[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5350 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 5350

To provide greater access to affordable pharmaceuticals, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 9, 2002

 Mr. Kennedy of Rhode Island introduced the following bill; which was 
 referred to the Committee on Energy and Commerce, and in addition to 
   the Committee on Ways and Means, 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 provide greater access to affordable pharmaceuticals, 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 ``Prescription Affordability and 
Medicine Safety Act of 2002''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) Although prescription drugs represent one of the 
        increasingly used medical care interventions in treating common 
        acute and chronic diseases, many Americans, especially the 
        elderly and other vulnerable populations, are often unable to 
        afford their medication because of excessive and persistent 
        drug price inflation.
            (2) In 1999, the top 5 pharmaceutical companies allocated a 
        higher proportion of their revenue to their income than to 
        research and development.
            (3) In 2000, over \1/3\ of the most frequently prescribed 
        drugs for seniors rose in price at a rate that was 3 times the 
        rate of inflation.
            (4) Prescription drug manufacturers continue to make 
        enormous profits on the backs of Americans.
            (5) Because of the limited availability of private or 
        public prescription drug coverage for the elderly, prescription 
        drugs represent the highest out-of-pocket medical care cost for 
        3 of 4 elderly patients, surpassed only by the cost of long-
        term care services.
            (6) Ninety percent of Americans who are 60 years of age or 
        older take 1 or more medications daily.
            (7) According to a recent study, around 60 percent of 
        doctors say that patients somewhat often talk with them about 
        specific disease or treatment they heard about from 
        prescription drug advertisements.
            (8) The National Institutes of Health, the Government's 
        most important health research arm, has helped develop almost 
        all of the 50 top-selling drugs from 1992 through 1997 for a 
        cost of over $175,000,000.
            (9) The pharmaceutical industry makes large profits off the 
        sale of drugs produced from the benefit of research paid for by 
        the United States and, aside from royalties, none of such 
        profits are reimbursed to United States taxpayers.
            (10) Only 24 percent of people over age 45 always ask their 
        pharmacist about drug side effects.
            (11) Only 31 percent of people over age 45 always ask their 
        pharmacists about cost-saving generic equivalents for new 
        prescriptions.

SEC. 3. GENERIC DRUG APPLICATION REVIEW.

    For the purpose of enabling the Food and Drug Administration to 
employ additional staff for the Office of Generic Drugs to review 
abbreviated applications for the approval of new drugs under section 
505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), 
and for the purpose of otherwise providing for accelerated reviews of 
such applications, there is authorized to be appropriated $5,000,000 
for each fiscal year, in addition to other authorizations of 
appropriations that are available for such purposes.

SEC. 4. GENERIC DRUG EDUCATION.

    For the purpose of enabling the Food and Drug Administration, 
through the Office of Generic Drugs, to continue the education program 
started in fiscal year 2001 on the use and therapeutic equivalency of 
drugs approved under section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)), there is authorized to be appropriated 
$1,000,000 for each fiscal year, in addition to other authorizations of 
appropriations that are available for such purpose.

SEC. 5. PRESCRIPTION DRUG ASSISTANCE PROGRAM; PROFITS FROM RESEARCH.

    The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by 
adding at the end the following:

                  ``TITLE XXVIII--PHARMACY ASSISTANCE

``SEC. 2801. GRANTS.

    ``(a) Authorization.--From amounts available from the revolving 
fund established under section 2803, the Secretary may make grants to 
States for the purpose of providing pharmacy assistance as described in 
subsection (b).
    ``(b) Use of Funds.--A grant may be made under subsection (a) only 
if the State involved agrees that funds received under the grant will 
be used--
            ``(1) to provide outreach services and education regarding 
        an existing State pharmacy benefit assistance program ; or
            ``(2) to establish or expand such a program.
    ``(c) Application.--To seek a grant under this section, a State 
shall submit an application to the Secretary at such time, in such 
manner, and accompanied by such information as the Secretary may 
reasonably require.
    ``(d) State Defined.--For purposes of this section, the term 
`State' means any of the several States, the District of Columbia, the 
Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana 
Islands, American Samoa, Guam, the Virgin Islands, or any other 
territory or possession of the United States.

