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

This Act may be cited as the ''Preserve Access to Affordable
Generics Act''.

SEC. 2. CONGRESSIONAL FINDINGS AND DECLARATION OF PURPOSES.

(a) Findings.--The Congress finds that--
(1) prescription drugs make up 11 percent of the national
health care spending but are 1 of the largest and fastest
growing health care expenditures;
(2) 56 percent of all prescriptions dispensed in the United
States are generic drugs, yet they account for only 13 percent
of all expenditures;
(3) generic drugs, on average, cost 63 percent less than
their brand-name counterparts;
(4) consumers and the health care system would benefit from
free and open competition in the pharmaceutical market and the
removal of obstacles to the introduction of generic drugs;
(5) full and free competition in the pharmaceutical
industry, and the full enforcement of antitrust law to prevent
anticompetitive practices in this industry, will lead to lower
prices, greater innovation, and inure to the general benefit of
consumers;
(6) the Federal Trade Commission has determined that some
brand name pharmaceutical manufacturers collude with generic
drug manufacturers to delay the marketing of competing, low-
cost, generic drugs;
(7) collusion by the brand name pharmaceutical
manufacturers is contrary to free competition, to the interests
of consumers, and to the principles underlying antitrust law;
(8) in 2005, 2 appellate court decisions reversed the
Federal Trade Commission's long-standing position, and upheld
settlements that include pay-offs by brand name pharmaceutical
manufacturers to generic manufacturers designed to keep generic
competition off the market;
(9) in the 6 months following the March 2005 court
decisions, the Federal Trade Commission found there were three
settlement agreements in which the generic received
compensation and agreed to a restriction on its ability to
market the product;
(10) the Federal Trade Commission found that more than /
3\ of the approximately ten settlement agreements made in 2006
include a pay-off from the brand in exchange for a promise by
the generic company to delay entry into the market; and
(11) settlements which include a payment from a brand name
manufacturer to a generic manufacturer to delay entry by
generic drugs are anti-competitive and contrary to the
interests of consumers.
(b) Purposes.--The purposes of this Act are--
(1) to enhance competition in the pharmaceutical market by
prohibiting anticompetitive agreements and collusion between
brand name and generic drug manufacturers intended to keep
generic drugs off the market;
(2) to support the purpose and intent of antitrust law by
prohibiting anticompetitive agreements and collusion in the
pharmaceutical industry; and
(3) to clarify the law to prohibit payments from brand name
to generic drug manufacturers with the purpose to prevent or
delay the entry of competition from generic drugs.

SEC. 3. UNLAWFUL COMPENSATION FOR DELAY.

The Clayton Act (15 U.S.C. 12 et seq.) is amended--
(1) by redesignating section 28 as section 29; and
(2) by inserting after section 27 the following:

''SEC. 28. UNLAWFUL INTERFERENCE WITH GENERIC MARKETING.

''(a) It shall be unlawful under this Act for any 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 which--
''(1) an ANDA filer receives anything of value; and
''(2) the ANDA filer agrees not to research, develop,
manufacture, market, or sell the ANDA product for any period of
time.
''(b) Nothing in this section 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.
''(c) In this section:
''(1) The term 'agreement' means anything that would
constitute an agreement under section 1 of the Sherman Act (15
U.S.C. 1) or section 5 of the Federal Trade Commission Act (15
U.S.C. 45).
''(2) The term 'agreement resolving or settling 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) 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)).
''(4) The term 'ANDA filer' means a party who has filed an
ANDA with the Federal Drug Administration.
''(5) The term 'ANDA product' means the product to be
manufactured under the ANDA that is the subject of the patent
infringement claim.
''(6) 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.
''(7) 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)).
''(8) The term 'NDA holder' means--
''(A) the party that received FDA approval to
market a drug product pursuant to an NDA;
''(B) 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
''(C) 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.
''(9) 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.
''(10) 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.''.

SEC. 4. 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.'.''.

SEC. 5. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

Section 505(j)(5)(D)(i)(V) of the Federal Food, Drug and Cosmetic
Act (21 U.S.C. 355(j)(5)(D)(i)(V)) is amended by inserting ''section 28
of the Clayton Act or'' after ''that the agreement has violated''.

SEC. 6. AUTHORIZATION OF APPROPRIATIONS.

There are authorized to be appropriated to the Federal Trade
Commission such sums as may be necessary to carry out the provisions of
this Act.
A:
Preserve Access to Affordable Generics Act - Amends the Clayton Act to make it unlawful for a person, in connection with the sale of a drug product, to be 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 product for any period. Excludes a resolution or settlement that includes no more than the right to market the generic product prior to the expiration of the patent.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreements are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the Federal Trade Commission (FTC) or the court that an agreement has violated this Act.