Detailed Instructions: In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Problem:SECTION 1. SHORT TITLE.

This Act may be cited as the ''Protecting Consumer Access to
Generic Drugs Act of 2007''.

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--
(1) in subclause (I)(bb)--
(A) by redesignating subitem (CC) as subitem (EE);
and
(B) by inserting after subitem (BB) the following:

''(CC) In a
declaratory judgment
action described in
subitem (AA), a court
dismisses the action
for lack of subject
matter jurisdiction,
either with or without
prejudice.

''(DD) The
applicant files with
the Secretary a
covenant by the patent
owner that the patent
owner will not sue the
applicant for
infringement with
respect to the
patent.''; and

(2) in subclause (V), by inserting ''section 2 of the
Protecting Consumer Access to Generic Drugs Act of 2007 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.'.''.
Solution:
Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages.

Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.

Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.