In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.

Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Prescription Drugs Act''.

SEC. 2. COMPULSORY LICENSING OF CERTAIN PATENTED MEDICAL INVENTIONS.

    (a) In General.--Chapter 14 of title 35, United States Code, is 
amended by adding at the end the following:
``Sec. 158. Compulsory licensing
    ``(a) Compulsory Licensing of Certain Patented Medical 
Inventions.--In the case of any subject invention relating to health in 
which a patent holder, contractor, exclusive licensee, or assignee has 
acquired title under this title, the Secretary of Health and Human 
Services shall have the right to establish other use of the subject 
matter of the patent without authorization of the right holder if the 
Secretary makes the determination described in subsection (b).
    ``(b) Determination.--The determination of the Secretary of Health 
and Human Services referred to in subsection (a) is a determination 
that--
            ``(1) the patent holder, contractor, licensee, or assignee 
        referred to in subsection (a) has not taken, or is not expected 
        to take within a reasonable time, effective steps to achieve 
        practical application of the subject invention in a field of 
        use;
            ``(2) such compulsory license is necessary to alleviate 
        health or safety needs which are not adequately satisfied by 
        the patent holder, contractor, licensee, or assignee; or
            ``(3) the patented material is priced higher than may be 
        reasonably expected based on criteria developed by the 
        Secretary of Commerce.
    ``(c) Factors in Authorizing Other Use.--In exercising the right 
under subsection (a) to authorize other use of the subject matter of a 
patent, the following shall apply:
            ``(1) Authorization of such use shall be considered on its 
        individual merits.
            ``(2) Such use may only be permitted if, prior to such use, 
        the proposed user has made efforts to obtain authorization from 
        the right holder on reasonable commercial terms and conditions 
        and that such efforts have not been successful within a 
        reasonable period of time. This requirement may be waived in 
        the case of a national emergency or other circumstances of 
        extreme urgency or in cases of public noncommercial use. In 
        situations of national emergency or other circumstances of 
        extreme urgency, the right holder shall, nevertheless, be 
        notified as soon as reasonably practicable. In the case of 
        public noncommercial use, where the Government or (if 
        applicable) a contractor of the Government, without making a 
        patent search, knows or has demonstrable grounds to know that a 
        valid patent is or will be used by or for the Government, the 
        right holder shall be informed promptly.
            ``(3) Such use shall be nonexclusive.
            ``(4) Such use shall be nonassignable, except with that 
        part of the enterprise or goodwill which enjoys such use.
            ``(5) Authorization for such use shall be liable, subject 
        to adequate protection of the legitimate interests of the 
        persons so authorized, to be terminated if and when the 
        circumstances which led to it cease to exist and are unlikely 
        to recur. The competent authority shall have the authority to 
        review, upon appropriate request, the continued existence of 
        such circumstances.
            ``(6) The right holder shall be paid adequate remuneration 
        in the circumstances of each case, taking into account the 
        economic value of the authorization.
            ``(7) The legal validity of any decision relating to the 
        authorization of such use shall be subject to judicial review 
        or other independent review by a distinct Federal authority.
            ``(8) Any decision relating to the remuneration provided in 
        respect of such use shall be subject to judicial review or 
        other independent review by a distinct Federal authority.
            ``(9) The condition set forth in paragraph (2) is not 
        applicable where such use is permitted to remedy a practice 
        determined after judicial or administrative process to be 
        anticompetitive. The need to correct anticompetitive practices 
        may be taken into account in determining the amount of 
        remuneration in such cases. The competent authorities shall 
        have the authority to refuse termination of authorization if 
        and when the conditions which led to such authorization are 
        likely to recur.
            ``(10) Where such use is authorized to permit the 
        exploitation of a patent (`the 2nd patent') which cannot be 
        exploited without infringing another patent (`the 1st patent'), 
        the following additional conditions shall apply:
                    ``(A) The invention claimed in the 2nd patent shall 
                involve an important technical advance of considerable 
                economic significance in relation to the invention 
                claimed in the 1st patent.
                    ``(B) The owner of the 1st patent shall be entitled 
                to a cross-license on reasonable terms to use the 
                invention claimed in the 2nd patent.
                    ``(C) The use authorized in respect of the 1st 
                patent shall be nonassignable except with the 
                assignment of the 2nd patent.
    ``(d) Consistency With TRIPS.--Regulations adopted under subsection 
(a) shall be consistent with provisions of the Agreement on Trade-
Related Aspects of Intellectual Property Rights referred to in section 
101(d)(15) of the Uruguay Round Agreements Act.''.
    (b) Conforming Amendment.--the table of contents for chapter 14 of 
title 35, United States Code, is amended by adding at the end the 
following new item:

``158. Compulsory licensing.''.