``SEC. 2802. PROFITS FROM RESEARCH.

    ``(a) In General.--Subject to subsection (b), the Secretary shall 
not approve any covered application for the approval of a biological 
product under section 351 of this Act or of a drug under section 505 of 
the Federal Food,  Drug, and Cosmetic Act unless the manufacturer 
submitting the application enters into an agreement with the Secretary 
that--
            ``(1) requires the manufacturer to pay the Secretary 7 
        percent of the gross amount received by the manufacturer from 
        sales of such biological product or drug; and
            ``(2) specifies the manner in which such gross amount will 
        be determined.
    ``(b) Exception.--The Secretary may waive the application of 
subsection (a) to a manufacturer of a biological product or drug when 
the Secretary determines that it would be in the public interest to 
exempt such manufacturer.
    ``(c) Covered Application.--For purposes of this section, the term 
`covered application' means an application that includes the results of 
research carried out--
            ``(1) by an entity of the National Institutes of Health; or
            ``(2) under an agreement under section 12 of the Stevenson-
        Wydler Technology Innovation Act of 1980.

``SEC. 2803. REVOLVING FUND.

    ``(a) Establishment.--There is hereby established in the Treasury a 
revolving fund which shall consist of the amounts deposited by the 
Secretary under subsection (b).
    ``(b) Deposit of Funds.--The Secretary shall deposit in the fund 
established under this section all payments made to the Secretary under 
an agreement pursuant to section 2802(a)(1).
    ``(c) Use of Amounts in Fund.--To the extent or in the amounts made 
available in advance in appropriations Acts, amounts in the fund 
established under this section shall be available to the Secretary to 
make grants under section 2801.''.

SEC. 6. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY PRESCRIPTION DRUG 
              MANUFACTURERS.

    (a) In General.--Part IX of subchapter B of chapter 1 of subtitle A 
of the Internal Revenue Code of 1986 (relating to items not deductible) 
is amended by adding at the end the following:

``SEC. 280I. LIMITATION ON DEDUCTIONS FOR ADVERTISING BY PRESCRIPTION 
              DRUG MANUFACTURERS.

    ``(a) In General.--No deduction shall be allowed under this chapter 
for any taxable year for any expenditure relating to the advertising, 
promoting, or marketing (in any medium) of any prescription drug 
manufactured by the taxpayer to the extent the aggregate amount of such 
expenditures exceeds 50 percent of the taxpayer's aggregate research 
and development expenditures for such taxable year.
    ``(b) Definitions and Special Rules.--For purposes of this 
section--
            ``(1) Prescription drugs.--The term `prescription drug' 
        means any drug subject to subsection (b)(1) of the Federal 
        Food, Drug, and Cosmetic Act.
            ``(2) Research and development expenditures.--The term 
        `research and development expenditures' means any expenditures 
        that may be treated as expenses under section 174.
            ``(3) Aggregation rules.--All members of the same 
        controlled group of corporations (within the meaning of section 
        52(a)) and all persons under common control (within the meaning 
        of section 52(b)) shall be treated as 1 person.''.
    (b) Clerical Amendment.--The table of sections for such part IX is 
amended by adding after the item relating to section 280H the 
following:

                                  ``Sec. 280I. Limitation on deductions 
                                        for advertising by prescription 
                                        drug manufacturers.''.
    (c) Effective Date.--The amendments made by this section shall 
apply to taxable years beginning after December 31, 2001.
    (d) Transfer to the Federal Hospital Insurance Trust Fund of 
Resulting Budgetary Savings.--There are authorized to be appropriated 
to the Federal Hospital Insurance Trust Fund established under section 
1817 of the Social Security Act amounts equal to the increase in 
Federal revenues resulting from the amendment made by subsection (a). 
Such appropriated amounts may be transferred from the general fund of 
the Treasury on the basis of estimates of such revenues made by the 
Secretary of the Treasury.

