[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1277 Reported in Senate (RS)]





                                                       Calendar No. 640

104th CONGRESS

  2d Session

                                S. 1277

                          [Report No. 104-394]

_______________________________________________________________________

                                 A BILL

  To provide equitable relief for the generic drug industry, and for 
                            other purposes.

_______________________________________________________________________

                            October 1, 1996

                       Reported with an amendment
                                                       Calendar No. 640
104th CONGRESS
  2d Session
                                S. 1277

                          [Report No. 104-394]

  To provide equitable relief for the generic drug industry, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

           September 27 (legislative day, September 25), 1995

  Mr. Brown (for himself, Mr. Pryor, and Mr. Campbell) introduced the 
 following bill; which was read twice and referred to the Committee on 
                             the Judiciary

                            October 1, 1996

               Reported by Mr. Hatch,  with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
  To provide equitable relief for the generic drug industry, and for 
                            other purposes.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Prescription Drug Equity 
Act of 1995''.</DELETED>

<DELETED>SEC. 2. EQUITABLE TREATMENT FOR THE GENERIC DRUG 
              INDUSTRY.</DELETED>

<DELETED>    (a) Sense of the Senate.--It is the sense of the Senate 
that the generic drug industry should be provided equitable relief in 
the same manner as other industries are provided with such relief under 
the patent transitional provisions of section 154(c) of title 35, 
United States Code, as amended by section 532 of the Uruguay Round 
Agreements Act of 1994 (Public Law 103-465; 108 Stat. 4983).</DELETED>
<DELETED>    (b) Approval of Applications of Generic Drugs.--For 
purposes of acceptance and consideration by the Secretary of an 
application under subsections (b), (c), and (j) of section 505, and 
subsections (b), (c), and (n) of section 512, of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355 (b), (c), and (j), and 360b (b), 
(c), and (n)), the expiration date of a patent that is the subject of a 
certification under section 505(b)(2)(A) (ii), (iii), or (iv), section 
505(j)(2)(A)(vii) (II), (III), or (IV), or section 512(n)(1)(H) (ii), 
(iii), or (iv) of such Act, respectively, made in an application 
submitted prior to June 8, 1995, or in an application submitted on or 
after that date in which the applicant certifies that substantial 
investment was made prior to June 8, 1995, shall be deemed to be the 
date on which such patent would have expired under the law in effect on 
the day preceding December 8, 1994.</DELETED>
<DELETED>    (c) Marketing Generic Drugs.--The remedies of section 
271(e)(4) of title 35, United States Code, shall not apply to acts--
</DELETED>
        <DELETED>    (1) that were commenced, or for which a 
        substantial investment was made, prior to June 8, 1995; 
        and</DELETED>
        <DELETED>    (2) that became infringing by reason of section 
        154(c)(1) of such title, as amended by section 532 of the 
        Uruguay Round Agreements Act (Public Law 103-465; 108 Stat. 
        4983).</DELETED>
<DELETED>    (d) Equitable Remuneration.--For acts described in 
subsection (c), equitable remuneration of the type described in section 
154(c)(3) of title 35, United States Code, as amended by section 532 of 
the Uruguay Round Agreements Act (Public Law 103-465; 108 Stat. 4983) 
shall be awarded to a patentee only if there has been--</DELETED>
        <DELETED>    (1) the commercial manufacture, use, offer to 
        sell, or sale, within the United States of an approved drug 
        that is the subject of an application described in subsection 
        (b); or</DELETED>
        <DELETED>    (2) the importation by the applicant into the 
        United States of an approved drug or of active ingredient used 
        in an approved drug that is the subject of an application 
        described in subsection (b).</DELETED>

<DELETED>SEC. 3. APPLICABILITY.</DELETED>

<DELETED>    The provisions of this Act shall govern--</DELETED>
        <DELETED>    (1) the approval or the effective date of approval 
        of applications under section 505(b)(2), 505(j), 507, or 
        512(n), of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355 (b)(2) and (j), 357, and 360b(n)) submitted on or after the 
        date of enactment of this Act; and</DELETED>
        <DELETED>    (2) the approval or effective date of approval of 
        all pending applications that have not received final approval 
        as of the date of enactment of this Act.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Pharmaceutical Industry Special 
Equity Act of 1996''.

SEC. 2. APPROVAL OF GENERIC DRUGS.

