Bill Sponsor
Senate Bill 659
116th Congress(2019-2020)
Biologic Patent Transparency Act
Introduced
Introduced
Introduced in Senate on Mar 5, 2019
Overview
Text
Introduced
Mar 5, 2019
Latest Action
Mar 5, 2019
Origin Chamber
Senate
Type
Bill
Bill
The primary form of legislative measure used to propose law. Depending on the chamber of origin, bills begin with a designation of either H.R. or S. Joint resolution is another form of legislative measure used to propose law.
Bill Number
659
Congress
116
Policy Area
Commerce
Commerce
Primary focus of measure is business investment, development, regulation; small business; consumer affairs; competition and restrictive trade practices; manufacturing, distribution, retail; marketing; intellectual property. Measures concerning international competitiveness and restrictions on imports and exports may fall under Foreign Trade and International Finance policy area.
Sponsorship by Party
Republican
Maine
Republican
Indiana
Republican
Kentucky
Republican
Missouri
Democrat
New Hampshire
Democrat
Virginia
Senate Votes (0)
House Votes (0)
No Senate votes have been held for this bill.
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.

Text (1)
Actions (2)
03/05/2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
03/05/2019
Introduced in Senate
Public Record
Record Updated
Nov 1, 2022 5:17:27 PM