[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 812 Reported in Senate (RS)]






                                                       Calendar No. 491
107th CONGRESS
  2d Session
                                 S. 812

 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 1, 2001

 Mr. Schumer (for himself, Mr. McCain, Mr. Johnson, Mrs. Clinton, Ms. 
    Stabenow, Mrs. Carnahan, Mr. Kohl, Mr. Daschle, Mr. Durbin, Mr. 
Wellstone, Mr. Edwards, and Mr. Miller) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

                July 11 (legislative day, July 10), 2002

               Reported by Mr. Kennedy, with an amendment
  [Omit the part struck through and insert the part printed in italic]

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.

    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 ``Greater Access to Affordable 
Pharmaceuticals Act of 2001''.

SEC. 2. FINDINGS; PURPOSES.

    (a) Findings.--Congress finds that--
            (1) prescription drug costs are increasing at an alarming 
        rate and are a major worry of American families and senior 
        citizens;
            (2) enhancing competition between generic drug 
        manufacturers and brand-name manufacturers can significantly 
        reduce prescription drug costs for American families;
            (3) the pharmaceutical market has become increasingly 
        competitive during the last decade because of the increasing 
        availability and accessibility of generic pharmaceuticals, but 
        competition must be further stimulated and strengthened;
            (4) the Federal Trade Commission has discovered that there 
        are increasing opportunities for drug companies owning patents 
        on brand-name drugs and generic drug companies to enter into 
        private financial deals in a manner that could restrain trade 
        and greatly reduce competition and increase prescription drug 
        costs for consumers;
            (5) generic pharmaceuticals are approved by the Food and 
        Drug Administration on the basis of scientific testing and 
        other information establishing that pharmaceuticals are 
        therapeutically equivalent to brand-name pharmaceuticals, 
        ensuring consumers a safe, efficacious, and cost-effective 
        alternative to brand-name innovator pharmaceuticals;
            (6) the Congressional Budget Office estimates that--
                    (A) the use of generic pharmaceuticals for brand-
                name pharmaceuticals could save purchasers of 
                pharmaceuticals between $8,000,000,000 and 
                $10,000,000,000 each year; and
                    (B) generic pharmaceuticals cost between 25 percent 
                and 60 percent less than brand-name pharmaceuticals, 
                resulting in an estimated average savings of $15 to $30 
                on each prescription;
            (7) generic pharmaceuticals are widely accepted by 
        consumers and the medical profession, as the market share held 
        by generic pharmaceuticals compared to brand-name 
        pharmaceuticals has more than doubled during the last decade, 
        from approximately 19 percent to 43 percent, according to the 
        Congressional Budget Office;
            (8) expanding access to generic pharmaceuticals can help 
        consumers, especially senior citizens and the uninsured, have 
        access to more affordable prescription drugs;
            (9) Congress should ensure that measures are taken to 
        effectuate the amendments made by the Drug Price Competition 
        and Patent Term Restoration Act of 1984 (98 Stat. 1585) 
        (referred to in this section as the ``Hatch-Waxman Act'') to 
        make generic drugs more accessible, and thus reduce health care 
        costs; and
            (10) it would be in the public interest if patents on drugs 
        for which applications are approved under section 505(c) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)) were 
        extended only through the patent extension procedure provided 
        under the Hatch-Waxman Act rather than through the attachment 
        of riders to bills in Congress.
    (b) Purposes.--The purposes of this Act are--
            (1) to increase competition, thereby helping all Americans, 
        especially seniors and the uninsured, to have access to more 
        affordable medication; and
            (2) to ensure fair marketplace practices and deter 
        pharmaceutical companies (including generic companies) from 
        engaging in anticompetitive action or actions that tend to 
        unfairly restrain trade.

