"Plus ça change, plus c'est la même chose," Jean-Baptiste Alphonse Karr (1849)
In the last years of the Biden Administration, the Federal Trade Commission issued a policy statement and sent letters to ten companies having Orange Book-listed patents claiming devices for administering drugs challenging the propriety of those listings and demanding that the companies delist these patents (see "FTC Announces Efforts to Police Pharmaceutical Companies' Patent Behavior" and "FTC Warns Pharma Companies It Means Business with Its Orange Book Listing Policy"). The changes during the past 100+ days of the Trump Presidency could hardly be more dramatic: Chairwoman Lina Khan and two Commissioners appointed by Democratic Presidents are gone (voluntarily or by disputed Presidential fiat) and almost any Biden initiative has been challenged or reversed; indeed, with apologies to Justice Jackson it can fairly be said that "the only [Biden initiative] which is valid is one which this [President] has not been able to get [his] hands on."
The FTC's crusade against Orange Book-listed device patents is the exception to this trend (proving that the perception that "drugs cost too much" and that patents are to blame is bipartisan, as is the seeming misunderstandings regarding the purported linkage between them). The latest FTC action has been another spate of warning letters sent to Novartis, Mylan, Teva, Amphastar, and Covis (indicating that at least some of the previously threatened companies had earlier complied).
One difference in this latest foray is the existence of the Federal Circuit affirmance of a district court order to delist, in Teva Pharms. Inc. v. Amneal Pharms. LLC, following the doctrinal grounds relied upon by the FTC in its former incarnation. This should come as no surprise, because the FTC filed amicus briefs before both courts, and the district court opinion was unabashed in incorporating the arguments in the FTC's brief in support of its ruling and the legal reasoning supporting it.
While the changes in philosophy between the two Administrations (and the composition of the FTC could not be more partisan), in practice the rhetoric in the letters are almost identical. Each letter asserts that the recipient has an "ongoing obligation to ensure the propriety of its patent listings in the FDA's [Orange Book]," citing the earlier letters, all the letters expressly referenced the Federal Circuit decision in Teva v. Amneal, and in Teva's case not limiting the delisting demand to the patents at issue in that case. The earlier public pronouncements are relegated to a footnote in these letters but were cited as a reminder nonetheless. And all these letters were signed by Kelse Moen, Deputy Director, Bureau of Competition; Mr. Moen was appointed by FTC Chair Andrew Ferguson on February 18, 2025.
The FTC has been enunciating these threats for almost two years, and while being conventionally active in pursuing judicial remedies as in Teva v. Amneal (and previously in the series of cases resulting in FTC v. Actavis) has not followed through on its demands.
The patents challenged by the FTC for each pharmaceutical company are as follows:
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