text: SECTION 1. SHORT TITLE.
  
      This Act may be cited as the ``Fair And Immediate Release of 
  Generic Drugs Act'' or the ``FAIR Generics Act''.
  
  SEC. 2. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING FIRST APPLICANT 
                STATUS.
  
      (a) Amendments to Federal Food, Drug, and Cosmetic Act.--
              (1) In general.--Section 505(j)(5)(B) of the Federal Food, 
          Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) is amended--
                      (A) in clause (iv)(II)--
                              (i) by striking item (bb); and
                              (ii) by redesignating items (cc) and (dd) 
                          as items (bb) and (cc), respectively; and
                      (B) by adding at the end the following:
      ``(v) First Applicant Defined.--As used in this subsection, the 
  term `first applicant' means an applicant--
              ``(I)(aa) 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; and
              ``(bb) that has not entered into a disqualifying agreement 
          described under clause (vii)(II); or
              ``(II)(aa) for the drug that is not described in subclause 
          (I) and that, with respect to the applicant and drug, each 
          requirement described in clause (vi) is satisfied; and
              ``(bb) that has not entered into a disqualifying agreement 
          described under clause (vii)(II).
      ``(vi) Requirement.--The requirements described in this clause are 
  the following:
              ``(I) The applicant described in clause (v)(II) submitted 
          and lawfully maintains 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 clause (v)(I) 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.
              ``(II) With regard to each such unexpired patent for which 
          the applicant described in clause (v)(II) submitted a 
          certification described in paragraph (2)(A)(vii)(IV), no action 
          for patent infringement was brought against such applicant 
          within the 45 day period specified in paragraph (5)(B)(iii); or 
          if an action was brought within such time period, such an 
          action was withdrawn or dismissed by a court (including a 
          district court) without a decision that the patent was valid 
          and infringed; or if an action was brought within such time 
          period and was not withdrawn or so dismissed, such 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).
              ``(III) If an applicant described in clause (v)(I) has 
          begun commercial marketing of such drug, the applicant 
          described in clause (v)(II) does not begin commercial marketing 
          of such drug until the date that is 30 days after the date on 
          which the applicant described in clause (v)(I) began such 
          commercial marketing.''.
              (2) Conforming amendment.--Section 505(j)(5)(D)(i)(IV) of 
          such Act (21 U.S.C. 355(j)(5)(D)(i)(IV)) is amended by striking 
          ``The first applicant'' and inserting ``The first applicant, as 
          defined in subparagraph (B)(v)(I),''.
      (b) Applicability.--The amendments made by subsection (a) shall 
  apply 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.
  
  SEC. 3. 180-DAY EXCLUSIVITY PERIOD AMENDMENTS REGARDING AGREEMENTS TO 
                DEFER COMMERCIAL MARKETING.
  
