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119-hr-3269119th Congress

ETHIC Act

Sponsored By: Representative Arrington, Jodey C. [R-TX-19]

Introduced

Summary

This bill would limit patent owners to asserting at most one patent per "Patent Group" against a generic or biosimilar applicant or product holder, aiming to cut through patent "thickets" that delay competition.

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  • Generic and biosimilar applicants and holders would face fewer parallel patent suits. The limit applies to applications under section 505(b)(2) or 505(j) of the Federal Food, Drug, and Cosmetic Act and to licensure under section 351(k) of the Public Health Service Act submitted on or after enactment.
  • Patent owners could no longer bring multiple infringement actions over different patents in the same Patent Group against the same party. They would be restricted to one asserted patent per Patent Group for each targeted party.
  • Courts and litigants would use a new "Patent Group" definition based on disclaimers under 35 U.S.C. 253 to determine which patents count together. That groups commonly owned patents or applications that reference one another via disclaimers.

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Bill Overview

Analyzed Economic Effects

1 provisions identified: 1 benefits, 0 costs, 0 mixed.

Caps patent claims in drug lawsuits

If enacted, in certain drug and biologic patent cases, a plaintiff would be limited to one patent per "Patent Group" against a covered party. A Patent Group would mean commonly owned patents tied together by a formal patent disclaimer. The limit would cover generic or follow-on drug and biosimilar applicants, holders of those approvals, and people making, selling, or importing those products. After one such case, the same plaintiff could not bring another case against that party on a different patent in the same Group. The rule would apply to applications filed on or after the date of enactment.

Sponsors & CoSponsors

Sponsor

Arrington, Jodey C. [R-TX-19]

TX • R

Cosponsors

  • Rep. Doggett, Lloyd [D-TX-37]

    TX • D

    Sponsored 5/8/2025

  • Rep. Issa, Darrell [R-CA-48]

    CA • R

    Sponsored 5/8/2025

  • Rep. Jayapal, Pramila [D-WA-7]

    WA • D

    Sponsored 5/8/2025

  • Rep. Pfluger, August [R-TX-11]

    TX • R

    Sponsored 5/8/2025

  • Rep. Dingell, Debbie [D-MI-6]

    MI • D

    Sponsored 5/9/2025

  • Rep. Tlaib, Rashida [D-MI-12]

    MI • D

    Sponsored 7/29/2025

  • Rep. Harshbarger, Diana [R-TN-1]

    TN • R

    Sponsored 4/6/2026

  • Rep. García, Jesús G. "Chuy" [D-IL-4]

    IL • D

    Sponsored 4/20/2026

  • Rep. Craig, Angie [D-MN-2]

    MN • D

    Sponsored 6/23/2026

Roll Call Votes

No roll call votes available for this bill.

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