3.0.0 3004 2023-01-11T13:25:04Z 2023-01-11T13:25:04Z Senate S S 2014-12-11 113 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2014-12-11T22:19:11Z 2014-12-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2014-12-11 Introduced in Senate IntroReferral 10000 9 Library of Congress H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT N B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2014-12-11 True Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Intellectual property Prescription drugs Health 00 2014-12-11 Introduced in Senate 2015-03-24T19:23:31Z 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.]]> Dormant Therapies Act of 2014 Display Title Dormant Therapies Act of 2014 Official Title as Introduced A bill to promote the development of meaningful treatments for patients. Introduced in Senate IS Short Titles as Introduced Dormant Therapies Act of 2014 Introduced in Senate 2014-12-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113s3004is/xml/BILLS-113s3004is.xml 2014-12-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.