<DELETED>SEC. 3. ACCELERATED GENERIC DRUG COMPETITION.</DELETED>

<DELETED>    (a) In General.--Section 505(j)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (B)(iv), by striking subclause 
        (II) and inserting the following:</DELETED>
                <DELETED>    ``(II) the earlier of--</DELETED>
                        <DELETED>    ``(aa) the date of a final 
                        decision of a court in an action described in 
                        clause (iii) (from which no appeal can or has 
                        been taken); or</DELETED>
                        <DELETED>    ``(bb) 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 patents that are the subject 
                        of the certification are invalid or not 
                        infringed;'';</DELETED>
        <DELETED>    (2) by redesignating subparagraphs (C) and (D) as 
        subparagraphs (E) and (F), respectively; and</DELETED>
        <DELETED>    (3) by inserting after subparagraph (B) the 
        following:</DELETED>
                <DELETED>    ``(C) Forfeiture of 180-day period.--
                </DELETED>
                        <DELETED>    ``(i) In general.--The 180-day 
                        period described in subparagraph (B)(iv) shall 
                        be forfeited by the previous applicant and 
                        become available to the next applicant 
                        submitting an application containing a 
                        certification described in paragraph 
                        (2)(A)(vii)(IV) if--</DELETED>
                                <DELETED>    ``(I) the previous 
                                applicant fails to market the drug 
                                within 90 days after the date on which 
                                the approval of the application for the 
                                drug is made effective under 
                                subparagraph (B)(iii);</DELETED>
                                <DELETED>    ``(II) the previous 
                                applicant withdraws the 
                                application;</DELETED>
                                <DELETED>    ``(III) the previous 
                                applicant amends the certification from 
                                a certification under subclause (IV) to 
                                a certification under paragraph 
                                (2)(A)(vii)(III), either voluntarily or 
                                as a result of a settlement or defeat 
                                in patent litigation;</DELETED>
                                <DELETED>    ``(IV) the previous 
                                applicant fails to get tentative 
                                approval of the application within 30 
                                months after the date on which the 
                                application is filed, unless the 
                                failure is caused by--</DELETED>
                                        <DELETED>    ``(aa) a change in 
                                        the requirements for tentative 
                                        approval of the application 
                                        imposed after the date on which 
                                        the application was filed; 
                                        or</DELETED>
                                        <DELETED>    ``(bb) other 
                                        extraordinary or unusual 
                                        circumstances, as determined by 
                                        the Secretary;</DELETED>
                                <DELETED>    ``(V) in a case in which, 
                                after the date on which the previous 
                                application was submitted under this 
                                subsection, new patent information is 
                                submitted for the drug under subsection 
                                (c)(2) for a patent for which 
                                certification is required under 
                                paragraph (2)(A)(vii)(IV), the previous 
                                applicant fails to challenge the patent 
                                that is the subject of the information 
                                within 60 days after the date on which 
                                the patent information is submitted; 
                                or</DELETED>
                                <DELETED>    ``(VI) the previous 
                                applicant is determined by the 
                                Secretary, after a fair and sufficient 
                                hearing and in consultation with the 
                                Federal Trade Commission, to have 
                                engaged in anticompetitive or collusive 
                                conduct, or any other conduct intended 
                                to unfairly monopolize the commercial 
                                manufacturing of the drug of the 
                                application.</DELETED>
                        <DELETED>    ``(ii) Availability.--The 180-day 
                        period described in subparagraph (B)(iv) shall 
                        be available only to--</DELETED>
                                <DELETED>    ``(I) the previous 
                                applicant submitting an application for 
                                a drug under this subsection containing 
                                a certification described in paragraph 
                                (2)(A)(vii)(IV) with respect to any 
                                patent; or</DELETED>
                                <DELETED>    ``(II) under clause (i), 
                                the next applicant submitting an 
                                application for a drug under this 
                                subsection containing such a 
                                certification with respect to any 
                                patent;</DELETED>
                        <DELETED>even if an application has been 
                        submitted for the drug under this subsection 
                        containing such a certification with respect to 
                        a different patent.</DELETED>
                        <DELETED>    ``(iii) Applicability.--The 180-
                        day period described in subparagraph (B)(iv) 
                        shall apply only if--</DELETED>
                                <DELETED>    ``(I) the application 
                                contains a certification described in 
                                paragraph (2)(A)(vii)(IV); 
                                and</DELETED>
                                <DELETED>    ``(II) an action is 
                                brought for infringement of a patent 
                                that is the subject of the 
                                certification or the applicant brings 
                                an action (not later than 50 days after 
                                the date on which the notice provided 
                                under paragraph (2)(B)(ii) was 
                                received), against the holder of the 
                                approved application for the listed 
                                drug.''.</DELETED>
<DELETED>    (b) Effective Date.--The amendment made by this section 
shall be effective 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)) 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.</DELETED>

<DELETED>SEC. 4. BIOEQUIVALENCE TESTING METHODS.</DELETED>

<DELETED>    Section 505(j)(8)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(8)(B)) is amended--</DELETED>
        <DELETED>    (1) in clause (i), by striking ``or'' at the 
        end;</DELETED>
        <DELETED>    (2) in clause (ii), by striking the period at the 
        end and inserting ``; or''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
                <DELETED>    ``(iii)(I) clauses (i) and (ii) are not 
                applicable, as determined by the Secretary;</DELETED>
                <DELETED>    ``(II) the effects of the drug and the 
                listed drug do not show a significant difference based 
                on tests (other than tests that assess rate and extent 
                of absorption), including--</DELETED>
                        <DELETED>    ``(aa) a bioequivalence study with 
                        a pharmacodynamic endpoint;</DELETED>
                        <DELETED>    ``(bb) a bioequivalence study with 
                        a clinical endpoint;</DELETED>
                        <DELETED>    ``(cc) in vitro methods; 
                        or</DELETED>
                        <DELETED>    ``(dd) any other methodology that 
                        demonstrates that no significant differences in 
                        therapeutic effects of active ingredients are 
                        expected; and</DELETED>
                <DELETED>    ``(III) limited confirmatory studies to 
                supplement the bioequivalence testing are considered 
                necessary by the Secretary.''.</DELETED>

