[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1225 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                S. 1225

   Entitled the ``Greater Access to Affordable Pharmaceuticals Act''.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             June 10, 2003

   Mr. Gregg (for himself, Mr. Schumer, Mr. McCain, and Mr. Kennedy) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   Entitled the ``Greater Access to Affordable Pharmaceuticals Act''.

    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''.

SEC. 2. 30-MONTH STAY-OF-EFFECTIVENESS PERIOD.

    (a) Abbreviated New Drug Applications.--Section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended--
            (1) in paragraph (2)(A)(vii), by inserting after ``each 
        patent'' the following: ``published by the Secretary under 
        subsection (b)(1) or (c)(2) at least 1 day before the date on 
        which the application is filed''; and
            (2) in paragraph (5)--
                    (A) in subparagraph (B)(iii)--
                            (i) by striking ``paragraph (2)(B)(i)'' 
                        each place it appears and inserting ``paragraph 
                        (2)(B)'';
                            (ii) in the first sentence, by inserting 
                        after ``of a patent'' the following: 
                        ``published by the Secretary under subsection 
                        (b)(1) or (c)(2) at least 1 day before the date 
                        on which the application is filed''; and
                            (iii) in subclauses (I), (II), and (III) of 
                        the second sentence, by striking ``the court'' 
                        and inserting ``the United States district 
                        court presiding over the matter'';
                    (B) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (E) and (F), respectively; and
                    (C) by inserting after subparagraph (B) the 
                following:
                    ``(C) Availability of 30-month period.--
                            ``(i) In general.--The 30-month period 
                        provided under subparagraph (B)(iii) shall be 
                        available only with respect to a patent 
                        published by the Secretary under subsection 
                        (b)(1) or (c)(2) at least 1 day before the date 
                        on which the application is filed.
                            ``(ii) Subsequently published patents.--
                                    ``(I) In general.--If a patent is 
                                published by the Secretary under 
                                subsection (b)(1) or (c)(2) subsequent 
                                to the filing of an application 
                                described in paragraph (2)(A) but 
                                before approval of that application 
                                (referred to in this clause as a 
                                `subsequently published patent'), and 
                                the patent claims the listed drug 
                                referred to in paragraph (2)(A)(i) or a 
                                use for the listed drug for which the 
                                applicant is seeking approval under 
                                this subsection and for which 
                                information is required to be filed 
                                under subsection (b) or (c), the 
                                applicant shall amend the application 
                                to include a certification described in 
                                paragraph (2)(A)(vii) or a statement 
                                described in paragraph (2)(A)(viii) for 
                                the patent.
                                    ``(II) No additional 30-month 
                                period.--The 30-month period described 
                                in subparagraph (B)(iii) shall not be 
                                available with respect to a 
                                certification described in paragraph 
                                (2)(A)(vii)(IV) when the subject of 
                                that certification is a subsequently 
                                published patent.
                                    ``(III) Challenge to subsequently 
                                published patent in separate 
                                proceeding.--If the same applicant 
                                makes a certification described in 
                                paragraph (2)(A)(vii)(IV) with respect 
                                to the subsequently published patent in 
                                a separate application under this 
                                subsection, the 30-month period 
                                provided under subparagraph (B)(iii) 
                                shall be available in connection with 
                                the separate application.
                            ``(iii) Civil action to obtain patent 
                        certainty.--
                                    ``(I) Declaratory judgment absent 
                                infringement action.--If the owner of a 
                                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 provided under paragraph 
                                (2)(B) was received, the applicant may 
                                bring a civil action against the owner 
                                of the patent for a declaratory 
                                judgment under section 2201 of title 
                                28, United States Code, that the patent 
                                is invalid, is unenforceable, or will 
                                not otherwise be infringed by the new 
                                drug for which the person seeks 
                                approval.
                                    ``(II) Counterclaim to infringement 
                                action.--
                                            ``(aa) In general.--If the 
                                        owner of the patent brings a 
                                        patent infringement action 
                                        against the applicant, the 
                                        applicant may assert a 
                                        counterclaim seeking an order 
                                        requiring the patent owner to 
                                        correct or delete patent 
                                        information filed by the patent 
                                        owner under subsection (b) or 
                                        (c) on the ground that the 
                                        patent does not claim--

                                                    ``(AA) the drug for 
                                                which the application 
                                                was approved; or

                                                    ``(BB) an approved 
                                                method of using the 
                                                drug.

