[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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