text: 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.
target: Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.
feat_title: 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.