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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1695 Reported in Senate (RS)]

                                                      Calendar No. 1127
110th CONGRESS
  2d Session
                                S. 1695

 To amend the Public Health Service Act to establish a pathway for the 
 licensure of biosimilar biological products, to promote innovation in 
               the life sciences, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             June 26, 2007

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

                           November 19, 2008

               Reported by Mr. Kennedy, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

 
 To amend the Public Health Service Act to establish a pathway for the 
 licensure of biosimilar biological products, to promote innovation in 
               the life sciences, and for other purposes.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Biologics Price Competition 
and Innovation Act of 2007''.</DELETED>

SEC. 2. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS.

<DELETED>    (a) Licensure of Biological Products as Biosimilar or 
Interchangeable.--Section 351 of the Public Health Service Act (42 
U.S.C. 262) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(1)(A), by inserting ``under 
        this subsection or subsection (k)'' after ``biologics 
        license''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>    ``(k) Licensure of Biological Products as Biosimilar or 
Interchangeable.--</DELETED>
        <DELETED>    ``(1) In general.--Any person may submit an 
        application for licensure of a biological product under this 
        subsection.</DELETED>
        <DELETED>    ``(2) Content.--</DELETED>
                <DELETED>    ``(A) In general.--</DELETED>
                        <DELETED>    ``(i) Required information.--An 
                        application submitted under this subsection 
                        shall include information demonstrating that--
                        </DELETED>
                                <DELETED>    ``(I) the biological 
                                product is biosimilar to a reference 
                                product based upon data derived from--
                                </DELETED>
                                        <DELETED>    ``(aa) analytical 
                                        studies that demonstrate that 
                                        the biological product is 
                                        highly similar to the reference 
                                        product notwithstanding minor 
                                        differences in clinically 
                                        inactive components;</DELETED>
                                        <DELETED>    ``(bb) animal 
                                        studies; and</DELETED>
                                        <DELETED>    ``(cc) a clinical 
                                        study or studies (including the 
                                        assessment of immunogenicity 
                                        and pharmacokinetics or 
                                        pharmacodynamics) that are--
                                        </DELETED>

                                                <DELETED>    ``(AA) 
                                                sufficient to 
                                                demonstrate safety, 
                                                purity, and potency in 
                                                1 or more appropriate 
                                                conditions of use for 
                                                which the reference 
                                                product is licensed and 
                                                intended to be used and 
                                                for which licensure is 
                                                sought for the 
                                                biological product; 
                                                and</DELETED>

                                                <DELETED>    ``(BB) 
                                                designed to avoid 
                                                needlessly duplicative 
                                                or unethical clinical 
                                                testing;</DELETED>

