Skip to main content
H.R. 4850 116th Congress House

Biologic Patent Transparency Act

Official title: To provide for certain additional requirements with respect to patent disclosures.

Introduced: October 23, 2019 See on congress.gov
Commerce Biological and life sciencesGeneticsGovernment information and archivesIntellectual propertyLicensing and registrations
Sign in to write a letter Sign in to watch
This bill died when the 116th Congress ended
It never became law before the 116th Congress (2019–2020) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 18, 2019
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Oct 26, 2019
Referred to the Subcommittee on Health.
Oct 23, 2019
Introduced in House
Oct 23, 2019
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.
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action December 18, 2019

Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 3
  • S 659 Identical bill Biologic Patent Transparency Act
  • S 4796 Fair Care Act of 2020
  • HR 8527 Fair Care Act of 2020
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 4850: Biologic Patent Transparency Act. 116th Congress. Open America. https://openamerica.io/bill/116-HR-4850/
MLA
"H.R. 4850: Biologic Patent Transparency Act." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-4850/.
Bluebook (legal)
H.R. 4850, 116th Cong. (2026), https://openamerica.io/bill/116-HR-4850/.
Markdown link
[H.R. 4850: Biologic Patent Transparency Act](https://openamerica.io/bill/116-HR-4850/)
Report a problem