Congress moves to block Big Pharma's patent-stacking trick that keeps drugs expensive

What it does

This bill prevents pharmaceutical companies from extending drug monopolies by filing multiple patents on the same drug or minor variations. It presumes that when the first patent on a drug expires, all related patents automatically expire too—unless the company can prove in court that each additional patent covers a genuinely different invention. The USPTO must also review its patent-examination practices to stop issuing overlapping drug patents that artificially extend market exclusivity.

Why we flagged it

The bill's core mechanism is straightforward: it restricts pharmaceutical patent-term extension strategies by presuming patent-term disclaimer when the first patent expires, unless the company proves distinct inventions. This directly targets the 'evergreening' practice—filing successive patents to delay generic entry—and accelerates generic competition.

What the text implies

• Shifts burden of proof: pharma companies must now affirmatively prove patent distinctness in court, rather than the government proving overlap. This materially increases litigation risk and cost for multi-patent drug portfolios.
• USPTO review requirement may lead to tighter examination standards going forward, reducing the number of overlapping drug patents issued in the future—a structural change that affects pharma R&D strategy.
• Generic manufacturers gain a presumption of patent expiration, lowering their litigation risk when launching generics and potentially accelerating market entry timelines.
• The bill does not cap damages or limit injunctions, so pharma can still litigate; it only shifts the presumption. Litigation costs may rise, but generic entry becomes more likely.

Who it affects

Ordinary people benefit through lower drug prices and faster generic competition. By blocking 'patent thickets'—stacks of overlapping patents that delay generics—this bill removes a major tool pharmaceutical companies use to keep prices high long after the original patent should have expired. Patients and taxpayers (who fund Medicare/Medicaid) gain access to cheaper medications sooner.

Who stands to gain

• generic pharmaceutical manufacturers
• biosimilar manufacturers
• pharmacy benefit managers (PBMs)
• health insurance companies
• Medicare and Medicaid programs

Named in the bill

US Patent and Trademark Office (USPTO), Under Secretary for Intellectual Property, House Committee on the Judiciary, Federal Food, Drug, and Cosmetic Act (Section 505), Public Health Service Act (Section 351), 35 USC Section 253, 35 USC Section 271, Ligand Pharmaceuticals (LGND), Vertex Pharmaceuticals (VRTX), West Pharmaceutical Services (WST), Alliant International University (ALL) — likely mismap

Where it stands

• Jan 31, 2025 — Introduced · Congress.gov: “Introduced in House”
• Jan 31, 2025 — Referred to House Committee on the Judiciary · Congress.gov: “Referred to the House Committee on the Judiciary”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

3 lobbying clients named this bill on 5 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $16,680,000 in lobbying spend. A filing names 53 bills on average, so that figure is what each filing reported, not a share belonging to this bill.

More lobbying clients named this bill than 61% of bills with at least one filing.

Patrick Ryan, the sponsor, reported $497,046 in PAC receipts in the 2026 cycle.

• Pharmaceutical Research and Manufacturers of America — $15,770,000 on 2 filings
• Gsk (fka Glaxosmithkline Inc.) — $890,000 on 1 filing
• American Intellectual Property Law Association (aipla) — $20,000 on 2 filings

Lobbying Disclosure Act filings through Jul 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.