[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1315 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 1315

 To amend the Federal Food, Drug, and Cosmetic Act to define the term 
 ``first applicant'' for purposes of filing an abbreviated application 
                            for a new drug.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 22, 2009

    Mr. Nelson of Florida (for himself and Mr. Kohl) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to define the term 
 ``first applicant'' for purposes of filing an abbreviated application 
                            for a new drug.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Price Competition Act of 
2009''.

SEC. 2. EXCLUSIVITY PERIOD.

    (a) First Applicant.--Section 505(j)(5) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (B)(iv)--
                    (A) in subclause (II), by striking item (bb) and 
                inserting the following:
                                            ``(bb) First applicant.--As 
                                        used in this subsection, the 
                                        term `first applicant' means--

                                                    ``(AA) an applicant 
                                                that, on the first day 
                                                on which a 
                                                substantially complete 
                                                application containing 
                                                a certification 
                                                described in paragraph 
                                                (2)(A)(vii)(IV) is 
                                                submitted for approval 
                                                of a drug, submits a 
                                                substantially complete 
                                                application that 
                                                contains and lawfully 
                                                maintains a 
                                                certification described 
                                                in paragraph 
                                                (2)(A)(vii)(IV) for the 
                                                drug; or

                                                    ``(BB) an applicant 
                                                for the drug not 
                                                described in item (AA) 
                                                that satisfies the 
                                                requirements of 
                                                subclause (III).''; and

                    (B) by adding at the end the following:
                                    ``(III) An applicant described in 
                                subclause (II)(bb)(BB) shall--
                                            ``(aa) submit and lawfully 
                                        maintain a certification 
                                        described in paragraph 
                                        (2)(A)(vii)(IV) or a statement 
                                        described in paragraph 
                                        (2)(A)(viii) for each unexpired 
                                        patent for which a first 
                                        applicant described in item 
                                        (AA) had submitted a 
                                        certification described in 
                                        paragraph (2)(A)(vii)(IV) on 
                                        the first day on which a 
                                        substantially complete 
                                        application containing such a 
                                        certification was submitted;
                                            ``(bb) with regard to each 
                                        such unexpired patent for which 
                                        the applicant submitted a 
                                        certification described in 
                                        paragraph (2)(A)(vii)(IV), no 
                                        action for patent infringement 
                                        was brought against the 
                                        applicant within the 45-day 
                                        period specified in paragraph 
                                        (5)(B)(iii), or if an action 
                                        was brought within such time 
                                        period, the applicant has 
                                        obtained the decision of a 
                                        court (including a district 
                                        court) that the patent is 
                                        invalid or not infringed 
                                        (including any substantive 
                                        determination that there is no 
                                        cause of action for patent 
                                        infringement or invalidity, and 
                                        including a settlement order or 
                                        consent decree signed and 
                                        entered by the court stating 
                                        that the patent is invalid or 
                                        not infringed); and
                                            ``(cc) but for the 
                                        effective date of approval 
                                        provisions in subparagraphs (B) 
                                        and (F) and sections 505A and 
                                        527, be eligible to receive 
                                        immediately effective approval 
                                        at a time before any other 
                                        applicant has begun commercial 
                                        marketing.''; and
            (2) in subparagraph (D)--
                    (A) in clause (i)(IV), by striking ``The first 
                applicant'' and inserting ``The first applicant, as 
                defined in subparagraph (B)(iv)(II)(bb)(AA),''; and
                    (B) in clause (iii), in the matter preceding 
                subclause (I)--
                            (i) by striking ``If all first applicants 
                        forfeit the 180-day exclusivity period under 
                        clause (ii)''; and
                            (ii) by inserting ``If all first 
                        applicants, as defined in subparagraph 
                        (B)(iv)(II)(bb)(AA), forfeit the 180-day 
                        exclusivity period under clause (ii) at a time 
                        at which no applicant has begun commercial 
                        marketing''.
    (b) Effective Date and Transitional Provision.--
            (1) Effective date.--The amendments made by subsection (a) 
        shall be effective only with respect to an application filed 
        under section 505(j) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(j)) to which the amendments made by section 
        1102(a) of the Medicare Prescription Drug Improvement and 
        Modernization Act of 2003 (Public Law 108-173) apply.
            (2) Transitional provision.--An application filed under 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)), to which the 180-day exclusivity period 
        described in paragraph (5)(iv) of such section does not apply, 
        and that contains a certification under paragraph 
        (2)(A)(vii)(IV) of such Act, shall be regarded as a previous 
        application containing such a certification within the meaning 
        of section 505(j)(5)(B)(iv) of such Act (as in effect before 
        the amendments made by Medicare Prescription Drug Improvement 
        and Modernization Act of 2003 (Public Law 108-173)) if--
                    (A) no action for infringement of the patent that 
                is the subject of such certification was brought 
                against the applicant within the 45-day period 
                specified in section 505(j)(5)(B)(iii) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(j)(5)(B)(iii)), or if an action was brought within 
                such time period, the applicant has obtained the 
                decision of a court (including a district court) that 
                the patent is invalid or not infringed (including any 
                substantive determination that there is no cause of 
                action for patent infringement or invalidity, and 
                including a settlement order or consent decree signed 
                and entered by the court stating that the patent is 
                invalid or not infringed);
                    (B) the application is eligible to receive 
                immediately effective approval, but for the effective 
                date of approval provisions in sections 505(j)(5)(B) 
                (as in effect before the amendment made by Public Law 
                108-173), 505(j)(5)(F), 505A, and 527 of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B), 
                355(j)(5)(F), 355a, 360cc); and
                    (C) no other applicant has begun commercial 
                marketing.
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