Congress quietly adds patent-infringement loophole for generic drugmakers

What it does

This bill requires pharmaceutical and biologic drug sponsors to share information consistently between the FDA and the U.S. Patent and Trademark Office (USPTO), certifying that data submitted to each agency matches. It also creates a legal defense against patent infringement claims if a patent holder failed to disclose material information to the USPTO as required by the bill. The stated goal is to prevent drug makers from hiding information that could affect patent validity while pursuing FDA approval.

Why we flagged it

The bill's primary mechanism is a disclosure mandate (transparency), but its operative enforcement tool is a new legal defense that shields alleged patent infringers from liability if the patent holder failed to disclose—effectively creating a safe harbor for generic/biosimilar makers at the expense of patent holders.

What the text implies

• Section 274 creates a non-disclosure defense available to 'any person' asserting infringement, including generic and biosimilar manufacturers. This defense applies even if the infringer itself knew of the non-disclosure, shifting enforcement burden entirely to patent holders and potentially undermining patent validity as a barrier to market entry.
• The bill applies retroactively to patents issued before enactment for any submissions/communications made after enactment, creating ongoing compliance risk for patent holders and potential litigation exposure for patents already in force.
• Trade secret protections for FDA-submitted data are waived 'to the extent the USPTO determines necessary for the public to understand the scope of patent claims'—a vague standard that may expose confidential manufacturing and formulation data beyond what patent law traditionally requires.
• The certification requirement ('to the best knowledge') creates liability exposure for patent holders if any material information is later discovered to have been omitted, even if omission was unintentional, incentivizing over-disclosure and potential competitive harm.
• By conditioning patent enforceability on FDA-USPTO information parity, the bill may indirectly pressure drug makers to disclose more to the USPTO than patent law requires, potentially narrowing patent scope and accelerating generic/biosimilar entry.

Section numbers refer to the bill text the analysis read — linked under Primary records below.

Who it affects

The bill creates transparency between FDA and USPTO filings, potentially exposing patent manipulation that inflates drug prices and delays generic competition—a public benefit. However, the non-disclosure defense (Section 274) may shield generic manufacturers and biosimilar makers from infringement liability even when they knowingly infringe valid patents, shifting enforcement risk to innovators and potentially reducing incentives for future drug development, which could harm patients seeking ne

Who stands to gain

• generic drug manufacturers
• biosimilar manufacturers
• follow-on biologic developers

Named in the bill

FDA (Food and Drug Administration), USPTO (U.S. Patent and Trademark Office), drug sponsors, biologic product applicants, patent holders, generic manufacturers, biosimilar manufacturers, DXCM (Dexcom), LGND (Ligand Pharmaceuticals), BSX (Boston Scientific), VRTX (Vertex Pharmaceuticals), REGN (Regeneron)

Where it stands

1 cosponsor: 1 Republicans.

• Aug 1, 2025 — Introduced · Congress.gov: “Introduced in Senate”
• Aug 1, 2025 — Referred to Senate Committee on Health, Education, Labor, and Pensions · Congress.gov: “Read twice and referred to the Committee on Health, Education, Labor, and Pensions”
• Mar 19, 2026 — Hearing held · Congress.gov: “Committee on Health, Education, Labor, and Pensions. Hearings held”
• Jun 17, 2026 — Reported out of committee · Congress.gov: “Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature…”

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

Money around this bill

33 lobbying clients named this bill on 35 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $47,180,000 in lobbying spend. A filing names 12 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 98% of bills with at least one filing.

Maggie Hassan, the sponsor, reported $608,285 in PAC receipts in the 2026 cycle. $16,500 of that came from 2 PACs tied to these lobbying clients.

• Chamber of Commerce of the U.S.A. — $16,950,000 on 1 filing
• Pharmaceutical Research and Manufacturers of America — $15,770,000 on 2 filings
• Amgen Inc — $2,440,000 on 1 filing
• Biotechnology Innovation Organization — $2,360,000 on 1 filing
• Pfizer Inc. — $1,880,000 on 1 filing

Lobbying Disclosure Act filings through Jul 22, 2026. A filing shows who paid to lobby on a bill it names, not what changed.