• The FTC recently announced that it has sent another round of letters disputing additional patent listings in the FDA’s Orange Book. With this latest action, the FTC has now challenged hundreds of listings filed by more than a dozen companies and their subsidiaries.
• These letters are likely not the end of the FTC’s crusade against allegedly “improper or inaccurate” listings.  The agency has warned that it may take further action, including initiating investigations of unfair competition under Section 5 of the FTC Act.  
• FTC’s latest actions illustrate that Orange Book patent listings continue to be a priority for the agency.

The Federal Trade Commission (FTC) has been busy scrutinizing patent listings in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book.  The agency recently sent a second tranche of letters to ten more pharmaceutical companies asserting that they improperly or inaccurately listed certain patents.  The letters inform the companies that the FTC has availed itself of FDA’s regulatory process regarding patent listing disputes and warn that further action may be taken by the agency, including an investigation of the conduct as an unfair method of competition under Section 5 of the FTC Act, 15 U.S.C. § 45. These letters followed similar letters that the FTC sent to ten manufacturers in November 2023 in which the FTC challenged over 100 patent listings in the Orange Book.  

As the FTC explained in a Policy Statement issued in September 2023, the agency believes that improper listing of patents in the Orange Book may be harming competition by (1) blocking FDA approval of a competing generic or follow-on product during an automatic stay period (generally 30 months), a mechanism imposed by the Hatch-Waxman Act of 1984 (P.L. 98-417) to identify and potentially resolve patent disputes while the generic or follow on products are reviewed by the FDA; and (2) generally disincentivizing investments in generic or follow on products and increasing the risk of delayed competition.  According to the Policy Statement, Orange Book listings can delay competition regardless of the validity or scope of the patent and regardless of whether the patent meets listing criteria. 

FTC’s interest in Orange Book patent listings is not new.  For example, the agency examined the competitive effects of Orange Book listings in 2002 and pointed to a number of instances where the 30-month stay prevented competition.  The agency has also filed amicus briefs in various cases explaining its position on the anticompetitive effects of improper Orange Book listings.  We provide a more in-depth review and analysis of congressional and agency actions related to Orange Book listings in this webinar. 

FTC’s latest action targets more than 300 Orange Book patent listings across 10 different companies, which brings the total to more than 400 patent listings across 14 companies and should send a message to industry and lawmakers that this issue remains a top priority for the agency.