Patent Quality: We Deserve More Than Assurances

Alex Moss | September 30, 2026

When the Patent Office grants patents that should never have issued, the public pays. Businesses face legal threats for using technology that should be available to everyone. Patients wait longer for affordable medicines. Resources that could support research and development go toward litigation instead.

At a recent Senate oversight hearing, Senators Adam Schiff and Peter Welch pressed USPTO Director John Squires on patent quality and drug patent thickets. Chair Thom Tillis called for follow-up on both. Their questions deserve answers backed by evidence.

Where is the evidence of quality?

Schiff’s questions followed a troubling GAO report dated April 2025. Examiners described pressure to prioritize output over thoroughness. GAO found that half the agency’s pilot programs lacked criteria for deciding whether to integrate them, and that supervisory reviews likely overstated examiners' adherence to quality standards. GAO also found that the Patent Office's own quality reviewers flagged errors in examiners' finished work, and that the quality office's management later reopened some of those reviews and changed 41 results. In 39 of them, the change removed the error finding. Most of the changes have no recorded reason. These reviews produce the quality numbers the agency reports to Congress, and the agency ties them to management bonuses.

GAO recommended changes to program evaluation, quality reviews, and public reporting. All eight recommendations remain open on GAO’s public tracker. GAO has not confirmed that the Patent Office has implemented any of them.

Meanwhile, Schiff described changes that raise further concerns: layoffs, higher production quotas, tighter limits on compensated examination time, restrictions on telework, and the elimination of patent examiners’ union representation. He asked how the agency could be confident these changes would not compound the pressures GAO identified.

Squires said quality and output had improved. He pointed to internal reviews, a declining backlog, and widespread use of AI to summarize applications. A declining backlog and widespread use of AI do not establish that issued patents meet legal standards. And GAO identified serious weaknesses in the internal reviews the agency uses to measure quality. It also found that the agency had not assessed whether its AI search tools help examiners find better prior art, which is critical to ensuring the quality of granted patents. The agency needs to show that its tools actually improve examination.

Schiff twice asked how improved quality was being measured. He did not receive a clear answer and requested one in writing. Tillis later joined the request, asking for the baseline used to measure improvement.

Congress should insist on that evidence. The public should not have to accept an unsupported assurance that faster examination is also better examination.

Drug patent thickets are a documented problem

Welch focused on a consequence of excessive patenting that Americans encounter at the pharmacy: overlapping patents that make it harder to introduce competing medicines.

A patent thicket can protect a drug from competition through the sheer expense of challenging its many patents. Even weak patents can contribute to that barrier. Patients bear the consequences when lower cost alternatives remain unavailable.

Tillis asked whether thickets are a real problem, and the evidence shows they are. A recent letter from PIPLI, joined by academics and nonprofits working to lower drug prices, documents patent thickets and the harm they cause.

Humira is the quintessential example. Although its basic patent expired in 2016, AbbVie accumulated dozens of additional patents. One peer-reviewed study found that roughly 80% of the 73 patents in its core U.S. portfolio were not patentably distinct from others in that portfolio. AbbVie used its patent thicket to secure settlements that postponed U.S. competition from more affordable biosimilars until five years after they became available in Europe.

The drug mirabegron (Myrbetriq) shows how related patents can create repeated barriers to competition. Astellas brought five successive lawsuits against generic competitors using “child” patents linked to the same parent patent through terminal disclaimers. Despite differences in wording, their claims covered the generic drug in essentially the same way. The result was nearly a decade of litigation, forcing competitors to confront substantially the same patent barrier repeatedly.

These examples make careful examination especially important. Every additional patent can create another obstacle to competition, even when it adds little to the protection already granted.

An existing tool can also help build thickets

Responding to Welch, Squires pointed to terminal disclaimers as a tool for addressing double patenting. Terminal disclaimers help applicants obtain multiple patents on indistinct variations of an invention, so they can help build the very thickets Welch was asking the agency to address.

A terminal disclaimer may prevent a later patent from extending beyond an earlier patent’s expiration, but it still allows companies to obtain multiple patents that they can assert separately against potential competitors. Requiring a generic or biosimilar manufacturer to challenge dozens or hundreds of patents one by one operates as a barrier to entry.

The USPTO itself attempted to address this problem with a May 2024 proposal that would have required certain patents linked through terminal disclaimers to become unenforceable when a linked patent claim was finally invalidated based on prior art. The agency explained that the proposal would reduce the cost of separate challenges and promote competition.

The Federal Trade Commission supported the proposal, explaining that “the strategic use of terminal disclaimers can facilitate the growth of patent thickets,” and thus “delay and frustrate the entry of new biosimilars and generic drugs, increasing prescription drug costs and limiting patients’ access to more affordable options.”

The agency withdrew that proposal in December 2024, citing resource constraints. The problem it sought to address remains.

Congress should ask why terminal disclaimers, which the agency itself identified as needing reform, are now offered as reassurance that existing safeguards are sufficient.

PIPLI urges Congress to follow through: demand evidence of patent quality, press for implementation of GAO’s recommendations, and examine reforms to limit drug patent thickets. Americans paying for medicines deserve a Patent Office that takes responsibility for the costs its decisions impose on them.