[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1038 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 1038

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           February 14, 2007

 Mr. Waxman (for himself, Mrs. Emerson, Mr. Pallone, Mr. Emanuel, and 
 Ms. Hirono) introduced the following bill; which was referred to the 
 Committee on Energy and Commerce, and in addition to the Committee on 
   the Judiciary, for a period to be subsequently determined by the 
  Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to provide for the licensing of 
   comparable and interchangeable 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.

    (a) Amendments.--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 `abbreviated biological product application' 
        means an abbreviated application for a license of a biological 
        product containing the same, or similar, active ingredient as a 
        reference product.
            ``(3) The term `reference product' means the single 
        licensed biological product, approved under subsection (a) or 
        subsection (k), against which a biological product is evaluated 
        for demonstration of safety, potency, or purity.
            ``(4) The term `comparable' or `comparability' in reference 
        to a biological product means the absence of clinically 
        meaningful differences between the 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, and 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 under subparagraph (B) shall be designed to avoid 
        duplicative and unethical clinical testing.
            ``(5) The terms `interchangeable' and `interchangeability' 
        mean, with respect to the condition of use involved, that the 
        biological product--
                    ``(A) is comparable to the reference product; and
                    ``(B) can be expected to produce the same clinical 
                result as the reference product in any given patient.
            ``(6) The term `thorough characterization' means an 
        analysis of structural features based upon appropriate 
        analytical and functional testing sufficient to identify 
        differences between a biological product and reference product 
        relevant to safety, purity or potency.
            ``(7) The term `final action' means, with respect to an 
        abbreviated biological product application, the Secretary's 
        issuance of a final action letter to the sponsor of an 
        abbreviated biological product application 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.
            ``(8) The term `final action date' means, with respect to 
        an abbreviated biological product application, the date by 
        which the Secretary must take a final action on the application 
        pursuant to subsection (k)(11).
            ``(9) 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).''.
    (b) Rule of Construction.--Nothing in this Act or the amendments 
made by this Act shall be construed to exclude an application for 
licensure of a biological product under section 351(k) from the 
definition of a human drug application in section 735(1)(C) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)(C)).

SEC. 3. REGULATION OF COMPARABLE AND INTERCHANGEABLE 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 ``under this 
        subsection or subsection (k)'' after ``biologics license''; and
            (2) by adding at the end the following subsection:
    ``(k) Regulation of Comparable and Interchangeable Biological 
Products.--
            ``(1) Submission of an abbreviated biological product 
        application.--Any person may file with the Secretary an 
        abbreviated biological product application. Any such 
        application shall include the following:
                    ``(A) Data demonstrating that the biological 
                product is comparable to or interchangeable with the 
                reference product.
                    ``(B) Data demonstrating that the biological 
                product and reference product contain highly similar 
                principal molecular structural features, 
                notwithstanding minor differences in heterogeneity 
                profile, impurities, or degradation patterns. The 
                Secretary shall find the following types of products to 
                contain highly similar 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 
                        modifications.
                            ``(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.
                Two biological products not enumerated in the foregoing 
                clauses may be demonstrated to contain highly similar 
                principal molecular structural features based upon such 
                data and other information characterizing the two 
                products as the Secretary determines to be necessary.
                    ``(C) Data demonstrating that the biological 
                product and reference product utilize the same 
                mechanism or mechanisms of action for the condition or 
                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 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 biological product are the same as those of the 
                reference product.
                    ``(F) Data demonstrating that the facility in which 
                the biological product is manufactured, processed, 
                packed, or held meets standards designed to assure that 
                the 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.--Any person, including 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 paragraph for a biological 
        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) FDA review of abbreviated 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 or 
                interchangeable 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 the 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.
