[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 726 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 726

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 26, 2009

   Mr. Schumer (for himself, Ms. Collins, Mr. Brown, Mr. Vitter, Ms. 
  Stabenow, Mr. Martinez, and Mrs. Shaheen) 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 
 biosimilar and biogeneric 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 ``Promoting Innovation and Access to 
Life-Saving Medicine Act''.

SEC. 2. DEFINITIONS.

    (a) Licensure.--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 that relies in part on data or information in an 
        application for another biological product licensed under this 
        section or approved under section 505 of the Federal Food, 
        Drug, and Cosmetic Act.
            ``(3) The term `reference product' means the single 
        licensed biological product, approved under subsection (a) or 
        (k), against which a biological product is evaluated for 
        demonstration of safety, potency, or purity.
            ``(4) 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.
            ``(5) 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)(13).
            ``(6) 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) Fees.--
            (1) Rule of construction.--The definition of a human drug 
        application in section 735(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 379g(1)) shall be construed to include 
        applications under section 351(k) of the Public Health Service 
        Act, as added by section 3, in addition to applications under 
        section 351(a) of such Act.
            (2) Supplement.--Section 735(2) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 379g(2)) is amended by adding at 
        the end the following: ``Notwithstanding the preceding 
        sentence, any request for an interchangeability determination 
        under section 351(k) of the Public Health Service Act shall be 
        treated as a supplement for purposes of this part, irrespective 
        of whether such request is included in an application for 
        licensure of a biological product or a subsequent 
        submission.''.

SEC. 3. REGULATION OF BIOSIMILAR AND BIOGENERIC BIOLOGICAL PRODUCTS.

    (a) In General.--Section 351 of the Public Health Service Act (42 
U.S.C. 262), as amended by section 2, is further 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 Biosimilar and Interchangeable Biological 
Products.--
            ``(1) Biosimilar.--In this subsection, the term 
        `biosimilar' or `biosimilarity', in reference to a biological 
        product, means no clinically meaningful differences between the 
        biological product and the reference product would be expected 
        in terms of the safety, purity, and potency if treatment were 
        to be initiated with the biological product instead of the 
        reference product.
            ``(2) Interchangeability.--In this subsection, the term 
        `interchangeable' or `interchangeability' means, with respect 
        to a given condition of use, that--
                    ``(A) the biological product is biosimilar to the 
                reference product; and
                    ``(B) if the biological product is intended to be 
                administered more than once to a given patient, the 
                patient can be switched one or more times between the 
                reference product and the biological product without an 
                expected increase in the risk of adverse effects, 
                including a clinically significant change in 
                immunogenicity, or diminished effectiveness, compared 
                to the expected risks from continuing to use the 
                reference product without such switching.
            ``(3) 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) Information demonstrating that the biological 
                product and reference product contain highly similar 
                molecular structural features, notwithstanding minor 
                differences in heterogeneity profile, impurities, or 
                degradation patterns.
                    ``(B) Information demonstrating that the biological 
                product is biosimilar to (as defined in paragraph (1)) 
                or interchangeable with (as defined in paragraph (2)) 
                the reference product for the condition or conditions 
                of use prescribed, recommended, or suggested in the 
                proposed labeling based upon, in the discretion of the 
                Secretary--
                            ``(i) information derived from chemical, 
                        physical, and biological assays, and other non-
                        clinical laboratory studies; and
                            ``(ii) information from any necessary 
                        clinical study or studies sufficient to confirm 
                        safety, purity, and potency.
                Any studies under clause (ii) shall be designed to 
                avoid duplicative and unethical clinical testing.
                    ``(C) Information 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 or can reasonably be determined. If 
                the applicant seeks to rely on a demonstration of 
                biosimilarity or interchangeability for a single 
                condition of use to support approval of additional 
                conditions of use that share the same mechanism or 
                mechanisms of action, information demonstrating that 
                such reliance is scientifically appropriate.