      (a) Amendments to Federal Food, Drug, and Cosmetic Act.--
              (1) Limitations on agreements to defer commercial marketing 
          date.--Section 505(j)(5)(B) of the Federal Food, Drug, and 
          Cosmetic Act (21 U.S.C. 355(j)(5)(B)), as amended by section 2, 
          is further amended by adding at the end the following:
              ``(vii) Agreement by first applicant to defer commercial 
          marketing; limitation on acceleration of deferred commercial 
          marketing date.--
                      ``(I) Agreement to defer approval or commercial 
                  marketing date.--An agreement described in this 
                  subclause is an agreement between a first applicant and 
                  the holder of the application for the listed drug or an 
                  owner of one or more of the patents as to which any 
                  applicant submitted a certification qualifying such 
                  applicant for the 180-day exclusivity period whereby 
                  that applicant agrees, directly or indirectly, (aa) not 
                  to seek an approval of its application that is made 
                  effective on the earliest possible date under this 
                  subparagraph, subparagraph (F) of this paragraph, 
                  section 505A, or section 527, (bb) not to begin the 
                  commercial marketing of its drug on the earliest 
                  possible date after receiving an approval of its 
                  application that is made effective under this 
                  subparagraph, subparagraph (F) of this paragraph, 
                  section 505A, or section 527, or (cc) to both items 
                  (aa) and (bb).
                      ``(II) Agreement that disqualifies applicant from 
                  first applicant status.--An agreement described in this 
                  subclause is an agreement between an applicant and the 
                  holder of the application for the listed drug or an 
                  owner of one or more of the patents as to which any 
                  applicant submitted a certification qualifying such 
                  applicant for the 180-day exclusivity period whereby 
                  that applicant agrees, directly or indirectly, not to 
                  seek an approval of its application or not to begin the 
                  commercial marketing of its drug until a date that is 
                  after the expiration of the 180-day exclusivity period 
                  awarded to another applicant with respect to such drug 
                  (without regard to whether such 180-day exclusivity 
                  period is awarded before or after the date of the 
                  agreement).
              ``(viii) Limitation on acceleration.--If an agreement 
          described in clause (vii)(I) includes more than 1 possible date 
          when an applicant may seek an approval of its application or 
          begin the commercial marketing of its drug--
                      ``(I) the applicant may seek an approval of its 
                  application or begin such commercial marketing on the 
                  date that is the earlier of--
                              ``(aa) the latest date set forth in the 
                          agreement on which that applicant can receive 
                          an approval that is made effective under this 
                          subparagraph, subparagraph (F) of this 
                          paragraph, section 505A, or section 527, or 
                          begin the commercial marketing of such drug, 
                          without regard to any other provision of such 
                          agreement pursuant to which the commercial 
                          marketing could begin on an earlier date; or
                              ``(bb) 180 days after another first 
                          applicant begins commercial marketing of such 
                          drug; and
                      ``(II) the latest date set forth in the agreement 
                  on which that applicant can receive an approval that is 
                  made effective under this subparagraph, subparagraph 
                  (F) of this paragraph, section 505A, or section 527, or 
                  begin the commercial marketing of such drug, without 
                  regard to any other provision of such agreement 
                  pursuant to which commercial marketing could begin on 
                  an earlier date, shall be the date used to determine 
                  whether an applicant is disqualified from first 
                  applicant status pursuant to clause (vii)(II).''.
              (2) Notification of fda.--Section 505(j) of such Act (21 
          U.S.C. 355(j)) is amended by adding at the end the following:
      ``(11)(A) The holder of an abbreviated application under this 
  subsection shall submit to the Secretary a notification that includes--
              ``(i)(I) the text of any agreement entered into by such 
          holder described under paragraph (5)(B)(vii)(I); or
              ``(II) if such an agreement has not been reduced to text, a 
          written detailed description of such agreement that is 
          sufficient to disclose all the terms and conditions of the 
          agreement; and
              ``(ii) the text, or a written detailed description in the 
          event of an agreement that has not been reduced to text, of any 
          other agreements that are contingent upon, provide a contingent 
          condition for, or are otherwise related to an agreement 
          described in clause (i).
      ``(B) The notification described under subparagraph (A) shall be 
  submitted not later than 10 business days after execution of the 
  agreement described in subparagraph (A)(i). Such notification is in 
  addition to any notification required under section 1112 of the 
  Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
      ``(C) Any information or documentary material filed with the 
  Secretary pursuant to this paragraph shall be exempt from disclosure 
  under section 552 of title 5, United States Code, and no such 
  information or documentary material may be made public, except as may 
  be relevant to any administrative or judicial action or proceeding. 
  Nothing in this paragraph is intended to prevent disclosure to either 
  body of the Congress or to any duly authorized committee or 
  subcommittee of the Congress.''.
              (3) Prohibited acts.--Section 301(e) of such Act (21 U.S.C. 
          331(e)) is amended by striking ``505 (i) or (k)'' and inserting 
          ``505 (i), (j)(11), or (k)''.
      (b) Infringement of Patent.--Section 271(e) of title 35, United 
  States Code, is amended by adding at the end the following:
      ``(7) The exclusive remedy under this section for an infringement 
  of a patent for which the Secretary of Health and Human Services has 
  published information pursuant to subsection (b)(1) or (c)(2) of 
  section 505 of the Federal Food, Drug, and Cosmetic Act shall be an 
  action brought under this subsection within the 45-day period described 
  in subsection (j)(5)(B)(iii) or (c)(3)(C) of section 505 of the Federal 
  Food, Drug, and Cosmetic Act.''.
      (c) Applicability.--
              (1) Limitations on acceleration of deferred commercial 
          marketing date.--The amendment made by subsection (a)(1) shall 
          apply only with respect to--
                      (A) 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; 
                  and
                      (B) an agreement described under section 
                  505(j)(5)(B)(vii)(I) of the Federal Food, Drug, and 
                  Cosmetic Act (as added by subsection (a)(1)) executed 
                  after the date of enactment of this Act.
              (2) Notification of fda.--The amendments made by paragraphs 
          (2) and (3) of subsection (a) shall apply only with respect to 
          an agreement described under section 505(j)(5)(B)(vii)(I) of 
          the Federal Food, Drug, and Cosmetic Act (as added by 
          subsection (a)(1)) executed after the date of enactment of this 
          Act.
target: Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patentholder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).
  
  Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing.
  
  Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug.
  
  Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement.
  
  Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.
feat_title: A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market.