ETHIC Act
Sponsored By: Representative Arrington
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.
Show full summary
- 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
TX • R
Cosponsors
Doggett
TX • D
Sponsored 5/8/2025
Issa
CA • R
Sponsored 5/8/2025
Jayapal
WA • D
Sponsored 5/8/2025
Pfluger
TX • R
Sponsored 5/8/2025
Dingell
MI • D
Sponsored 5/9/2025
Tlaib
MI • D
Sponsored 7/29/2025
Harshbarger
TN • R
Sponsored 4/6/2026
Roll Call Votes
No roll call votes available for this bill.
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