text: SECTION 1. PATENT TERM RESTORATION REVIEW PROCEDURE FOR CERTAIN DRUG 
                PRODUCTS.
  
      (a) Short Title.--This Act may be cited as the ``Drug Patent Term 
  Restoration Review Procedure Act of 1999''.
      (b) Patent Term Restoration.--
              (1) In general.--Chapter 14 of title 35, United States 
          Code, is amended by inserting after section 155A the following 
          new section:
  ``Sec. 155B. Patent term restoration review procedure for certain drug 
                products
      ``(a) Definitions.--For purposes of this section--
              ``(1) the term `Commissioner' means the Commissioner of 
          Patents and Trademarks; and
              ``(2) the term `drug product' has the meaning given that 
          term under section 156(f)(2)(A), but does not include drugs or 
          products described under section 156(f)(2)(B).
      ``(b) Special Patent Term Review Procedure.--
              ``(1) In general.--
                      ``(A) Patent restored.--The term of any patent 
                  described under subparagraph (B) shall be restored 
                  under paragraph (3) from the expiration date determined 
                  under section 154 (including any extension granted 
                  under section 156), if the Commissioner determines that 
                  the standards under paragraph (2) have been met.
                      ``(B) Patent.--Subparagraph (A) refers to any 
                  patent that--
                              ``(i) has been extended under section 156, 
                          subject to the 2-year limitation described 
                          under section 156(g)(6)(c);
                              ``(ii) is in force on--
                                      ``(I) September 24, 1984;
                                      ``(II) the date of enactment of 
                                  this section; and
                                      ``(III) the date of filing an 
                                  application under this section; and
                              ``(iii) claims a drug product, a method of 
                          using a drug product, or a method of 
                          manufacturing a drug product.
              ``(2) Standards.--
                      ``(A) In general.--Upon application by the owner of 
                  record of the patent or its agent under paragraph (5) 
                  and consideration of the application and all materials 
                  submitted by parties that would be aggrieved by grant 
                  of the restoration of a patent, the term of a patent 
                  described in paragraph (1) shall be restored if the 
                  Commissioner determines that--
                              ``(i) the period set forth in section 
                          156(g)(1)(B)(ii) for the drug product exceeded 
                          60 months;
                              ``(ii) the owner of record of the patent or 
                          its agent has established by clear and 
                          convincing evidence that the patent owner acted 
                          with due diligence (as such term is defined in 
                          section 156(d)(3) and applied in section 
                          156(d)(2)) during the regulatory review period 
                          referred to in section 156(g)(1)(B); and
                              ``(iii) granting the patent restoration 
                          would not be detrimental to the public interest 
                          and the interest of fairness, as defined by the 
                          factors set forth in paragraph (7).
                      ``(B) Determination.--
                              ``(i) Deduction of time.--If the 
                          Commissioner determines there is substantial 
                          evidence that the patent owner did not act with 
                          due diligence during a part of the regulatory 
                          review period, that part shall be deducted from 
                          the total amount of time in the applicable 
                          regulatory review period referred to in section 
                          156(g)(1)(B), and the resulting period, shall 
                          be the basis for calculating the patent 
                          restoration term under paragraph (3) of this 
                          subsection.
                              ``(ii) FDA consultation.--The Food and Drug 
                          Administration shall be consulted with respect 
                          to the Commissioner's determinations under 
                          subparagraph (A) (i), (ii), and (iii). If there 
                          is a dispute concerning the underlying facts 
                          between the patent owner and the Food and Drug 
                          Administration, the Food and Drug 
                          Administration shall make the relevant records 
                          of the Administration available to the 
                          Commissioner.
              ``(3) Restoration term.--If the Commissioner determines 
          that the standards in paragraph (2) have been met for a patent, 
          the term of such patent shall be restored for a period equal to 
          the regulatory review period as defined in section 156(g)(1)(B) 
          (taking into account any deduction under paragraph (2)(B)(i)), 
          without taking into account the 2-year limitation described in 
          section 156(g)(6)(C), except that--
                      ``(A) the total of the period of the patent term 
                  restoration granted under this section and any patent 
                  term extension previously granted under section 156 
                  shall be subject to the time period limitations 
                  described in section 156(c)(2)-156 (c)(4) and 
                  (g)(6)(A); and
                      ``(B) any patent term extension previously granted 
                  under section 156 shall be subtracted from the period 
                  of the patent term restoration granted under this 
                  subsection.