SEC. 7. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.

    (a) Abbreviated New Drug Applications.--
            (1) In general.--Clause (iii) of section 505(j)(5)(B) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(j)(5)(B)) is amended to read as follows:
            ``(iii) If the applicant made a certification described in 
        subclause (IV) of paragraph (2)(A)(vii):
                    ``(I) If such certification concerns a patent 
                (other than a patent that claims a process for 
                manufacturing the listed drug) for which patent 
                information was submitted under subsection (b), the 
                approval shall be made effective immediately unless an 
                action is brought for infringement of a patent which is 
                the subject of the certification before the expiration 
                of 45 days from the date the notice provided under 
                paragraph (2)(B)(i) is received. If such an action is 
                brought before the expiration of such days, the 
                approval shall be made effective upon the expiration of 
                the 30-month period beginning on the date of the 
                receipt of the notice provided under paragraph 
                (2)(B)(i) or such shorter or longer period as the court 
                may order because either party to the action failed to 
                reasonably cooperate in expediting the action, except 
                that--
                            ``(aa) if before the expiration of such 
                        period the court decides that such patent is 
                        invalid or not infringed, the approval shall be 
                        made effective on the date of the court 
                        decision;
                            ``(bb) if before the expiration of such 
                        period the court decides that such patent has 
                        been infringed, the approval shall be made 
                        effective on such date as the court orders 
                        under section 271(e)(4)(A) of title 35, United 
                        States Code; or
                            ``(cc) if before the expiration of such 
                        period the court grants a preliminary 
                        injunction prohibiting the applicant from 
                        engaging in the commercial manufacture or sale 
                        of the drug until the court decides the issues 
                        of patent validity and infringement and if the 
                        court decides that such patent is invalid or 
                        not infringed, the approval shall be made 
                        effective on the date of such court decision.
                ``In such an action, each of the parties shall 
                reasonably cooperate in expediting the action. Until 
                the expiration of 45 days from the date the notice made 
                under paragraph (2)(B)(i) is received, no action may be 
                brought under section 2201 of title 28, United States 
                Code, for a declaratory judgment with respect to the 
                patent. Any action brought under such section 2201 
                shall be brought in the judicial district where the 
                defendant has its principal place of business or a 
                regular and established place of business. The 30-month 
                period provided under the second sentence of this 
                clause shall not apply to a certification under 
                paragraph (2)(A)(vii)(IV) made with respect to a patent 
                for which patent information was submitted under 
                subsection (c)(2).
                    ``(II) If the certification referred to at the 
                beginning of this clause concerns a patent (other than 
                a patent that claims a process for manufacturing the 
                listed drug) for which patent information was submitted 
                under subsection (c)(2), the approval shall be made 
                effective on the date that is 45 days after the date on 
                which the notice provided under paragraph (2)(B) is 
                received, unless a civil action for infringement of the 
                patent, accompanied by a motion for preliminary 
                injunction to enjoin the applicant from engaging in the 
                commercial manufacture or sale of the drug, is filed on 
                or before such date, in which case the approval shall 
                be made effective--
                            ``(aa) on the date of a court action 
                        declining to grant a preliminary injunction; or
                            ``(bb) if the court has granted a 
                        preliminary injunction prohibiting the 
                        applicant from engaging in the commercial 
                        manufacture or sale of the drug--
                                    ``(AA) on issuance by a court of a 
                                determination that the patent is 
                                invalid or is not infringed;
                                    ``(BB) on issuance by a court of an 
                                order revoking the preliminary 
                                injunction or permitting the applicant 
                                to engage in the commercial manufacture 
                                or sale of the drug; or
                                    ``(CC) on the date specified in a 
                                court order under section 271(e)(4)(A) 
                                of title 35, United States Code, if the 
                                court determines that the patent is 
                                infringed.
                ``Each of the parties shall reasonably cooperate in 
                expediting a civil action under this subclause. If the 
                notice under paragraph (2)(B) contains an address for 
                the receipt of expedited notification of a civil action 
                under this subclause, the plaintiff shall, on the date 
                on which the complaint is filed, simultaneously cause a 
                notification of the civil action to be delivered to 
                that address by the next business day.''.
            (2) Failure to bring infringement action.--Paragraph (5) of 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)) is amended by adding at the end the following:
    ``(E) If, in connection with an application under this subsection, 
the applicant provides an owner of a patent notice under paragraph 
(2)(B) with respect to the patent, and the owner of the patent fails to 
bring a civil action against the applicant for infringement of the 
patent on or before the date that is 45 days after the date on which 
the notice is received, the owner of the patent shall be barred from 
bringing a civil action for infringement of the patent in connection 
with the development, manufacture, use, offer to sell, or sale of the 
drug for which the application was filed or approved under this 
subsection.''.
    (b) Other Applications.--
            (1) In general.--Subparagraph (C) of section 505(c)(3) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) 
        is amended to read as follows:
            ``(C) If the applicant made a certification described in 
        subsection (b)(2)(A)(iv):
                    ``(i) If such certification concerns a patent 
                (other than a patent that claims a process for 
                manufacturing the listed drug) for which patent 
                information was submitted under subsection (b), the 
                approval shall be made effective immediately unless an 
                action is brought for infringement of a patent which is 
                the subject of the certification before the expiration 
                of 45 days from the date the notice provided under 
                subsection (b)(3)(A) is received. If such an action is 
                brought before the expiration of such days, the 
                approval may be made effective upon the expiration of 
                the 30-month period beginning on the date of the 
                receipt of the notice provided under subsection 
                (b)(3)(A) or such shorter or longer period as the court 
                may order because either party to the action failed to 
                reasonably cooperate in expediting the action, except 
                that--
                            ``(I) if before the expiration of such 
                        period the court decides that such patent is 
                        invalid or not infringed, the approval shall be 
                        made effective on the date of the court 
                        decision;
                            ``(II) if, before the expiration of such 
                        period, the court decides that such patent has 
                        been infringed, the approval shall be made 
                        effective on such date as the court orders 
                        under section 271(e)(4)(A) of title 35, United 
                        States Code; or
                            ``(III) if before the expiration of such 
                        period the court grants a preliminary 
                        injunction prohibiting the applicant from 
                        engaging in the commercial manufacture or sale 
                        of the drug until the court decides the issues 
                        of patent validity and infringement and if the 
                        court decides that such patent is invalid or 
                        not infringed, the approval shall be made 
                        effective on the date of such court decision.
                ``In such an action, each of the parties shall 
                reasonably cooperate in expediting the action. Until 
                the expiration of 45 days from the date the notice made 
                under subsection (b)(3)(A) is received, no action may 
                be brought under section 2201 of title 28, United 
                States Code, for a declaratory judgment with respect to 
                the patent. Any action brought under such section 2201 
                shall be brought in the judicial district where the 
                defendant has its principal place of business or a 
                regular and established place of business. The 30-month 
                period provided under the second sentence of this 
                subparagraph shall not apply to a certification under 
                subsection (b)(2)(A)(iv) made with respect to a patent 
                for which patent information was submitted under 
                subsection (c)(2).
                    ``(ii) If the certification referred to at the 
                beginning of this subparagraph concerns a patent (other 
                than a patent that claims a process for manufacturing 
                the listed drug) for which patent information was 
                submitted under subsection (c)(2), the approval shall 
                be made effective on the date that is 45 days after the 
                date on which the notice provided under subsection 
                (b)(3) is received, unless a civil action for 
                infringement of the patent, accompanied by a motion for 
                preliminary injunction to enjoin the applicant from 
                engaging in the commercial manufacture or sale of the 
                drug, is filed on or before such date, in which case 
                the approval shall be made effective--
                            ``(I) on the date of a court action 
                        declining to grant a preliminary injunction; or
                            ``(II) if the court has granted a 
                        preliminary injunction prohibiting the 
                        applicant from engaging in the commercial 
                        manufacture or sale of the drug--
                                    ``(aa) on issuance by a court of a 
                                determination that the patent is 
                                invalid or is not infringed;
                                    ``(bb) on issuance by a court of an 
                                order revoking the preliminary 
                                injunction or permitting the applicant 
                                to engage in the commercial manufacture 
                                or sale of the drug; or
                                    ``(cc) on the date specified in a 
                                court order under section 271(e)(4)(A) 
                                of title 35, United States Code, if the 
                                court determines that the patent is 
                                infringed.
                ``Each of the parties shall reasonably cooperate in 
                expediting a civil action under this clause. If the 
                notice under subsection (b)(3) contains an address for 
                the receipt of expedited notification of a civil action 
                under this clause, the plaintiff shall, on the date on 
                which the complaint is filed, simultaneously cause a 
                notification of the civil action to be delivered to 
                that address by the next business day.''.
            (2) Failure to bring infringement action.--Subsection (c) 
        of section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(c)(3)) is amended by adding at the end the 
        following:
    ``(5) If, in connection with an application under subsection 
(b)(2), the applicant provides an owner of a patent notice under 
subsection (b)(3) with respect to the patent, and the owner of the 
patent fails to bring a civil action against the applicant for 
infringement of the patent on or before the date that is 45 days after 
the date on which the notice is received, the owner of the patent shall 
be barred from bringing a civil action for infringement of the patent 
in connection with the development, manufacture, use, offer to sell, or 
sale of the drug for which the application was filed or approved under 
subsection (b)(2).''.
    (c) Effective Date.--The amendments made by subsections (a) and (b) 
shall be effective with respect to any certification under subsection 
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) made after the date of enactment 
of this Act in an application filed under subsection (b)(2) or (j) of 
that section, including with respect to patent information that was 
submitted to the Secretary before such date under subsection (c)(2) of 
such Act.