SEC. 3. REPORT ON PHARMACEUTICAL COSTS AND SALES.

    (a) Report Requirement.--Any person engaged in the manufacture and 
sale of any drug approved under section 505 or 512 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355, 360b) for which a patent is 
still in effect shall report to the Congress annually an audit of all 
financial information relevant to the pricing of that drug nationally 
and internationally, including the costs of research and development, 
sufficient to assess the reasonableness of that pricing, in accordance 
with specifications developed by the Secretary of Commerce in 
consultation with the Commissioner of Food and Drugs.
    (b) Disqualification From Participation in Federal Programs as 
Penalty for Noncompliance.--In the case of a person who the Secretary 
of Commerce determines has failed to submit a report required under 
subsection (a) on a timely basis, the person shall be ineligible to 
receive payment from the Federal Government or under any Federal 
program (including under the medicare and medicaid programs) for any 
prescription drug or biologic it manufactures or sells until the date 
the Secretary determines that such failure has ceased.

Ex Output:
Requires any person engaged in the manufacture and sale of any new drug or new animal drug approved under the Federal Food, Drug, and Cosmetic Act, for which a patent is still in effect, to report annually to Congress an audit of all financial information relevant to that drug's pricing nationally and internationally, including research and development costs, sufficient to assess the reasonableness of that pricing. Requires disqualification from participation in Federal programs as a penalty for noncompliance with this reporting requirement.


Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Post Office Relocation Act of 
1997''.

SEC. 2. GUIDELINES FOR RENOVATION, RELOCATION, CLOSING, OR 
              CONSOLIDATION OF POST OFFICES.