<DELETED>SEC. 5. CITIZEN PETITIONS.</DELETED>

<DELETED>    Section 505(j)(5) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)(5)) (as amended by section 3(a)) is amended by 
inserting after subparagraph (C) the following:</DELETED>
                <DELETED>    ``(D) Citizen petitions.--</DELETED>
                        <DELETED>    ``(i) In general.--Notwithstanding 
                        any other provision of law, any petition 
                        submitted under section 10.30 of title 21, Code 
                        of Federal Regulations (or any successor 
                        regulation), shall include a statement that to 
                        the best knowledge and belief of the 
                        petitioner, the petition--</DELETED>
                                <DELETED>    ``(I) includes all 
                                information and views on which the 
                                petitioner relies;</DELETED>
                                <DELETED>    ``(II) is well grounded in 
                                fact and is warranted by law (including 
                                regulations);</DELETED>
                                <DELETED>    ``(III) is not submitted 
                                for any improper purpose, such as to 
                                harass or cause unnecessary 
                                delay;</DELETED>
                                <DELETED>    ``(IV) does not contain a 
                                materially false, misleading, or 
                                fraudulent statement that the 
                                petitioner has knowingly and willingly 
                                included; and</DELETED>
                                <DELETED>    ``(V) includes all 
                                representative data and information 
                                known to the petitioner that is 
                                favorable or unfavorable to the 
                                petition.</DELETED>
                        <DELETED>    ``(ii) Applicability of criminal 
                        provision.--Section 1001 of title 18, United 
                        States Code, shall apply to a person that 
                        submits a petition under section 10.30 of title 
                        21, Code of Federal Regulations (or any 
                        successor regulation).</DELETED>
                        <DELETED>    ``(iii) Investigations.--
                        </DELETED>
                                <DELETED>    ``(I) In general.--The 
                                Federal Trade Commission shall 
                                investigate, on receipt of a complaint 
                                or upon its own initiative, any 
                                petition submitted under section 10.30 
                                of title 21, Code of Federal 
                                Regulations (or any successor 
                                regulation), that may have been 
                                submitted for an improper purpose, such 
                                as to delay competition or agency 
                                action.</DELETED>
                                <DELETED>    ``(II) Referral.--If the 
                                Commission finds that a petitioner has 
                                engaged in conduct that may be illegal, 
                                the Commission shall refer the petition 
                                to the Antitrust Division of the 
                                Department of Justice for further 
                                action.</DELETED>
                        <DELETED>    ``(iv) Notice of receipt of 
                        consideration.--</DELETED>
                                <DELETED>    ``(I) In general.--A 
                                person that submits a petition under 
                                section 10.30 of title 21, Code of 
                                Federal Regulations (or any successor 
                                regulation), shall provide a written 
                                notice to the Federal Trade Commission 
                                if the person receives any 
                                consideration for submitting the 
                                petition.</DELETED>
                                <DELETED>    ``(II) A notice under 
                                subclause (I) shall include--</DELETED>
                                        <DELETED>    ``(aa) the name of 
                                        the person or entity that 
                                        provided the 
                                        consideration;</DELETED>
                                        <DELETED>    ``(bb) the dollar 
                                        value of the consideration, if 
                                        provided in cash, or a 
                                        description of such 
                                        consideration;</DELETED>
                                        <DELETED>    ``(cc) the date on 
                                        which the consideration was 
                                        provided; and</DELETED>
                                        <DELETED>    ``(dd) any other 
                                        information that the Commission 
                                        requires to be 
                                        disclosed.''.</DELETED>