SEC. 8. EXCLUSIVITY FOR ACCELERATED GENERIC DRUG APPLICANTS.

    (a) In General.--Section 505(j)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (B)(iv)--
                    (A) in the text preceding subclause (I), by 
                inserting ``the earlier of--'' after ``not earlier than 
                one hundred and eighty days after'';
                    (B) by striking ``or'' at the end of subclause (I);
                    (C) by striking subclause (II) and all that follows 
                through the end; and
                    (D) by adding after subclause (I) the following:
                    ``(II) the date of a final decision of a court 
                (from which no appeal has been or can be taken, other 
                than a petition to the Supreme Court for a writ of 
                certiorari) holding that the patent that is the subject 
                of the certification is invalid or not infringed, or
                    ``(III) the date of a settlement order or consent 
                decree signed by a Federal judge that enters a final 
                judgment and includes a finding that the patent that is 
                the subject of the certification is invalid or not 
                infringed.''; and
            (2) by inserting after subparagraph (D) the following:
    ``(E) Forfeiture of 180-day period.--
            ``(i) In general.--Except as provided in clause (ii), if a 
        forfeiture event occurs with respect to a first application--
                    ``(I) the 180-day period under subparagraph (B)(iv) 
                shall be forfeited by the first applicant; and
                    ``(II) any subsequent application shall become 
                effective as provided under clause (i), (ii), or (iii) 
                of subparagraph (B), and clause (iv) of subparagraph 
                (B) shall not apply to the subsequent application.
            ``(ii) Forfeiture to first subsequent applicant.--If the 
        subsequent application that is the first to be made effective 
        under clause (i) was the first among a number of subsequent 
        applications to be filed--
                    ``(I) that first subsequent application shall be 
                treated as the first application under this 
                subparagraph (including clause (i)) and as the previous 
                application under subparagraph (B)(iv); and
                    ``(II) any other subsequent applications shall 
                become effective as provided under clause (i), (ii), or 
                (iii) of subparagraph (B), but clause (iv) of 
                subparagraph (B) shall apply to any such subsequent 
                application.
            ``(iii) Availability.--The 180-day period under 
        subparagraph (B)(iv) shall be available to a first applicant 
        submitting an application for a drug with respect to any patent 
        without regard to whether an application has been submitted for 
        the drug under this subsection containing such a certification 
        with respect to a different patent.
            ``(iv) Applicability.--The 180-day period described in 
        subparagraph (B)(iv) shall apply to an application only if a 
        civil action is brought against the applicant for infringement 
        of a patent that is the subject of the certification.
            ``(v) Definitions.--In this subparagraph:
                    ``(I) Application.--The term `application' means an 
                application for approval of a drug under this 
                subsection containing a certification under paragraph 
                (2)(A)(vii)(IV) with respect to a patent.
                    ``(II) First application.--The term `first 
                application' means the first application to be filed 
                for approval of the drug.
                    ``(III) Forfeiture event.--The term `forfeiture 
                event', with respect to an application under this 
                subsection, means the occurrence of any of the 
                following:
                            ``(aa) Failure to market.--The applicant 
                        fails to market the drug by the later of--
                                    ``(AA) the date that is 60 days 
                                after the date on which the approval of 
                                the application for the drug is made 
                                effective under clause (iii) of 
                                subparagraph (B) (unless the Secretary 
                                extends the date because of 
                                extraordinary or unusual 
                                circumstances); or
                                    ``(BB) if 1 or more civil actions 
                                have been brought against the applicant 
                                for infringement of a patent subject to 
                                a certification under paragraph 