    Section 404(b) of title 39, United States Code, is amended to read 
as follows--
    ``(b)(1) The Postal Service, prior to making a determination under 
subsection (a)(3) of this section as to the necessity for the 
renovation, relocation, closing, or consolidation of any post office, 
shall provide adequate notice of its intention to renovate, relocate, 
close, or consolidate such post office at least 60 days prior to the 
proposed date of such renovation, relocation, closing, or consolidation 
to persons served by such post office.
    ``(2) Such notification shall be made in writing and shall be hand 
delivered or delivered by mail to persons served by such post office, 
and shall be published in one or more newspapers of general circulation 
within the zip codes served by such post office. Such notification 
shall include--
            ``(A) an identification of the renovation, relocation, 
        closing, or consolidation;
            ``(B) a summary of the reasons for the renovation, 
        relocation, closing, or consolidation; and
            ``(C) the proposed date for the renovation, relocation, 
        renovation, closing, or consolidation.
    ``(3) Any person served by the post office may offer an alternative 
renovation, relocation, consolidation, or closing proposal within the 
60 day notice period. The Postal Service shall deliver a response in 
writing by hand delivery or certified mail to the person making the 
proposal. In a case in which the Postal Service rejects a bona fide 
proposal, the Postal Service shall state in writing the reasons for the 
rejection.
    ``(4) At the end of the 60 day notice period, the Postal Service 
shall make a determination under subsection (a)(3). Prior to making a 
final determination, the Postal Service shall conduct a hearing, and 
persons served by the post office may present oral or written testimony 
with respect to the renovation, relocation, closing, or consolidation 
of such post office. The Postal Service, in making a determination as 
to whether or not to renovate, relocate, close, or consolidate a post 
office shall consider--
            ``(A) the extent to which such post office is part of a 
        core downtown business area;
            ``(B) the effect of such renovation, relocation, closing, 
        or consolidation on the community served by such post office;
            ``(C) whether the community served by such post office 
        opposes a renovation, relocation, closing, or consolidation;
            ``(D) the effect of such renovation, relocation, closing, 
        or consolidation on employees of the Postal Service employed at 
        such office;
            ``(E) whether such renovation, relocation, closing, or 
        consolidation is consistent with the policy of the Government, 
        as stated in section 101(b) of this title, that the Postal 
        Service shall provide a maximum degree of effective and regular 
        postal services to rural areas, communities, and small towns 
        where post offices are not self sustaining;
            ``(F) the quantified long-term economic saving to the 
        Postal Service resulting from such renovation, relocation, 
        closing, or consolidation;
            ``(G) whether postal officials engaged in negotiations with 
        persons served by the post office concerning the proposed 
        renovation, relocation, closing, or consolidation;
            ``(H) whether management of the post office contributed to 
        a desire to relocate;
            ``(I) the adequacy of the existing post office, and whether 
        all reasonable alternatives have been explored; and
            ``(J) such other factors as the Postal Service determines 
        are necessary.
    ``(5) Any determination of the Postal Service to renovate, 
relocate, close, or consolidate a post office shall be in writing and 
shall include the findings of the Postal Service with respect to the 
considerations required to be made under paragraph (4) of this 
subsection. Such determination and findings shall be made available to 
persons served by such post office.
    ``(6) The Postal Service shall take no action to renovate, 
relocate, close, or consolidate a post office until 60 days after its 
written determination is made available to persons served by such post 
office.
    ``(7) A determination of the Postal Service to renovate, relocate, 
close, or consolidate any post office may be appealed by any person 
served by such post office to the Postal Rate Commission within 30 days 
after such determination is made available to such person under 
paragraph (5). The Commission shall review such determination on the 
basis of the record before the Postal Service in the making of such 
determination. The Commission shall make a determination based upon 
such review no later than 120 days after receiving any appeal under 
this paragraph. The commission shall set aside any determination, 
findings, and conclusions found to be--
            ``(A) arbitrary, capricious, an abuse of discretion, or 
        otherwise not in accordance with the law;
            ``(B) without observance of procedure required by law; or
            ``(C) unsupported by substantial evidence on the record.
The Commission may affirm the determination of the Postal Service or 
order that the entire matter be returned for further consideration, but 
the Commission may not modify the determination of the Postal Service. 
The Commission may suspend the effectiveness of the determination of 
the Postal Service until the final disposition of the appeal. The 
provisions of section 556, section 557, and chapter 7 of title 5 shall 
not apply to any review carried out by the Commission under this 
paragraph.
    ``(8) In a case in which a community has procedures to address the 
renovation, relocation, closing, or consolidation of buildings in the 
community, and the public participation requirements of such procedures 
are more stringent than those provided in this subsection, the Postal 
Service shall follow such procedures and disregard the procedures 
established in this subsection.
    ``(9) The Postal Service, in making a determination to renovate, 
relocate, close, or consolidate any post office, shall comply with any 
zoning, planning, or land use regulations, or building codes applicable 
to State or local public entities, including the zoning authority, of 
the local jurisdiction.''.

SEC. 3. POLICY STATEMENT.

    Section 101(g) of title 39, United States Code, is amended by 
adding at the end the following: ``The Postal Service shall also 
consider the effect a new postal facility may have on the community 
served by the prior facility.''.

Ex Output:
Post Office Relocation Act of 1997 - Modifies Federal postal provisions to require a 60-day notice before the renovation, relocation, closing, or consolidation (currently, the closing or consolidation) of a post office.  Requires such notice to be:  (1) hand delivered or delivered by mail; and (2) published in one or more newspapers of general circulation within the zip codes served by such post office. 
Sets forth provisions which:  (1) allow any person served by the post office to offer an alternative renovation, relocation, consolidation, or closing proposal within such 60-day period; and (2) require the Postal Service to conduct a hearing to allow the individual to present oral or written testimony. 
Revises the factors to be considered in deciding whether or not to renovate, relocate, close, or consolidate a post office to include:  (1) the extent to which the post office is part of a core downtown business area; (2) the sentiment of the community; (3) whether postal officials negotiated with persons served; (4) whether management of the post office contributed to a desire to relocate; and (5) the adequacy of the existing post office. 
Requires the Postal Service to follow a community's public participation procedures to address the renovation, relocation, closing, or consolidation of buildings in the community if participation requirements of such procedures are more stringent than those provided in this Act. 
Requires the Postal Service, in making a determination to renovate, relocate, close, or consolidate any post office, to comply with any zoning, planning, or land use regulations or building codes applicable to State or local public entities, including the zoning authority of the local jurisdiction. 
Includes within the Postal Service policy with respect to planning and building new postal facilities that the Service consider the effect a new facility may have on the community.