                    ``(D) Information to show that the condition or 
                conditions of use prescribed, recommended, or suggested 
                in the proposed labeling 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) Information demonstrating that the facility 
                in which the biological product is manufactured, 
                processed, packed, or held meets standards designed to 
                ensure that the biological product continues to be 
                safe, pure, and potent.
            ``(4) 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 abbreviated biological product 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 (3), 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 for its proposed condition or 
        conditions of use.
            ``(5) Approval of biosimilar or interchangeable biological 
        products.--
                    ``(A) Determination of biosimilarity.--Upon review 
                of an application submitted under paragraph (3) for a 
                biological product and any other information available 
                to the Secretary, including information in the 
                application for the reference product, the Secretary 
                shall issue a biosimilar biological product license for 
                the conditions of use prescribed, recommended, or 
                suggested in the proposed labeling for the product, 
                unless the Secretary finds and informs the applicant 
                (including provision of a detailed explanation) that--
                            ``(i) information submitted in the 
                        application and any other information available 
                        to the Secretary is insufficient to show that 
                        the biological product and the reference 
                        product contain highly similar molecular 
                        structural features, notwithstanding minor 
                        differences in heterogeneity profile, 
                        impurities, or degradation patterns;
                            ``(ii) information submitted in the 
                        application and any other information available 
                        to the Secretary is insufficient to show that 
                        the biological product is biosimilar to the 
                        reference product for the condition or 
                        conditions of use prescribed, recommended, or 
                        suggested in the labeling proposed in the 
                        application;
                            ``(iii) information submitted in the 
                        application and 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 proposed 
                        labeling for the biological product, unless the 
                        mechanism or mechanisms of action are not known 
                        and cannot reasonably be determined for the 
                        reference product for such condition or 
                        conditions;
                            ``(iv) if the applicant has demonstrated 
                        biosimilarity for a single condition of use 
                        sharing the same mechanism of action as other 
                        conditions of use of the reference product, and 
                        has sought approval of one or more such other 
                        conditions of use on the basis of such 
                        demonstration, information submitted in the 
                        application and any other information available 
                        to the Secretary is insufficient to show the 
                        safety, purity, and potency of one or more such 
                        other conditions of use;
                            ``(v) information submitted in the 
                        application and 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;
                            ``(vi) information submitted in the 
                        application and any other information available 
                        to the Secretary is insufficient to show that 
                        the condition or conditions of use prescribed, 
                        recommended, or suggested in the proposed 
                        labeling 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;
                            ``(vii) information submitted in the 
                        application and 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 proposed 
                        labeling 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;
                            ``(viii) information submitted in the 
                        application and 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 ensure that the 
                        biological product continues to be safe, pure, 
                        and potent;
                            ``(ix) the Secretary has, for reasons of 
                        safety, purity, or potency, other than reasons 
                        that are unique to the reference product--
                                    ``(I) withdrawn or suspended the 
                                license of the reference product;
                                    ``(II) published a notice of 
                                opportunity for hearing to withdraw 
                                such license; or
                                    ``(III) determined that the 
                                reference product has been withdrawn 
                                from sale; or
                            ``(x) the application contains an untrue 
                        statement of material fact.
                    ``(B) Determinations on interchangeability.--
                Subject to subparagraph (C) and paragraph (11), 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, but the approved product is as 
                        safe and effective for its approved uses as the 
                        reference product.
                    ``(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 (11) 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 
                        (11) has expired.
            ``(6) Designation of official name.--
                    ``(A) In general.--If, pursuant to section 508 of 
                the Federal Food, Drug, and Cosmetic Act, the Secretary 
                determines that designation of an official name for a 
                biosimilar biological product is necessary or desirable 
                in the interests of usefulness or simplicity, the 
                Secretary shall designate the same official name for 
                the biosimilar biological product as the Secretary 
                designated for the reference product.
                    ``(B) Limitation.--This paragraph shall not apply 
                to products approved under paragraph (7).
