Biologic Patent Transparency Act
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Oct 23, 2019)
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.
What just happenedDec 18, 2019
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Who’s behind it
- Introduced in HouseOct 23, 2019
- Dec 18, 2019Committee
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Courts, Intellectual Property, and the Internet Subcommittee - Oct 26, 2019Committee
Referred to the Subcommittee on Health.
Health Subcommittee - Oct 23, 2019IntroReferralH11100
Referred 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.
Judiciary Committee - Oct 23, 2019IntroReferralH11100
Referred 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.
Energy and Commerce Committee - Oct 23, 2019IntroReferralIntro-H
Introduced in House
- Oct 23, 2019IntroReferral1000
Introduced in House