Polsinelli
Key Takeaways
- The Federal Trade Commission (FTC), now under Republican leadership, has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices
- Despite new Warning Letters, many of the questioned patents were already delisted or tied to discontinued products, suggesting limited immediate impact on generic competition
- Both branded and generic drugmakers may need to reassess litigation strategies and patent listings as regulatory and enforcement dynamics evolve
During the past two years, we have reported on actions regarding the listing of certain patents in the U.S. Food and Drug Administration’s (FDA) Orange Book for drug/device products where the patents focus on the device aspect of the product.1 During the Biden Administration, the FTC, under Democratic-led leadership, started taking note of what it deemed to be “improper” Orange Book patent listings. The question of whether the FTC will remain active in this field was still open with all the changes implemented by the Trump Administration, and the FTC. The FTC has now at least partially answered this question. They will continue to focus on the propriety and accuracy of certain Orange Book Patent listings. The FDA has historically treated the listing patents as a administrative matter, and does not question the information provided by the NDA holder. As we noted on July 17, 2024, those proceedings initiated by FTC had a minimal impact, as many of the patents remained in the Orange Book.
However, on December 20, 2024, the United States Court of Appeals for the Federal Circuit held that certain patents that were listed in the Orange Book for an asthma inhaler should have been delisted as the claims in question did not recite the active ingredient. Teva Branded Pharmaceutic Products R&D, Inc. and others Amneal Pharmaceuticals of New York, LLC and others (Fed. Cir Case 2024-1936 (Dec. 20, 2024). On March 3, 2025 the Federal Circuit denied Teva’s request for an en bloc hearing. We have noticed that many device patents have been removed from the Orange Book in recent updates, presumably on the request of the NDA holders. To determine if this is a viable strategy for generic companies, it’s important to analyze the competitive landscape, timeliness of FDA review, types of patents held by the brand, and the expiration dates of each patent. But, with the significant changes brought about by the Trump Administration, it was an open question how active the FTC would be going forward, even after the Teva decision.
Specifically, on January 20, 2025, President Trump designated Andrew Ferguson to become the new Chairman of the FTC. On March 18, 2025, Trump fired the remaining two Democratic FTC Commissioners. All these changes raised the question of whether a Republican-led FTC will continue to target Orange Book listings. This question seems to have a resounding ‘yes’. The new FTC leadership sent warning letters to seven companies on May 21, 2025. These letters were similar to those sent in 2023 or 2024, and questioned the legitimacy of multiple product listings. In the same way as the previous Warning Letters the FTC took action to establish patent dispute procedures with FDA. In the May 21, 2025, FTC Press Release, Commissioner Ferguson stated:
The American people voted for transparent, competitive and fair healthcare markets and President Trump is taking action. . . . The FTC will continue to vigorously pursue firms that use practices that harm competition. The FTC will continue to vigorously pursue firms using practices that harm competition.
We have reviewed each of the seven Warning Letters published by FTC (that cover 16 products) and a deeper dive indicates that Commissioner Ferguson’s proclamation may not have a significant impact on competition. Seven of the 16 brand-name products have been discontinued, while one product already has several generic competitors. Two patents will expire within three months. For five other products, Orange Book listed patents that were not questioned by FTC are expiring sooner than those whose validity was questioned. Only one of the 16 products appears to list only patents that have been questioned by FTC. At the time of the FTC’s letter, several patents had already been removed from the Orange Book. As we have discussed, the FDA’s role in patent listing is purely ministerial. It will be interesting to see if the new FDA leadership takes a different approach. Both branded and generic companies will need to rethink strategies when it comes to patents that are listed in the Orange Book but have been questioned. In the case of products that have both FTC-questioned and unquestioned patents on the Orange Book, the brand and generic companies may want legal certainty. They may prefer to include both types of patents into a single lawsuit rather than separate suits. Even if device-related patents are eventually removed from the Orange Book there is still the possibility that litigation will occur at some point. The industry should pay close attention to the future developments in this field.
Chad A. Landmon and Andrew M. Solomon. Federal Circuit Refuses To Rehear Case Involving orange Book Listing of Device patents, Polsinelli, (Mar. Court ruling alters the calculation for Orange Book Patent listings, Polsinelli, Jan. 23, 2025, Federal Circuit Decides Case Involving Orange Book List of Device Patents Polsinelli, Dec. 23, 2024, The FTC’s challenge to the listing of Device Patents in Orange Book: What is the challenge?, Polsinelli, Jul. 17, 2024). 17, 2024),