              ``(4) Infringement.--During the period of any restoration 
          granted under this subsection, the rights derived from a patent 
          the term of which is restored shall be determined in accordance 
          with sections 156(b) and 271.
              ``(5) Procedure.--
                      ``(A) Time for filing.--Any application under this 
                  section shall be filed with the Commissioner within 90 
                  days after the date of enactment of this section.
                      ``(B) Filing.--Upon submission of an application to 
                  the Commissioner by the owner of record of a patent 
                  referred to in paragraph (1) or its agent for a 
                  determination in accordance with paragraph (3)--
                              ``(i) the Commissioner shall publish within 
                          30 days after the submission in the Federal 
                          Register a notice of receipt of an application 
                          and make the application available to the 
                          public upon request;
                              ``(ii) any interested party may submit 
                          comments on the application within the 60-day 
                          period beginning on the date of publication of 
                          the notice;
                              ``(iii) within 7 days following the 
                          expiration of that 60-day period, the 
                          Commissioner shall forward a copy of all 
                          comments received to the applicant, who shall 
                          be entitled to submit a response to such 
                          comments to the Commissioner within 45 days 
                          after receipt of such comments;
                              ``(iv) within 30 days following receipt of 
                          the applicant's response to comments or, if 
                          there are no such comments, within 30 days 
                          following expiration of the 60-day comment 
                          period, the Commissioner shall, in writing--
                                      ``(I) determine whether to grant 
                                  the application; and
                                      ``(II) make specific findings 
                                  regarding the criteria set forth in 
                                  paragraph (2) (including, where 
                                  appropriate, findings regarding the 
                                  public interest and fairness factors 
                                  set forth in paragraph (7)); and
                              ``(v) if the Commissioner determines that 
                          the standards set forth in paragraph (2) have 
                          been met, the Commissioner shall--
                                      ``(I) issue to the applicant a 
                                  certificate of restoration, under seal, 
                                  for the period prescribed under 
                                  paragraph (3); and
                                      ``(II) record the certificate in 
                                  the official file of the patent, which 
                                  certificate shall be in effect from the 
                                  date it issues and shall be considered 
                                  a part of the original patent.
                      ``(C) Patent term during review.--If the term of a 
                  patent for which an application has been submitted 
                  under this section would expire before a determination 
                  to issue a certificate of restoration is made under 
                  subparagraph (B), the Commissioner may extend, until 
                  such determination is made (but not to exceed 1 year) 
                  the term of the patent if the Commissioner determines 
                  that the patent likely would be eligible for 
                  restoration.
                      ``(D) Record and review.--The Commissioner's 
                  determination under subparagraph (B)(iv) shall be based 
                  solely on the record developed under this subsection. 
                  Except as provided in section 141, the Commissioner's 
                  determination shall not be reviewable in any court.
              ``(6) Application fee.--The applicant shall pay a fee for 
          an application made under this subsection which shall be 
          determined in accordance with the same criteria as the fees 
          established under section 156(h).
              ``(7) Public interest and fairness.--When required to make 
          a determination under paragraph (2)(A)(iii), the Commissioner 
          shall consider each of the following factors and shall not rely 
          solely on any single factor:
                      ``(A) Whether grant of the application would result 
                  in the public having no other commercially available 
                  alternatives to treat the same disease or condition as 
                  the drug claimed in the patent that is the subject of 
                  the patent term restoration request.
                      ``(B) Whether grant of the application would 
                  disserve society's interest in the availability of 
                  innovative drugs at competitive prices.
                      ``(C) Whether denial of the application would 
                  disserve society's interest in encouraging and 
                  rewarding pharmaceutical research and innovation.
