[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1598 Introduced in House (IH)]







106th CONGRESS
  1st Session
                                H. R. 1598

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 28, 1999

  Mr. Bryant (for himself, Mr. McDermott, Mrs. Bono, Mr. Duncan, Mr. 
Wicker, Mr. Jenkins, Mr. Franks of New Jersey, Mr. Ford, Mr. Blunt, Mr. 
Wamp, Mr. Hoyer, Mr. Rothman, Mr. Menendez, Mr. Gordon, Mrs. Tauscher, 
  Mr. Delahunt, Ms. Jackson-Lee of Texas, Ms. Eshoo, Mr. Pastor, Mr. 
Conyers, Mr. Smith of Texas, Mr. Payne, Mrs. Emerson, Mr. Hilleary, and 
Mr. Frelinghuysen) introduced the following bill; which was 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. SHORT TITLE.

    This Act may be cited as the ``Patent Fairness Act of 1999''.

SEC. 2. PATENT TERM RESTORATION REVIEW PROCEDURE FOR CERTAIN DRUG 
              PRODUCTS.

    (a) 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 such term 
        under section 156(f)(2)(A).
    ``(b) Special Patent Term Review Procedure.--
            ``(1) In general.--The term of any patent, in force on 
        September 24, 1984, and on the date of the filing of an 
        application under this section, that claims--
                    ``(A) a drug product,
                    ``(B) a method of using a drug product, or
                    ``(C) a method of manufacturing a drug product,
        shall be restored under paragraph (4) from the expiration date 
        of the patent term determined under section 154 (including any 
        extension granted under section 156) if the Commissioner 
        determines that the standards under paragraph (2) have been 
        met.
            ``(2) Standards.--Upon application, filed under paragraph 
        (6), by the owner of record of a patent described in paragraph 
        (1) or its agent and consideration of the application and all 
        materials submitted by parties that would be aggrieved by grant 
        of the restoration of the term of such patent, the term of such 
        patent shall be restored if the Commissioner determines that--
                    ``(A) the period set forth in section 
                156(g)(1)(B)(ii) for the drug product exceeded 60 
                months; and
                    ``(B) there is no substantial evidence overcoming 
                the rebuttable presumption that the applicant for 
                patent term restoration for the drug product acted with 
                due diligence (as such term is defined in section 
                156(d)(3)) during the period referred to in section 
                156(g)(1)(B)(ii).
        If the Commissioner determines there is substantial evidence 
        that the applicant for patent term restoration did not act with 
        due diligence during a part of the period referred to in 
        section 156(g)(1)(B)(ii) that part shall be deducted from the 
        total amount of time in such period for purposes of paragraph 
        (4).
            ``(3) Records.--The Commissioner may request and obtain 
        relevant records from the Food and Drug Administration to 
        verify the facts underlying the Commissioner's determinations 
        under paragraph (2). Such records shall be afforded the same 
        protections against public disclosure that apply to such 
        records when in the possession of the Food and Drug 
        Administration.
            ``(4) 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 restoration 
        period equal to the period set forth in section 
        156(g)(1)(B)(ii) for the drug product that is the subject of an 
        application under paragraph (6), except that--
                    ``(A) the restoration period shall be reduced by 
                any deduction made pursuant to paragraph (2);
                    ``(B) if the sum of--
                            ``(i) the remaining term of such patent 
                        after the date of the approval of the drug 
                        product covered by the patent under the 
provision of law under which the regulatory review occurred, and
                            ``(ii) the restoration period as revised 
                        under subparagraph (A),
        exceeds 14 years, the restoration period shall be reduced so 
        that the total of such periods does not exceed 14 years; and
                    ``(C) the restoration period, after any adjustment 
                required by subparagraph (A) or (B) plus any previous 
                extension of the patent term under section 156(c), 
                shall not exceed 5 years.
            ``(5) 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.
            ``(6) Procedure.--
                    ``(A) Time for filing.--An application under this 
                section shall be filed with the Commissioner within 90 
                days after the date of the enactment of this section.
                    ``(B) Filing and determination.--Upon the filing of 
                an application to the Commissioner under this section--
                            ``(i) the Commissioner shall publish within 
                        30 days of its filing a notice in the Federal 
                        Register of receipt of the application;
                            ``(ii) any party who would be aggrieved by 
                        the granting of a patent term restoration under 
                        the application may submit comments on the 
                        application within the 30-day period beginning 
                        on the date of publication of the notice under 
                        clause (i);
                            ``(iii) within 7 days following the 
                        expiration of the 30-day comment 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 30 days after 
                        receipt of the comments from the Commissioner;
                            ``(iv) within 30 days following the receipt 
                        of the applicant's response to comments or, if 