<DELETED>SEC. 6. PATENT CERTIFICATION.</DELETED>

<DELETED>    (a) Abbreviated New Drug Applications.--Section 505(j)(5) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) (as 
amended by section 3(a)(2)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (B), by striking clause (iii) 
        and inserting the following:</DELETED>
                        <DELETED>    ``(iii) Certification that patent 
                        is invalid or will not be infringed.--
                        </DELETED>
                                <DELETED>    ``(I) In general.--Except 
                                as provided in subclauses (II) and 
                                (III), if the applicant made a 
                                certification described in paragraph 
                                (2)(A)(vii)(IV), the approval shall be 
                                made effective on the expiration of 45 
                                days after the date on which the notice 
                                provided under paragraph (2)(B)(ii) was 
                                received.</DELETED>
                                <DELETED>    ``(II) Action for patent 
                                infringement.--If an action is brought 
                                for infringement of a patent that is 
                                the subject of the certification before 
                                the expiration of the 45-day period 
                                beginning on the date on which the 
                                notice provided under paragraph 
                                (2)(B)(ii) was received, the approval 
                                shall be made effective on the 
                                expiration of the 45-day period unless 
                                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.</DELETED>
                                <DELETED>    ``(III) Patent invalid or 
                                not infringed.--If the court decides 
                                that the patent is invalid or was not 
                                infringed, the approval shall be made 
                                effective on the date of the court 
                                decision.</DELETED>
                                <DELETED>    ``(IV) Patent infringed.--
                                If the court decides that the patent 
                                was 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.</DELETED>
                                <DELETED>    ``(V) Procedure.--In an 
                                action described in subclause (II)--
                                </DELETED>
                                        <DELETED>    ``(aa) each of the 
                                        parties shall reasonably 
                                        cooperate in expediting the 
                                        action;</DELETED>
                                        <DELETED>    ``(bb) until the 
                                        expiration of 45 days after the 
                                        date the notice provided under 
                                        paragraph (2)(B)(i) was 
                                        received, no civil action may 
                                        be brought under section 2201 
                                        of title 28, United States 
                                        Code, for a declaratory 
                                        judgment with respect to the 
                                        patent, except as provided in 
                                        subparagraph (H); and</DELETED>
                                        <DELETED>    ``(cc) any such 
                                        civil action shall be brought 
                                        in the judicial district in 
                                        which the defendant has its 
                                        principal place of business or 
                                        a regular and established place 
                                        of business.''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
                <DELETED>    ``(G) Civil action for declaratory 
                judgment.--A person that files an abbreviated 
                application for a new drug under this paragraph may 
                bring a civil action against the holder of an approved 
                application for a listed drug for a declaratory 
                judgment to determine whether the patent that claims 
                the listed drug or a method of using the drug is 
                invalid or will not be infringed.</DELETED>
                <DELETED>    ``(H) Civil action to determine legal 
                status.--Notwithstanding any other provision of law, if 
                information on a patent for a listed drug has been 
                published under subsection (c)(2) for at least 1 year 
                after the date on which an abbreviated application for 
                approval of a new drug was filed under this subsection 
                in relation to the listed drug, the person that filed 
                the abbreviated application or the holder of the 
                approved application for the listed drug may 
                immediately bring a civil action to determine the legal 
                status of the patent for the listed drug.''.</DELETED>
<DELETED>    (b) New Drug Applications.--Section 505(c)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) is amended 
by striking subparagraph (C) and inserting the following:</DELETED>
                <DELETED>    ``(C) Certification that patent is invalid 
                or will not be infringed.--</DELETED>
                        <DELETED>    ``(i) In general.--Except as 
                        provided in clauses (ii) and (iii), if the 
                        applicant made a certification described in 
                        subsection (b)(2)(A)(iv), the approval shall be 
                        made effective on the expiration of 45 days 
                        after the date on which the notice provided 
                        under subsection (b)(3)(B) was 
                        received.</DELETED>
                        <DELETED>    ``(ii) Action brought before 
                        expiration of 45 days.--If an action is brought 
                        for infringement of a patent that is the 
                        subject of the certification before the 
                        expiration of the 45-day period beginning on 
                        the date the notice provided under subsection 
                        (b)(3)(B) was received, the approval shall be 
                        made effective on the expiration of the 45-day 
                        period unless 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.</DELETED>
                        <DELETED>    ``(iii) Patent invalid or not 
                        infringed.--If the court decides that the 
                        patent is invalid or not infringed, the 
                        approval shall be made effective on the date of 
                        the court decision.</DELETED>
                        <DELETED>    ``(iv) Patent infringed.--If the 
                        court decides that the patent has been 
                        infringed, the approval may be made effective 
                        on such date as the court orders under section 
                        271(e)(4)(A) of title 35, United States 
                        Code.</DELETED>
                        <DELETED>    ``(v) Procedure.--In an action 
                        described in clause (ii)--</DELETED>
                                <DELETED>    ``(I) each of the parties 
                                shall reasonably cooperate in 
                                expediting the action;</DELETED>
                                <DELETED>    ``(II) until the 
                                expiration of 45 days after the date 
                                the notice provided under subsection 
                                (b)(3)(B) was received, no civil action 
                                may be brought under section 2201 of 
                                title 28, United States Code, for a 
                                declaratory judgment with respect to 
                                the patent, except as provided in 
                                subsection (j)(5)(H); and</DELETED>
                                <DELETED>    ``(III) any such civil 
                                action shall be brought in the judicial 
                                district where the defendant has its 
                                principal place of business or a 
                                regular and established place of 
                                business.''.</DELETED>
<DELETED>    (c) Effective Date.--The amendments made by this section 
shall not apply to an application submitted under section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) before the date of 
enactment of this Act.</DELETED>