                      ``(D) Whether denial of the application would be 
                  unfair to the applicant, in comparison to others who 
                  have experienced the benefits of a 5-year patent 
                  restoration under section 156 while experiencing 
                  similar regulatory review delays.
                      ``(E) Whether other manufacturers, before the date 
                  of enactment of this section, have submitted 
                  applications under sections 505(b)(2) or (j) of the 
                  Federal Food, Drug, and Cosmetic Act that are 
                  sufficiently complete to permit substantive review and 
                  have made substantial investments to manufacture a 
                  generic version of the particular drug that is the 
                  subject of the patent term restoration application, 
                  which would not receive the compensation specified 
                  under subsection (e) of the Drug Patent Term 
                  Restoration Review Procedure Act of 1999.''.
              (2) Technical and conforming amendment.--The table of 
          sections for chapter 14 of title 35, United States Code, is 
          amended by inserting after the item relating to section 155A 
          the following:
  
  ``155B. Patent term restoration review procedure for certain drug 
                              products.''.
      (c) Appeal of Determinations of the Commissioner.--Section 141 of 
  title 35, United States Code, is amended by adding at the end the 
  following: ``The applicant under section 155B, or any aggrieved party 
  that made a submission commenting on an application under section 155B, 
  may appeal the determination of the Commissioner under such section to 
  the United States Court of Appeals for the Federal Circuit.''.
      (d) Court Jurisdiction.--
              (1) Court of appeals for the federal circuit.--Section 
          1295(a)(4) of title 28, United States Code, is amended--
                      (A) in subparagraph (B), by striking ``or'' after 
                  the semicolon;
                      (B) in subparagraph (C), by adding ``or'' after the 
                  semicolon; and
                      (C) by inserting after subparagraph (C) the 
                  following:
                      ``(D) the Commissioner of Patents and Trademarks 
                  under section 155B of title 35;''.
              (2) Jurisdiction based on infringement of patent.--Section 
          271(e) of title 35, United States Code, is amended by adding at 
          the end the following:
              ``(5) In any action brought under paragraph (2) involving a 
          patent, the term of which has been restored under section 155B, 
          the alleged infringer shall have the right to seek compensation 
          under subsection (e) of the Drug Patent Term Restoration Review 
          Procedure Act of 1999.''.
      (e) Compensation.--
              (1) In general.--In the event a person has submitted an 
          application described in section 505(b)(2) or 505(j) of the 
          Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2),(j)) 
          for a drug product covered by a patent for which a patent term 
          restoration was provided under section 155B of title 35, United 
          States Code (as added by subsection (a)(1)) and such 
          application has been found by the Food and Drug Administration 
          on or before the date of the enactment of this section to be 
          sufficiently complete to permit substantive review, such person 
          shall be entitled to compensation of $2,000,000 by the patent 
          owner. Any holder of a Type II Drug Master File that has 
          permitted a reference to its Type II Drug Master File to be 
          made in such application shall be entitled to compensation of 
          $1,000,000 by the patent owner.
              (2) Limits on liability.--A patent owner shall not be 
          required to make under paragraph (1) payments exceeding--
                      (A) $10,000,000 to persons submitting applications 
                  described in such paragraph, or
                      (B) $5,000,000 to holders of Type II Drug Master 
                  Files.
          If the aggregate limits are insufficient to pay the applicants 
          or holders the full amounts specified in paragraph (1), each 
          such applicant or holder shall be paid its per capita share of 
          the aggregate liability imposed by paragraph (1) upon the 
          patent holder.
      (f) Effect of Filing of Abbreviated Applications.--The fact that 1 
  or more abbreviated applications have been filed under section 505 (b) 
  or (j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (b) 
  or (j)) for approval of a drug product, which is covered by a patent 
  that is the subject of an application for term restoration under this 
  section, shall not preclude the grant of such term restoration.
      (g) Report to Congress.--Not later than 1 year after the effective 
  date of this section, the Commissioner of Patents and Trademarks 
  shall--
              (1) submit to Congress a report evaluating the patent term 
          restoration review procedure established under this section; 
          and
              (2) include in such report a recommendation whether 
          Congress should consider establishing such a patent term 
          restoration review procedure for other patents.
