When Truth Speaks: Challenging the USPTO’s “Settled Expectations” Rule

Alex Moss | October 20, 2025

In recent months, the U.S. Patent and Trademark Office (USPTO) has systematically shielded invalid patents from challenge. Now, thanks to former USPTO Director Kathi Vidal the Public Interest Patent Law Institute (PIPLI) filed an amicus brief arguing the agency has strayed from its statutory mandate and is harming the public it exists to serve.

Radically Unexpected

The case is In re Cambridge Industries USA, Inc. The issue is the USPTO's “settled expectations” rule, which now shields patents older than approximately six years from meaningful review—even when those patents may be invalid. This is a radical departure from practice and reason.

Integrity in Peril

Integrity can only rest on a foundation: when mistakes occur during patent examination, they need to be corrected. This is not unfair to patent owners—it is the backbone of a functional patent system. Congress understood this when it created Inter Partes Review (IPR), a streamlined process for challenging patents that fail to meet specific legal requirements for patentability. Unchecked, these patents can do real harm by impeding innovators, driving up costs for consumers, or enabling abusive litigation.

The "settled expectations" rule fractures this foundation. By declaring that older patents are effectively immune from review, the rule cuts directly at the public's interest in patent validity. USPTO data cited in the brief shows that in 82% of IPR cases involving patents older than six years, at least one claim was found invalid.

When we shield old patents from scrutiny precisely because they are old, we are not protecting settled expectations. We are helping owners of invalid patents profit at the public's expense.

The Human Cost of Broken Principles

The "settled expectations" rule disproportionately empowers Patent Assertion Entities—organizations that produce nothing, innovate nothing, but acquire aging patents to extract settlements from those who do.

Consider what this means in practice. A small software company builds something genuinely new. A PAE holding a decade-old patent—one that was examined hastily, without access to critical prior art, and may well be invalid—files suit. The company faces a choice: spend millions in litigation costs with no guarantee of justice, or settle. Most settle. Some fight back—and win—but still go bankrupt. This is not the patent system promoting innovation; it is the patent system taxing innovation to enrich assertion.

The numbers tell a story of compounding harm. PAE litigation costs the U.S. economy over $700 million annually in jury verdicts alone, not counting the far larger tide of settlements extracted under threat. Researchers have documented that firms reduce their research and development spending after being targeted by PAEs. Between 1990 and 2010, defendants lost approximately half a trillion dollars to such litigation. These are not merely costs—they represent medicines not developed, technologies not refined, and jobs not created.

Real World Consequences

The stakes for the American people couldn't be higher. The brief highlights how the rule particularly harms access to affordable medicines. Biosimilar manufacturers typically need eight years for development—but under the "settled expectations" rule, by the time they're ready to bring products to market, the blocking patents are already too old to challenge efficiently through IPR.

Indeed, the need to challenge an invalid patent typically does not become apparent until long after the patent's issuance, when its harms to patients and innovation are already being felt—when patients are already denied access to affordable care.

Public Interest Representation

Former Director Vidal's willingness to represent PIPLI pro bono in this matter carries particular weight; she helped establish the framework that the current USPTO unlawfully set aside. The brief does not celebrate her tenure or critique her successors' motives. It simply, clearly documents a departure from law, from procedure, and from the evidence-based policymaking that protects the public interest.

This is what service looks like when it is aligned with the common good: a willingness to stand for principle even—or especially—when it requires speaking difficult truths about institutions one has led.

Looking Ahead

PIPLI will continue to monitor Cambridge Industries and the other cases now raising these questions. We are grateful to Katherine Vidal and the team at Winston & Strawn LLP for making our participation possible. We are grateful to all who work to bend the arc of patent law back toward its proper purpose: serving the public by rewarding genuine innovation, not by protecting error.