The Biopharmaceutical Industry Still Needs Clarity from the FDA on Orange Book Listings

Recently, the U.S. Federal Trade Commission (FTC) sent letters to 10 biopharmaceutical companies, challenging the listing of a number of patents in the U.S. Food and Drug Administration’s (FDA) Orange Book. The Orange Book lists patents for small molecule medicines that the FDA has approved as safe and effective. In the letters, the FTC argues that certain patent listings are “improper and blocking competition in the market” – an unnecessary and disappointing move since the innovative biopharmaceutical industry has taken great efforts to comply with the FDA statute and related regulations.  

The industry does not support the listing of inappropriate patents in the Orange Book. Instead, the industry seeks to comply with Orange Book listing requirements established by the FDA.  Accordingly, as the agency responsible for setting the guidelines for the types of patents that must be listed in the Orange Book, the FDA needs to provide clearer guidance on the listing of certain drug delivery device patents.

FDA’s lack of guidance on this issue persists despite the industry's continued pleas for clarification regarding the listing of such patents. 

Biopharmaceutical companies have asked the FDA for over 15 years for guidelines on whether certain drug delivery device patents should be listed. After years of unanswered questions, PhRMA raised the issue during a 2015 FDA comment period on Hatch-Waxman proposed regulations. PhRMA also filed comments in 2020 and 2021 that asked the FDA to address the drug delivery device patent issue contemplated by the FTC letters but to no avail. 

FDA itself acknowledges that more clarity could be warranted. It issued a report in June 2020 that noted that the FDA would create a “multidisciplinary working group within the Agency to evaluate whether additional clarity is needed regarding the types of patent information that should be included on, or removed from, the Orange Book.”

Now, despite the industry’s long-pending requests for clarity from the FDA, the FTC is choosing to label companies as acting inappropriately rather than encouraging the FDA to work with the industry to clarify guidelines and ensure compliance. Moving forward, we hope the FDA will take steps to establish clear guidelines for listing of drug delivery device patents.