[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3995 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 3995

 To prohibit brand name drug companies from compensating generic drug 
companies to delay the entry of a generic drug into the market, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 9, 2012

 Mr. Rush (for himself and Mr. Waxman) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on the Judiciary, for a period to be 
subsequently determined by the Speaker, in each case for consideration 
  of such provisions as fall within the jurisdiction of the committee 
                               concerned

_______________________________________________________________________

                                 A BILL


 
 To prohibit brand name drug companies from compensating generic drug 
companies to delay the entry of a generic drug into the market, 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 ``Protecting Consumer Access to 
Generic Drugs Act of 2012''.

SEC. 2. UNFAIR AND DECEPTIVE ACTS AND PRACTICES RELATED TO NEW DRUG 
              APPLICATIONS.

    (a) Conduct Prohibited.--It shall be unlawful for any person to 
directly or indirectly be a party to any agreement resolving or 
settling a patent infringement claim in which--
            (1) an ANDA filer receives anything of value; and
            (2) the ANDA filer agrees not to research, develop, 
        manufacture, market, or sell, for any period of time, the drug 
        that is to be manufactured under the ANDA involved and is the 
        subject of the patent infringement claim.
    (b) Exceptions.--Notwithstanding subsection (a)(1), subsection (a) 
does not prohibit a resolution or settlement of a patent infringement 
claim in which the value received by the ANDA filer includes no more 
than--
            (1) the right to market the drug that is to be manufactured 
        under the ANDA involved and is the subject of the patent 
        infringement claim, before the expiration of--
                    (A) the patent that is the basis for the patent 
                infringement claim; or
                    (B) any other statutory exclusivity that would 
                prevent the marketing of such drug; and
            (2) the waiver of a patent infringement claim for damages 
        based on prior marketing of such drug.
    (c) Enforcement.--A violation of subsection (a) shall be treated as 
an unfair and deceptive act or practice and an unfair method of 
competition in or affecting interstate commerce prohibited under 
section 5 of the Federal Trade Commission Act (15 U.S.C. 45). The 
Federal Trade Commission shall enforce this Act in the same manner, by 
the same means, and with the same jurisdiction as though all applicable 
terms and provisions of the Federal Trade Commission Act were 
incorporated into and made a part of this Act.
    (d) Definitions.--In this section:
            (1) Agreement.--The term ``agreement'' means anything that 
        would constitute an agreement for purposes of section 5 of the 
        Federal Trade Commission Act (15 U.S.C. 45).
            (2) Agreement resolving or settling.--The term ``agreement 
        resolving or settling'', in reference to a patent infringement 
        claim, includes any agreement that is contingent upon, provides 
        a contingent condition for, or is otherwise related to the 
        resolution or settlement of the claim.
            (3) ANDA.--The term ``ANDA'' means an abbreviated new drug 
        application for the approval of a new drug under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
            (4) ANDA filer.--The term ``ANDA filer'' means a party that 
        has filed an ANDA with the Food and Drug Administration.
            (5) Patent infringement.--The term ``patent infringement'' 
        means infringement of any patent or of any filed patent 
        application, extension, reissuance, renewal, division, 
        continuation, continuation in part, reexamination, patent term 
        restoration, patent of addition, or extension thereof.
            (6) Patent infringement claim.--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 drug to be manufactured under 
        such ANDA may infringe any patent.

SEC. 3. FTC RULEMAKING.

    The Federal Trade Commission may, by rule promulgated under section 
553 of title 5, United States Code, exempt certain agreements described 
in section 2 if the Commission finds such agreements to be in 
furtherance of market competition and for the benefit of consumers. 
Consistent with the authority of the Commission, such rules may include 
interpretive rules and general statements of policy with respect to the 
practices prohibited under section 2.

SEC. 4. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD UNDER THE FFDCA.

    Section 505(j)(5)(D)(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(5)(D)(i)) is amended in subclause (V) by inserting 
``section 2 of the Protecting Consumer Access to Generic Drugs Act of 
2012 or'' after ``that the agreement has violated''.

SEC. 5. NOTICE AND CERTIFICATION OF AGREEMENTS.

    (a) Notice of All Agreements.--Section 1112(c)(2) of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (21 
U.S.C. 3155 note) is amended by--
            (1) striking ``the Commission the'' and inserting ``the 
        Commission (1) the''; and
            (2) inserting before the period at the end the following: 
        ``; and (2) a description of the subject matter of any other 
        agreement the parties enter into within 30 days of an entering 
        into an agreement covered by subsection (a) or (b)''.
    (b) Certification of Agreements.--Section 1112 of such Act is 
amended by adding at the end the following:
    ``(d) Certification.--The Chief Executive Officer or the company 
official responsible for negotiating any agreement required to be filed 
under subsection (a), (b), or (c) shall execute and file with the 
Assistant Attorney General and the Commission a certification as 
follows: `I declare under penalty of perjury that the following is true 
and correct: The materials filed with the Federal Trade Commission and 
the Department of Justice under section 1112 of subtitle B of title XI 
of the Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003, with respect to the agreement referenced in this 
certification: (1) represent the complete, final, and exclusive 
agreement between the parties; (2) include any ancillary agreements 
that are contingent upon, provide a contingent condition for, or are 
otherwise related to, the referenced agreement; and (3) include written 
descriptions of any oral agreements, representations, commitments, or 
promises between the parties that are responsive to subsection (a) or 
(b) of such section 1112 and have not been reduced to writing.'.''.
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