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.
USA115th CongressS-3738| Senate
| Updated: 12/11/2018
Orrin G. Hatch
Republican Senator
Utah
Cosponsors (1)
Health, Education, Labor, and Pensions Committee
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
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.
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Timeline
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Health
Administrative remediesDrug safety, medical device, and laboratory regulationFraud offenses and financial crimesIntellectual propertyLicensing and registrationsPrescription drugsSecurities
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.
USA115th CongressS-3738| Senate
| Updated: 12/11/2018
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.
View Full TextSuggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Orrin G. Hatch
Republican Senator
Utah
Cosponsors (1)
Health, Education, Labor, and Pensions Committee
Health
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
Administrative remediesDrug safety, medical device, and laboratory regulationFraud offenses and financial crimesIntellectual propertyLicensing and registrationsPrescription drugsSecurities