                    ``(C) Report to congress.--Not later than 5 years 
                after the date of the enactment of this subsection, the 
                Comptroller General of the United States shall submit a 
                report to the Congress on public health and economic 
                impacts associated with practices for designating the 
                official names of biosimilar biological products in the 
                United States and in other countries that approve 
                biosimilar biological products.
            ``(7) Other approval provisions.--The Secretary shall 
        approve an application for a license submitted under paragraph 
        (4) if the application and any other information available to 
        the Secretary, including information in the application for the 
        reference product, are sufficient to establish the safety, 
        purity, and potency of the biosimilar biological product for 
        the proposed condition or conditions of use for such product.
            ``(8) Establishing interchangeability for biosimilar 
        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 biosimilar 
                biological product and the reference product. An 
                applicant may withdraw a request for an 
                interchangeability 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. Except as provided 
                in paragraph (11), 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 2 years after enactment of 
                this subsection, the Secretary shall issue guidance 
                regarding standards and requirements for 
                interchangeability. The Secretary is authorized to make 
                determinations of interchangeability under paragraph 
                (5)(B) prior to issuing guidance under this 
                subparagraph.
            ``(9) Interchangeability labeling for interchangeable 
        biological products.--Except as provided in paragraph (11), 
        upon a determination of interchangeability, the Secretary 
        shall, at the request of the applicant, provide for the label 
        of the interchangeable 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) Delay of approval.--
                    ``(A) Applicable delay period.--
                            ``(i) 5-year period.--If an application 
                        under this subsection refers to a biological 
                        product described in clause (i) of subparagraph 
                        (B), the Secretary may not approve such 
                        application before the expiration of--
                                    ``(I) the 5-year period beginning 
                                on such product's approval date; or
                                    ``(II) such period, as extended 
                                under subparagraph (D).
                            ``(ii) 3-year period.--If an application 
                        under this subsection refers to a biological 
                        product described in subparagraph (C), the 
                        Secretary may not approve such application for 
                        the conditions of approval of such product 
                        before the expiration of--
                                    ``(I) the 3-year period beginning 
                                on such product's approval date; or
                                    ``(II) such period, as extended 
                                under subparagraph (D).
                    ``(B) No major substance previously approved.--
                            ``(i) In general.--A biological product is 
                        described in this clause if--
                                    ``(I) an application is submitted 
                                for such product under subsection (a);
                                    ``(II) no major substance of the 
                                product, nor any highly similar major 
                                substance, has been approved in any 
                                other application under subsection (a);
                                    ``(III) the application submitted 
                                for such product is approved after the 
                                date of the enactment of this 
                                subsection; and
                                    ``(IV) the application submitted 
                                for such product could not and did not 
                                rely on any clinical safety, purity, or 
                                potency study in any other application 
                                approved under this section or any 
                                clinical safety or effectiveness study 
                                in any application approved under 
                                section 505 of the Federal Food, Drug, 
                                and Cosmetic Act.
                            ``(ii) Exclusions.--Biological products not 
                        described in clause (i) include the following:
                                    ``(I) Protein biological products 
                                that differ in structure solely due to 
                                post-translational events, infidelity 
                                of translation or transcription, or 
                                minor differences in amino acid 
                                sequence.
                                    ``(II) 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) Glycosylated protein 
                                products that differ in structure 
                                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) 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 live viral products for the same 
                                indication.
                        The Secretary may by regulation identify 
                        additional biological products not described in 
                        clause (i).
                    ``(C) Major substance previously approved.--A 
                biological product is described in this subparagraph 
                if--
                            ``(i) an application is submitted for such 
                        product under subsection (a);
                            ``(ii) such product includes a major 
                        substance that has been approved in another 
                        application under subsection (a), or any highly 
                        similar major substance;
                            ``(iii) the application submitted for such 
                        product is approved after the date of the 
                        enactment of this subsection;
                            ``(iv) the application submitted for such 
                        product contains reports of new clinical 
                        investigations (other than pharmacokinetic or 
                        pharmacodynamic studies) essential to the 
                        approval of the application and conducted or 
                        sponsored by the applicant; and
                            ``(v) the product represents a significant 
                        therapeutic advance, which may include 
                        demonstration of safety, purity, and potency 
                        for a significant new indication or 
                        subpopulation, other than a pediatric 
                        subpopulation.