                                            ``(bb) No damages.--An 
                                        applicant shall not be entitled 
                                        to damages on a counterclaim 
                                        under item (aa).
                                            ``(cc) No independent cause 
                                        of action.--Item (aa) does not 
                                        authorize the assertion of a 
                                        claim described in item (aa) in 
                                        any civil action or proceeding 
                                        other than a counterclaim 
                                        described in item (aa).''.
    (b) Applications Generally.--Section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355) is amended--
            (1) in subsection (b)(2)(A), by inserting after ``each 
        patent'' the following: ``published by the Secretary under 
        paragraph (1) or subsection (c)(2) at least 1 day before the 
        date on which the application is filed''; and
            (2) in subsection (c)--
                    (A) in paragraph (3)(C)--
                            (i) by striking ``paragraph (3)(B)'' each 
                        place it appears and inserting ``paragraph 
                        (3)'';
                            (ii) in the first sentence, by inserting 
                        after ``of a patent'' the following: 
                        ``published by the Secretary under paragraph 
                        (2) or subsection (b)(1) at least 1 day before 
                        the date on which the application is filed''; 
                        and
                            (iii) in clauses (i), (ii), and (iii) of 
                        the second sentence, by striking ``the court'' 
                        and inserting ``the United States district 
                        court presiding over the matter'';
                    (B) by redesignating paragraph (4) as paragraph 
                (5); and
                    (C) by inserting after paragraph (3) the following:
            ``(4) Availability of 30-month period.--
                    ``(A) In general.--The 30-month period provided 
                under paragraph (3)(C) shall be available only with 
                respect to a patent published by the Secretary under 
                paragraph (2) or subsection (b)(1) at least 1 day 
                before the date on which the application is filed.
                    ``(B) Subsequently published patents.--
                            ``(i) In general.--If a patent is published 
                        by the Secretary under paragraph (2) or 
                        subsection (b)(1) subsequent to the filing of 
                        an application described in subsection (b)(2) 
                        but before approval of that application 
                        (referred to in this subparagraph as a 
                        `subsequently published patent'), and the 
                        patent claims the listed drug or a use for the 
                        listed drug for which the applicant is seeking 
                        approval, the applicant shall amend the 
                        application to include a certification 
                        described in subsection (b)(2)(A) or a 
                        statement described in subsection (b)(2)(B) for 
                        the patent.
                            ``(ii) No additional 30-month period.--The 
                        30-month period described in paragraph (3)(C) 
                        shall not be available with respect to a 
                        certification described in subsection 
                        (b)(2)(A)(iv) when the subject of that 
                        certification is a subsequently published 
                        patent.
                            ``(iii) Challenge to subsequently published 
                        patent in separate proceeding.--If the same 
                        applicant makes a certification described in 
                        subsection (b)(2)(A)(iv) with respect to the 
                        subsequently published patent in a separate 
                        application under this subsection, the 30-month 
                        period provided under paragraph (3)(C) shall be 
                        available in connection with the separate 
                        application.
                    ``(C) Civil action to obtain patent certainty.--
                            ``(i) Declaratory judgment absent 
                        infringement action.--If the owner of a 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 provided under paragraph 
                        (2)(B) was received, the applicant may bring a 
                        civil action against the owner of the patent 
                        for a declaratory judgment under section 2201 
                        of title 28, United States Code, that the 
                        patent is invalid, is unenforceable, or will 
                        not otherwise be infringed by the new drug for 
                        which the person seeks approval.
                            ``(ii) Counterclaim to infringement 
                        action.--
                                    ``(I) In general.--If the owner of 
                                the patent brings a patent infringement 
                                action against the applicant, the 
                                applicant may assert a counterclaim 
                                seeking an order requiring the patent 
                                owner to correct or delete patent 
                                information filed by the patent owner 
                                under subsection (b) or (c) on the 
                                ground that the patent either does not 
                                claim the drug for which the 
                                application was approved or does not 
                                claim--
                                            ``(aa) the drug for which 
                                        the application was approved; 
                                        or
                                            ``(bb) an approved method 
                                        of using the drug.
                                    ``(II) No damages.--An applicant 
                                shall not be entitled to damages on a 
                                counterclaim under subclause (I).
                                    ``(III) No independent cause of 
                                action.--Subclause (I) does 
not authorize the assertion of a claim described in subclause (I) in 
any civil action or proceeding other than a counterclaim described in 
subclause (I).''.
    (c) Infringement Actions.--Section 271(e) of title 35, United 
States Code, is amended by adding at the end the following:
            ``(5) Case or controversy.--The filing of an application 
        described in paragraph (2) that includes a 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), 
        and the failure of the owner of the patent to bring an action 
        for infringement of a patent that is the subject of the 
        certification before the expiration of 45 days after the date 
        on which the notice provided under subsection (b)(3) or 
        (j)(2)(B) of that section is received, shall establish an 
        actual controversy between the applicant and the patent owner 
        sufficient to confer subject matter jurisdiction in the courts 
        of the United States for any action brought by the applicant 
        under section 2201 of title 28 for a declaratory judgment that 
        any patent that is the subject of the certification is invalid, 
        unenforceable, or not infringed.''.
    (d) 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 or in an amendment to an application filed under 
subsection (b)(2) or (j) of that section.

