If Congress set out to deliberately jeopardize American lives and well-being, it could hardly devise a more effective strategy than eroding patent protections that fuel domestic medical innovation.  

Yet that’s precisely what three dangerous bills now before Congress threaten to accomplish.  

For over two centuries, by way of background, the United States has led the world in protecting intellectual property (IP) – patents, copyrights, trademarks and trade secrets.  Today, the U.S. consistently remains atop world rankings of IP protection, and that’s no historical accident.  Rather, our Founding Fathers deliberately protected IP in Article I of our Constitution, which resulted in making America the world’s unrivaled engine of innovation, technological advance, commercial prosperity and global leadership.  

Today, the U.S. pharmaceutical sector offers perhaps the clearest and most beneficial example.  

Specifically, America accounts for an astonishing two-thirds of all new lifesaving drugs introduced to the world, despite only claiming 4% of the world’s population.  As a direct result, despite myths to the contrary, American consumers access far more innovative drugs than citizens in the rest of the industrialized world.  

That’s the direct result of U.S. patent protections.  

After all, developing new medicines requires years or even decades of research and billions of dollars in investment, all with no guarantee of success.  Without the certainty that patent rights provide, fewer investors would assume those risks, fewer companies would pursue groundbreaking therapies and fewer patients would ultimately benefit from medical advances.  

Inexplicably, however, Congress is considering three bills that would move us in exactly the wrong direction:  (1) S. 2658, the so-called “Medication Affordability and Patent Integrity Act”; (2) S. 1954, the misnamed “Biosimilar Red Tape Elimination Act”; and (3) S. 3014, the “Ensuring Timely Access to Generics Act of 2025.”  

Of particular concern is S. 2658, which the Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to consider this week.  That misguided legislation would require pharmaceutical companies to provide the U.S. Patent and Trademark Office (USPTO) with information submitted to the Food and Drug Administration (FDA) dubiously deemed material to patentability, while certifying consistency between submissions to both agencies.  Failure to comply could result in the draconian penalty of forfeiting enforcement of its patent rights.  

The fundamental flaw underlying that proposal is the fact that it irrationally treats the FDA and USPTO as though they perform the same function, when they do not.  

Specifically, the FDA evaluates whether a medicine is safe and effective.  As part of that process, it receives enormous volumes of proprietary scientific, manufacturing and formulation information under strict confidentiality protections.  The USPTO, in contrast, serves an entirely different purpose.  It evaluates whether an invention qualifies as novel, non-obvious and meritorious of patent protection.  Most pivotally, those patent applications focus on technical claims and are generally published for public review.  

That obviously creates serious risks for confidential business information, patent particulars and trade secrets.  

Although the bill’s proponents claim that transferred information would receive protections similar to those afforded by the FDA, merely instructing the USPTO to develop such procedures wouldn’t magically transform it into an agency designed to manage highly sensitive FDA submissions.  At a moment when American companies already face aggressive competition from foreign rivals like China, Congress should be strengthening protections for valuable intellectual property, not creating new opportunities for inadvertent disclosure.  

Proponents also claim that S. 2658 is necessary to prevent companies from manipulating our patent system.  Existing law, however, already addresses that concern.  Deliberately withholding material information from patent examiners can render a patent unenforceable, and patent challengers also possess avenues through review proceedings and federal litigation to challenge improperly issued patents.  

Accordingly, S. 2658 merely imposes sweeping new burdens under the false rationalization of solving a “problem” that doesn’t even exist.  

Most troubling of all, S. 2658 imposes an indefensibly disproportionate penalty.  

Namely, a party could lose the ability to enforce a constitutionally protected patent right not because its patent lacks merit, not because fraud occurred and not because deception was established, but simply because of a procedural filing error.  

The “Biosimilar Red Tape Elimination Act” and the “Ensuring Timely Access to Generics Act of 2025” raise similar concerns.  Proponents market both as efforts to accelerate competition and reduce costs, but both would instead treat patents as obstacles to be weakened rather than protections that make innovation possible.  

While Congress rightly seeks lower drug costs as a policy goal, policymakers must soberly remember that today's cures exist only because yesterday's innovators possessed confidence that their discoveries would be protected by strong patents under the U.S. system.  Undermining those protections may generate convenient political talking points today, but that would mean fewer medical breakthroughs tomorrow.  

Simply put, Congress must remember that American leadership in pharmaceutical innovation did not emerge by accident.  Rather, that occurred because of a system that respects IP, rewards risk-taking and encourages investment in scientific discovery.  At a moment when the nation faces growing competition from abroad, lawmakers should strengthen that successful formula rather than dismantle it.  

That means rejecting S. 2658, S. 1954 and S. 3014, and instead reaffirming America's longstanding commitment to intellectual property rights.  

Critical medical innovation and the American lives depend upon it.