[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3582 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3582

 To prohibit brand name drug companies from compensating generic drug 
    companies to delay the entry of a generic drug into the market.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 27, 2006

   Mr. Kohl (for himself, Mr. Leahy, Mr. Grassley, and Mr. Schumer) 
introduced the following bill; which was read twice and referred to the 
           Committee on Commerce, Science, and Transportation

_______________________________________________________________________

                                 A BILL


 
 To prohibit brand name drug companies from compensating generic drug 
    companies to delay the entry of a generic drug into the market.

    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 ``Preserve Access to Affordable 
Generics Act''.

SEC. 2. UNFAIR COMPETITION.

    Section 5 of the Federal Trade Commission Act (15 U.S.C. 45) is 
amended by adding at the end the following:
    ``(o)(1) It shall be considered an unfair method of competition 
affecting commerce under subsection (a)(1) for a person, in connection 
with the sale of a drug product, to directly or indirectly be a party 
to any agreement resolving or settling a patent infringement claim in 
which--
            ``(A) an ANDA filer receives anything of value; and
            ``(B) the ANDA filer agrees not to research, develop, 
        manufacture, market, or sell the ANDA product for any period of 
        time.
    ``(2) Construction.--Nothing in this subsection shall prohibit a 
resolution or settlement of patent infringement claim in which the 
value paid by the NDA holder to the ANDA filer as a part of the 
resolution or settlement of the patent infringement claim includes no 
more than the right to market the ANDA product prior to the expiration 
of the patent that is the basis for the patent infringement claim.
    ``(3) In this subsection:
            ``(A) The term `ANDA' means an abbreviated new drug 
        application, as defined under section 505(j) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
            ``(B) The term `ANDA filer' means a party who has filed an 
        ANDA with the Federal Drug Administration.
            ``(C) The term `ANDA product' means the product to be 
        manufactured under the ANDA that is the subject of the patent 
        infringement claim.
            ``(D) The term `drug product' means a finished dosage form 
        (e.g., tablet, capsule, or solution) that contains a drug 
        substance, generally, but not necessarily, in association with 
        1 or more other ingredients, as defined in section 314.3(b) of 
        title 21, Code of Federal Regulations.
            ``(E) The term `NDA' means a new drug application, as 
        defined under section 505(b) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(b)).
            ``(F) The term `NDA holder' means--
                    ``(i) the party that received FDA approval to 
                market a drug product pursuant to an NDA;
                    ``(ii) a party owning or controlling enforcement of 
                the patent listed in the Approved Drug Products With 
                Therapeutic Equivalence Evaluations (commonly known as 
                the `FDA Orange Book') in connection with the NDA; or
                    ``(iii) the predecessors, subsidiaries, divisions, 
                groups, and affiliates controlled by, controlling, or 
                under common control with any of the entities described 
                in subclauses (i) and (ii) (such control to be presumed 
                by direct or indirect share ownership of 50 percent or 
                greater), as well as the licensees, licensors, 
                successors, and assigns of each of the entities.
            ``(G) The term `patent infringement' means infringement of 
        any patent or of any filed patent application, extension, 
        reissue, renewal, division, continuation, continuation in part, 
        reexamination, patent term restoration, patents of addition and 
        extensions thereof.
            ``(H) The term `patent infringement claim' means any 
        allegation made to an ANDA filer, whether or not included in a 
        complaint filed with a court of law, that its ANDA or ANDA 
        product may infringe any patent held by, or exclusively 
        licensed to, the NDA holder of the drug product.''.
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