<DELETED>SEC. 7. PATENT INFORMATION.</DELETED>

<DELETED>    Section 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) is amended--</DELETED>
        <DELETED>    (1) in subsection (b), by striking ``(b)(1) Any 
        person'' and all that follows through paragraph (1) and 
        inserting the following:</DELETED>
<DELETED>    ``(b) Applications.--</DELETED>
        <DELETED>    ``(1) In general.--</DELETED>
                <DELETED>    ``(A) Filing.--Any person may file with 
                the Secretary an application with respect to any drug 
                subject to subsection (a).</DELETED>
                <DELETED>    ``(B) Contents.--A person that files an 
                application shall submit to the Secretary as a part of 
                the application with respect to a drug--</DELETED>
                        <DELETED>    ``(i) full reports of 
                        investigations that have been made to show 
                        whether or not such drug is safe for use and 
                        whether the drug is effective in use;</DELETED>
                        <DELETED>    ``(ii) a full list of the articles 
                        used as components of the drug;</DELETED>
                        <DELETED>    ``(iii) a full statement of the 
                        composition of the drug;</DELETED>
                        <DELETED>    ``(iv) a full description of the 
                        methods used in, and the facilities and 
                        controls used for, the manufacture, processing, 
                        and packing of the drug;</DELETED>
                        <DELETED>    ``(v) such samples of the drug and 
                        of the articles used as components of the drug 
                        as the Secretary may require; and</DELETED>
                        <DELETED>    ``(vi) specimens of the labeling 
                        proposed to be used for the drug.</DELETED>
                <DELETED>    ``(C) Patent information.--</DELETED>
                        <DELETED>    ``(i) In general.--The applicant 
                        shall file with the application the patent 
                        number and expiration date of any patent that 
                        claims a drug or method of using a drug and 
                        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 for which 
                        the applicant submitted the 
                        application.</DELETED>
                        <DELETED>    ``(ii) Amendment of application.--
                        If an application is filed with respect to a 
                        drug and a patent as described in clause (i) is 
                        issued after the filing date but before 
                        approval of the application, the applicant 
                        shall amend the application to include the 
                        information required by clause (i).</DELETED>
                        <DELETED>    ``(iii) Publication of 
                        information.--On approval of the application, 
                        the Secretary shall publish information 
                        submitted under clauses (i) and (ii).</DELETED>
                <DELETED>    ``(D) Guidance.--The Secretary shall, in 
                consultation with the Director of the National 
                Institutes of Health and with representatives of the 
                drug manufacturing industry, review and develop 
                guidance, as appropriate, on the inclusion of women and 
                minorities in clinical trials required by subparagraph 
                (B)(i).''; and</DELETED>
        <DELETED>    (2) in paragraph (2)(A)--</DELETED>
                <DELETED>    (A) by striking ``which claims'' the first 
                place it appears and all that follows through 
                ``subsection and''; and</DELETED>
                <DELETED>    (B) by striking ``subsection (c)--'' and 
                inserting ``and 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 for which the investigations 
                were conducted--'';</DELETED>
        <DELETED>    (3) in the first sentence of subsection (c)(2)--
        </DELETED>
                <DELETED>    (A) by inserting ``such patent 
                information'' after ``shall file''; and</DELETED>
                <DELETED>    (B) by striking ``Secretary,'' and all 
                that follows and inserting ``Secretary.'';</DELETED>
        <DELETED>    (4) in subsection (j)(2)(vii), by striking ``which 
        claims the listed drug'' and all that follows through ``under 
        this subsection and'' and inserting ``for the listed drug 
        referred to in clause (i)''; and</DELETED>
        <DELETED>    (5) by adding at the end the following:</DELETED>
<DELETED>    ``(o) Patent Information.--</DELETED>
        <DELETED>    ``(1) Applicability.--This subsection applies to a 
        holder of an approved application under subsection (c) that 
        files a patent--</DELETED>
                <DELETED>    ``(A) that claims, with regard to a drug 
                of the application, a drug or method of using a drug; 
                and</DELETED>
                <DELETED>    ``(B) for 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, after the date of approval of 
                the application.</DELETED>
        <DELETED>    ``(2) Certification.--A holder of a patent 
        described in paragraph (1) shall--</DELETED>
                <DELETED>    ``(A) inform the Secretary of the filing 
                of the patent; and</DELETED>
                <DELETED>    ``(B) certify that the information is a 
                complete and accurate listing of all such 
                patents.</DELETED>
        <DELETED>    ``(3) Secretary.--The Secretary shall list the 
        information provided under paragraph (2) in accordance with 
        subsection (j)(7).''.</DELETED>

<DELETED>SEC. 8. REPORT.</DELETED>

<DELETED>    (a) In General.--Not later than the date that is 5 years 
after the date of enactment of this Act, the Federal Trade Commission 
shall submit to Congress a report describing the extent to which 
implementation of the amendments made by this Act--</DELETED>
        <DELETED>    (1) has enabled products to come to market in a 
        fair and expeditious manner, consistent with the rights of 
        patent owners under intellectual property law; and</DELETED>
        <DELETED>    (2) has promoted lower prices of drugs and greater 
        access to drugs through price competition.</DELETED>
<DELETED>    (b) Authorization of Appropriations.--There is authorized 
to be appropriated to carry out this section $5,000,000.</DELETED>

SEC. 3. 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.''.

SEC. 4. LIMITATION OF 30-MONTH STAY TO CERTAIN PATENTS.

