3.0.0 659 2022-11-01T17:17:27Z 2022-11-01T17:17:27Z Senate S 2019-03-05 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2019-03-05T22:22:47Z Biologic Patent Transparency Act 116 4850 HR 2019-12-18 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Identical bill CRS Lower Health Care Costs Act 116 1895 S 2019-07-08 Placed on Senate Legislative Calendar under General Orders. Calendar No. 133. Related 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 2019-03-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-03-05 Introduced in Senate IntroReferral 10000 9 Library of Congress C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. N K000384 Sen. Kaine, Tim [D-VA] Timothy Kaine D VA M. 2019-03-05 True P000449 Sen. Portman, Rob [R-OH] Rob Portman R OH 2019-03-05 True S001181 Sen. Shaheen, Jeanne [D-NH] Jeanne Shaheen D NH 2019-03-05 True B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2019-03-05 True S000770 Sen. Stabenow, Debbie [D-MI] Debbie Stabenow D MI 2019-03-05 True H001089 Sen. Hawley, Josh [R-MO] Josh Hawley R MO 2019-04-03 False P000603 Sen. Paul, Rand [R-KY] Rand Paul R KY 2019-05-01 False M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2019-05-06 False Commerce Biological and life sciences Genetics Government information and archives Intellectual property Licensing and registrations Commerce 00 2019-03-05 Introduced in Senate 2020-08-08T13:46:53Z 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 Short Title(s) as Introduced Biologic Patent Transparency Act Introduced in Senate IS Official Title as Introduced A bill to provide for certain additional requirements with respect to patent disclosures. Introduced in Senate IS Introduced in Senate 2019-03-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s659is/xml/BILLS-116s659is.xml 2019-03-05 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.