FTC Alleges Misuse of Orange Book Listings: Puts10 Pharma Companies on Notice

November 10, 2023

On Tuesday, the FTC announced that it is cracking down on companies it asserts is improperly or inaccurately placing drugs on the list of FDA-approved products, known as the Orange Book. The challenge may result in removal of products from the Orange Book.

An Orange Book listed drug places a burden on a would-be generic company seeking to obtain approval of a generic drug. If a patent is listed in the Orange Book a generic drug applicant must give notice to the branded product owner of its generic filing, an ANDA. The Branded product owner can then file for patent infringement and obtain a thirty-month stay of the FDA approval of the generic equivalent. The objective is to provide the companies time to resolve the litigation, however, an improper listing may delay the generic approval and adversely affect the competitive conditions.

In a six-page policy statement, found here, the FTC advised that it was putting “market participants on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether these constitute unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act.” The FTC asserted that some brand companies were exploiting the Orange Book listing process to prevent or delay marketing of generic drugs, citing to a single example Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 408 (2012). In its policy statement, the FTC asserted that improper patent listing “may constitute an unfair method of competition in violation of Section 5 of the FTC Act or illegal monopolization.” It also threatened “[I]ndividuals who submit or cause the submission of improper Orange Book patent listings, including those who certify compliance under 21 C.F.R. § 314.53(c)(2)(ii)(R), may be held individually liable. Further, if the FTC encounters false certifications filed under 21 C.F.R. §314.53(c)(2)(ii)(R) that may constitute a potential criminal violation for the submission of false statements, the Commission may refer such cases to the U.S. Department of Justice for further investigation.” Improper listings may be disputed by impacted parties under 21 C.F.R. 314.53(f)(1) which was promulgated in response to the Caraco decision.

According to published reports 10 companies, including AbbVie, AstraZeneca, and GSK are now in scrutiny by the FTC for improperly or inaccurately listing items in the Orange Book ostensibly to hold off generic competition. The patents challenged by the FTC include those covering inhalable asthma treatments from AstraZeneca and Boehringer Ingelheim; epinephrine autoinjectors from Mylan; and the AbbVie dry eye drug Restasis. The other companies who received FTC notice letters are Impax Laboratories, Kaleo, and subsidiaries of GSK and Teva Pharmaceutical, FTC press release here.

This is yet another example of Pharma being in the bullseye of regulators.