PUBLIC LAW 108–173—DEC. 8, 2003
117 STAT. 2453
‘‘(ii) if the certification is in an amendment or supplement to the application, at the time at which the applicant submits the amendment or supplement, regardless of whether the applicant has already given notice with respect to another such certification contained in the application or in an amendment or supplement to the application. ‘‘(C) RECIPIENTS OF NOTICE.—An applicant required under this paragraph 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 this subsection 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). ‘‘(D) CONTENTS OF NOTICE.—A notice required under this paragraph 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)(i) by redesignating paragraph (4) as paragraph (5); and (ii) by inserting after paragraph (3) the following paragraph: ‘‘(4)(A) An applicant may not amend or supplement an application referred to in paragraph (2) to seek approval of a drug that is a different drug than the drug identified in the application as submitted to the Secretary. ‘‘(B) With respect to the drug for which such an application is submitted, nothing in this subsection or subsection (c)(3) prohibits an applicant from amending or supplementing the application to seek approval of a different strength.’’; and (2) in subsection (c)(3)— (A) in the first sentence, by striking ‘‘under the following’’ and inserting ‘‘by applying the following to each certification made under subsection (b)(2)(A)’’; (B) in subparagraph (C)— (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 subsection (b)(3) 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 paragraph (2) or subsection (b)(1) before the date on which the application (excluding an amendment or supplement to the application) was submitted.’’; (ii) in the second sentence— (I) by striking ‘‘paragraph (3)(B)’’ and inserting ‘‘subsection (b)(3)’’;
VerDate 11-MAY-2000
13:59 Aug 30, 2004
Jkt 019194
PO 00000
Frm 00389
Fmt 6580
Sfmt 6581
D:\STATUTES\2003\19194PT3.001
APPS10
PsN: 19194PT3
�
