[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 4016 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 4016

To amend the Public Health Service Act to provide for the licensing of 
        comparable biological products, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 29, 2006

 Mr. Schumer (for himself, Mrs. Clinton, Mr. Leahy, and Ms. Stabenow) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to provide for the licensing of 
        comparable biological products, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Access to Life-Saving Medicine 
Act''.

SEC. 2. DEFINITIONS.

    Section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)) 
is amended--
            (1) by striking ``In this section, the term `biological 
        product' means'' and inserting the following: ``In this 
        section:
            ``(1) The term `biological product' means''; and
            (2) by adding at the end the following:
            ``(2) The term `comparable biological product application' 
        means an abbreviated application for a license of a biological 
        product containing the same, or similar, active ingredient as a 
        biological product for which a license has been approved under 
        subsection (a). A comparable biologic application is a human 
        drug application under section 735(1)(C) of the Federal Food, 
        Drug, and Cosmetic Act.
            ``(3) The term `reference product' under this Act means the 
        single licensed biological product, approved under subsection 
        (a) or subsection (k), against which a comparable biological 
        product is evaluated for demonstration of safety, potency, or 
        purity.
            ``(4) The term `comparable' in reference to a comparable 
        biological product application means the absence of clinically 
        meaningful differences between the comparable biological 
        product and the reference product in terms of the safety, 
        purity, and potency of the product based upon--
                    ``(A) data derived from chemical, physical, and 
                biological assays, other non-clinical laboratory 
                studies; and
                    ``(B) data from any necessary clinical study or 
                studies sufficient to confirm safety, purity, and 
                potency in one or more appropriate conditions of use 
                for which the reference product is licensed and 
                intended to be used.
        Any studies described in subparagraph (B) shall be designed to 
        avoid duplicative and unethical clinical testing.
            ``(5) The term `thorough characterization' means an 
        analysis of structural features based upon appropriate 
        analytical and functional testing sufficient to identify 
        differences between a new and reference biological product 
        relevant to safety, purity or potency.
            ``(6) The term `interchangeable' means that a biological 
        product contains an active ingredient or ingredients with 
        principal molecular structural features comparable to the 
        reference product, and that the comparable biological product 
        can be expected to produce the same clinical result as the 
        reference product in any given patient in the condition or 
        conditions of use for which both products are labeled.
            ``(7) The term `process for the review of a comparable 
        biological product application' means, with respect to a 
        comparable biological product application, the procedural 
        activities of the Secretary with respect to the review of human 
        drug applications and supplements as defined in section 735(6) 
        of the Federal Food, Drug, and Cosmetic Act, except as 
        otherwise defined herein.
            ``(8) The term `final action' means, with respect to a 
        comparable biological product application, the Secretary's 
        issuance on the final action date of a final action letter to 
        the sponsor of a comparable biological product application 
        under this Act which--
                    ``(A) approves the application, or
                    ``(B) disapproves the application and sets forth in 
                detail an enumeration of the specific deficiencies in 
                the particular application and of the specific, 
                enumerated actions the sponsor would be required to 
                take in order for the sponsor to receive a final action 
                letter that approves such application.
            ``(9) The term `final action date' means, with respect to 
        an abbreviated comparable biological product application, the 
        date that is eight calendar months following the sponsor's 
        submission of such application, or 180 days following the 
        Secretary's notification of the sponsor that its application 
        has been accepted for filing, whichever is earlier, except that 
        the final action date hereunder may be extended for such period 
        of time as is agreed to by the Secretary and the sponsor of 
        such application in a jointly executed written agreement that 
        is counter-signed by the Secretary and the sponsor of such 
        application no later than 30 days prior to the final action 
        date provided for by this subsection.
            ``(10) The term `reviewing division' means the division 
        responsible for the review of an application for approval of a 
        biological product (including all scientific and medical 
        matters, chemistry, manufacturing, and controls).''.

SEC. 3. REGULATION OF CERTAIN BIOLOGICAL PRODUCTS.