    (a) In General.--With respect to any patent, the term of which is 
modified under section 154(c)(1) of title 35, United States Code, as 
amended by the Uruguay Round Agreements Act (Public Law 103-465; 108 
Stat. 4983), the remedies of section 271(e)(4) of title 35, United 
States Code, shall not apply if--
            (1) such patent is the subject of a certification described 
        under--
                    (A) section 505 (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355 (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)); or
                    (B) section 512(n)(1)(H)(iv) of such Act (21 U.S.C. 
                360b(n)(1)(H)(iv));
            (2) on or after the date of enactment of this section, such 
        a certification is made in an application that was filed under 
        section 505 or 512 of the Federal Food, Drug, and Cosmetic Act 
        and accepted for filing by the Food and Drug Administration 
        prior to June 8, 1995; and
            (3) a final order, from which no appeal is pending or may 
        be made, has been entered in an action brought under chapter 28 
        or 29 of title 35, United States Code--
                    (A) finding that the person who submitted such 
                certification made a substantial investment of the type 
                described under section 154(c)(2) of title 35, United 
                States Code, as amended by the Uruguay Round Agreements 
                Act; and
                    (B) establishing the amount of equitable 
                remuneration of the type described under section 
                154(c)(3) of title 35, United States Code, as amended 
                by the Uruguay Round Agreements Act, that is required 
                to be paid by the person who submitted such 
                certification to the patentee for the product that is 
                the subject of the certification.
    (b) Determination of Substantial Investment.--In determining 
whether a substantial investment has been made in accordance with this 
section, the court shall find that--
            (1) a complete application submitted under section 505 or 
        512 of the Federal Food, Drug, and Cosmetic Act was found by 
        the Secretary of Health and Human Services on or before June 8, 
        1995 to be sufficiently complete to permit substantive review; 
        and
            (2) the total sum of the investment made by the person 
        submitting such an application--
                    (A) is specifically related to the research, 
                development, manufacture, sale, marketing, or other 
                activities undertaken in connection with, the product 
                covered by such an application; and
                    (B) does not solely consist of that person's 
                expenditures related to the development and submission 
                of the information contained in such an application.
    (c) Compensation.--(1) In connection with the entry of the order 
described in subsection (a) (3), the court may order that the patentee 
pay equitable compensation, to the person that submitted such an 
application, for the period commencing on the date a certification 
described in subsection (a)(1) was first made and ending on the date of 
the entry of the order described in subsection (a)(3).
    (2) The court may order payment of equitable compensation under 
paragraph (1) if marketing of the product that is the subject of the 
certification was delayed as a result of an action brought pursuant to 
this section.
    (d) Effective Date of Approval of Application.--In no event shall 
the Food and Drug Administration make the approval of an application 
under sections 505 or 512 of the Federal Food, Drug, and Cosmetic Act, 
which is subject to the provisions of this Act, effective prior to the 
entry of the order described in subsection (a)(3).
    (e) Applicability.--The provisions of this section shall not apply 
to any patent the term of which, inclusive of any restoration period 
provided under section 156 of title 35, United States Code, would have 
expired on or after June 8, 1998, under the law in effect on the date 
before December 8, 1994.

SEC. 3. APPLICATION OF CERTAIN BENEFITS AND TERM EXTENSIONS TO ALL 
              PATENTS IN FORCE ON A CERTAIN DATE.

    For the purposes of this Act and the provisions of title 35, United 
States Code, all patents in force on June 8, 1995, including those in 
force by reason of section 156 of title 35, United States Code, are 
entitled to the full benefit of the Uruguay Round Agreements Act of 
1994 and any extension granted before such date under section 156 of 
title 35, United States Code.

SEC. 4. EXTENSION OF PATENTS RELATING TO NONSTEROIDAL ANTI-INFLAMMATORY 
              DRUGS.

    (a) In General.--Notwithstanding section 154 of title 35, United 
States Code, the term of patent shall be extended for any patent which 
encompasses within its scope of composition of matter known as a 
nonsteroidal anti-inflammatory drug if--
            (1) during the regulatory review of the drug by the Food 
        and Drug Administration the patentee--
                    (A) filed a new drug application in 1982 under 
                section 505 of the Federal Food, Drug and Cosmetic Act 
                (21 U.S.C. 355); and
                    (B) awaited approval by the Food and Drug 
                Administration for at least 96 months; and
            (2) such new drug application was approved in 1991.
    (b) Term.--The term of any patent described in subsection (a) shall 
be extended from its current expiration date for a period of 2 years.
    (c) Notification.--No later than 90 days after the date of 
enactment of this Act, the patentee of any patent described in 
subsection (a) shall notify the Commissioner of Patents and Trademarks 
of the number of any patent extended under such subsection. On receipt 
of such notice, the Commissioner shall confirm such extension by 
placing a notice thereof in the official file of such patent and 
publishing an appropriate notice of such extension in the Official 
Gazette of the Patent and Trademark Office.

SEC. 5. SENSE OF THE SENATE.

    It is the sense of the Senate that litigation pursuant to this Act 
will be concluded as expeditiously as possible.