Recently, the United States Federal Trade Commission (FTC) sent letters to medical device companies and drugmakers disputing the accuracy or relevance of more than 100 patents found in the Food and Drug Administration’s (FDA’s) Orange Book listing of approved products. Many of the patents at issue were for asthma inhalers, epinephrine autoinjectors, and other drug products that may lead to delayed generic competition.
The Orange Book is a list of drug products that are approved by the FDA as safe and effective. When a brand pharmaceutical company lists a patent in the Orange Book, it can lead to a statutory stay that blocks the introduction of generic competition for 30 months. Under FDA regulations, any interested person can dispute the accuracy or relevance of patent information published in the Orange Book.
A total of ten companies received letters, including Teva Branded Pharmaceutical; Norton Limited; Mylan Specialty LP; Kaleo Inc; Impax Labs; Glaxo Smith Kline; Glaxo Group; Boehringer Ingelheim; Astrazeneca LP; and Abbvie, Inc.
The FTC also notified the FDA that it was disputing the accuracy or relevance of the listed information for the patents, which may require that the manufacturer either remove the listing or certify under penalty of perjury that the listings do comply with all applicable statutory and regulatory requirements. As noted in the letters, they were sent to let the company know that the FTC “availed ourselves of the FDA’s regulatory process and submitted patent listing dispute communications with the FDA” regarding the selected patents. The letters conclude by stating while the agency opted to use the FDA’s regulatory dispute process at this time, it also retained “the right to take any further action the public interest may require, which may include investigating this conduct as an unfair method of competition under Section 5 of the FTC Act, 15 U.S.C. § 45, and as described in the Policy Statement.”
These letters follow a policy statement issued by the FTC that gave warning the agency would be scrutinizing the improper submission of patents for listings in the Orange Book as improper patents may “constitute an unfair method of competition in violation of Section 5 of the FTC Act” and “disincentivize investments in developing a competing product and increase the risk of delayed generic and follow-on product entry, reducing patient access to more affordable prescription drugs and increasing costs to the healthcare system.”
“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.”
“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.”