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