Patent System in Crisis: Experts Warn Overhaul Hurts American Patients and Manufacturers

Rachel Burttram & Alex Moss | April 30, 2025

On April 25, 2025, the Public Interest Patent Law Institute (PIPLI) hosted an online roundtable discussion about the new administration’s radical overhaul at the U.S. Patent and Trademark Office (USPTO), which you can watch here. The roundtable highlighted grave concerns about the patent system’s extreme change of direction and the implications for American innovators, patients, manufacturers, and consumers. Panelists emphasized the need for greater transparency from leadership and renewed attention to the USPTO’s core mission—granting patents based on technical merit—to ensure it promotes innovation rather than impede genuine ingenuity.

The discussion included panelists Joe Matal, current Principal at Clear IP, LLC and former USPTO Associate Solicitor and Interim Under Secretary and Director, Julie Burke, leading expert on patent office practices & procedures and former USPTO Patent Quality Assurance Specialist, Melissa Wasserman, Associate Dean for Research at The University of Texas School of Law, Christopher Suarez, IP and Technology Partner at Steptoe LLP, Gregory Maurer, patent attorney at Klarquist Sparkman LLP, and moderator Alex Moss, PIPLI’s Executive Director.

With complementary perspectives and diverse expertise, the panelists offered critical insights into the perilous state of the patent system and its practical implications for creators and consumers across technological sectors, especially medical patients, manufacturers, and small businesses.

1. Crisis in Patent Examination

•       Backlogs and Resource Shortages: Julie Burke raised concerns about the USPTO cutting access to non-patent literature (NPL) databases, including Chemical Abstracts (CAS) and Dialog, which are critical for properly examining biotech and pharma patents. "If those resources are being withheld, examiners will struggle to make novelty and obviousness rejections... This could lead to more invalid patents being granted." She also noted that examiners already face pressure from a “historically high backlog of unexamined applications,” exacerbated by hiring freezes and high attrition rates.

·       Training and IT Challenges: Because changes have sharply reduced (or eliminated) “other time” allocations for senior examiners, Burke warned that junior examiners now lack the mentorship and training they need to review patent applications accurately. Panelists also emphasized that the USPTO's outdated IT systems slow workflows, with examiners reporting delays of 20–30 seconds per prior art reference review. Greg Mauer emphasized that the current IT system crashes nearly daily, while Burke criticized the lack of IT modernization, comparing current infrastructure to “the Titanic post-iceberg.”

2. Lower Patent Quality and Higher Drug Prices

•       Erosion of Patent Quality: Melissa Wasserman emphasized that giving PTO examiners less time and fewer resources—such as cutting off access to NPL databases—would result in more errors, more erroneous decisions, and more wrongly granted patents.

•       Inflated Drug Prices: Professor Wasserman explained that wrongly granted patents block competition, leading to delayed generic entry and higher drug prices. She noted that reducing the number of wrongly granted pharmaceutical patents would incur “substantial savings to the public, both in paying the lower generic price as well as having broader access” to the scientific knowledge that potential competitors need to conduct research.

•       Weakened PTAB Compounds Harm of Patent Examination Errors: The weakening of PTAB (Patent Trial and Appeal Board) as a validity-check mechanism means more low-quality drug patents may survive, delaying cheaper generics. Joe Matal warned, “If we’re allowing more invalid patents and taking away the cheaper alternative to challenge them [PTAB], we’re left with a system that’s much worse off.”

3. Reduced PTAB Access and Economic Consequences

·       Protection for Invalid Patents: Matal explained that the USPTO’s Acting Director has unilaterally imposed new rules that will sharply curtail access to the PTAB, even for petitioners with compelling evidence against patent claims that were wrongly granted. Matal also noted that the changes are likely to apply retroactively, preventing challenges that were filed—and would have been granted—before these changes.

·       Golden Age for Patent Trolls: As one of the authors of the America Invents Act (AIA), which created the PTAB review system, Matal emphasized that these restrictive policies undermine the AIA’s goal of providing a cost-effective and reliable review alternative to district courts. Matal warned that denying PTAB reviews risks “wealth transfer” to non-practicing entities (NPEs), discouraging U.S. manufacturing investment, and ushering in a “golden age of the patent troll over the coming years.” Chris Suarez called out rising unpredictability, forcing plaintiffs and defendants into more expensive jury trials where technical arguments often fail.

·       Disadvantaging American Innovators: Small innovators and startups face disproportionate harm from unreliable patents and prolonged pendency. Matal cautioned that the current trajectory risks “damaging the patent system’s legitimacy” and long-term economic health. Mauer advised that declining trust in the U.S. system could discourage investment in U.S. manufacturing and technology sectors, diverting investment to countries with stronger patent quality mechanisms. 

Takeaway: The new administration’s radical overhaul of the Patent Office will lead to more invalid patents and fewer ways of challenging them. These new changes undermine efforts to reduce drug prices and spur domestic manufacturing, particularly in high-tech fields. The panelists emphasized the urgent need to improve patent quality by restoring resources for patent examination and PTAB access as well as improving IT infrastructure and strategic planning. The future of the Patent Office needs to focus on a structure that fosters cutting-edge innovation, encourages timely competition, and optimizes affordable access to medicine – none of which are on the horizon for the current patent system.