed patents, remaining exclusivity periods, and competitive dynamics in specific therapeutic markets. As the FTC continues to evaluate its approach, the pharmaceutical industry awaits clarity on enforcement priorities and the ultimate scope of the agency's Orange Book oversight.