                                <DELETED>    ``(II) 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;</DELETED>
                                <DELETED>    ``(III) 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;</DELETED>
                                <DELETED>    ``(IV) the route of 
                                administration, the dosage form, and 
                                the strength of the biological product 
                                are the same as those of the reference 
                                product; and</DELETED>
                                <DELETED>    ``(V) 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.</DELETED>
                        <DELETED>    ``(ii) Determination by 
                        secretary.--The Secretary may determine, in the 
                        Secretary's discretion, that an element 
                        described in clause (i)(I) is unnecessary in an 
                        application submitted under this 
                        subsection.</DELETED>
                        <DELETED>    ``(iii) Additional information.--
                        An application submitted under this subsection 
                        may include--</DELETED>
                                <DELETED>    ``(I) at the applicant's 
                                option, publicly-available information 
                                regarding the Secretary's previous 
                                determination that the reference 
                                product is safe, pure, and potent; 
                                and</DELETED>
                                <DELETED>    ``(II) any additional 
                                information in support of the 
                                application, including publicly-
                                available information with respect to 
                                the reference product or another 
                                biological product.</DELETED>
                <DELETED>    ``(B) Interchangeability.--An application 
                (or a supplement to an application) submitted under 
                this subsection may include information demonstrating 
                that the biological product is interchangeable with the 
                reference product.</DELETED>
        <DELETED>    ``(3) Evaluation by secretary.--Upon review of an 
        application (or a supplement to an application) submitted under 
        this subsection, the Secretary shall license the biological 
        product under this subsection if the Secretary determines that 
        the information submitted in the application (or the 
        supplement) is sufficient to show that the biological product--
        </DELETED>
                <DELETED>    ``(A) is biosimilar to the reference 
                product; or</DELETED>
                <DELETED>    ``(B) is interchangeable with the 
                reference product.</DELETED>
        <DELETED>    ``(4) Safety standards for determining 
        interchangeability.--Upon review of an application submitted 
        under this subsection or any supplement to such application, 
        the Secretary shall determine the biological product to be 
        interchangeable with the reference product if the Secretary 
        determines that the information submitted in the application 
        (or a supplement to such application) is sufficient to show 
        that--</DELETED>
                <DELETED>    ``(A) the biological product--</DELETED>
                        <DELETED>    ``(i) is biosimilar to the 
                        reference product; and</DELETED>
                        <DELETED>    ``(ii) can be expected to produce 
                        the same clinical result as the reference 
                        product in any given patient; and</DELETED>
                <DELETED>    ``(B) for a biological product that is 
                administered more than once to an individual, the risk 
                in terms of safety or diminished efficacy of 
                alternating or switching between use of the biological 
                product and the reference product is not greater than 
                the risk of using the reference product without such 
                alternation or switch.</DELETED>
        <DELETED>    ``(5) General rules.--</DELETED>
                <DELETED>    ``(A) One reference product per 
                application.--A biological product, in an application 
                submitted under this subsection, may not be evaluated 
                against more than 1 reference product.</DELETED>
                <DELETED>    ``(B) Review.--An application submitted 
                under this subsection shall be reviewed by the division 
                within the Food and Drug Administration that is 
                responsible for the review and approval of the 
                application under which the reference product is 
                licensed.</DELETED>
                <DELETED>    ``(C) Risk evaluation and mitigation 
                strategies.--The authority of the Secretary with 
                respect to risk evaluation and mitigation strategies 
                under the Federal Food, Drug, and Cosmetic Act shall 
                apply to biological products licensed under this 
                subsection in the same manner as such authority applies 
                to biological products licensed under subsection 
                (a).</DELETED>
        <DELETED>    ``(6) Exclusivity for first interchangeable 
        biological product.--Upon review of an application submitted 
        under this subsection 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) that the 
        second or subsequent biological product is interchangeable for 
        any condition of use until the earlier of--</DELETED>
                <DELETED>    ``(A) 1 year after the first commercial 
                marketing of the first interchangeable biosimilar 
                biological product to be approved as interchangeable 
                for that reference product;</DELETED>
                <DELETED>    ``(B) 18 months after--</DELETED>
                        <DELETED>    ``(i) a final court decision on 
                        all patents in suit in an action instituted 
                        under subsection (l)(6) against the applicant 
                        that submitted the application for the first 
                        approved interchangeable biosimilar biological 
                        product; or</DELETED>
                        <DELETED>    ``(ii) the dismissal with or 
                        without prejudice of an action instituted under 
                        subsection (l)(6) against the applicant that 
                        submitted the application for the first 
                        approved interchangeable biosimilar biological 
                        product; or</DELETED>
                <DELETED>    ``(C)(i) 42 months after approval of the 
                first interchangeable biosimilar biological product if 
                the applicant that submitted such application has been 
                sued under subsection (l)(6) and such litigation is 
                still ongoing within such 36-month period; or</DELETED>
                <DELETED>    ``(ii) 18 months after approval of the 
                first interchangeable biosimilar biological product if 
                the applicant that submitted such application has not 
                been sued under subsection (l)(6).</DELETED>
        <DELETED>For purposes of this paragraph, the term `final court 
        decision' means a final decision of a court from which no 
        appeal (other than a petition to the United States Supreme 
        Court for a writ of certiorari) has been or can be 
        taken.</DELETED>
        <DELETED>    ``(7) Exclusivity for reference product.--
        </DELETED>
                <DELETED>    ``(A) Effective date of biosimilar 
                application approval.--Approval of an application under 
                this subsection may not be made effective by the 
                Secretary until the date that is 12 years after the 
                date on which the reference product was first licensed 
                under subsection (a).</DELETED>
                <DELETED>    ``(B) Filing period.--An application under 
                this subsection may not be submitted to the Secretary 
                until the date that is 4 years after the date on which 
                the reference product was first licensed under 
                subsection (a).</DELETED>
        <DELETED>    ``(8) Guidance documents.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary may, 
                after opportunity for public comment, issue guidance in 
                accordance, except as provided in subparagraph (B)(i), 
                with section 701(h) of the Federal Food, Drug, and 
                Cosmetic Act with respect to the process for the 
                submission of applications for, and licensure of, a 
                biological product under this subsection. Any such 
