Recent Changes in Discretionary Denials of Drug Patent Challenges
Publication Date
11-2025
Abstract
Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of "discretionary denials," invoking a new "settled expectations" rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes are especially consequential for biologic drugs, where large "patent thickets" can delay biosimilar entry and sustain high drug prices. Additional procedural reforms, such as reducing allowable brief length by 60% and consolidating all institution decisions under the Director, further constrain challengers and reduces transparency. Together, these policies undermine the congressional purpose of ensuring that invalid patents do not block competition. Congress should clarify when discretionary denials are appropriate and prohibit non-merits-based rationales like "settled expectations" to preserve effective patent oversight and timely access to affordable medicines.
Recommended Citation
S. S. Tu, Arti Rai & Aaron S. Kesselheim,
Recent Changes in Discretionary Denials of Drug Patent Challenges,
3
Health Aff. Sch.
(2025).
Available at:
https://scholarship.law.ua.edu/fac_articles/863