SEC. 3. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.

    (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 2) is 
amended--
            (1) in subparagraph (B)(iv), 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 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 otherwise 
                                        infringed;''; and
            (2) by inserting after subparagraph (C) the following:
                    ``(D) Forfeiture of 180-day exclusivity period.--
                            ``(i) Definition of forfeiture event.--In 
                        this subparagraph, the term `forfeiture event', 
                        with respect to an application under this 
                        subsection, means the occurrence of any of the 
                        following:
                                    ``(I) 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 subparagraph (B)(iii); 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 
                                        otherwise infringed, the date 
                                        that is 60 days after 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) in 
                                        the last of those civil actions 
                                        to be decided.
                                    ``(II) Withdrawal of application.--
                                The applicant withdraws the 
                                application.
                                    ``(III) Amendment of 
                                certification.--The applicant amends 
                                the certification from a certification 
                                under paragraph (2)(A)(vii)(IV) to a 
                                certification under paragraph 
                                (2)(A)(vii)(III).
                                    ``(IV) Failure to obtain tentative 
                                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 a 
                                change in the requirements for approval 
                                of the application imposed after the 
                                date on which the application is filed.
                                    ``(V) 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)--
                                            ``(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).
                                    ``(VI) Agreement with patent 
                                owner.--The applicant enters into an 
                                agreement with the owner of the 
                                patent--
                                            ``(aa) that is the subject 
                                        of the certification under 
                                        paragraph (2)(A)(vii)(IV); and
                                            ``(bb) that the Federal 
                                        Trade Commission determines has 
                                        violated the antitrust laws (as 
                                        defined in section 1 of the 
                                        Clayton Act (15 U.S.C. 12), 
                                        except that the term includes 
                                        section 5 of the Federal Trade 
                                        Commission Act (15 U.S.C. 45) 
                                        to the extent that that section 
                                        applies to unfair methods of 
                                        competition).
                            ``(ii) Forfeiture.--The 180-day exclusivity 
                        period described in subparagraph (B)(iv) shall 
                        be forfeited by an applicant if a forfeiture 
                        event occurs.
                            ``(iii) Subsequent applicant.--If an 
                        applicant forfeits the 180-day exclusivity 
                        period under clause (ii)--
                                    ``(I) a subsequent application 
                                containing a certification described in 
                                paragraph (2)(A)(vii)(IV) shall become 
                                effective immediately on approval; and
                                    ``(II) the subsequent applicant 
                                shall not be eligible for a 180-day 
                                exclusivity period under subparagraph 
                                (B)(iv).
                    ``(E) 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.''.
    (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)(VI) of that Act 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).

SEC. 4. BIOAVAILABILITY AND BIOEQUIVALENCE.

    (a) In General.--Section 505(j)(8) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(8)) is amended--
            (1) by striking subparagraph (A) and inserting the 
        following:
            ``(A)(i) The term `bioavailability' means the rate and 
        extent to which the active ingredient or therapeutic ingredient 
        is absorbed from a drug and becomes available at the site of 
        drug action.
            ``(ii) For a drug that is not intended to be absorbed into 
        the bloodstream, the Secretary may assess bioavailability by 
        scientifically valid measurements intended to reflect the rate 
        and extent and extent to which the active ingredient or active 
        moeity becomes available at the site of drug action.''; and
            (2) by adding at the end the following:
            ``(C) For a drug that is not intended to be absorbed into 
        the bloodstream, the Secretary may establish alternative, 
        scientifically valid methods to show bioequivalence if the 
        alternative methods are expected to detect a significant 
        difference between the drug and the listed drug in safety and 
        therapeutic effect.''.
    (b) Effect of Amendment.--The amendment made by subsection (a) does 
not alter the standards for approval of drugs under section 505(j) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

SEC. 5. REMEDIES FOR INFRINGEMENT.

    Section 287 of title 35, United States Code, is amended by adding 
at the end the following:
    ``(d) Consideration.--In making a determination with respect to 
remedy brought for infringement of a patent that claims a drug or a 
method or using a drug, the court shall consider whether information on 
the patent was filed as required under 21 U.S.C. 355 (b) or (c), and, 
if such information was required to be filed but was not, the court may 
refuse to award treble damages under section 284.''.

SEC. 6. CONFORMING AMENDMENTS.

    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), 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), by 
        striking ``(j)(5)(D)'' each place it appears and inserting 
        ``(j)(5)(F)''; and
            (3) in subsections (e) and (l), by striking 
        ``505(j)(5)(D)'' each place it appears and inserting 
        ``505(j)(5)(F)''.
                                 <all>