S. 3004 · 113th Congress
Dormant Therapies Act of 2014
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Never voted on. It didn't reach a floor vote before the 113th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
HatchSponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Dec 11, 2014
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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Dormant Therapies Act of 2014
Latest action (Dec 11, 2014): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Dec 11, 2014
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.