    (a) In General.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended--
            (1) in subsection (a)(1)(A), by inserting after ``biologics 
        license'' the following: ``, or comparable biologics 
        license,''; and
            (2) by adding at the end the following subsection:
    ``(k) Regulation of Comparable Biological Products.--
            ``(1) Submission of a comparable biological product 
        application.--Any person may file with the Secretary an 
        abbreviated comparable biological product application that 
        includes the following:
                    ``(A) Data demonstrating that the comparable 
                biological product is comparable to the reference 
                product.
                    ``(B) Data demonstrating that the comparable 
                biological product and reference product contain 
                comparable principal molecular structural features as 
                demonstrated by thorough characterization of the two 
                products, notwithstanding minor differences in 
                heterogeneity profile, impurities, or degradation 
                patterns. The Secretary shall find the following types 
                of products to contain comparable principal molecular 
                structural features:
                            ``(i) Two protein biological products with 
                        differences in structure between them solely 
                        due to post-translational events, infidelity of 
                        translation or transcription, or minor 
                        differences in amino acid sequence.
                            ``(ii) Two polysaccharide biological 
                        products with similar saccharide repeating 
                        units, even if the number of units differ and 
                        even if there are differences in post-
                        polymerization modifications.
                            ``(iii) Two glycosylated protein products 
                        with differences in structure between them 
                        solely due to post-translational events, 
                        infidelity of translation or transcription, or 
                        minor differences in amino acid sequence, and 
                        if they had similar saccharide repeating units, 
                        even if the number of units differ and even if 
                        there were differences in post-polymerization.
                            ``(iv) Two polynucleotide biological 
                        products with identical sequence of purine and 
                        pyrimidine bases (or their derivatives) bound 
                        to an identical sugar backbone (ribose, 
                        deoxyribose, or modifications of these sugars).
                            ``(v) Closely related, complex partly 
                        definable biological products with similar 
                        therapeutic intent, such as two live viral 
                        products for the same indication.
                The principal molecular structural features of two 
                biological products not enumerated in the foregoing 
                clauses may be demonstrated to be comparable based upon 
                such data and other information characterizing the two 
                products as the Secretary determines to be necessary.
                    ``(C) Data demonstrating that the comparable 
                biological product and reference product utilize the 
                same mechanism or mechanisms of action for the 
                conditions of use prescribed, recommended, or suggested 
                in the proposed labeling, but only to the extent the 
                mechanism or mechanisms of action are known for the 
                reference product.
                    ``(D) Information to show that the condition or 
                conditions of use prescribed, recommended, or suggested 
                in the labeling proposed for the comparable biological 
                product have been previously approved for the reference 
                product.
                    ``(E) Information to show that the route of 
                administration, the dosage form, and the strength of 
                the comparable biological product are the same as those 
                of the reference product.
                    ``(F) Data demonstrating that the facility in which 
                the comparable biological product is manufactured, 
                processed, packed, or held meets standards designed to 
                assure that the comparable biological product continues 
                to be safe, pure, and potent.
                    ``(G) At the applicant's option, publicly-available 
                information regarding the Secretary's previous 
                determination that the reference product is safe, pure, 
                and potent.
                    ``(H) Any additional data and information in 
                support of the application, including publicly-
                available information with respect to the reference 
                product or another biological product.
            ``(2) Other applications.--A person who has not conducted 
        and does not have a right of reference to the studies in the 
        application for a reference product may submit an application 
        under this section for a biologic product that differs from, or 
        incorporates a change to, the reference product with respect to 
        one or more characteristics described in subparagraphs (A) 
        through (E) of paragraph (1), including a difference in safety, 
        purity, or potency, so long as the application contains 
        sufficient information to establish the safety, purity, and 
        potency of the biological product relative to the reference 
        product for its proposed condition or conditions of use.
            ``(3) Postmarketing studies.--If the Secretary has agreed 
        with the sponsor of the reference product that the sponsor 
        shall conduct one or more postmarketing safety studies, the 
        applicant may agree with the Secretary to conduct a similar 
        postmarketing safety study or studies upon a reasonable showing 
        that such study or studies would provide relevant information 
        not available from the studies on the reference product. The 
        Secretary shall not, as a condition of approval, propose any 
        additional postmarketing studies.
            ``(4) FDA review of comparable biological product 
        applications.--
                    ``(A) Guidance regarding review of applications.--
                The Secretary shall issue guidance for the individuals 
                who review applications submitted under paragraph (1) 
                or (2), which shall relate to promptness in conducting 
                the review, technical excellence, lack of bias and 
                conflict of interest, and knowledge of regulatory and 
                scientific standards, and which shall apply equally to 
                all individuals who review such applications.
                    ``(B) Meetings with sponsors and applicants.--The 
                Secretary shall meet with a sponsor of an investigation 
                or an applicant for approval of a comparable biological 
                product under this subsection if the sponsor or 
                applicant makes a reasonable written request for a 
                meeting for the purpose of reaching agreement on the 
                design and size of studies needed for approval of such 
                application. The sponsor or applicant shall provide 
                information necessary for discussion and agreement on 
                the design and size of such studies. Minutes of any 
                such meeting shall be prepared by the Secretary and 
                made available to the sponsor or applicant.
                    ``(C) Agreements.--Any agreement regarding the 
                parameters of design and size of the studies of a 
                biological product under this paragraph that is reached 
                between the Secretary and a sponsor or applicant shall 
                be reduced to writing and made part of the 
                administrative record by the Secretary. Such agreement 
                shall not be changed after the testing begins, except--
                            ``(i) with the written agreement of the 
                        sponsor or applicant; or
                            ``(ii) pursuant to a decision, made in 
                        accordance with subparagraph (D) by the 
                        director of the reviewing division, that a 
                        substantial scientific issue essential to 
                        determining the safety, purity, and potency of 
                        the biological product has been identified 
                        after the testing has begun.
                    ``(D) Procedure regarding certain decisions.--A 
                decision under subparagraph (C)(ii) by the director 
                shall be in writing and the Secretary shall provide to 
                the sponsor or applicant an opportunity for a meeting 
                at which the director and the sponsor or applicant will 
                be present and at which the director will document the 
                scientific issue involved.
                    ``(E) Effect of decisions.--The written decisions 
                of the reviewing division shall be binding upon, and 
                may not directly or indirectly be changed by, the field 
                or compliance office personnel unless such field or 
                compliance office personnel demonstrate to the 
                reviewing division why such decision should be 
                modified.
                    ``(F) Delays by reviewing divisions.--No action by 
                the reviewing division may be delayed because of the 
                unavailability of information from or action by field 
                personnel unless the reviewing division determines that 
                a delay is necessary to assure the marketing of a safe, 
                pure, and potent biological product.
            ``(5) Approval of comparable biological products.--The 
        Secretary shall review the information submitted in the 
        application and any other information available to the 
        Secretary and shall issue, subject to paragraph (9), a 
        comparable biological product license for all conditions of use 
        of the reference product sharing the same mechanism of action 
        for which the applicant has demonstrated comparability for a 
        single condition of use, or, if the mechanism of action is 
        unknown, for the condition or conditions of use for which the 
        data submitted establishes comparability, unless the Secretary 
        finds and informs the applicant that--
                    ``(A) information submitted in the application or 
                any other information available to the Secretary is 
                insufficient to show that the comparable biological 
                product and the reference product contain comparable 
                principal molecular structural features as demonstrated 
                by thorough characterization of the two products;
                    ``(B) information submitted in the application or 
                any other information available to the Secretary is 
                insufficient to show that the comparable biological 
                product is comparable to the reference product for the 
                condition or conditions of use prescribed, recommended, 
                or suggested in the labeling proposed in the 
                application;
                    ``(C) information submitted in the application or 
                any other information available to the Secretary is 
                insufficient to show that the comparable biological 
                product and reference product utilize the same 
