Sec. 5. Elimination of exclusive rights to market drugs and biological products
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Notwithstanding title 35, United States Code, relevant provisions of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) (including amendments made by the Drug Price Competition and Patent Term Restoration Act of 1984 ( Public Law 98–417 ; commonly referred to as the Hatch-Waxman Act )), the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ), and any other provision of law providing any patent right or exclusive marketing period for any drug, biological product, or manufacturing process for a drug or biological product (such as pediatric extensions under section 505A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355a ) or orphan drug marketing exclusivity under subchapter B of chapter V of such Act ( 21 U.S.C. 360aa et seq.)), no person shall have the right to exclusively manufacture, distribute, sell, or use a drug, a biological product, or a manufacturing process for a drug or biological product in interstate commerce, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents under section 505(j) of such Act ( 21 U.S.C. 355(j) ).
A person that is eligible for prize payments from the Fund as provided for in section 9, 10, or 11 shall receive such payments— in lieu of any remuneration the person would have otherwise received for the exclusive marketing, distribution, sale, or use of a drug, biological product, or manufacturing process for a drug or biological product but for the application of subsection (a); and in addition to any other remuneration that such person receives by reason of the nonexclusive marketing, distribution, sale, or use of the drug, biological product, or manufacturing process for a drug or biological product.
This section shall apply only with respect to the marketing, distribution, sale, or use of a drug, a biological product, or a manufacturing process for a drug or biological product that occurs on or after October 1, 2018.
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- Pub. L. 98-417
- Pub. L. 108-173
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Sec. 5
Elimination of exclusive rights to market drugs and biological products
Pub. L.Pub. L. 98-417
Pub. L.Pub. L. 108-173
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