Biologic Patent Transparency Act
Latest action · Mar 5, 2019 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedMar 5, 2019
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Biologic Patent Transparency Act
This bill requires the holder of a license to market a biologic drug to disclose all patents believed to be covering that drug. The bill also directs the Department of Health and Human Services (HHS) to make such information publicly available. (Biologics are drugs produced through natural processes or isolated from natural sources.)
The holder of a market approval license for a biologic product shall submit a list to HHS of all patents that the holder reasonably believes would be infringed by an unauthorized person making, using, offering to sell, selling, or importing that product. The license holder shall update HHS as to any relevant patents granted after the initial submission and as to listed patents that were later invalidated or rendered unenforceable.
If a patent that should have been listed was not timely disclosed to HHS, the patent holder may not sue for infringement of that patent.
HHS shall publish an easily searchable list of all biologics that have received market approval or for which an application for approval has been filed. The list shall contain information including (1) the official and proprietary name of the product, (2) the patents the license holder has listed under this bill, (3) whether various market exclusivity periods apply to the product, and (4) information about whether the product is interchangeable with another biologic product.
Cosponsors 8
Members who signed on, in the order they did. Signatures ran from Mar 5, 2019 to May 6, 2019; 5 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MI | Debbie Stabenow | Original | Mar 5, 2019 |
| D-NH | Jeanne Shaheen | Original | Mar 5, 2019 |
| R-IN | Mike Braun | Original | Mar 5, 2019 |
| R-OH | Rob Portman | Original | Mar 5, 2019 |
| D-VA | Tim Kaine | Original | Mar 5, 2019 |
| R-MO | Josh Hawley | Apr 3, 2019 | |
| R-KY | Rand Paul | May 1, 2019 | |
| R-AK | Lisa Murkowski | May 6, 2019 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| Senate | Health, Education, Labor, and Pensions Committee | Referred Mar 5, 2019 |
Actions 2
Everything that happened, newest first.
- Mar 5, 2019Introduced in Senate
- Mar 5, 2019Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
In the Congressional Record 3
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| Senate | Debate and remarks S2872 | Tim Kaine D-VA | May 15, 2019 |
| Senate | Debate and remarks S2252 | Lamar Alexander R-TN | Apr 4, 2019 |
| Senate | Debate and remarks S1752–S1754 | Susan M. Collins R-ME | Mar 11, 2019 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Printed hearings 1
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| — | AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 202042 pages | Appropriations Committee | Mar 28, 2019 |
CRS reports 3
Congressional Research Service work that CRS links to this bill or the law it became, newest first.
Cite it 3
Products on other subjects that cite it, usually among other measures.
| Product | Title | Kind | Published |
|---|---|---|---|
| R46741 | Drug Pricing and Intellectual Property: The Legislative Landscape for the 117th Congress | Report | Mar 31, 2021 |
| R46221 | Drug Pricing and Pharmaceutical Patenting Practices Archived | Report | Feb 11, 2020 |
| R44620 | Biologics and Biosimilars: Background and Key Issues | Report | Jun 6, 2019 |
Related bills 4
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 1895 | Lower Health Care Costs Act | Related bill | Jul 8, 2019 |
| S 4796 | Fair Care Act of 2020 | Related bill | Oct 5, 2020 |
| HR 4850 | Biologic Patent Transparency Act | Identical bill | Dec 18, 2019 |
| HR 8527 | Fair Care Act of 2020 | Related bill | Oct 2, 2020 |
Titles 2
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- A bill to provide for certain additional requirements with respect to patent disclosures.
- Short Title(s) as Introduced
- Biologic Patent Transparency Act
Subjects
Assigned by the Library of Congress. Policy area: Commerce.
Text 1
Each version as it was printed, newest first.
- Mar 5, 2019Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