                mechanism or mechanisms of action for the conditions of 
                use prescribed, recommended, or suggested in the 
                labeling proposed for the comparable biological 
                product, unless the mechanism or mechanisms of action 
                are not known for the reference product for such 
                condition or conditions;
                    ``(D) information submitted in the application or 
                any other information available to the Secretary is 
                insufficient to show that the route of administration, 
                the dosage form, and the strength of the comparable 
                biological product are the same as those of the 
                reference product;
                    ``(E) information submitted in the application or 
                any other information available to the Secretary is 
                insufficient to show that the condition or conditions 
                of use prescribed, recommended, or suggested in the 
                labeling proposed for the comparable biological product 
                are limited to one or more of the same use or uses as 
                have been previously approved for the reference 
                product;
                    ``(F) information submitted in the application or 
                any other information available to the Secretary shows 
                (i) the inactive ingredients of the comparable 
                biological product are unsafe for use under the 
                conditions prescribed, recommended, or suggested in the 
                labeling proposed for the biological product, or (ii) 
                the composition of the comparable biological product is 
                unsafe under such conditions because of the type or 
                quantity of inactive ingredients included or the manner 
                in which the inactive ingredients are included;
                    ``(G) information submitted in the application or 
                any other information available to the Secretary fails 
                to demonstrate that the facility in which the 
                comparable biological product is manufactured, 
                processed, packed, or held meets standards designed to 
                assure that the comparable biological product continues 
                to be safe, pure, and potent;
                    ``(H) the Secretary has withdrawn or suspended the 
                license of the reference product, for safety or 
                effectiveness reasons, or has published a notice of 
                opportunity for hearing to withdraw such license for 
                safety or effectiveness reasons, or the Secretary has 
                determined that the reference product has been 
                withdrawn from sale for safety or effectiveness 
                reasons; or
                    ``(I) the application contains an untrue statement 
                of material fact; and
        provides the applicant with a detailed explanation for the 
        decision.
            ``(6) Other approval provisions.--The Secretary shall 
        approve, under the provisions of paragraph (5), an application 
        for a license submitted under paragraph (2), except that the 
        Secretary shall approve such an application that would 
        otherwise be disapproved by reason of one or more of 
        subparagraphs (A) through (E) of paragraph (5), if the 
        application and any other information available to the 
        Secretary contains sufficient information to establish the 
        safety, purity, and potency of the comparable biological 
        product relative to the reference product for the proposed 
        condition or conditions of use for such product.
            ``(7) Interchangeability determinations for comparable 
        biological products.--An applicant may request in an original 
        application or supplement to an application that the Secretary 
        make a determination as to the interchangeability of a 
        comparable biological product and the reference product. An 
        applicant may withdraw a request for a determination at any 
        time. A request for an interchangeability determination 
        submitted after the filing of an application shall be 
        considered a major amendment to the application. In response to 
        such a request, the Secretary shall, at such time as the 
        application or supplement is approved, publish a therapeutic 
        comparability evaluation code indicating either that the 
        comparable biological product has been shown to be 
        interchangeable with the reference product, or that 
        interchangeability has not been established. Nothing in this 
        subsection shall be construed to prohibit the Secretary from 
        making a determination of interchangeability at any time after 
        approval.
            ``(8) Interchangeability labeling for comparable biological 
        products.--Upon a determination of interchangeability under 
        paragraph (7), the label of the comparable biological product 
        at the time of licensure may include a statement, if requested 
        by the sponsor, that it is interchangeable with the biological 
        reference product to which the sponsor of the comparable 
        biological product application has demonstrated comparability 
        to the reference product for the conditions of use prescribed, 
        recommended, or suggested in the labeling proposed for the 
        comparable biological product.