            ``(4) Approval of comparable or interchangeable biological 
        products.--
                    ``(A) Determination of comparability.--Upon review 
                of an application submitted under paragraph (1) or (2) 
                for a biological product, the Secretary shall issue a 
                comparable biological product license for all 
                conditions of use of the reference product sharing the 
                same mechanism or mechanisms of action for which the 
                applicant has demonstrated comparability for a single 
                condition of use, or, if the mechanism or mechanisms of 
                action are unknown, for the condition or conditions of 
                use for which the data submitted establishes 
                comparability, unless the Secretary finds and informs 
                the applicant that--
                            ``(i) information submitted in the 
                        application or any other information available 
                        to the Secretary is insufficient to show that 
                        the 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;
                            ``(ii) information submitted in the 
                        application or any other information available 
                        to the Secretary is insufficient to show that 
                        the biological product and the reference 
                        product contain highly similar principal 
                        molecular structural features, notwithstanding 
                        minor differences in heterogeneity profile, 
                        impurities, or degradation patterns;
                            ``(iii) information submitted in the 
                        application or any other information available 
                        to the Secretary is insufficient to show that 
                        the 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 biological product, unless the 
                        mechanism or mechanisms of action are not known 
                        for the reference product for such condition or 
                        conditions;
                            ``(iv) 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 biological product are 
                        the same as those of the reference product;
                            ``(v) 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 biological product are limited 
                        to one or more of the same use or uses as have 
                        been previously approved for the reference 
                        product;
                            ``(vi) information submitted in the 
                        application or any other information available 
                        to the Secretary shows (I) the inactive 
                        ingredients of the 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 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;
                            ``(vii) information submitted in the 
                        application or any other information available 
                        to the Secretary fails to demonstrate that the 
                        facility in which the biological product is 
                        manufactured, processed, packed, or held meets 
                        standards designed to assure that the 
                        biological product continues to be safe, pure, 
                        and potent;
                            ``(viii) 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
                            ``(ix) the application contains an untrue 
                        statement of material fact; and
                provides the applicant with a detailed explanation for 
                the decision.
                    ``(B) Determinations on interchangeability.--
                Subject to subparagraph (C) and paragraph (10), upon 
                issuing a product license for a biological product 
                under subparagraph (A), the Secretary shall make and 
                publish one of the following determinations:
                            ``(i) Such product is interchangeable with 
                        the reference product for one or more specified 
                        conditions of use prescribed, recommended, or 
                        suggested in the labeling of the biological 
                        product.
                            ``(ii) Interchangeability has not been 
                        established.
                    ``(C) Determination of interchangeability of 
                subsequent biological product.--If the Secretary 
                determines that an application meets the approval 
                requirements of subparagraph (A), and, prior to the 
                issuance of a product license, the Secretary has made a 
                determination of interchangeability of another 
                biological product and the reference product for which 
                the exclusivity period under paragraph (10) has not 
                expired, the Secretary shall--
                            ``(i) issue the product license for the 
                        subsequent biological product; and
                            ``(ii) defer issuing any determination of 
                        interchangeability as to the subsequent 
                        biological product and the reference product 
                        until the exclusivity period under paragraph 
                        (10) has expired.
            ``(5) Postmarketing studies for applications submitted 
        under paragraph (1).--If the Secretary has agreed with the 
        sponsor of the reference product, at the time of approval or 
        any time thereafter, that the sponsor shall conduct one or more 
        postmarketing safety studies, a person submitting an 
        application for a biological product under paragraph (1) 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 for such biological product.
            ``(6) Designation of official name.--If, pursuant to 
        section 508 of the Federal Food, Drug, and Cosmetic Act, the 
        Secretary determines that designation of an official name for a 
        comparable biological product is necessary or desirable in the 
        interests of usefulness or simplicity, the Secretary shall 
        designate the same official name for the comparable biological 
        product as the Secretary designated for the reference product. 
        This paragraph shall not apply to products approved under 
        paragraph (7).
            ``(7) Other approval provisions.--The Secretary shall 
        approve, under the provisions of paragraph (4)(A), 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 (4)(A), if the 
        application and any other information available to the 
        Secretary are sufficient 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.
            ``(8) Establishing interchangeability for comparable 
        biological products.--
                    ``(A) In general.--In an original application or a 
                supplement to an application under this subsection, an 
                applicant may submit information to the Secretary to 
                demonstrate the interchangeability of a comparable 
                biological product and the reference product. An 
                applicant may withdraw an interchangeability submission 
                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. Nothing in this subsection shall be 
                construed to prohibit the Secretary from making a 
                determination of interchangeability at any time after 
                approval.
                    ``(B) Guidance.--Within one year after enactment of 
                the Access to Life-Saving Medicine Act, the Secretary 
                shall issue guidance regarding standards and 
                requirements for interchangeability. The Secretary may 
                make determinations of interchangeability under 
                paragraph (4)(B) prior to issuing guidance under this 
                subparagraph.