Ex Input:
SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Drug Competition Act of 2002''.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) prescription drug prices are increasing at an alarming 
        rate and are a major worry of many senior citizens and American 
        families;
            (2) there is a potential for companies with patent rights 
        regarding brand name drugs and companies which could 
        manufacture generic versions of such drugs to enter into 
        financial deals that could tend to restrain trade and greatly 
        reduce competition and increase prescription drug expenditures 
        for American citizens; and
            (3) enhancing competition among these companies can 
        significantly reduce prescription drug expenditures for 
        Americans.

SEC. 3. PURPOSES.

    The purposes of this Act are--
            (1) to provide timely notice to the Department of Justice 
        and the Federal Trade Commission regarding agreements between 
        companies with patent rights regarding brand name drugs and 
        companies which could manufacture generic versions of such 
        drugs; and
            (2) by providing timely notice, to enhance the 
        effectiveness and efficiency of the enforcement of the 
        antitrust and competition laws of the United States.

SEC. 4. DEFINITIONS.

    In this Act:
            (1) ANDA.--The term ``ANDA'' means an Abbreviated New Drug 
        Application, as defined under section 201(aa) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321(aa)).
            (2) Assistant attorney general.--The term ``Assistant 
        Attorney General'' means the Assistant Attorney General in 
        charge of the Antitrust Division of the Department of Justice.
            (3) Brand name drug.--The term ``brand name drug'' means a 
        drug approved under section 505(c) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(c)).
            (4) Brand name drug company.--The term ``brand name drug 
        company'' means the party that received Food and Drug 
        Administration approval to market a brand name drug pursuant to 
        an NDA, where that drug is the subject of an ANDA, or a party 
        owning or controlling enforcement of any patent listed in the 
        Approved Drug Products With Therapeutic Equivalence Evaluations 
        of the Food and Drug Administration for that drug, under 
        section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(b)).
            (5) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.
            (6) Generic drug.--The term ``generic drug'' means a 
        product that the Food and Drug Administration has approved 
        under section 505(j) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(j)).
            (7) Generic drug applicant.--The term ``generic drug 
        applicant'' means a person who has filed or received approval 
        for an ANDA under section 505(j) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355(j)).
            (8) NDA.--The term ``NDA'' means a New Drug Application, as 
        defined under section 505(b) et seq. of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355(b) et seq.)

SEC. 5. NOTIFICATION OF AGREEMENTS.

    (a) In General.--
            (1) Requirement.--A generic drug applicant that has 
        submitted an ANDA containing a certification under section 
        505(j)(2)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(j)(2)(vii)(IV)) and a brand name drug company 
        that enter into an agreement described in paragraph (2), prior 
        to the generic drug that is the subject of the application 
        entering the market, shall each file the agreement as required 
        by subsection (b).
            (2) Definition.--An agreement described in this paragraph 
        is an agreement regarding--
                    (A) the manufacture, marketing or sale of the brand 
                name drug that is the subject of the generic drug 
                applicant's ANDA;
                    (B) the manufacture, marketing or sale of the 
                generic drug that is the subject of the generic drug 
                applicant's ANDA; or
                    (C) the 180-day period referred to in section 
                505(j)(5)(B)(iv) of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) as it applies 
                to such ANDA or to any other ANDA based on the same 
                brand name drug.
    (b) Filing.--
            (1) Agreement.--The generic drug applicant and the brand 
        name drug company entering into an agreement described in 
        subsection (a)(2) shall file with the Assistant Attorney 
        General and the Commission the text of any such agreement, 
        except that the generic drug applicant and the brand-name drug 
        company shall not be required to file an agreement that solely 
        concerns--
                    (A) purchase orders for raw material supplies;
                    (B) equipment and facility contracts;
                    (C) employment or consulting contracts; or
                    (D) packaging and labeling contracts.
            (2) Other agreements.--The generic drug applicant and the 
        brand name drug company entering into an agreement described in 
        subsection (a)(2) shall file with the Assistant Attorney 
        General and the Commission the text of any other agreements not 
        described in subsection (a)(2) between the generic drug 
        applicant and the brand name drug company which are contingent 
        upon, provide a contingent condition for, or are otherwise 
        related to an agreement which must be filed under this Act.
            (3) Description.--In the event that any agreement required 
        to be filed by paragraph (1) or (2) has not been reduced to 
        text, both the generic drug applicant and the brand name drug 
        company shall file written descriptions of the non-textual 
        agreement or agreements that must be filed sufficient to reveal 
        all of the terms of the agreement or agreements.

