The Senate Just Declared War on Pharma's Favorite Legal Trick

The message to pharma is clear: protect your real innovations all you want. Just stop papering over old drugs with a wall of incremental filings designed to scare off competition.

Why This Bill Keeps Coming Back

If this legislation sounds familiar, that's because it is. The Senate has been trying to pass some version of it since 2023. The original S.150 cleared the chamber by unanimous consent in July 2024, only to die when the House never voted on it before the 118th Congress ended.

Senators reintroduced it in March 2025 alongside a companion bill targeting "product hopping" (when a company discontinues an older drug and steers patients to a newer, still-patented version). Now the updated bill, S.1041, has passed the Senate again and heads to the House for what supporters hope is a better outcome this time.

The Congressional Budget Office has estimated the legislation would save taxpayers roughly $3 billion over a decade. That number reflects faster biosimilar entry and lower prices for government health programs.

The Drugs in the Crosshairs

The bill doesn't name specific products. It doesn't have to. The targets are obvious.

Keytruda (pembrolizumab), Merck's cancer juggernaut, has assembled a large patent portfolio with expirations stretching to approximately 2040. Its core composition patents expire around 2028, but the thicket could push meaningful biosimilar competition well into the 2030s. Analysts see it as a deliberate echo of the Humira playbook.

Dupixent (dupilumab) is the Sanofi/Regeneron immunology blockbuster with an expanding list of indications. Stelara (ustekinumab), J&J's biologic, has U.S. biosimilar entry expected in the 2025-2026 window.

Research suggests a pattern: moderate thickets (30 to 50 patents) typically delay biosimilars by one to three years past core patent expiry. Extensive thickets (80-plus patents) can push that delay to three to six years. At 130-plus patents, you get the Humira scenario, where competition arrives nearly a decade late.

Pharma's Response: Polite Alarm

PhRMA, the industry's main lobbying group, struck a diplomatic but defensive tone. The group said it supports "the full lifecycle of medicines, from innovation to generic and biosimilar uptake" but expressed "concerns with Congress prohibiting innovators from enforcing lawfully granted patents."

Translation: we don't love this.

On the other side, PCMA (which represents pharmacy benefit managers) called patent-thicket reform "critical" to ending anti-competitive practices. Patient-affordability groups, including Patients For Affordable Drugs Now, praised the Senate vote and pushed for House action.

The FTC Is Already Circling

The Senate bill doesn't exist in a vacuum. The Federal Trade Commission has been waging its own war on patent fortresses since 2023, when it declared that improperly listed patents constitute unfair competition.

The agency has challenged more than 300 patent listings and sent warning letters to companies including AbbVie, AstraZeneca, Novartis, and others. In a landmark moment in December 2025, Teva asked the FDA to remove more than 200 device patents from the Orange Book (the registry that can trigger automatic 30-month litigation stays) after sustained FTC pressure and a Federal Circuit ruling.

A joint DOJ/FTC report on prescription drug competition, expected later this year, could recommend even more aggressive measures. The regulatory and legislative tracks are converging: patent thickets are being squeezed from both directions.

What Happens Next

The bill now moves to the House, where its fate is less certain. Previous versions cleared the Senate with ease, only to stall in the lower chamber. But the political dynamics have shifted. Drug pricing remains a bipartisan hot button. The FTC's enforcement actions have built public awareness. And the sheer scale of upcoming patent cliffs (biologics worth hundreds of billions in revenue face expiring patents between 2025 and 2029) means the stakes keep rising.

For biosimilar developers, the bill represents a potential sea change: fewer patents to navigate, shorter litigation timelines, and lower costs to challenge entrenched incumbents. For big pharma, it means the era of building legal fortresses around aging biologics may be nearing its end.

Twenty patents is still a formidable defense. But it's a far cry from 132.

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