[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1172 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                S. 1172

To provide a patent term restoration review procedure for certain drug 
                               products.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 27, 1999

Mr. Torricelli introduced the following bill; which was read twice and 
               referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
To provide a patent term restoration review procedure for certain drug 
                               products.

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

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''.
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