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S. 3004: Dormant Therapies Act of 2014

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S. 3004: Dormant Therapies Act of 2014

113th Congress · introduced 2014-12-11 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2014-12-11 · official record
  2. Who proposed it: Sen. Hatch, Orrin G. [R-UT] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Dormant Therapies Act of 2014

Plain summary

Dormant Therapies Act of 2014 - Requires the Department of Health and Human Services (HHS) to designate medicines being, or intended to be, investigated to address unmet medical needs as dormant therapies. Gives a dormant therapy a 15-year protection period during which no drug can be approved by relying on the approval of the dormant therapy absent a right of reference from the holder of the approved application for the dormant therapy. Requires the sponsor of a potential dormant therapy to have a clinical plan to investigate the medicine and intend to file an application for approval or licensure of the medicine as a new drug or biological product. Prohibits the active moiety of the medicine from being the same as an active moiety in a drug or highly similar to one in a biological product for which an application has been submitted. Requires the sponsor of a potential dormant therapy to list their patents that apply to the medicine and waive rights to those patents at the end of the dormant therapy protection period if the medicine is approved. Allows a sponsor to withdraw a dormant therapy designation request unless the medicine has been approved or licensed. Entitles the sponsor of a dormant therapy to extend patents that apply to the medicine to the end of the protection period. Prohibits a dormant therapy from receiving specified protections that apply to pediatric, infectious disease, or rare disease or condition medicines. Directs HHS to require a sponsor to certify that the clinical plan for a dormant therapy has been completed and that approval was based on investigations in the clinical plan.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Dormant Therapies Act of 2014

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Hatch, Orrin G. [R-UT] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Michael F. Bennet (D-CO)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

Record fed-us-cong113-s3004 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113