            ``(9) Exclusivity.--
                    ``(A) In general.--Notwithstanding any other 
                provision of law, the Secretary shall not approve a 
                second or subsequent comparable biological product 
                application, and no holder of a biologic product 
                license approved under subsection (a) shall 
                manufacture, market, sell, or distribute a rebranded 
                interchangeable biologic, directly or indirectly, or 
                authorize any other person to manufacture, market, 
                sell, or distribute a rebranded interchangeable 
                biologic that is interchangeable with the reference 
                product, until the earlier of--
                            ``(i) 180 days after the first commercial 
                        marketing of the first interchangeable 
                        comparable biological product to be approved as 
                        interchangeable for that same reference 
                        product;
                            ``(ii) one year after--
                                    ``(I) a final court decision on all 
                                patents in suit in an action instituted 
                                under paragraph (16)(C) against the 
                                applicant that submitted the 
                                application for the first approved 
                                interchangeable comparable biological 
                                product; or
                                    ``(II) the dismissal with or 
                                without prejudice of an action 
                                instituted under paragraph (16)(C) 
                                against the applicant that submitted 
                                the application for the first approved 
                                interchangeable comparable biological 
                                product; or
                            ``(iii)(I) 36 months after approval of the 
                        first interchangeable comparable biological 
                        product if the applicant has been sued under 
                        paragraph (16)(C) and such litigation is still 
                        ongoing within such 36-month period; or
                            ``(II) one year after approval in the event 
                        that the first approved interchangeable 
                        comparable applicant has not been sued under 
                        paragraph (16)(C).
                Notwithstanding the foregoing provision, the sponsor of 
                a subsequent comparable biological product application 
                that has demonstrated interchangeability with the 
                reference product may elect, at its option, to have the 
                product approved as a non-interchangeable comparable 
                biological product whose approval will not be delayed 
                by operation of this paragraph. For purposes of this 
                paragraph, the term `final court decision' means a 
                final decision of a court from which no appeal (other 
                than a petition to the United States Supreme Court for 
                a writ of certiorari) has been or can be taken.
                    ``(B) Rebranded interchangeable biologic.--For 
                purposes of this subsection, the term `rebranded 
                interchangeable biologic'--
                            ``(i) means any rebranded interchangeable 
                        version of a reference product that the holder 
                        of the biological product license approved 
                        under subsection (a) for that reference product 
                        seeks to commence marketing, selling, or 
                        distributing, directly or indirectly; and
                            ``(ii) does not include any product to be 
                        marketed, sold, or distributed--
                                    ``(I) by an entity eligible for 
                                exclusivity with respect to such 
                                product under this paragraph; or
                                    ``(II) after expiration of any 
                                exclusivity with respect to such 
                                product under this paragraph.
            ``(10) Hearing.--If the Secretary decides to disapprove a 
        comparable biological product application, the Secretary shall 
        give the applicant notice of an opportunity for a hearing 
        before the Secretary on the question of whether such 
        application is approvable. If the applicant elects to accept 
        the opportunity for hearing by written request within thirty 
        days after such notice, such hearing shall commence not more 
        than ninety days after the expiration of such thirty days 
        unless the Secretary and the applicant otherwise agree. Any 
        such hearing shall thereafter be conducted on an expedited 
        basis and the Secretary's order thereon shall be issued within 
        ninety days after the date fixed by the Secretary for filing 
        final briefs.
            ``(11) Final action date.--The Secretary shall take a final 
        action on a comparable biological product application by the 
        final action date.
            ``(12) Request for delay of final action.--Notwithstanding 
        any other provision of law, the Secretary shall not fail or 
        refuse to take a final action on a comparable biological 
        product application by the final action date on the basis that 
        a person, other than the sponsor of the comparable biological 
        product, has requested (in a petition or otherwise) that the 
        Secretary refuse to take or otherwise defer such final action, 
        and no court shall enjoin the Secretary from taking final 
        action or stay the effect of final action previously taken by 
        the Secretary, except by issuance of a permanent injunction 
        based upon an express finding of clear and convincing evidence 
        that the person seeking to have the Secretary refuse to take or 
        otherwise to deter final action by the final action date--
                    ``(A) has prevailed on the merits of the person's 
                complaint against the Secretary;
                    ``(B) will suffer imminent and actual irreparable 
                injury, constituting more than irrecoverable economic 
                loss, and that also will threaten imminent destruction 
                of such person's business; and
                    ``(C) has an interest that outweighs the 
                overwhelming interest that the public has in obtaining 
                prompt access to a comparable biological product.
