3.0.0 4850 2022-11-01T04:17:43Z 2022-11-01T04:17:43Z House HR 2019-10-23 116 [Congressional Record Volume 165, Number 168 (Wednesday, October 23, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. SPANBERGER:H.R. 4850.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 18[Page H8459]]]> hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2019-12-18T18:58:48Z Referred to 2019-10-23T14:03:45Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-10-26T18:25:33Z Referred to 2019-10-23T14:03:40Z Biologic Patent Transparency Act 116 659 S 2019-03-05 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS Fair Care Act of 2020 116 4796 S 2020-10-05 Read twice and referred to the Committee on Finance. Related bill CRS Fair Care Act of 2020 116 8527 HR 2020-10-02 Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, Education and Labor, the Judiciary, Oversight and Reform, House Administration, Rules, the Budget, and Armed Services, 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 bill CRS 2019-12-18 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2019-10-26 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-10-23 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. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2019-10-23 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-10-23 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-10-23 Introduced in House IntroReferral 1000 9 Library of Congress S001209 Rep. Spanberger, Abigail Davis [D-VA-7] Abigail Spanberger D VA Davis 7 N R000585 Rep. Reed, Tom [R-NY-23] Tom Reed R NY 23 2019-10-23 True G000588 Rep. Gonzalez, Anthony [R-OH-16] Anthony Gonzalez R OH 16 2019-12-18 False Commerce Biological and life sciences Genetics Government information and archives Intellectual property Licensing and registrations Commerce 00 2019-10-23 Introduced in House 2020-08-11T15:22:06Z 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.

]]> Biologic Patent Transparency Act Display Title Biologic Patent Transparency Act Official Title as Introduced To provide for certain additional requirements with respect to patent disclosures. Introduced in House IH Short Title(s) as Introduced Biologic Patent Transparency Act Introduced in House IH Introduced in House 2019-10-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr4850ih/xml/BILLS-116hr4850ih.xml 2019-12-18 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.