FTC Challenges Patent Listings in Orange Book
In a major move aimed at curbing rising drug prices and promoting fair competition, the Federal Trade Commission (FTC) has challenged the legitimacy of more than 100 patents listed in FDA’s Orange Book (also known as “Approved Drug Products with Therapeutic Equivalence Evaluations”). The disputed patents are held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products.
FTC’s action is the next stage of increased patent-listing scrutiny announced in September (see story) that warned brand-name pharmaceutical companies they could face legal action if they improperly list patents in FDA’s Orange Book. “Improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives and keep prices artificially high,” according to the policy statement. “The FTC will scrutinize improper Orange Book patent listings as potential unfair methods of competition in violation of Section 5 of the FTC Act. The FTC is making clear that improper Orange Book listings may be an unfair method of competition in violation of the FTC Act. We won’t hesitate to use all our tools to combat illegal practices that are inflating the price of health care, including medicines.”
FTC sent notice letters to 10 companies — AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva. “The notice letters and the patent listing dispute notifications provided to FDA identify specific patents that FTC contends are improperly listed for specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors, also commonly known as EpiPens,” an FTC news release says.
“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,” FDA commissioner Robert Califf is quoted in the release as saying. “The FDA will continue its longstanding engagement with FTC to help protect American consumers.”
“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 says.
“FDA regulations allow any interested person to dispute the accuracy or relevance of patent information published in the Orange Book,” FTC continues. “While the FTC is utilizing the FDA’s patent listing dispute process to address patents relating to these products, and potentially others, the letters to the drug companies highlight that the commission retains the right to take any further action as needed in the public interest, which includes investigating the manufacturers’ conduct as a violation of FTC laws.”