FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book

Today, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

The Commission has also notified FDA that it disputes the accuracy or relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.  

The FTC sent notice letters to 10 companies, which include: 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.

“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” said FTC Chair Lina M. Khan. “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.”

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.

Last month, the FTC 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.

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.

“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,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will continue its longstanding engagement with FTC to help protect American consumers.”

According to the FTC’s policy statement, costs associated with challenging improperly listed patents can disincentivize investments in developing generic drugs, which risks delaying or thwarting competitive generic alternatives. Delays in generic competition, even if brief, can reduce patient access to more affordable alternatives and increase costs across the entire health care system.

FDA regulations allow any interested person to dispute the accuracy or relevance of patent information published in the Orange Book. 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.