            ``(9) Interchangeability labeling for comparable biological 
        products.--Upon a determination of interchangeability, the 
        Secretary, if requested by the applicant, shall provide for the 
        label of the comparable biological product to include a 
        statement that the biological product is interchangeable with 
        the reference product for the conditions of use prescribed, 
        recommended, or suggested in the labeling for which 
        interchangeability has been established.
            ``(10) Exclusivity.--
                    ``(A) In general.--Upon review of an abbreviated 
                biological product application relying on the same 
                reference product for which a prior biological product 
                has received a determination of interchangeability for 
                any condition of use, the Secretary shall not make a 
                determination under paragraph (4)(B) that the second or 
                subsequent biological product is interchangeable for 
                any condition of use, and no holder of a biological 
                product license approved under subsection (a) shall 
                manufacture, market, sell, or distribute a rebranded 
                interchangeable biological product, directly or 
                indirectly, or authorize any other person to 
                manufacture, market, sell, or distribute a rebranded 
                interchangeable biological product, for any condition 
                of use, 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 reference product;
                            ``(ii) one year after--
                                    ``(I) a final court decision on all 
                                patents in suit in an action instituted 
                                under paragraph (17)(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 (17)(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 (17)(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 (17)(C).
                For purposes of this subparagraph, 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 biological 
                product.--For purposes of this subsection, the term 
                `rebranded interchangeable biological product'--
                            ``(i) means any rebranded interchangeable 
                        version of the reference product involved 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.
            ``(11) Hearing.--If the Secretary decides to disapprove an 
        abbreviated 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.
            ``(12) Final action date.--
                    ``(A) In general.--The Secretary shall take a final 
                action on an abbreviated biological product application 
                by the date that is 8 calendar months following the 
                sponsor's submission of such application, or 180 days 
                following the Secretary's notification to the applicant 
                that its application has been accepted for filing, 
                whichever is earlier.
                    ``(B) Extension.--The final action date provided by 
                subparagraph (A) with respect to an application may be 
                extended for such period of time as is agreed to by the 
                Secretary and the applicant in a jointly executed 
                written agreement that is counter-signed by the 
                Secretary and the applicant no later than 30 days prior 
                to such date.
            ``(13) Request for delay of final action.--Notwithstanding 
        paragraph (18) or any other provision of law, the Secretary 
        shall not fail or refuse to take a final action on an 
        abbreviated biological product application by the final action 
        date on the basis that a person, other than the comparable 
        biological product applicant, 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 defer 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.
            ``(14) 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 after the joint 
        execution of any such written agreement.
            ``(15) 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.
            ``(16) 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 abbreviated biological 
        product applications under this subsection.
            ``(17) 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 under this 
                        subsection may send a written request for 
                        patent information to the holder of the 
                        approved application for the reference product. 
                        The holder of the approved application for the 
                        reference product shall, not later than 60 days 
                        after the date on which the holder receives the 
                        request, provide to the applicant or 
                        prospective applicant a list of all those 
                        patents owned by, or licensed to, the holder of 
                        the approved application that the holder 
                        believes in good faith relate to the reference 
                        product, including patents that claim the 
                        approved biological 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 of 
                        not more than $1,000 to offset the cost of 
                        responding to the request for information.
                            ``(iii) Updates.--For a period of two years 
                        beginning on the date on which the holder of 
                        the approved application for the reference 
                        product receives the request for information, 
                        the holder shall send to the applicant or 
                        prospective applicant updates of its response 
                        to the request for information by identifying 
                        all relevant patents issued or licensed to the 
                        holder after the initial response under clause 
                        (i). Any such update must be provided, in the 
                        case of a new patent, not later than 30 days 
                        after the date on which the patent is issued 
                        and, in the case of a license, not later than 
                        30 days after the date on which the holder 
                        obtains the license.
                            ``(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 
                submitting an application under this subsection, the 
                applicant may provide a notice of the application with 
                respect to any one or more patents identified by the 
                holder of the reference product pursuant to 
                subparagraph (A). 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 the approved 
                        application for the reference product and to 
                        the owner of any patent identified by the 
                        holder pursuant to subparagraph (A);
                            ``(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, are unenforceable, or will not be 
                        infringed by the commercial sale of the product 
                        for which approval is being sought under this 
                        subsection; and
                            ``(iii) identify 1 or more judicial 
                        districts in which the applicant consents to 
                        such suit being brought.
