In a development of interest to legal professionals in large corporations and law firms, the Federal Trade Commission (FTC) is adopting a novel approach in its ongoing fight against drug makers alleged to have inappropriately listed patents in the Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly referred to as the “Orange Book.” If successful, this could signal a new trend in the way FTC deals with such cases.
The litigation in question was announced by the FTC on November 7, 2023. The Commission has challenged the listing of more than 100 patents in the Orange Book. This announcement follows a policy statement the FTC released on September 14. That initial public statement detailed the FTC’s perception on how potentially wrongful Orange Book patent listings could be seen as a contravention of antitrust laws and committed the FTC to future regulatory action.
This comes at a time of heightened scrutiny of business practices in the pharmaceutical industry, particularly in relation to patent listings in the Orange Book. This book is a critical resource in the world of biopharmaceutical law, as it provides information on drug products approved on the basis of safety and effectiveness by the FDA.
The FTC’s allegation that over 100 patents have potentially been wrongly listed in this resource is significant. If the FTC’s challenge proves successful, it could serve as a lesson for pharmaceutical companies on the perils of impropriety in patent listings. It also emphasizes the importance of maintaining a close watch on patent practices in the pharmaceutical industry and an understanding of the FTC’s position on antitrust violations.
Legal professionals advising companies in the pharmaceutical sector would be well-advised to track these developments. A shift in FTC’s approach could necessitate a review of current patent practices to ensure that they are still compliant with regulations. A key part of this process will involve maintaining a finger on the pulse of FTC enforcement patterns, which appear to be increasingly aggressive and have potential far-reaching implications.
To learn more details about this latest FTC action, click here.