            ``(13) Report on extensions of final action date.--The 
        Secretary shall prepare and submit to the President, the 
        Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor, 
        and Pensions of the Senate a report regarding any jointly 
        executed written agreement to extend the final action date 
        under this Act within 15 calendar days of the joint execution 
        of any such written agreement.
            ``(14) Report on failure to take final action.--The 
        Secretary shall prepare and submit annually to the President, 
        the Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor, 
        and Pensions of the Senate a report detailing the specific and 
        particularized reasons enumerated by the Reviewing Division for 
        each instance of the Secretary's failure to take final action 
        by the final action date in the previous year.
            ``(15) Regulations.--The Secretary shall establish, by 
        regulation within 2 years after the date of the enactment of 
        this subsection, requirements for the efficient review, 
        approval, suspension, and revocation of comparable biological 
        product applications under this subsection.
            ``(16) Patents.--
                    ``(A) Request for patent information.--
                            ``(i) In general.--At any time, including 
                        at the initial stages of development, an 
                        applicant or a prospective applicant may send a 
                        written request for patent information to the 
                        holder of the approved application for the 
                        reference product. Within 60 days of receipt of 
                        such request, the holder of the approved 
                        application for the reference product shall 
                        provide to the applicant or prospective 
                        applicant a list of all patents owned by, or 
                        licensed to, the holder of the approved 
                        application that the application holder in good 
                        faith believes relate to the reference product, 
                        including patents that claim the approved 
                        biologic product, any method of using such 
                        product, any component of such product, or any 
                        method or process of manufacturing such product 
                        or component.
                            ``(ii) Costs of complying with request.--
                        The application holder may demand payment not 
                        exceeding $1,000 to offset the cost of 
                        responding to the information request.
                            ``(iii) Updates.--For a period of two years 
                        from the date of the request for information, 
                        the holder of the approved application for the 
                        reference product shall update its response to 
                        the request for information by identifying 
                        newly issued or licensed relevant patents. The 
                        updates must be provided within 30 days of 
                        patent issuance, for newly issued patents, and 
                        within 30 days of obtaining a license, for 
                        newly licensed patents.
                            ``(iv) Additional requests.--The applicant 
                        may submit additional requests for patent 
                        information, subject to the requirements of 
                        this paragraph, at any time.
                    ``(B) Patent notifications.--At any time after the 
                submission of the application, the applicant may 
                provide a notice under this subparagraph with respect 
                to any one or more patents provided by the holder of 
                the reference product provided in response to a request 
                under this paragraph. An applicant may submit 
                additional notices at any time, and each notice shall 
                be subject to the provisions of this subparagraph. Each 
                notice shall--
                            ``(i) be sent to the holder of approved 
                        application for the reference product and to 
                        the owner of the patent identified pursuant to 
                        subparagraph (A)(i);
                            ``(ii) include a detailed statement of the 
                        factual and legal bases for the applicant's 
                        belief that the patents included in the notice 
                        are invalid, unenforceable, or will not be 
                        infringed by the commercial sale of the product 
                        for which approval is or has been sought; and
                            ``(iii) identify the judicial district or 
                        districts in which the applicant consents to 
                        suit being brought in response to the notice.
                    ``(C) Action for infringement.--
                            ``(i) Timeframe for bringing action.--
                        Within 45 days of receipt of notice described 
                        in subparagraph (B), the holder of the approved 
                        application for the reference product, or the 
                        owner of the patent, may bring an action 
                        infringement solely with respect to the patent 
                        or patents included in such notice.
                            ``(ii) Appropriate judicial district.--
                        Notwithstanding section 1391 of title 28, 
                        United States Code, an infringement action 
                        brought within the 45-day period referenced in 
                        clause (i) may be brought only in the judicial 
                        district identified pursuant to subparagraph 
                        (B)(iii).
