Biologic Patent Transparency Act
Latest action · Dec 18, 2019 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
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.
- IntroducedOct 23, 2019
- Passed HouseNot reached
- Passed SenateNot 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 2
Members who signed on, in the order they did. Signatures ran from Oct 23, 2019 to Dec 18, 2019, with 1 there on the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-NY | Tom Reed | Original | Oct 23, 2019 |
| R-OH | Anthony Gonzalez | Dec 18, 2019 |
Actions 4
Everything that happened, newest first.
- Dec 18, 2019Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
- Oct 26, 2019Referred to the Subcommittee on Health.
- Oct 23, 2019Introduced in House
- Oct 23, 2019Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Related bills 3
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 659 | Biologic Patent Transparency Act | Identical bill | Mar 5, 2019 |
| S 4796 | Fair Care Act of 2020 | Related bill | Oct 5, 2020 |
| HR 8527 | Fair Care Act of 2020 | Related bill | Oct 2, 2020 |
Subjects
Assigned by the Library of Congress. Policy area: Commerce.
Text 1
Each version as it was printed, newest first.
- Oct 23, 2019Introduced in House
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.