                                (2)(A)(vii)(IV) or 1 or more civil 
                                actions have been brought by the 
                                applicant for a declaratory judgment 
                                that such a patent is invalid or not 
                                infringed, the date that is 60 days 
                                after the date of a final decision 
                                (from which no appeal has been or can 
                                be taken, other than a petition to the 
                                Supreme Court for a writ of certiorari) 
                                in the last of those civil actions to 
                                be decided (unless the Secretary 
                                extends the date because of 
                                extraordinary or unusual 
                                circumstances).
                            ``(bb) Withdrawal of application.--The 
                        applicant withdraws the application.
                            ``(cc) Amendment of certification.--The 
                        applicant, voluntarily or as a result of a 
                        settlement or defeat in patent litigation, 
                        amends the certification from a certification 
                        under paragraph (2)(A)(vii)(IV) to a 
                        certification under paragraph (2)(A)(vii)(III).
                            ``(dd) Failure to obtain approval.--The 
                        applicant fails to obtain tentative approval of 
                        an application within 30 months after the date 
                        on which the application is filed, unless the 
                        failure is caused by--
                                    ``(AA) a change in the requirements 
                                for approval of the application imposed 
                                after the date on which the application 
                                is filed; or
                                    ``(BB) other extraordinary 
                                circumstances warranting an exception, 
                                as determined by the Secretary.
                            ``(ee) Failure to challenge patent.--In a 
                        case in which, after the date on which the 
                        applicant submitted the application, new patent 
                        information is submitted under subsection 
                        (c)(2) for the listed drug for a patent for 
                        which certification is required under paragraph 
                        (2)(A), the applicant fails to submit, not 
                        later than the date that is 60 days after the 
                        date on which the Secretary publishes the new 
                        patent information under paragraph (7)(A)(iii) 
                        (unless the Secretary extends the date because 
                        of extraordinary or unusual circumstances)--
                                    ``(AA) a certification described in 
                                paragraph (2)(A)(vii)(IV) with respect 
                                to the patent to which the new patent 
                                information relates; or
                                    ``(BB) a statement that any method 
                                of use claim of that patent does not 
                                claim a use for which the applicant is 
                                seeking approval under this subsection 
                                in accordance with paragraph 
                                (2)(A)(viii).
                            ``(ff) Unlawful conduct.--The Federal Trade 
                        Commission determines that the applicant 
                        engaged in unlawful conduct with respect to the 
                        application in violation of section 1 of the 
                        Sherman Act.
                    ``(IV) Subsequent application.--The term 
                `subsequent application' means an application for 
                approval of a drug that is filed subsequent to the 
                filing of a first application for approval of that 
                drug.''.
    (b) Applicability.--The amendment made by subsection (a) shall 
apply only with respect to an application filed under section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) after the 
date of enactment of this Act for a listed drug for which no 
certification under section 505(j)(2)(A)(vii)(IV) of that Act was made 
before the date of enactment of this Act, except that if  a forfeiture 
event described in section 505(j)(5)(E)(v)(III)(ff) of that Act (as 
amended by this section) occurs in the case of an applicant, the 
applicant shall forfeit the 180-day period under section 
505(j)(5)(B)(iv) of that Act without regard to when the applicant made 
a certification under section 505(j)(2)(A)(vii)(IV) of that Act.

