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Code · BILL · 113th Congress · S. 626 (Introduced in Senate) — To de-link research and development incentives from drug prices for new medicines to treat HIV/AIDS and to stimulate... · Sec. 5

Sec. 5. Elimination of exclusive rights to market drugs and biological products

367 words·~2 min read·/bill/113/s/626/is/section-5

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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 qualifying treatment for HIV/AIDS or manufacturing process for a qualifying treatment for HIV/AIDS (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 qualifying treatment for HIV/AIDS or a manufacturing process for a qualifying treatment for HIV/AIDS 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 Prize Fund for HIV/AIDS 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 qualifying treatment for HIV/AIDS or manufacturing process for a qualifying treatment for HIV/AIDS 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 qualifying treatment for HIV/AIDS or manufacturing process for a qualifying treatment for HIV/AIDS.
This section shall apply only with respect to the marketing, distribution, sale, or use of a qualifying treatment for HIV/AIDS or a manufacturing process for a qualifying treatment for HIV/AIDS that occurs on or after October 1, 2014. In the case of a dual use product, the elimination of exclusive rights under subsection
(a)shall apply only with respect to the manufacture, distribution, marketing, sale, or use of the product for the treatment of HIV/AIDS.
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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
U.S.C.§ 301
U.S.C.§ 355a
U.S.C.§ 360aa
U.S.C.§ 355
Pub. L.Pub. L. 98-417
Pub. L.Pub. L. 108-173
Cites 6Cited by 0 across 0 sources
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