Page:United States Statutes at Large Volume 122.djvu/4100

 12 2 STA T .407 7 PUBLIC LA W 110 –3 7 9—O CT. 8, 2008 ‘ ‘ (i i )ap a ten tte rm e x ten s i o n u n d er se c tion 156 o f tit l e 3 5 ,U nited S tates C ode, su bj ecttot h ere q uire - ments of such section . ‘‘( B ) AP P LICAT I ON; ANTI B IOTIC DRUG D ES CRIBED. — ‘‘(i) APPLICATION.—An application described in this clause is an application for mar k etin g submitted under this section after the date of the enactment of this subsection in w hich the drug that is the subject of the application contains an antibiotic drug described in clause (ii). ‘‘(ii) ANTIBIOTIC DRUG.—An antibiotic drug described in this clause is an antibiotic drug that was the subject of 1 or more applications recei v edb y the Secretary under section 5 07 of this Act (as in effect before N ovember 2 1,1 9 97), none of which was approved by the Secretary under such section. ‘‘(3) L I M ITATIONS.— ‘‘(A) EX CLUSI V ITIES AND EXTENSIONS.— P aragraphs (1)(A) and (2)(A) shall not be construed to entitle a drug that is the subject of an approved application described in subparagraphs (1)(B)(i) or (2)(B)(i), as applicable, to any market exclusivities or patent extensions other than those exclusivities or extensions described in paragraph (1)(A) or (2)(A). ‘‘(B) CONDITIONS O F USE.—Paragraphs (1)(A) and (2)(A)(i) shall not apply to any condition of use for which the drug referred to in subparagraph (1)(B)(i) or (2)(B)(i), as applicable, was approved before the date of the enact- ment of this subsection. ‘‘( 4 ) APPLICATION OF CERTAIN PROVISIONS.—Notwith- standing section 125, or any other provision, of the F ood and D rug Administration M oderni z ation Act of 1997, or any other provision of law, and subject to the limitations in paragraphs (1), (2), and (3), the provisions of the Drug Price Competition and Patent T erm R estoration Act of 19 8 4 shall apply to any drug subject to paragraph (1) or any drug with respect to which an election is made under paragraph (2)(A). ’ ’. (b) TRANSITIONAL RULES.— (1) W ith respect to a patent issued on or before the date of the enactment of this Act, any patent information required to be filed with the Secretary of H ealth and Human Services under subsection (b)(1) or (c)(2) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to be listed on a drug to which subsection (v)(1) of such section 505 (as added by this section) applies shall be filed with the Secretary not later than 60 days after the date of the enactment of this Act. (2) With respect to any patent information referred to in paragraph (1) of this subsection that is filed with the Sec- retary within the 60-day period after the date of the enactment of this Act, the Secretary shall publish such information in the electronic version of the list referred to at section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) as soon as it is received, but in no event later than the date that is 90 days after the enactment of this Act. (3) With respect to any patent information referred to in paragraph (1) that is filed with the Secretary within the Publicat i on.De a d line. 21USC35 5 note.

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