    (a) Abbreviated New Drug Applications.--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)--
                    (A) in clause (iii)--
                            (i) by striking ``(iii) If the applicant 
                        made a certification described in subclause 
                        (IV) of paragraph (2)(A)(vii),'' and inserting 
                        the following:
                            ``(iii) Subclause (iv) certification with 
                        respect to certain patents.--If the applicant 
                        made a certification described in paragraph 
                        (2)(A)(vii)(IV) with respect to a patent (other 
                        than a patent that claims a process for 
                        manufacturing the listed drug) for which patent 
                        information was filed with the Secretary under 
                        subsection (c)(2)(A),''; and
                            (ii) by adding at the end the following: 
                        ``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 filed with the Secretary under 
                        subsection (c)(2)(B).'';
                    (B) by redesignating clause (iv) as clause (v); and
                    (C) by inserting after clause (iii) the following:
                            ``(iv) Subclause (iv) certification with 
                        respect to other patents.--
                                    ``(I) In general.--If the applicant 
                                made a certification described in 
                                paragraph (2)(A)(vii)(IV) with respect 
                                to a patent not described in clause 
                                (iii) for which patent information was 
                                published by the Secretary under 
                                subsection (c)(2)(D), 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) was 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, was filed on or 
                                before the date that is 45 days after 
                                the date on which the notice was 
                                received, 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.

                                    ``(II) Cooperation.--Each of the 
                                parties shall reasonably cooperate in 
                                expediting a civil action under 
                                subclause (I).
                                    ``(III) Expedited notification.--If 
                                the notice under paragraph (2)(B) 
                                contains an address for the receipt of 
                                expedited notification of a civil 
                                action under subclause (I), 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.''; and
            (2) by inserting after subparagraph (B) the following:
                    ``(C) Failure to bring infringement action.--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.--Section 505(c)) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(c)) (as amended by section 
9(a)(3)(A)(iii)) is amended--
            (1) in paragraph (3)--
                    (A) in subparagraph (C)--
                            (i) by striking ``(C) If the applicant made 
                        a certification described in clause (iv) of 
                        subsection (b)(2)(A),'' and inserting the 
                        following:
                    ``(C) Clause (iv) certification with respect to 
                certain patents.--If the applicant made a certification 
                described in subsection (b)(2)(A)(iv) with respect to a 
                patent (other than a patent that claims a process for 
                manufacturing the listed drug) for which patent 
                information was filed with the Secretary under 
                paragraph (2)(A),''; and
                            (ii) by adding at the end the following: 
                        ``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 filed with the 
                        Secretary under paragraph (2)(B).''; and
                    (B) by inserting after subparagraph (C) the 
                following:
                    ``(D) Clause (iv) certification with respect to 
                other patents.--
                            ``(i) In general.--If the applicant made a 
                        certification described in subsection 
                        (b)(2)(A)(iv) with respect to a patent not 
                        described in subparagraph (C) for which patent 
                        information was published by the Secretary 
                        under paragraph (2)(D), 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) was 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, was filed on or before the date 
                        that is 45 days after the date on which the 
                        notice was received, 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.
                            ``(ii) Cooperation.--Each of the parties 
                        shall reasonably cooperate in expediting a 
                        civil action under clause (i).
                            ``(iii) Expedited notification.--If the 
                        notice under subsection (b)(3) contains an 
                        address for the receipt of expedited 
                        notification of a civil action under clause 
                        (i), 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.''; and
            (2) by inserting after paragraph (3) the following:
            ``(4) Failure to bring infringement action.--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.--
            (1) In general.--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.
            (2) Transition provision.--In the case of applications 
        under section 505(b) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 355(b)) filed before the date of enactment of 
        this Act--
                    (A) a patent (other than a patent that claims a 
                process for manufacturing a listed drug) for which 
                information was submitted to the Secretary of Health 
                and Human Services under section 505(b)(1) of the 
                Federal Food, Drug, and Cosmetic Act (as in effect on 
                the day before the date of enactment of this Act) shall 
                be subject to subsections (c)(3)(C) and (j)(5)(B)(iii) 
                of section 505 of the Federal Food, Drug, and Cosmetic 
                Act (as amended by this section); and
                    (B) any other patent (including a patent for which 
                information was submitted to the Secretary under 
                section 505(c)(2) of that Act (as in effect on the day 
                before the date of enactment of this Act)) shall be 
                subject to subsections (c)(3)(D) and (j)(5)(B)(iv) of 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (as amended by this section).