SEC. 9. BIOEQUIVALENCE.

    (a) In General.--The amendments to part 320 of title 21, Code of 
Federal Regulations, promulgated by the Commissioner of Food and Drugs 
on July 17, 1991 (57 Fed. Reg. 17997 (April 28, 1992)), shall continue 
in effect as an exercise of authorities under sections 501, 502, 505, 
and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 
352, 355, 371).
    (b) Effect.--Subsection (a) does not affect the authority of the 
Commissioner of Food and Drugs to amend part 320 of title 21, Code of 
Federal Regulations.
    (c) Effect of Section.--This section shall not be construed to 
alter the authority of the Secretary of Health and Human Services to 
regulate biological products under the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.). Any such authority shall be exercised 
under that Act as in effect on the day before the date of enactment of 
this Act.

SEC. 10. FILING OF PATENT INFORMATION WITH THE FOOD AND DRUG 
              ADMINISTRATION.

    (a) Filing After Approval of an Application.--
            (1) In general.--Section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) (as amended by section 
        9(a)(2)(B)(ii)) is amended in subsection (c) by striking 
        paragraph (2) and inserting the following:
            ``(2) Patent information.--
                    ``(A) In general.--Not later than the date that is 
                30 days after the date of an order approving an 
                application under subsection (b) (unless the Secretary 
                extends the date because of extraordinary or unusual 
                circumstances), the holder of the application shall 
                file with the Secretary the patent information 
                described in subparagraph (C) with respect to any 
                patent--
                            ``(i)(I) that claims the drug for which the 
                        application was approved; or
                            ``(II) that claims an approved method of 
                        using the drug; and
                            ``(ii) with respect to which a claim of 
                        patent infringement could reasonably be 
                        asserted if a person not licensed by the owner 
                        engaged in the manufacture, use, or sale of the 
                        drug.
                    ``(B) Subsequently issued patents.--In a case in 
                which a patent described in subparagraph (A) is issued 
                after the date of an order approving an application 
                under subsection (b), the holder of the application 
                shall file with the Secretary the patent information 
                described in subparagraph (C) not later than the date 
                that is 30 days after the date on which the patent is 
                issued (unless the Secretary extends the date because 
                of extraordinary or unusual circumstances).
                    ``(C) Patent information.--The patent information 
                required to be filed under subparagraph (A) or (B) 
                includes--
                            ``(i) the patent number;
                            ``(ii) the expiration date of the patent;
                            ``(iii) with respect to each claim of the 
                        patent--
                                    ``(I) whether the patent claims the 
                                drug or claims a method of using the 
                                drug; and
                                    ``(II) whether the claim covers--
                                            ``(aa) a drug substance;
                                            ``(bb) a drug formulation;
                                            ``(cc) a drug composition; 
                                        or
                                            ``(dd) a method of use;
                            ``(iv) if the patent claims a method of 
                        use, the approved use covered by the claim;
                            ``(v) the identity of the owner of the 
                        patent (including the identity of any agent of 
                        the patent owner); and
                            ``(vi) a declaration that the applicant, as 
                        of the date of the filing, has provided 
                        complete and accurate patent information for 
                        all patents described in subparagraph (A).
                    ``(D) Publication.--On filing of patent information 
                required under subparagraph (A) or (B), the Secretary 
                shall--
                            ``(i) immediately publish the information 
                        described in clauses (i) through (iv) of 
                        subparagraph (C); and
                            ``(ii) make the information described in 
                        clauses (v) and (vi) of subparagraph (C) 
                        available to the public on request.
                    ``(E) Civil action for correction or deletion of 
                patent information.--
