S. 142, Preserve Access to Affordable Generics and Biosimilars Act

3.0.0 142 2025-07-21T19:32:26Z 2025-07-21T19:32:26Z Senate S S 2023-01-30 118 ssju00 Judiciary Committee Senate Standing Reported By 2023-03-01T21:18:59Z Markup By 2023-02-09T17:53:19Z Referred To 2023-01-30T23:14:26Z 2023-03-01 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 20. Calendars 2023-03-01 ssju00 Judiciary Committee Senate Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report. Committee 2023-03-01 Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. 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 with an amendment in the nature of a substitute 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 K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN N 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 C001096 Sen. Cramer, Kevin [R-ND] Kevin Cramer R ND 2023-01-30 True B001277 Sen. Blumenthal, Richard [D-CT] Richard Blumenthal D CT 2023-01-30 True K000377 Sen. Kelly, Mark [D-AZ] Mark Kelly D AZ 2023-01-30 True V000128 Sen. Van Hollen, Chris [D-MD] Chris Van Hollen D MD 2023-01-30 True B001288 Sen. Booker, Cory A. [D-NJ] Cory Booker D NJ 2023-01-30 True O000174 Sen. Ossoff, Jon [D-GA] Jon Ossoff D GA 2023-02-01 False E000295 Sen. Ernst, Joni [R-IA] Joni Ernst R IA 2023-02-01 False W000800 Sen. Welch, Peter [D-VT] Peter Welch D VT 2023-02-09 False 2024-03-13T15:24:00Z S. 142, Preserve Access to Affordable Generics and Biosimilars Act https://www.cbo.gov/publication/60083 As reported by the Senate Committee on the Judiciary on March 1, 2023 Health Administrative law and regulatory procedures 2023-03-01T19:30:26Z Civil actions and liability 2023-03-01T19:30:26Z Competition and antitrust 2023-03-01T19:30:26Z Contracts and agency 2023-03-01T19:30:26Z Federal Trade Commission (FTC) 2023-03-01T19:30:26Z Intellectual property 2023-03-01T19:30:26Z Judicial review and appeals 2023-03-01T19:30:26Z Licensing and registrations 2023-03-01T19:30:26Z Manufacturing 2023-03-01T19:30:26Z Marketing and advertising 2023-03-01T19:30:26Z Prescription drugs 2023-03-01T19:30:26Z Health 2023-02-14T16:15:31Z

00 2023-01-30 Introduced in Senate 2023-06-01T15:48:46Z Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

25 2023-03-01 Reported to Senate 2023-07-18T15:34:11Z Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

Preserve Access to Affordable Generics and Biosimilars Act Display Title 45 Preserve Access to Affordable Generics and Biosimilars Act 2024-07-24T15:23:46Z Short Title(s) as Introduced 101 Preserve Access to Affordable Generics and Biosimilars Act 2024-05-24T13:42:49Z Introduced in Senate IS Short Title(s) as Reported to Senate 103 Preserve Access to Affordable Generics and Biosimilars Act 2024-05-24T13:42:28Z S Senate Reported to Senate RS Official Title as Introduced 6 A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable companies to delay the entry of biosimilar biological products and interchangeable biological products. 2023-02-10T03:28:48Z Introduced in Senate IS Reported to Senate 2023-03-01T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s142rs/xml/BILLS-118s142rs.xml Introduced in Senate 2023-01-30T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s142is/xml/BILLS-118s142is.xml 2023-03-01 Placed on Senate Legislative Calendar under General Orders. Calendar No. 20. 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.