                    ``(D) Limitation on declaratory judgment actions.--
                No action may be brought under section 2201 of title 
                28, United States Code by the recipient of a notice 
                under subparagraph (B) for a declaration of 
                infringement, validity, or enforceability with respect 
                to any patent which was not identified in the notice, 
                and with respect to the application under which the 
                notice was sent, or with respect to the product of that 
                application, prior to the commercial marketing of that 
                product. With respect to a patent identified in the 
                notice, notwithstanding section 1391 of title 28, any 
                such action may be brought only in the judicial 
                districts identified in the notice.
                    ``(E) Discretion of applicants.--A comparable 
                biological product applicant may not be compelled, by 
                court order or otherwise, to initiate the procedures 
                set forth in this paragraph. The decision as to whether 
                to invoke the procedures set forth in this paragraph is 
                left entirely to the discretion of the applicant or 
                prospective applicant.
            ``(17) Petitions and civil actions regarding approval of 
        certain applications.--
                    ``(A) In general.--With respect to a pending 
                application submitted under paragraph (1) or (2), if a 
                petition is submitted to the Secretary that seeks to 
                have the Secretary take, or refrain from taking, any 
                form of action relating to the approval of the 
                application, including a delay in the effective date of 
                the application, the following applies, subject to 
                subparagraph (E):
                            ``(i)(I) In the case of an application 
                        under paragraph (2), the Secretary may not, 
                        subject to subclause (III), consider the 
                        petition if it is submitted later than 180 days 
                        prior to the date on which the approval of the 
                        application may first be made effective.
                            ``(II) In the case of an application under 
                        paragraph (1), the Secretary may not, subject 
                        to subclause (III), consider the petition if it 
                        is submitted later than 180 days prior to the 
                        date on which the approval of the application 
                        may first be made effective.
                            ``(III) The restriction established in 
                        subclause (I) or (II) (as the case may be) does 
                        not apply to the petition if the Secretary 
                        determines that the petitioner has shown good 
                        cause for the failure to submit the petition by 
                        the applicable date under such subclause.
                            ``(ii)(I) The Secretary may not, on the 
                        basis of the petition, delay approval of the 
                        application unless the Secretary determines 
                        that a delay is necessary to protect the public 
                        health. Consideration of a petition shall be 
                        separate and apart from the review and approval 
                        of the application.
                            ``(II) With respect to a determination by 
                        the Secretary under subclause (I) that a delay 
                        is necessary to protect the public health:
                                    ``(aa) The Secretary shall publish 
                                on the Internet site of the Food and 
                                Drug Administration a statement 
                                providing the reasons underlying the 
                                determination.
                                    ``(bb) Not later than 10 days after 
                                making the determination, the Secretary 
                                shall provide notice to the sponsor of 
                                the application and an opportunity for 
                                a meeting with the Commissioner to 
                                discuss the determination.
                            ``(iii) The Secretary shall take final 
                        agency action on the petition not later than 
                        180 days after the date on which the petition 
                        is submitted. The Secretary shall not extend 
                        such period, even with the consent of the 
                        petitioner, for any reason, including based 
                        upon the submission of comments relating to the 
                        petition or supplemental information supplied 
                        by the petitioner.
                            ``(iv) The Secretary may not consider the 
                        petition for review unless it is signed and 
                        contains the following verification: `I certify 
                        that, to my best knowledge and belief: (a) this 
                        petition includes all information and views 
                        upon which the petition relies; (b) this 
                        petition includes representative data and/or 
                        information known to the petitioner which are 
                        unfavorable to the petition; and (c) I have 
                        taken reasonable steps to ensure that any 
                        representative data and/or information which 
                        are unfavorable to the petition were disclosed 
                        to me. I further certify that the information 
                        upon which I have based the action requested 
                        herein first became known to the party on whose 
                        behalf this petition is submitted on or about 
                        the following date: _______. I received or 
                        expect to receive payments, including cash and 
                        other forms of consideration, from the 
                        following persons or organizations to file this 
                        petition: ________. I verify under penalty of 
                        perjury that the foregoing is true and 
                        correct.'.
