3.0.0 1435 2023-01-11T13:49:06Z 2023-01-11T13:49:06Z Senate S 2021-04-28 117 ssju00 Judiciary Committee Senate Standing Markup by 2021-07-29T13:00:02Z Referred to 2021-04-28T21:25:03Z Affordable Prescriptions for Patients Through Promoting Competition Act of 2021 117 2873 HR 2021-09-29 Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 27 - 16. Related bill CRS Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act 117 2884 HR 2021-09-30 Ordered to be Reported in the Nature of a Substitute by Voice Vote. Related bill CRS Reduced Costs and Continued Cures Act 117 5260 HR 2022-11-01 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Related bill CRS Reduced Costs and Continued Cures Act of 2021 117 5237 HR 2022-11-01 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Related bill CRS 2021-07-29 ssju00 Judiciary Committee Senate Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2021-04-28 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. IntroReferral 2021-04-28 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 2021-04-28 True G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2021-07-15 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2021-07-28 False K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2021-07-28 False M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2021-08-02 False H001089 Sen. Hawley, Josh [R-MO] Josh Hawley R MO 2021-08-03 False B001288 Sen. Booker, Cory A. [D-NJ] Cory Booker D NJ 2021-08-03 False C001098 Sen. Cruz, Ted [R-TX] Ted Cruz R TX 2021-08-03 False O000174 Sen. Ossoff, Jon [D-GA] Jon Ossoff D GA 2021-08-03 False E000295 Sen. Ernst, Joni [R-IA] Joni Ernst R IA 2021-09-20 False K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2021-09-21 False S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2021-09-21 False P000595 Sen. Peters, Gary C. [D-MI] Gary Peters D MI 2021-09-21 False L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2021-09-21 False B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2021-09-30 False K000377 Sen. Kelly, Mark [D-AZ] Mark Kelly D AZ 2022-03-15 False 2022-06-06T17:11:00Z Estimated Budgetary Effects of S. 1435, the Affordable Prescriptions for Patients Act of 2021 https://www.cbo.gov/publication/58180 As ordered reported by the Senate Committee on the Judiciary on July 29, 2021 Commerce Administrative remedies Civil actions and liability Competition and antitrust Consumer affairs Drug safety, medical device, and laboratory regulation Federal Trade Commission (FTC) Health Health care costs and insurance Inflation and prices Intellectual property Judicial review and appeals Manufacturing Prescription drugs Commerce 00 2021-04-28 Introduced in Senate 2022-03-30T14:33:49Z Affordable Prescriptions for Patients Act of 2021

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.

Generally, product-hopping 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 follow-on product is a modified version of the reference drug that shares an indication (what the drug is used for) with the reference drug.

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.

A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.

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.

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Affordable Prescriptions for Patients Act of 2021 Display Title Affordable Prescriptions for Patients Act of 2021 Official Title as Introduced A bill to amend the Federal Trade Commission Act to prohibit product hopping, and for other purposes. Introduced in Senate IS Short Title(s) as Introduced Affordable Prescriptions for Patients Act of 2021 Introduced in Senate IS Introduced in Senate 2021-04-28T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s1435is/xml/BILLS-117s1435is.xml 2021-07-29 Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably. 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.