SEC. 5. 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)) (as amended by section 4(a)) is 
amended--
            (1) in subparagraph (B)(v), by striking subclause (II) and 
        inserting the following:
                                    ``(II) the earlier of--
                                            ``(aa) 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
                                            ``(bb) 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 (C) the following:
                    ``(D) Forfeiture of 180-day period.--
                            ``(i) 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) or 
                                                (iv) 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 (15 U.S.C. 1).
                                    ``(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.
                            ``(ii) Forfeiture of 180-day period.--
                                    ``(I) In general.--Except as 
                                provided in subclause (II), if a 
                                forfeiture event occurs with respect to 
                                a first application--
                                            ``(aa) the 180-day period 
                                        under subparagraph (B)(v) shall 
                                        be forfeited by the first 
                                        applicant; and
                                            ``(bb) any subsequent 
                                        application shall become 
                                        effective as provided under 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subparagraph (B), and 
                                        clause (v) 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 
                                subclause (I) was the first among a 
                                number of subsequent applications to be 
                                filed--
                                            ``(aa) that first 
                                        subsequent application shall be 
                                        treated as the first 
                                        application under this 
                                        subparagraph (including 
                                        subclause (I)) and as the 
                                        previous application under 
                                        subparagraph (B)(v); and
                                            ``(bb) any other subsequent 
                                        applications shall become 
                                        effective as provided under 
                                        clause (i), (ii), (iii), or 
                                        (iv) of subparagraph (B), but 
                                        clause (v) of subparagraph (B) 
                                        shall apply to any such 
                                        subsequent application.
                            ``(iii) Availability.--The 180-day period 
                        under subparagraph (B)(v) 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)(v) 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.''.
    (b) Applicability.--The amendment made by subsection (a) shall be 
effective 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)(D)(i)(III)(ff) of that Act occurs 
in the case of an applicant, the applicant shall forfeit the 180-day 
period under section 505(j)(5)(B)(v) of that Act without regard to when 
the applicant made a certification under section 505(j)(2)(A)(vii)(IV) 
of that Act.

SEC. 6. FAIR TREATMENT FOR INNOVATORS.

    (a) Basis for Application.--Section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(3)(B), by striking the second 
        sentence and inserting ``The notice shall include a detailed 
        statement of the factual and legal basis of the applicant's 
        opinion that, as of the date of the notice, the patent is not 
        valid or is not infringed, and shall include, as appropriate 
        for the relevant patent, a description of the applicant's 
        proposed drug substance, drug formulation, drug composition, or 
        method of use. All information disclosed under this 
        subparagraph shall be treated as confidential and may be used 
        only for purposes relating to patent adjudication. Nothing in 
        this subparagraph precludes the applicant from amending the 
        factual or legal basis on which the applicant relies in patent 
        litigation.''; and
            (2) in subsection (j)(2)(B)(ii), by striking the second 
        sentence and inserting ``The notice shall include a detailed 
        statement of the factual and legal basis of the opinion of the 
        applicant that, as of the date of the notice, the patent is not 
        valid or is not infringed, and shall include, as appropriate 
        for the relevant patent, a description of the applicant's 
        proposed drug substance, drug formulation, drug composition, or 
        method of use. All information disclosed under this 
        subparagraph shall be treated as confidential and may be used 
        only for purposes relating to patent adjudication. Nothing in 
        this subparagraph precludes the applicant from amending the 
        factual or legal basis on which the applicant relies in patent 
        litigation.''.
    (b) Injunctive Relief.--Section 505(j)(5)(B) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(B)) (as amended by section 
4(a)(1)) is amended--
            (1) in clause (iii), by adding at the end the following: 
        ``A court shall not regard the extent of the ability of an 
        applicant to pay monetary damages as a whole or partial basis 
        on which to deny a preliminary or permanent injunction under 
        this clause.''; and
            (2) in clause (iv), by adding at the end the following:
                    ``(IV) Injunctive relief.--A court shall not regard 
                the extent of the ability of an applicant to pay 
                monetary damages as a whole or partial basis on which 
                to deny a preliminary or permanent injunction under 
                this clause.''.

SEC. 7. 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. 8. REPORT.

    (a) In General.--Not later than the date that is 5 years after the 
date of enactment of this Act, the Federal Trade Commission shall 
submit to Congress a report describing the extent to which 
implementation of the amendments made by this Act--
            (1) has enabled products to come to market in a fair and 
        expeditious manner, consistent with the rights of patent owners 
        under intellectual property law; and
            (2) has promoted lower prices of drugs and greater access 
        to drugs through price competition.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000.

SEC. 9. CONFORMING AND TECHNICAL AMENDMENTS.

