To amend the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes.

United States115th CongressHR-7251House of Representatives
Updated: Dec 11, 2018

Summary

Hatch-Waxman Integrity Act of 2018 This bill amends the Federal Food, Drug, and Cosmetic Act and the Securities Exchange Act of 1934 to prevent a generic drug or biosimilar manufacturer from using a specific review process for challenging pharmaceutical drug or biologic patents.

Bill texts

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Introduced (House)View official text

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Timeline

Latest companion bill action

S-3738: A bill to amend the Federal Food, Drug, and Cosmetic Act and Securities Exchange Act of 1934 to prevent the inter partes review process for challenging patents from diminishing competition in the pharmaceutical industry and with respect to drug innovation, and for other purposes.

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  1. Referred to the Committee on Energy and Commerce, and in addition to the Committee on Financial 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.

    House of Representatives

  2. Introduced in House

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