The United States Federal Trade Commission (FTC) announced that it has challenged the Orange Book listings of more than 100 patents related to combination products, with most of those patents related to inhaler device components such as dose counters. According to warning letters that the FTC sent to sponsors of the NDAs affected by challenges, the inhalers involved include Advair HFA, Arnuity Ellipta, Atrovent HFA, Combivent Respimat, Flovent HFA, ProAir DigiHaler, ProAir HFA, QVAR 40, Spiriva, Spiriva Respimat, Symbicort, and Ventolin HFA.
In its warning letters, the commission cited a September 2023 policy statement which points out that the relevant statutes forbid sponsors from submitting patents that cover something other than the active ingredient, drug composition, formulation, or method of use. “Yet,” the statement says, “certain manufacturers have submitted patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it.”
According to the FTC press release, “When the listing of a drug substance or drug product patent is disputed consistent with the applicable FDA regulations FDA will send the statement of dispute to the New Drug Application (NDA) holder who will then have 30 days to withdraw or amend these listings, or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.”
FTC Chair Lina Khan commented, “Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition. The FTC’s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens. We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.”
FDA Commissioner Robert Califf said, “The FDA reminds all NDA holders they are obligated to ensure that patent listings comply with statutory and regulatory requirements and to substantively respond to statements of dispute provided under the FDA’s patent listing dispute process. The FDA will continue its longstanding engagement with FTC to help protect American consumers.”
Read the FTC press release.
