Sec. 348. Exclusivity period for brand name biological products

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Section 351(k)(7)(A) of the Public Health Service Act ( 42 U.S.C. 262(k)(7)(A) ) is amended by striking 12 years and inserting 5 years . Paragraphs (2)(A) and (3)(A) of section 351(m) of the Public Health Service Act ( 42 U.S.C. 262(m) ) is amended by striking 12 years each place it appears and inserting 5 years . This Act and the amendments made by this Act apply only with respect to a biological product for which the reference product (as such term is used in section 351 of the Public Health Service Act ( 42 U.S.C. 262 )) is licensed under subsection

(a)of such section on or after the date of enactment of this Act.

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U.S. Code

Regulation of biological products
§ 262

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Sec. 348

Exclusivity period for brand name biological products

U.S.C.§ 262

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