SEC. 6. FILING DEADLINES.

    Any filing required under section 5 shall be filed with the 
Assistant Attorney General and the Commission not later than 10 
business days after the date the agreements are executed.

SEC. 7. DISCLOSURE EXEMPTION.

    Any information or documentary material filed with the Assistant 
Attorney General or the Commission pursuant to this Act shall be exempt 
from disclosure under section 552 of title 5, and no such information 
or documentary material may be made public, except as may be relevant 
to any administrative or judicial action or proceeding. Nothing in this 
section is intended to prevent disclosure to either body of Congress or 
to any duly authorized committee or subcommittee of the Congress.

SEC. 8. ENFORCEMENT.

    (a) Civil Penalty.--Any brand name drug company or generic drug 
applicant which fails to comply with any provision of this Act shall be 
liable for a civil penalty of not more than $11,000, for each day 
during which such entity is in violation of this Act. Such penalty may 
be recovered in a civil action brought by the United States, or brought 
by the Commission in accordance with the procedures established in 
section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)).
    (b) Compliance and Equitable Relief.--If any brand name drug 
company or generic drug applicant fails to comply with any provision of 
this Act, the United States district court may order compliance, and 
may grant such other equitable relief as the court in its discretion 
determines necessary or appropriate, upon application of the Assistant 
Attorney General or the Commission.

SEC. 9. RULEMAKING.

    The Commission, with the concurrence of the Assistant Attorney 
General and by rule in accordance with section 553 of title 5 United 
States Code, consistent with the purposes of this Act--
            (1) may define the terms used in this Act;
            (2) may exempt classes of persons or agreements from the 
        requirements of this Act; and
            (3) may prescribe such other rules as may be necessary and 
        appropriate to carry out the purposes of this Act.

SEC. 10. SAVINGS CLAUSE.

    Any action taken by the Assistant Attorney General or the 
Commission, or any failure of the Assistant Attorney General or the 
Commission to take action, under this Act shall not bar any proceeding 
or any action with respect to any agreement between a brand name drug 
company and a generic drug applicant at any time under any other 
provision of law, nor shall any filing under this Act constitute or 
create a presumption of any violation of any antitrust or competition 
laws.

SEC. 11. EFFECTIVE DATE.

    This Act shall--
            (1) take effect 30 days after the date of enactment of this 
        Act; and
            (2) shall apply to agreements described in section 5 that 
        are entered into 30 days after the date of enactment of this 
        Act.

            Passed the Senate November 18, 2002.

            Attest:

                                                  JERI THOMSON,

                                                             Secretary.

Ex Output:

Drug Competition Act of 2002 - (Sec. 5) Requires a generic drug applicant that has submitted an Abbreviated New Drug Application (ANDA) and a brand name drug company that enter into an agreement, prior to the generic drug entering the market, regarding the manufacture, marketing, or sale of the brand name or the generic drug, or regarding the 180-day semi-exclusivity period referred to in the Federal Food, Drug, and Cosmetic Act as it applies to such ANDA or any other ANDA based on the same brand name drug, to each file such agreement and any related agreements with the Assistant Attorney General and the Federal Trade Commission (FTC). Makes an exception for agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, or employment or consulting contracts. Requires such agreements to be filed not later than ten business days after the date they are executed.(Sec. 7) Exempts any such information or documentary material filed from disclosure under the Freedom of Information Act. Prohibits such information or material from being made public, except as relevant to any administrative or judicial action or proceeding.(Sec. 8) Subjects an applicant or company to a civil penalty of up to $11,000 for each day such entity fails to comply with this Act, recoverable in a civil action brought by the United States or the FTC. Authorizes a U.S. district court to order compliance and grant equitable relief.