                    ``(D)(i) Supplement.--If a supplement to an 
                application approved under subsection (a) is approved 
                no later than 1 year before the expiration of a period 
                to which the applicant is entitled under subparagraph 
                (A), the period described in subparagraph (A) shall, 
                except as provided in clause (ii), be extended by 6 
                months if--
                            ``(I) the supplement contains reports of 
                        new clinical investigations (other than 
                        pharmacokinetic or pharmacodynamic studies) 
                        essential to the approval of the supplement and 
                        conducted or sponsored by the person submitting 
                        the supplement; and
                            ``(II) the change provides a significant 
                        therapeutic advance, which may include 
                        demonstration of safety, purity, and potency 
                        for a significant new indication or 
                        subpopulation, other than a pediatric 
                        subpopulation.
                    ``(ii) Adjustment.--Any period of market 
                exclusivity extended under subclause (I) or (II) of 
                clause (i) for a biological product shall be reduced by 
                3 months if the organization designated under 
                subparagraph (E) notifies the Secretary that, with 
                respect to any major substance contained in the 
                biological product, the combined annual gross sales in 
                the United States for all biological products--
                            ``(I) containing the major substance; and
                            ``(II) owned or marketed by the applicant 
                        or its affiliates;
                exceeded $1,000,000,000 in the calendar year preceding 
                approval of the supplement involved.
                    ``(iii) Limitation.--Only one extension under this 
                subparagraph may be granted for any biological product.
                    ``(E)(i) Designation.--The Secretary shall 
                designate an organization other than the Food and Drug 
                Administration to make the determination of combined 
                annual gross sales described in clause (ii). Prior to 
                designating such organization, the Secretary shall 
                determine that such organization is independent and is 
                qualified to evaluate the sales of pharmaceutical 
                products. The Secretary shall re-evaluate the 
                designation of such organization once every 3 years.
                    ``(ii) Notification.--The organization designated 
                under clause (i) shall--
                            ``(I) determine, with respect to each major 
                        substance contained in each biological product 
                        that is the subject of a pending supplement 
                        under subparagraph (D)(i), the amount of the 
                        combined annual gross sales in the United 
                        States in the preceding calendar year for all 
                        biological products--
                                    ``(aa) containing the major 
                                substance; and
                                    ``(bb) owned or marketed by the 
                                applicant or its affiliates; and
                            ``(II) notify the Secretary of such 
                        determination.
                    ``(F) Definition.--In this paragraph, the term 
                `approval date' means the date of approval of an 
                application for the biological product under subsection 
                (a).
            ``(11) 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 (5)(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 
                        biological product to be approved as 
                        interchangeable for that reference product;
                            ``(ii) one year after--
                                    ``(I) a final court decision in 
                                favor of the applicant on all patents 
                                in suit in an action instituted under 
                                paragraph (18)(C) against the applicant 
                                that submitted the application for the 
                                first approved interchangeable 
                                biological product; or
                                    ``(II) the dismissal with or 
                                without prejudice of an action 
                                instituted under paragraph (18)(C) 
                                against the applicant that submitted 
                                the application for the first approved 
                                interchangeable biological product; or
                            ``(iii)(I) 36 months after approval of the 
                        first interchangeable biological product if the 
                        applicant has been sued under paragraph (18)(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 
                        biological product applicant has not been sued 
                        under paragraph (18)(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.
            ``(12) 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 30 days 
        after such notice, such hearing shall commence not more than 90 
        days after the expiration of such 30 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 90 days after 
        the date fixed by the Secretary for filing final briefs.
            ``(13) Final action date.--
                    ``(A) In general.--The Secretary shall take a final 
                action on an abbreviated biological product application 
                by the date that is 10 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--
                            ``(i) such final action date; or
                            ``(ii) the date on which any prior 
                        extension under this subparagraph expires.
