3.0.0 2375 2023-01-11T13:44:08Z 2023-01-11T13:44:08Z House HR 2019-04-29 116 [Congressional Record Volume 165, Number 69 (Monday, April 29, 2019)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. NADLER:H.R. 2375.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8 of the United States Constitution[Page H3303]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-04-30T19:16:06Z Discharged from 2020-12-24T15:25:19Z Referred to 2019-04-29T18:00:22Z hsju00 Judiciary Committee House Standing Reported by 2020-12-24T15:25:11Z Markup by 2019-04-30T20:46:17Z Referred to 2019-04-29T18:00:17Z H. Rept. 116-693 Preserve Access to Affordable Generics and Biosimilars Act 116 64 S 2019-01-09 Read twice and referred to the Committee on the Judiciary. Related bill CRS Competitive DRUGS Act of 2019 116 1344 HR 2019-03-25 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS 2020-12-24 Placed on the Union Calendar, Calendar No. 576. Calendars H12410 2 House floor actions U00576 2020-12-24 Committee on Energy and Commerce discharged. Discharge H12300 2 House floor actions hsif00 Energy and Commerce Committee 2020-12-24 Committee on Energy and Commerce discharged. Committee 5500 9 Library of Congress hsif00 Energy and Commerce Committee 2020-12-24 Reported by the Committee on Judiciary. H. Rept. 116-693, Part I. Committee H12200 2 House floor actions hsju00 Judiciary Committee 2020-12-24 Reported by the Committee on Judiciary. H. Rept. 116-693, Part I. Committee 5000 9 Library of Congress hsju00 Judiciary Committee 2019-04-30 hsju00 Judiciary Committee 1 House committee actions Ordered to be Reported by Voice Vote. Committee 2019-04-30 hsju00 Judiciary Committee 1 House committee actions Committee Consideration and Mark-up Session Held. Committee 2019-04-30 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-04-29 Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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 2019-04-29 Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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 2019-04-29 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-04-29 Introduced in House IntroReferral 1000 9 Library of Congress N000002 Rep. Nadler, Jerrold [D-NY-10] JERROLD NADLER D NY 10 N C001093 Rep. Collins, Doug [R-GA-9] Doug Collins R GA 9 2019-04-29 True C001084 Rep. Cicilline, David N. [D-RI-1] David Cicilline D RI N. 1 2019-04-29 True C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2019-04-30 False M001187 Rep. Meadows, Mark [R-NC-11] Mark Meadows R NC 11 2019-05-07 False 2019-05-09T15:29:00Z H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act https://www.cbo.gov/publication/55225 As ordered reported by the House Committee on the Judiciary on April 30, 2019 Health Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Congressional oversight Contracts and agency Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Marketing and advertising Prescription drugs Health 00 2019-04-29 Introduced in House 2021-07-29T13:03:12Z 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 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.

]]> 08 2020-12-24 Reported to House, Part I 2021-09-01T19:17:39Z 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 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 Preserve Access to Affordable Generics and Biosimilars Act Official Title as Introduced To prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market. Reported in House RH Short Title(s) as Introduced Preserve Access to Affordable Generics and Biosimilars Act Introduced in House IH Short Title(s) as Reported to House Preserve Access to Affordable Generics and Biosimilars Act H House Reported in House RH Reported in House 2020-12-24T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr2375rh/xml/BILLS-116hr2375rh.xml Introduced in House 2019-04-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr2375ih/xml/BILLS-116hr2375ih.xml 2020-12-24 Placed on the Union Calendar, Calendar No. 576. 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.