PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2449
to another such certification contained in the application or in an amendment or supplement to the application. ‘‘(iii) RECIPIENTS OF NOTICE.—An applicant required under this subparagraph to give notice shall give notice to— ‘‘(I) each owner of the patent that is the subject of the certification (or a representative of the owner designated to receive such a notice); and ‘‘(II) the holder of the approved application under subsection (b) for the drug that is claimed by the patent or a use of which is claimed by the patent (or a representative of the holder designated to receive such a notice). ‘‘(iv) CONTENTS OF NOTICE.—A notice required under this subparagraph shall— ‘‘(I) state that an application that contains data from bioavailability or bioequivalence studies has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification; and ‘‘(II) include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed.’’; and (B) by adding at the end the following subparagraph: ‘‘(D)(i) An applicant may not amend or supplement an application to seek approval of a drug referring to a different listed drug from the listed drug identified in the application as submitted to the Secretary. ‘‘(ii) With respect to the drug for which an application is submitted, nothing in this subsection prohibits an applicant from amending or supplementing the application to seek approval of a different strength. ‘‘(iii) Within 60 days after the date of the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, the Secretary shall issue guidance defining the term ‘listed drug’ for purposes of this subparagraph.’’; and (2) in paragraph (5)— (A) in subparagraph (B)— (i) by striking ‘‘under the following’’ and inserting ‘‘by applying the following to each certification made under paragraph (2)(A)(vii)’’; and (ii) in clause (iii)— (I) in the first sentence, by striking ‘‘unless’’ and all that follows and inserting ‘‘unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted.’’; and (II) in the second sentence— (aa) by striking subclause (I) and inserting the following:
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