      (h) Effective Date.--This section shall take effect on the date of 
  enactment of this section and an owner of record of a patent referred 
  to under section 155B(b)(1) of title 35, United States Code (as added 
  by this section); or an agent of the owner shall be immediately 
  eligible on such a date to submit an application to the Commissioner 
  for a determination in accordance with subsection (b)(3) of such 
  section.
  
  SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
  
      (a) Limitation on Use of Patents to Prevent ANDA Approval.--
              (1) Application.--Section 505(b)(2) of the Federal Food, 
          Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)) is amended by 
          adding at the end the following:
  ``For an approved product claimed in a patent, the term of which has 
  been restored pursuant to section 155B of title 35, United States Code, 
  the certification required by subparagraph (A) is limited to any patent 
  that claims an active ingredient, including any salt or ester of the 
  active ingredient, of the approved product, alone or in combination 
  with another active ingredient.''.
              (2) Abbreviated application.--Section 505(j)(2)(A) of the 
          Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) 
          is amended by adding at the end the following:
  ``For an approved product claimed in a patent, the term of which has 
  been restored pursuant to section 155B of title 35, United States Code, 
  the certification required by clause (vii) is limited to any patent 
  that claims an active ingredient, including any salt or ester of the 
  active ingredient, of the approved product, alone or in combination 
  with another active ingredient.''.
      (b) Exclusivity for Generic Drug.--Section 505(j)(5)(B)(iv) of the 
  Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is 
  amended by inserting after ``containing such certification'' the 
  following: ``and for which an action for infringement of a patent which 
  is the subject of such a certification has been brought before the 
  expiration of 45 days from the date of the notice provided under 
  paragraph (2)(B)(i) is received''.
target: (Sec. 1) Defines such standards as: (1) a regulatory review period from application submission to application approval exceeding 60 months; (2) clear and convincing evidence by the owner of record of the patent (or its agent) that the patent owner acted with due diligence; and (3) absence of any detriment by the granting of patent restoration to the public interest and the interest of fairness. Requires subtraction from the total amount of the restoration term of any time during the regulatory review period during which the Commissioner finds that the applicant for patent term restoration did not act with due diligence.
  Limits a restoration period, together with any extension period, and subject to other specified restrictions and adjustments, to five years.
  Requires restoration term applications to be filed within 90 days after enactment of this Act.
  Specifies factors of public interest and fairness the Commissioner shall consider when making a term restoration determination, including whether: (1) grant of the application would disserve society's interest in the availability of innovative drugs at competitive prices; or (2) denial of the application would disserve society's interest in encouraging and rewarding pharmaceutical research and innovation.
  Provides for: (1) claim determination procedure; (2) a one-year extension of the patent term pending final disposition; and (3) appeal of the Commissioner's determinations to the U.S. Court of Appeals for the Federal Circuit only.
  Entitles to compensation by the patent owner of any person who has submitted an new drug application under the Federal Food, Drug, and Cosmetic Act for a drug product covered by a patent for which a patent term was restored under this Act, if such application has been found by the Food and Drug Administration on or before enactment of this Act to be sufficiently complete to permit substantive review. Sets the amount of compensation at: (1) $2 million; or (2) $1 million for any holder of a Type II Drug Master File that has permitted a reference to its File to be made in such application. Limits a patent owner's overall liability to: (1) $10 million to persons submitting new drug applications; or (2) $5 million to holders of Type II Drug Master Files.
  Requires the Commissioner to report to Congress: (1) an evaluation of the patent term restoration review procedure established by this Act; and (2) a recommendation whether Congress should consider establishing such a patent term review procedure for patents not covered by this Act.
  (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to limit a certain required certification in an application (including an abbreviated application) for an approved product claimed in a patent whose term has been restored, to any patent that claims an active ingredient, including any salt or ester of the active ingredient, of the approved product, alone or in combination with another active ingredient (thus limiting the use of patents to prevent new drug approval).
feat_title: Drug Patent Term Restoration Review Procedure Act of 1999