                    ``(B) Exhaustion of administrative remedies.--
                            ``(i) Final agency action within 180 
                        days.--The Secretary shall be considered to 
                        have taken final agency action on a petition 
                        referred to in subparagraph (A) if--
                                    ``(I) during the 180-day period 
                                referred to in clause (iii) of such 
                                subparagraph, the Secretary makes a 
                                final decision within the meaning of 
                                section 10.45(d) of title 21, Code of 
                                Federal Regulations; or
                                    ``(II) such period expires without 
                                the Secretary having made such a final 
                                decision.
                            ``(ii) Dismissal of certain civil 
                        actions.--If a civil action is filed with 
                        respect to a petition referred to in 
                        subparagraph (A) before final agency action 
                        within the meaning of clause (i) has occurred, 
                        the court shall dismiss the action for failure 
                        to exhaust administrative remedies.
                    ``(C) Applicability of certain regulations.--The 
                provisions of this section are in addition to the 
                requirements for the submission of a petition to the 
                Secretary that apply under section 10.30 or 10.35 of 
                title 21, Code of Federal Regulations.
                    ``(D) Annual report on delays in approvals per 
                petitions.--The Secretary shall annually submit to the 
                Congress a report that specifies--
                            ``(i) the number of applications under this 
                        subsection that were approved during the 
                        preceding 12-month period;
                            ``(ii) the number of such applications 
                        whose effective dates were delayed by petitions 
                        referred to in subparagraph (A) during such 
                        period; and
                            ``(iii) the number of days by which the 
                        applications were so delayed.
                    ``(E) Exception.--This paragraph does not apply to 
                a petition that is made by the sponsor of an 
                application under this subsection and that seeks only 
                to have the Secretary take or refrain from taking any 
                form of action with respect to that application.
                    ``(F) Definition.--For purposes of this paragraph, 
                the term `petition' includes any request to the 
                Secretary, without regard to whether the request is 
                characterized as a petition.''.
    (b) Additional Amendments.--Section 271(e) of title 35, United 
States Code, is amended--
            (1) in paragraph (2)--
                    (A) by striking ``or'' at the end of subparagraph 
                (A);
                    (B) by adding ``or'' at the end of subparagraph 
                (B);
                    (C) by inserting after subparagraph (B) the 
                following:
            ``(C) a notice described in section 351(k)(16)(B) of the 
        Public Health Service Act, but only with respect to a patent 
        identified in such a notice,''; and
                    (D) in the matter after and below subparagraph (C) 
                (as inserted by clause (iii) of this subparagraph), by 
                inserting before the period the following: ``, or if 
                the notice described in subparagraph (C) is provided in 
                connection with an application to obtain a license to 
                engage in the commercial manufacture, use, or sale of a 
                biological product claimed in a patent or the use of 
                which is claimed in a patent before the expiration of 
                such patent'' ; and
            (2) by adding at the end the following paragraph:
    ``(5) Notwithstanding the preceding subsection:
            ``(A) A patent that is disclosed in a response to a request 
        for patent information pursuant to subparagraph (A) of section 
        351(k)(16) of the Public Health Service Act with respect to 
        which a notice was provided pursuant to subparagraph (B) of 
        such section, and for which an action for infringement of the 
        patent was (I) brought after the expiration of the 45-day 
        period described in such subparagraph, or (II) brought before 
        the expiration of the 45-day period described in such section 
        351, but not maintained through a final court decision or a 
        dismissal with prejudice regarding the validity, 
        enforceability, and/or infringement, the sole and exclusive 
        remedy which may be granted by a court upon a finding of 
        infringement of such patent by the person who submitted the 
        notice described in subclause (A), or any person found to have 
        induced or contributed to such infringement, shall be a 
        reasonable royalty.
            ``(B) No action for infringement can be brought under this 
        section against an applicant that sent a request for patent 
        information pursuant to subparagraph (A)(i) of section 
        351(k)(16) of the Public Health Service Act by the owner of a 
        patent that should have been disclosed in response to such a 
        request, but was not timely disclosed under that 
        subparagraph.''.
                                 <all>