    (a) Section 505.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (a), by striking ``(a) No person'' and 
        inserting ``(a) In General.--No person'';
            (2) in subsection (b)--
                    (A) by striking ``(b)(1) Any person'' and inserting 
                the following:
    ``(b) Applications.--
            ``(1) Requirements.--
                    ``(A) In general.--Any person'';
                    (B) in paragraph (1)--
                            (i) in the second sentence--
                                    (I) by redesignating subparagraphs 
                                (A) through (F) as clauses (i) through 
                                (vi), respectively, and adjusting the 
                                margins appropriately;
                                    (II) by striking ``Such persons'' 
                                and inserting the following:
                    ``(B) Information to be submitted with 
                application.--A person that submits an application 
                under subparagraph (A)''; and
                                    (III) by striking ``application'' 
                                and inserting ``application--'';
                            (ii) by striking the third through fifth 
                        sentences; and
                            (iii) in the sixth sentence--
                                    (I) by striking ``The Secretary'' 
                                and inserting the following:
                    ``(C) Guidance.--The Secretary''; and
                                    (II) by striking ``clause (A)'' and 
                                inserting ``subparagraph (B)(i)''; and
                    (C) in paragraph (2)--
                            (i) by striking ``clause (A) of such 
                        paragraph'' and inserting ``paragraph 
                        (1)(B)(i)'';
                            (ii) in subparagraphs (A) and (B), by 
                        striking ``paragraph (1) or''; and
                            (iii) in subparagraph (B)--
                                    (I) by striking ``paragraph 
                                (1)(A)'' and inserting ``paragraph 
                                (1)(B)(i)''; and
                                    (II) by striking ``patent'' each 
                                place it appears and inserting 
                                ``claim''; and
            (3) in subsection (c)--
                    (A) in paragraph (3)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``(A) If the 
                                applicant'' and inserting the 
                                following:
                    ``(A) Clause (i) or (ii) certification.--If the 
                applicant''; and
                                    (II) by striking ``may'' and 
                                inserting ``shall'';
                            (ii) in subparagraph (B)--
                                    (I) by striking ``(B) If the 
                                applicant'' and inserting the 
                                following:
                    ``(B) Clause (iii) certification.--If the 
                applicant''; and
                                    (II) by striking ``may'' and 
                                inserting ``shall'';
                            (iii) by redesignating subparagraph (D) as 
                        subparagraph (E); and
                            (iv) in subparagraph (E) (as redesignated 
                        by clause (iii)), by striking ``clause (A) of 
                        subsection (b)(1)'' each place it appears and 
                        inserting ``subsection (b)(1)(B)(i)''; and
                    (B) by redesignating paragraph (4) as paragraph 
                (5); and
            (4) in subsection (j)--
                    (A) in paragraph (2)(A)--
                            (i) in clause (vi), by striking ``clauses 
                        (B) through ((F)'' and inserting ``subclauses 
                        (ii) through (vi) of subsection (b)(1)'';
                            (ii) in clause (vii), by striking ``(b) 
                        or''; and
                            (iii) in clause (viii)--
                                    (I) by striking ``(b) or''; and
                                    (II) by striking ``patent'' each 
                                place it appears and inserting 
                                ``claim''; and
                    (B) in paragraph (5)--
                            (i) in subparagraph (B)--
                                    (I) in clause (i)--
                                            (aa) by striking ``(i) If 
                                        the applicant'' and inserting 
                                        the following:
                            ``(i) Subclause (i) or (ii) 
                        certification.--If the applicant''; and
                                            (bb) by striking ``may'' 
                                        and inserting ``shall'';
                                    (II) in clause (ii)--
                                            (aa) by striking ``(ii) If 
                                        the applicant'' and inserting 
                                        the following:
                            ``(i) Subclause (iii) certification.--If 
                        the applicant''; and
                                            (bb) by striking ``may'' 
                                        and inserting ``shall'';
                                    (III) in clause (iii), by striking 
                                ``(2)(B)(i)'' each place it appears and 
                                inserting ``(2)(B)''; and
                                    (IV) in clause (v) (as redesignated 
                                by section 4(a)(1)(B)), by striking 
                                ``continuing'' and inserting 
                                ``containing''; and
                            (ii) by redesignating subparagraphs (C) and 
                        (D) as subparagraphs (E) and (F), respectively.
    (b) Section 505A.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i)--
                    (A) by striking ``(c)(3)(D)(ii)'' each place it 
                appears and inserting ``(c)(3)(E)(ii)''; and
                    (B) by striking ``(j)(5)(D)(ii)'' each place it 
                appears and inserting ``(j)(5)(F)(ii)'';
            (2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii)--
                    (A) by striking ``(c)(3)(D)'' each place it appears 
                and inserting ``(c)(3)(E)''; and
                    (B) by striking ``(j)(5)(D)'' each place it appears 
                and inserting ``(j)(5)(F)'';
            (3) in subsections (e) and (l)--
                    (A) by striking ``505(c)(3)(D)'' each place it 
                appears and inserting ``505(c)(3)(E)''; and
                    (B) by striking ``505(j)(5)(D)'' each place it 
                appears and inserting ``505(j)(5)(F)''; and
            (4) in subsection (k), by striking ``505(j)(5)(B)(iv)'' and 
        inserting ``505(j)(5)(B)(v)''.
    (c) Section 527.--Section 527(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the second sentence by 
striking ``505(c)(2)'' and inserting ``505(c)(1)(B)''.




                                                       Calendar No. 491

107th CONGRESS

  2d Session

                                 S. 812

_______________________________________________________________________

                                 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act to provide greater 
                 access to affordable pharmaceuticals.

_______________________________________________________________________

                July 11 (legislative day, July 10), 2002

                       Reported with an amendment