3.0.0 150 2025-07-21T19:32:26Z 2025-07-21T19:32:26Z Senate S S 2023-01-30 118 ssju00 Judiciary Committee Senate Standing Reported By 2023-03-01T21:18:15Z Markup By 2023-02-09T14:52:36Z Referred To 2023-01-30T23:12:11Z 2024-07-15 14:03:00 Held at the desk. Floor H15000 2 House floor actions 2024-07-15 14:02:01 Received in the House. Floor H14000 2 House floor actions 2024-07-12 Senate Message on Senate action sent to the House. Floor 2024-07-11 Senate Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S4537-4538) Floor 2024-07-11 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent. Floor 17000 9 Library of Congress 2024-07-11 Senate Measure laid before Senate by unanimous consent. (consideration: CR S4537-4538) Floor 2023-03-01 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 22. Calendars 2023-03-01 ssju00 Judiciary Committee Senate Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report. Committee 2023-03-01 Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report. Committee 14000 9 Library of Congress ssju00 Judiciary Committee 2023-02-09 ssju00 Judiciary Committee Senate Committee on the Judiciary. Ordered to be reported without amendment favorably. Committee 2023-01-30 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. IntroReferral 2023-01-30 Introduced in Senate IntroReferral 10000 9 Library of Congress C001056 Sen. Cornyn, John [R-TX] John Cornyn R TX N B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2023-01-30 True G000386 Sen. Grassley, Chuck [R-IA] Chuck Grassley R IA 2023-01-30 True D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2023-01-30 True C001098 Sen. Cruz, Ted [R-TX] Ted Cruz R TX 2023-01-30 True K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2023-01-30 True B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2023-05-02 False W000800 Sen. Welch, Peter [D-VT] Peter Welch D VT 2023-05-02 False M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2024-04-09 False 2024-06-13T21:09:00Z https://www.cbo.gov/publication/60412 As reported by the Senate Committee on the Judiciary on March 1, 2023 Health Administrative remedies 2023-03-01T19:30:27Z Civil actions and liability 2023-03-01T19:30:26Z Competition and antitrust 2023-03-01T19:30:26Z Consumer affairs 2023-03-01T19:30:26Z Drug safety, medical device, and laboratory regulation 2023-03-01T19:30:26Z Federal Trade Commission (FTC) 2023-03-01T19:30:26Z Health care costs and insurance 2023-03-01T19:30:26Z Inflation and prices 2023-03-01T19:30:26Z Intellectual property 2023-03-01T19:30:26Z Judicial review and appeals 2023-03-01T19:30:26Z Manufacturing 2023-03-01T19:30:26Z Prescription drugs 2023-03-01T19:30:26Z Health 2023-02-13T20:30:31Z

00 2023-01-30 Introduced in Senate 2023-03-24T16:20:19Z <p><strong>Affordable Prescriptions for Patients Act of 2023 </strong></p> <p>This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. </p> <p>Generally, <em>product-hopping</em> describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a <em>follow-on product</em> is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantially similar to an indication of the reference drug.</p> <p>The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. </p> <p>A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.</p> <p>The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval. </p> </p> <p>

25 2023-03-01 Reported to Senate 2023-04-07T15:07:52Z <p><strong>Affordable Prescriptions for Patients Act of 2023 </strong></p> <p>This bill prohibits product hopping by drug manufacturers, authorizes the Federal Trade Commission to enforce this prohibition, and imposes limits on patent litigation involving biological products. </p> <p>Generally, <em>product-hopping</em> describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a <em>follow-on product</em> is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantially similar to an indication of the reference drug.</p> <p>The bill presumes product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration (FDA) has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product. </p> <p>A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.</p> <p>The bill also limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get FDA market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval. </p> </p> <p>

55 2024-07-11 Passed Senate 2024-09-19T19:12:28Z <p><strong>Affordable Prescriptions for Patients Act of 2023 </strong></p><p>This bill&nbsp;limits in certain instances the number of patents that a reference biological product manufacturer can assert in a patent infringement lawsuit against a company seeking to sell a biosimilar version. </p><p>Specifically, if the biosimilar manufacturer completes certain actions as part of an abbreviated pathway to get market approval, the bill limits, subject to exceptions and waivers, the number of certain types of patents that the reference product manufacturer may assert, such as patents filed more than four years after the reference product received market approval.</p><p>&nbsp;</p><p>&nbsp;</p>

Display Title 45 2024-07-14T11:03:14Z Short Title(s) as Passed Senate 105 2024-07-12T05:08:15Z S Senate Engrossed in Senate ES Short Title(s) as Introduced 101 2024-05-24T13:42:49Z Introduced in Senate IS Short Title(s) as Reported to Senate 103 2024-05-24T13:42:29Z S Senate Reported to Senate RS Official Title as Introduced 6 2024-04-10T08:08:44Z Introduced in Senate IS 2399 118 SAMDT In the nature of a substitute. 2024-07-16T11:08:14Z 2024-07-11 Amendment SA 2399 agreed to in Senate by Unanimous Consent. SA 2399 https://www.congress.gov/amendment/118th-congress/senate-amendment/2399 C001056 Sen. Cornyn, John [R-TX] John Cornyn R TX 2024-07-11T17:22:54Z 2024-07-11T04:00:00Z Senate 118 S Senate S 150 2025-07-21 6 2024-07-11 0 Senate Amendment SA 2399 agreed to in Senate by Unanimous Consent. Floor 2024-07-11 0 Senate Amendment SA 2399 proposed by Senator Cornyn. (consideration: CR S4537-4538) Floor 2024-07-11 IntroReferral Intro-S 9 Library of Congress 2024-07-11 Senate amendment proposed (on the floor): Amendment SA 2399 proposed by Senator Cornyn. Floor 93000 9 Library of Congress 2024-07-11 Senate amendment submitted Floor 91000 9 Library of Congress 2024-07-11 Senate amendment agreed to: Amendment SA 2399 agreed to in Senate by Unanimous Consent. Floor 94000 9 Library of Congress 1 Engrossed in Senate 2024-07-11T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s150es/xml/BILLS-118s150es.xml Reported to Senate 2023-03-01T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s150rs/xml/BILLS-118s150rs.xml Introduced in Senate 2023-01-30T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s150is/xml/BILLS-118s150is.xml 2024-07-15 Held at the desk. 14:03:00 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.