            ``(14) Request for delay of final action.--Subject to 
        paragraph (19)(A)(i) and notwithstanding 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 
        biosimilar 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 biosimilar biological product.
            ``(15) 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.
            ``(16) 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.
            ``(17) 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. The Secretary may 
        not use the absence of final regulations as a basis for the 
        Secretary to fail to act on an application submitted under this 
        subsection.
            ``(18) 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, licensed to, or otherwise 
                        under the control of, 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 formulation of such 
                        product, any method of using such product, any 
                        component of such product, or any method or 
                        process that can be used to manufacture such 
                        product or component, regardless of whether 
                        that method or process is used to manufacture 
                        the reference product.
                            ``(ii) Updates.--For a period of 2 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.
                            ``(iii) Additional requests.--The applicant 
                        may submit additional requests under clause (i) 
                        for patent information, and each such request 
                        shall be subject to the requirements of this 
                        paragraph.
                            ``(iv) Notification to patent holder.--
                        Within 30 days of receiving a request under 
                        this subparagraph, the holder of the approved 
                        application for the reference product shall 
                        give notice of such request to the owner of any 
                        patent licensed to, or otherwise under the 
                        control of, the holder that is identified by 
                        the holder pursuant to clause (i).
                    ``(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) or with respect to any one or more 
                patents owned by, licensed to, or otherwise under the 
                control of the holder of the approved application, but 
                not identified 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) be submitted to the Federal Trade 
                        Commission, which shall treat such notice as 
                        confidential.
                    ``(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.
                    ``(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.
                    ``(E) Declaratory judgment action.--
                            ``(i) In general.--With respect to any 
                        patent identified in a notification under 
                        subparagraph (A) or (B) for which the holder, 
                        or the owner of the patent--
                                    ``(I) has not brought an action for 
                                infringement under subparagraph (C); or
                                    ``(II) has brought an action for 
                                infringement under subparagraph (C), 
                                but subsequently dismissed that action 
                                without prejudice;
                        the applicant may bring an action for a 
                        declaratory judgment under section 2201 of 
                        title 28, United States Code, that such patent 
                        is invalid or not infringed by the biological 
                        product at issue.
                            ``(ii) Case or controversy.--The courts of 
                        the United States shall have, and shall 
                        exercise, subject matter jurisdiction to hear 
                        such an action to the full extent permitted by 
                        article III of the Constitution.
                    ``(F) Discretion of applicants.--An applicant or 
                prospective applicant for a biosimilar 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.
            ``(19) Petitions and civil actions regarding approval of 
        certain applications.--
                    ``(A) In general.--With respect to a pending 
                application submitted under paragraph (3) or (4), 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) Denial based on intent to delay.--If the 
                Secretary determines that a petition or supplement to 
                the petition was submitted with the primary purpose of 
                delaying the licensure or the approval of a condition 
                of use for a biological product, the Secretary may deny 
                the petition at any point based on such determination. 
                The Secretary may issue guidance to describe the 
                factors that will be used to determine under this 
                subparagraph whether a petition is submitted with the 
                primary purpose of delaying the approval of an 
                application.
                    ``(C) 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, in which case the petition 
                                shall be deemed to have been denied.
                            ``(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.
                    ``(D) 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).
                    ``(E) 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.
                    ``(F) 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.
                    ``(G) 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.
            ``(20) Authorization of appropriations.--To carry out this 
        subsection, there are authorized to be appropriated such sums 
        as may be necessary for fiscal years 2010 and 2011.''.
    (b) Additional Amendments.--
            (1) Venue.--Section 1404 of title 28, United States Code, 
        is amended by adding at the end the following:
    ``(e) Venue in Certain Patent Infringement Disputes.--
            ``(1) In general.--In any action for patent infringement 
        brought by the holder or owner of the patent pursuant to 
        section 351(k)(18)(C) of the Public Health Service Act, the 
        defendant may move to transfer the action to any other district 
        in which jurisdiction is proper.
