[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[S. 1191 Introduced in Senate (IS)]







104th CONGRESS
  1st Session
                                S. 1191

  To provide for the availability of certain generic human and animal 
                     drugs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               August 11 (legislative day, July 10), 1995

   Mr. Pryor introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
  To provide for the availability of certain generic human and animal 
                     drugs, 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 Consumer Access to Prescription 
Drugs Act of 1995''.

SEC. 2. APPROVAL AND MARKETING OF GENERIC DRUGS.

    (a) Approval of Applications.--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), 
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.
    (b) Right To Market.--The remedies of section 271(e)(4) of title 
35, United States Code, shall not apply to acts which--
            (1) were commenced or for which a substantial investment 
        was made prior to June 8, 1995; and
            (2) 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).
    (c) Equitable Remuneration.--For acts described in subsection (b), 
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) may 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 (a); or
            (2) the importation into the United States of an approved 
        drug that is the subject of an application described in 
        subsection (a).

SEC. 3. DEFINITIONS.

    (a) Acts Which Were Commenced.--The submission of an application 
for approval of a drug 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)) prior to June 8, 1995, or the subsequent making, 
using, offering to sell, selling, or importing of the drug which is the 
subject of the application, shall constitute acts which were commenced 
prior to June 8, 1995, as that term is used in this Act and in section 
154(c)(2) of title 35, United States Code, as amended by section 532 of 
the Uruguay Round Agreements Act (Public Law 103-465; 108 Stat. 4983). 
A person who submits such application, and a person who supplied any 
active ingredient used by such person in such drug, shall be deemed to 
have performed acts which were commenced prior to June 8, 1995.
    (b) Substantial Investment.--The development of a product 
formulation and the manufacture of an experimental batch of a drug that 
becomes the subject of an application, or the initiation of stability 
or bioequivalency studies, by an applicant referred to in section 
505(b)(2), 505(j), or 512(n), or by a manufacturer of a drug referred 
to in section 507, of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355 (b)(2) and (j), 360b(n), and 357) shall constitute 
substantial investment, as that term is used in this Act and in section 
154(c)(2)(A) of title 35, United States Code, as amended by section 532 
of the Uruguay Round Agreements Act (Public Law 103-465; 108 Stat. 
4983). A person who supplied any active ingredient used by such 
applicant in such drug or by such manufacturer in such drug shall be 
deemed to have made substantial investment by having supplied the 
active ingredient to such applicant or such manufacturer.

SEC. 4. APPLICABILITY.

    (a) Applicability to Approval of Applications.--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.
    (b) Applicability in Judicial Proceedings.--The provisions of this 
Act shall apply in any action that--
            (1) relates to the approval or marketing of a drug or the 
        infringement of a patent; and
            (2)(A) is brought in a Federal or State court on or after 
        the date of enactment of this Act; or
            (B) is brought in a Federal or State court prior to the 
        date of enactment of this Act and pending on such date.
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