Page:United States Statutes at Large Volume 117.djvu/2477

 117 STAT. 2458

PUBLIC LAW 108–173—DEC. 8, 2003 a substantive review and contains all the information required by paragraph (2)(A). ‘‘(dd) TENTATIVE APPROVAL.— ‘‘(AA) IN GENERAL.—The term ‘tentative approval’ means notification to an applicant by the Secretary that an application under this subsection meets the requirements of paragraph (2)(A), but cannot receive effective approval because the application does not meet the requirements of this subparagraph, there is a period of exclusivity for the listed drug under subparagraph (F) or section 505A, or there is a 7-year period of exclusivity for the listed drug under section 527. ‘‘(BB) LIMITATION.—A drug that is granted tentative approval by the Secretary is not an approved drug and shall not have an effective approval until the Secretary issues an approval after any necessary additional review of the application.’’; and (2) by inserting after subparagraph (C) the following: ‘‘(D) FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.— ‘‘(i) DEFINITION OF FORFEITURE EVENT.—In this subparagraph, the term ‘forfeiture event’, with respect to an application under this subsection, means the occurrence of any of the following: ‘‘(I) FAILURE TO MARKET.—The first applicant fails to market the drug by the later of— ‘‘(aa) the earlier of the date that is— ‘‘(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or ‘‘(BB) 30 months after the date of submission of the application of the first applicant; or ‘‘(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred: ‘‘(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.

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