Congress moves to block Big Pharma's patent-stacking trick that keeps drugs expensive
H.R. 890 — Stopping Pharma’s Ripoffs and Drug Savings For All Act · Filed by Patrick Ryan (D-NY) · Introduced Jan 31, 2025 · Referred to committee
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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.
The full analysis lists 4 implications of this text.
Who stands to gain
generic pharmaceutical manufacturers; biosimilar manufacturers; pharmacy benefit managers (PBMs)