Imagine paying $1,000 a month for a life-saving drug while knowing a cheaper generic version exists—but can’t reach the market. This isn’t a dystopian fantasy. It’s the direct result of a U.S. patent system that’s buckling under pressure, allowing low-quality patents to block competition and inflate prices. A bombshell 2025 GAO report exposes how the U.S. Patent and Trademark Office (USPTO) is failing at its most basic job: ensuring patents reward true innovation, not legal gaming.

The Patent Eligibility Restoration Act of 2025 (PERA), introduced in the U.S. Senate, claims to “restore” clarity to patent law. However, its sweeping changes risk monopolizing access to life-saving medical innovations and stifling competition across critical economic sectors.

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). The roundtable highlighted grave concerns about the patent system’s extreme change of direction and the implications for American innovators, patients, manufacturers, and consumers.

In a powerful display of bipartisan unity, the Senate Judiciary Committee this week advanced a sweeping legislative package aimed at lowering prescription drug costs by curbing the pharmaceutical industry’s abusive patenting and marketing practices. The committee’s unanimous approval of four bills and strong bipartisan support for others underscores widespread recognition that pharmaceutical companies’ anti-competitive practices—such as “pay-for-delay” deals and patent abuses—hurt American patients, providers, and taxpayers alike.

The bills, which will head next to the Senate floor, are the culmination of years of groundwork by lawmakers on both sides of the aisle, with the Committee’s Chairman, Senator Chuck Grassley (R-IA), providing pivotal leadership in bringing lawmakers of both parties together to address pharmaceutical industry abuses. As the Senator emphasized in a recent Q&A: “when Big Pharma games the system to keep generics off the market . . . , Congress needs to iron out the kinks in the system to help lower drug prices and save taxpayer dollars.”

The U.S. Patent and Trademark Office (USPTO)—America’s guardian of innovation—is gutting its own mission through reckless policy changes that prioritize speed over scrutiny. Recent decisions to slash examiner resources, dismantle training programs, and fast-track patent approvals threaten to flood the system with low-quality patents, eroding public trust and handing monopolies to corporations at the expense of genuine inventors, entrepreneurs, and patients.

A coalition public interest groups sent letters to Chairman Durbin and members of the Senate Judiciary Committee, emphasizing the important public benefits that come from an administrative process allowing the Patent Office to reevaluate—and when, appropriate—cancel patents that do not meet the threshold for patentability under the law. The letter highlights the value of this process for lowering drug prices when wrongly granted patents drive them up.

Public Interest Patent Law Institute (PIPLI) is releasing case studies that demonstrate the efficacy of patent challenge proceedings in lowering drug prices, building on groundbreaking research by Charles Duan of American University’s Washington College of Law that provides compelling evidence of the transformative power of IPR in catalyzing significant price reductions and expanding access to vital pharmaceuticals.

As both U.S. and European government agencies heighten their focus on standard-essential patents (SEP), grasping the economic stakes of SEP licensing is increasingly critical. A new study from Professor John L. Turner (supported by the Public Interest Patent Law Institute) offers a promising new approach to SEP royalty setting that is designed to align with the goals of both standardization and patent protection.

The European Commission (EC) recently opened the floor for comments on a ground-breaking proposed regulation concerning the licensing of standard-essential patents (SEPs). At the Public Interest Patent Law Institute (PIPLI), we see the regulation as a positive step toward a more fair and efficient SEP licensing landscape. but we also see concerning aspects that need to be changed. While the proposal may not be flawless, its potential for reshaping the SEP licensing landscape, promoting efficiency, and establishing a level playing field is well worth the work of improving it.

Restricting access to patent challenges will chill innovation and endanger the health of millions of Americans, but that is what the Patent Office is proposing to do. It needs to hear from you how harmful its proposed restrictions will be. Together, we can convince it do the right thing.

When members of Congress asked about the Patent Office’s recently proposed rules at an oversight hearing, Director Kathi Vidal repeatedly stated that the proposal reflected feedback from unidentified “stakeholders.” Given the proposal’s one-sided slant, these oblique references to stakeholders whose feedback influenced the proposal only raised more questions. To ensure the public gets the answers that it needs—and is entitled to receive, the Public Interest Patent Law Institute (PIPLI) has submitted a Freedom of Information Act (FOIA) request seeking records of the Patent Office’s external communications about the proposed rules.

PIPLI and other public interest groups are calling on Congress to protect access to administrative proceedings for challenging invalid patents.