                            ``(i) In general.--A person that has filed 
                        an application under subsection (b)(2) or (j) 
                        for a drug may bring a civil action against the 
                        holder of the approved application for the drug 
                        seeking an order requiring that the holder of 
                        the application amend the application--
                                    ``(I) to correct patent information 
                                filed under subparagraph (A); or
                                    ``(II) to delete the patent 
                                information in its entirety for the 
                                reason that--
                                            ``(aa) the patent does not 
                                        claim the drug for which the 
                                        application was approved; or
                                            ``(bb) the patent does not 
                                        claim an approved method of 
                                        using the drug.
                            ``(ii) Limitations.--Clause (i) does not 
                        authorize--
                                    ``(I) a civil action to correct 
                                patent information filed under 
                                subparagraph (B); or
                                    ``(II) an award of damages in a 
                                civil action under clause (i).
                    ``(F) No claim for patent infringement.--An owner 
                of a patent with respect to which a holder of an 
                application fails to file information on or before the 
                date required under subparagraph (A) or (B) shall be 
                barred from bringing a civil action for infringement of 
                the patent against a person that--
                            ``(i) has filed an application under 
                        subsection (b)(2) or (j); or
                            ``(ii) manufactures, uses, offers to sell, 
                        or sells a drug approved under an application 
                        under subsection (b)(2) or (j).''.
            (2) Transition provision.--
                    (A) Filing of patent information.--Each holder of 
                an application for approval of a new drug under section 
                505(b) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(b)) that has been approved before the date 
                of enactment of this Act shall amend the application to 
                include the patent information required under the 
                amendment made by paragraph (1) not later than the date 
                that is 30 days after the date of enactment of this Act 
                (unless the Secretary of Health and Human Services 
                extends the date because of extraordinary or unusual 
                circumstances).
                    (B) No claim for patent infringement.--An owner of 
                a patent with respect to which a holder of an 
                application under subsection (b) of section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
                fails to file information on or before the date 
                required under subparagraph (A) shall be barred from 
                bringing a civil action for infringement of the patent 
                against a person that--
                            (i) has filed an application under 
                        subsection (b)(2) or (j) of that section; or
                            (ii) manufactures, uses, offers to sell, or 
                        sells a drug approved under an application 
                        under subsection (b)(2) or (j) of that section.
    (b) Filing With an Application.--Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(2)--
                    (A) in subparagraph (A), by striking ``and'' at the 
                end;
                    (B) in subparagraph (B), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by adding at the end the following:
                    ``(C) with respect to a patent that claims both the 
                drug and a method of using the drug or claims more than 
                1 method of using the drug for which the application is 
                filed--
                            ``(i) a certification under subparagraph 
                        (A)(iv) on a claim-by-claim basis; and
                            ``(ii) a statement under subparagraph (B) 
                        regarding the method of use claim.''; and
            (2) in subsection (j)(2)(A), by inserting after clause 
        (viii) the following:
``With respect to a patent that claims both the drug and a method of 
using the drug or claims more than 1 method of using the drug for which 
the application is filed, the application shall contain a certification 
under clause (vii)(IV) on a claim-by-claim basis and a statement under 
clause (viii) regarding the method of use claim.''.
                                 <all>