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

  1st Session
                                S. 1277

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


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                   IN THE SENATE OF THE UNITED STATES

           September 27 (legislative day, September 25), 1995

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

_______________________________________________________________________

                                 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,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prescription Drug Equity Act of 
1995''.

SEC. 2. EQUITABLE TREATMENT FOR THE GENERIC DRUG INDUSTRY.

    (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).
    (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.
    (c) Marketing Generic Drugs.--The remedies of section 271(e)(4) of 
title 35, United States Code, shall not apply to acts--
            (1) that were commenced, or for which a substantial 
        investment was made, prior to June 8, 1995; and
            (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).
    (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--
            (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
            (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).

SEC. 3. APPLICABILITY.

    The provisions of this Act shall govern--
            (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
            (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.
                                 <all>