            ``(2) Timing.--The schedule applicable to a motion under 
        paragraph (1) is as follows:
                    ``(A) A motion under paragraph (1) shall be filed 
                by the defendant no later than 45 days after service of 
                the complaint.
                    ``(B) A response to such a motion, if any, shall be 
                filed no later than 20 days after service of the 
                motion.
                    ``(C) A reply to such response, if any, shall be 
                filed no later than 10 days after service of the 
                response.
                    ``(D) The schedule set forth in this paragraph may 
                be modified only by agreement of all parties.
            ``(3) Resolution.--When ruling on any motion filed under 
        paragraph (2), the greatest weight shall be given to the 
        following factors:
                    ``(A) The interest in identifying a district court 
                in which the case will be adjudicated expeditiously.
                    ``(B) The strong public interest in obtaining 
                prompt judicial resolution of patent disputes so that 
                the biological product which is the subject of the 
                patent dispute may be brought to market as 
                expeditiously as possible, consistent with fair and 
                prompt resolution of patent disputes.
            ``(4) No delay.--An action described in paragraph (1) shall 
        proceed as expeditiously as possible while the court considers 
        a motion under this subsection, and the court may not stay the 
        proceedings because a motion under this subsection has been 
        filed.''.
            (2) 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)(18)(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'';
                    (B) by adding at the end the following paragraph:
            ``(6)(A) This paragraph applies 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)(18) 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 or licensee of a patent that should have 
        been disclosed in response to a request for patent information 
        made by an applicant pursuant to subparagraph (A) of section 
        351(k)(18) of the Public Health Service Act, but that was not 
        timely disclosed under that subparagraph, may not bring an 
        action under this title for infringement of that patent.'';
                    (C) in paragraph (5)--
                            (i) by adding ``(A)'' in front of 
                        ``Where''; and
                            (ii) by adding the following subparagraph:
                    ``(B) Where a person has provided a notice 
                described in subparagraph (B) of section 351(k)(18) of 
                the Public Health Service Act, and neither the holder 
                for the approved biological product or the owner of a 
                patent identified in the notice brought an action for 
                infringement of such patent before the expiration of 45 
                days after the date on which the notice was received, 
                the courts of the United States shall, to the extent 
                consistent with the Constitution, have and exercise 
                subject matter jurisdiction in any action brought by 
                such person under section 2201 of title 28 for a 
                declaratory judgement that such patent is invalid or 
                not infringed.''; and
                    (D) in paragraph (4), by striking ``in paragraph 
                (2)'' in both places it appears and inserting ``in 
                subparagraphs (2)(A) or (2)(B)''.
            (3) 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)''.
    (c) Review of Applications Submitted During Exclusivity Periods.--
            (1) User fee goals.--
                    (A) Revision.--Within 180 days after the date of 
                the enactment of this Act, the Secretary of Health and 
                Human Services, in consultation with the relevant 
                stakeholders, shall revise the PDUFA reauthorization 
                performance goals and procedures with respect to the 
                user fee goals for abbreviated biological product 
                applications under section 351(k) of the Public Health 
                Service Act, as added by subsection (a) of this 
                section, that are submitted more than 2 years in 
                advance of the expiration of any period of exclusive 
                marketing to which the reference drug is entitled under 
                subsection (k)(10) or subsection (l) of section 351 of 
                the Public Health Service Act, as added by subsection 
                (a) of this section and section 4 respectively.
                    (B) Considerations.--In revising the user fee goals 
                for applications described in subparagraph (A), the 
                Secretary shall consider--
                            (i) the need to provide sufficient time so 
                        that a decision on whether to approve the 
                        application can be made in advance of the 
                        expiration of any exclusivity, and considering 
                        the possibility that amendments will be 
                        necessary after the initial decision and prior 
                        to approval; and
                            (ii) the importance of conserving agency 
                        resources.