                        there are no such comments, within 30 days 
                        following expiration of the 30-day comment 
                        period, the Commissioner shall, in writing--
                                    ``(I) determine whether to grant 
                                the patent term restoration for which 
                                the application was filed; and
                                    ``(II) make specific findings 
                                regarding the criteria set forth in 
                                paragraph (2); and
                            ``(V) if the Commissioner grants such 
                        patent term restoration, on the same date that 
                        the Commissioner makes the determination under 
                        clause (iv) the Commissioner shall--
                                    ``(I) issue to the applicant a 
                                certificate of patent term restoration, 
                                under seal, for the period prescribed 
                                under paragraph (4); and
                                    ``(II) record the certificate in 
                                the official file of the patent, which 
                                certificate shall be in effect from 
                                such date and shall be considered a 
                                part of the original patent.
                    ``(C) Interim restoration.--If the term of a patent 
                that is the subject of an application filed under this 
                section would otherwise expire before a determination 
                under subparagraph (B)(iv) is made, the Commissioner 
                shall extend the term of such patent until--
                            ``(i) a determination is made under such 
                        subparagraph to restore the term of such 
                        patent, or
                            ``(ii) 60 days after a determination is 
                        made under such subparagraph to not restore the 
                        patent term,
                as applicable. If the Commissioner determines not to 
                restore the patent term, then during the 60-day period 
                described in clause (ii), an applicant may apply to the 
                United States Court of Appeals for the Federal Circuit 
                for an order directing the Commissioner to extend the 
                patent pending judicial review and subsequent 
                Commissioner action following that review.
                    ``(D) Record.--The Commissioner's determination 
                under subparagraph (B)(iv) shall be based solely on the 
                record developed under this subsection.
            ``(7) Application fee.--The applicant shall pay a fee for 
        an application made under paragraph (6) which shall be 
        established in accordance with the same criteria applicable to 
        fees required under section 156(h). If no such fee has been 
        established at the time of the application, the applicant may 
provide the Commissioner with an undertaking, satisfactory to the 
Commissioner, to pay the subsequently established fee.''.
            (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.''.
    (b) Appeal of Determinations of the Commissioner.--Section 141 of 
the 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 made under such 
section may appeal the determination of the Commissioner with respect 
to the application involved under such section only to the United 
States Court of Appeals for the Federal Circuit.''.
    (c) Court Jurisdiction.--Section 1295(a)(4) of title 28, United 
States Code, is amended--
            (1) in subparagraph (B), by striking ``or'' after the 
        semicolon;
            (2) in subparagraph (C), by adding ``or'' after the 
        semicolon; and
            (3) by inserting after subparagraph (C) the following:
                    ``(D) the Commissioner of Patents and Trademarks 
                under section 155B of title 35;''.
    (d) 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 $1,000,000 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 
        $500,000 by the patent owner.
            (2) Limits on liability.--A patent owner shall not be 
        required to make under paragraph (1) payments exceeding--
                    (A) $5,000,000 to persons submitting applications 
                described in such paragraph, or
                    (B) $2,500,000 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.
    (e) Effect of Filing of Abbreviated Applications.--The fact that 
one or more applications have been filed under section 505(b)(2) or 
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(2),(j)) for approval of a drug or a method of using a drug which 
is claimed by a patent that is the subject of an application under 
section 155B of title 35, United States Code, for restoration of the 
patent term shall not affect the grant of such patent term restoration.
    (f) Report.--Not later than 1 year after the date of the enactment 
of this section, the Commissioner of Patents and Trademarks shall 
submit to Congress a report evaluating the patent term restoration 
review procedure established under section 155B of title 35, United 
States Code, and shall include in such report a recommendation whether 
Congress should consider establishing such a patent term review 
procedure for patents not covered by such section.
    (g) Effective Date.--The owner of record of a patent referred to in 
section 155B(b)(1) of title 35, United States Code (as added by 
subsection (a)(1)) or an agent of the owner shall be immediately 
eligible on the date of the enactment of this section to submit an 
application to the Commissioner of Patents and Trademarks for a 
determination in accordance with section 155B(b)(6) of such title.
                                 <all>