                    ``(C) Action for infringement.--Within 45 days 
                after the date on which the holder of the approved 
                application for the reference product, or the owner of 
                a patent, receives a notice under subparagraph (B), the 
                holder or patent owner may bring an action for 
                infringement only with respect to the patent or patents 
                included in the notice, and only in a judicial district 
                identified pursuant to subparagraph (B)(iii).
                    ``(D) Limitation on declaratory judgment actions.--
                With respect to any patent relating to a product that 
                is the subject of an application under this subsection, 
                the recipient of a notice under subparagraph (B) with 
                respect to that application may not, prior to the 
                commercial marketing of the product, bring any action 
                under section 2201 of title 28, United States Code, for 
                a declaration of infringement, validity, or 
                enforceability of any such patent that was not 
                identified in the notice. With respect to any such 
                patent identified in the notice, any such action may, 
                notwithstanding chapter 87 of title 28, United States 
                Code, be brought only in a judicial district identified 
                in the notice.
                    ``(E) Discretion of applicants.--An applicant or 
                prospective applicant for a comparable biological 
                product under this subsection may not be compelled, by 
                court order or otherwise, to initiate the procedures 
                set forth in this paragraph. Nothing in this paragraph 
                requires an applicant or a prospective applicant to 
                invoke the procedures set forth in this paragraph.
            ``(18) 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) The Secretary may not, on the 
                        basis of the petition, delay approval of the 
                        application unless the Secretary determines, 
                        within 30 days after receiving the petition, 
                        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.
                            ``(ii) 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.
                            ``(iii) 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 (ii) 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 any successor 
                                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 (or any successor 
                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.--
            (1) Patents.--Section 271(e) of title 35, United States 
        Code, is amended--
                    (A) in paragraph (2)--
                            (i) by striking ``or'' at the end of 
                        subparagraph (A);
                            (ii) by adding ``or'' at the end of 
                        subparagraph (B);
                            (iii) by inserting after subparagraph (B) 
                        the following:
            ``(C) a notice described in section 351(k)(17)(B) of the 
        Public Health Service Act, but only with respect to a patent 
        identified in such notice,''; and
                            (iv) in the matter following 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
                    (B) by adding at the end the following paragraph:
    ``(6) (A) This paragraph applies, in lieu of paragraph (4), in the 
case of a patent--
                    ``(i) which is disclosed in a response to a request 
                for patent information pursuant to subparagraph (A) of 
                section 351(k)(17) of the Public Health Service Act;
                    ``(ii) with respect to which a notice was provided 
                pursuant to subparagraph (B) of such section; and
                    ``(iii) for which an action for infringement of the 
                patent--
                            ``(I) was brought after the expiration of 
                        the 45-day period described in subparagraph (C) 
                        of such section; or
                            ``(II) was brought before the expiration of 
                        the 45-day period described in subclause (I), 
                        but which was dismissed without prejudice or 
                        was not prosecuted to judgment in good faith.
            ``(B) In an action for infringement of a patent described 
        in subparagraph (A), the sole and exclusive remedy that may be 
        granted by a court, upon a finding that the person who 
        submitted the notice described in subparagraph (A)(ii) 
        infringed the patent, or that any person induced or contributed 
        to infringement of the patent, shall be a reasonable royalty.
            ``(C) The owner of a patent that should have been disclosed 
        in response to a request for patent information made by an 
        applicant pursuant to subparagraph (A)(i) of section 351(k)(17) 
        of the Public Health Service Act, but that was not timely 
        disclosed under that subparagraph, may not bring an action 
        under this section for infringement of that patent.''.
            (2) Conforming amendments.--
                    (A) Title 28.--Section 2201(b) of title 28, United 
                States Code, is amended by inserting before the period 
                the following: ``, or section 351 of the Public Health 
                Service Act''.
                    (B) Public health service act.--Subjection (j) of 
                section 351 of the Public Health Service Act (42 U.S.C. 
                262) is amended by inserting ``or subsection (k)'' 
                after ``subsection (a)''.
                                 <all>