            (2) Review priorities.--In setting priorities with respect 
        to the review of applications described in paragraph (1)(A), 
        the Secretary shall take into account the number of years in 
        advance of the expiration of any exclusivity granted to the 
        reference drug that an application was submitted.
            (3) Submission of revised performance goals to congress.--
        The Secretary shall, within 30 days after revising the PDUFA 
        reauthorization performance goals and procedures under this 
        subsection, submit to the Committee on Energy and Commerce of 
        the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate a letter 
        describing the revised goals and the basis for such revisions.
            (4) Definitions.--In this subsection:
                    (A) The terms ``abbreviated biological product 
                application'' and ``reference product'' have the 
                meanings given to those terms in section 351(i) of the 
                Public Health Service Act, as amended by section 2(a).
                    (B) The term ``PDUFA reauthorization performance 
                goals and procedures'' means the performance goals and 
                procedures of the Food and Drug Administration, agreed 
                to for purposes of the reauthorization of part 2 of 
                subchapter C of chapter VII of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 279g et seq.; relating to 
                the prescription drug user fee program) for fiscal year 
                2008 and succeeding fiscal years.

SEC. 4. PEDIATRIC STUDIES OF BIOLOGICAL PRODUCTS.

    Section 351 of the Public Health Service Act (42 U.S.C. 262), as 
amended by section 3, is further amended by adding at the end the 
following:
    ``(l) Pediatric Studies.--
            ``(1) Application of certain provisions.--The provisions of 
        section 505A of the Federal Food, Drug, and Cosmetic Act shall, 
        except as inconsistent with this section, apply to biological 
        products approved under subsection (a) or (k) of this section 
        to the same extent and in the same manner as such provisions 
        apply to drugs approved under subsection (c) or (j), 
        respectively, of section 505 of the Federal Food, Drug, and 
        Cosmetic Act.
            ``(2) Market exclusively for new biological products.--If, 
        prior to approval of an application that is submitted under 
        subsection (a) of this section, the Secretary determines that 
        information relating to the use of a new biological product in 
        the pediatric population may produce health benefits in that 
        population, the Secretary makes a written request for pediatric 
        studies (which shall include a timeframe for completing such 
        studies), the applicant agrees to the request, such studies are 
        completed using appropriate formulations for each age group for 
        which the study is requested within any such timeframe, and the 
        reports thereof are submitted and accepted in accordance with 
        section 505A(d)(3) of the Federal Food, Drug, and Cosmetic 
        Act--
                    ``(A) the period for such biological product 
                referred to in subparagraph (A) of subsection (k)(10), 
                including any extension under subparagraph (D) of such 
                subsection, is extended by 6 months; and
                    ``(B) if the biological product is designated under 
                section 526 for a rare disease or condition, the period 
                for such biological product referred to in section 
                527(a) is deemed to be 7 years and 6 months rather than 
                7 years.
            ``(3) Market exclusivity for already-marketed biological 
        products.--If the Secretary determines that information 
        relating to the use of a licensed biological product in the 
        pediatric population may produce health benefits in that 
        population and makes a written request to the holder of an 
        approved application under subsection (a) of this section for 
        pediatric studies (which shall include a timeframe for 
        completing such studies), the holder agrees to the request, 
        such studies are completed using appropriate formulations for 
        each age group for which the study is requested within any such 
        timeframe, and the reports thereof are submitted and accepted 
        in accordance with section 505A(d)(3) of the Federal Food, 
        Drug, and Cosmetic Act--
                    ``(A) the period for such biological product 
                referred to in subparagraph (A) of subsection (k)(10), 
                including any extension under subparagraph (D) of such 
                subsection, is extended by 6 months; and
                    ``(B) if the biological product is designated under 
                section 526 for a rare disease or condition, the period 
                for such biological product referred to in section 
                527(a) is deemed to be 7 years and 6 months rather than 
                7 years.
            ``(4) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (2)(A), (2)(B), (3)(A), or (3)(B) if 
        the determination under section 505A(d)(3) is made later than 9 
        months prior to the expiration of such period.''.
                                 <all>