                guidance may be general or specific.</DELETED>
                <DELETED>    ``(B) Public comment.--</DELETED>
                        <DELETED>    ``(i) In general.--The Secretary 
                        shall provide the public an opportunity to 
                        comment on any proposed guidance issued under 
                        subparagraph (A) before issuing final 
                        guidance.</DELETED>
                        <DELETED>    ``(ii) Input regarding most 
                        valuable guidance.--The Secretary shall 
                        establish a process through which the public 
                        may provide the Secretary with input regarding 
                        priorities for issuing guidance.</DELETED>
                <DELETED>    ``(C) No requirement for application 
                consideration.--The issuance (or non-issuance) of 
                guidance under subparagraph (A) shall not preclude the 
                review of, or action on, an application submitted under 
                this subsection.</DELETED>
                <DELETED>    ``(D) Requirement for product class-
                specific guidance.--If the Secretary issues product 
                class-specific guidance under subparagraph (A), such 
                guidance shall include a description of--</DELETED>
                        <DELETED>    ``(i) the criteria that the 
                        Secretary will use to determine whether a 
                        biological product is highly similar to a 
                        reference product in such product class; 
                        and</DELETED>
                        <DELETED>    ``(ii) the criteria, if available, 
                        that the Secretary will use to determine 
                        whether a biological product meets the 
                        standards described in paragraph (4).</DELETED>
                <DELETED>    ``(E) Certain product classes.--</DELETED>
                        <DELETED>    ``(i) Guidance.--The Secretary may 
                        indicate in a guidance document that the 
                        science and experience, as of the date of such 
                        guidance, with respect to a product or product 
                        class (not including any recombinant protein) 
                        does not allow approval of an application for a 
                        license as provided under this subsection for 
                        such product or product class.</DELETED>
                        <DELETED>    ``(ii) Modification or reversal.--
                        The Secretary may issue a subsequent guidance 
                        document under subparagraph (A) to modify or 
                        reverse a guidance document under clause 
                        (i).</DELETED>
                        <DELETED>    ``(iii) No effect on ability to 
                        deny license.--Clause (i) shall not be 
                        construed to require the Secretary to approve a 
                        product with respect to which the Secretary has 
                        not indicated in a guidance document that the 
                        science and experience, as described in clause 
                        (i), does not allow approval of such an 
                        application.</DELETED>
<DELETED>    ``(l) Patents.--</DELETED>
        <DELETED>    ``(1) Confidential access to subsection (k) 
        application.--</DELETED>
                <DELETED>    ``(A) Application of paragraph.--Unless 
                otherwise agreed to by a person that submits an 
                application under subsection (k) (referred to in this 
                subsection as the `subsection (k) applicant') and the 
                sponsor of the application for the reference product 
                (referred to in this paragraph as the `reference 
                product sponsor'), the provisions of this paragraph 
                shall apply to the exchange of information described in 
                this subsection.</DELETED>
                <DELETED>    ``(B) In general.--</DELETED>
                        <DELETED>    ``(i) Provision of confidential 
                        information.--When a subsection (k) applicant 
                        submits an application under subsection (k), 
                        such applicant shall provide to the persons 
                        described in clause (ii), subject to the terms 
                        of this paragraph, confidential access to the 
                        information required to be produced pursuant to 
                        paragraph (2) and any other information that 
                        the subsection (k) applicant determines, in its 
                        sole discretion, to be appropriate (referred to 
                        in this subsection as the `confidential 
                        information').</DELETED>
                        <DELETED>    ``(ii) Recipients of 
                        information.--The persons described in this 
                        clause are the following:</DELETED>
                                <DELETED>    ``(I) Outside counsel.--
                                One or more attorneys designated by the 
                                reference product sponsor who are 
                                employees of an entity other than the 
                                reference product sponsor (referred to 
                                in this paragraph as the `outside 
                                counsel'), provided that such attorneys 
                                do not engage, formally or informally, 
                                in patent prosecution relevant or 
                                related to the reference 
                                product.</DELETED>
                                <DELETED>    ``(II) In-house counsel.--
                                One attorney that represents the 
                                reference product sponsor who is an 
                                employee of the reference product 
                                sponsor, provided that such attorney 
                                does not engage, formally or 
                                informally, in patent prosecution 
                                relevant or related to the reference 
                                product.</DELETED>
                <DELETED>    ``(C) Limitation on disclosure.--No person 
                that receives confidential information pursuant to 
                subparagraph (B) shall disclose any confidential 
                information to any other person or entity, including 
                the reference product sponsor employees, outside 
                scientific consultants, or other outside counsel 
                retained by the reference product sponsor, without the 
                prior written consent of the subsection (k) applicant, 
                which shall not be unreasonably withheld.</DELETED>
                <DELETED>    ``(D) Use of confidential information.--
                Confidential information shall be used for the sole and 
                exclusive purpose of determining, with respect to each 
                patent assigned to or exclusively licensed by the 
                reference product sponsor, whether a claim of patent 
                infringement could reasonably be asserted if the 
                subsection (k) applicant engaged in the manufacture, 
                use, offering for sale, sale, or importation into the 
                United States of the biological product that is the 
                subject of the application under subsection 
                (k).</DELETED>
                <DELETED>    ``(E) Ownership of confidential 
                information.--The confidential information disclosed 
                under this paragraph is, and shall remain, the property 
                of the subsection (k) applicant. By providing the 
                confidential information pursuant to this paragraph, 
                the subsection (k) applicant does not provide the 
                reference product sponsor or the outside counsel any 
                interest in or license to use the confidential 
                information, for purposes other than those specified in 
                subparagraph (D).</DELETED>
                <DELETED>    ``(F) Effect of infringement action.--In 
                the event that the reference product sponsor files a 
                patent infringement suit, the use of confidential 
                information shall continue to be governed by the terms 
                of this paragraph until such time as a court enters a 
                protective order regarding the information. Upon entry 
                of such order, the subsection (k) applicant may 
                redesignate confidential information in accordance with 
                the terms of that order. No confidential information 
                shall be included in any publicly-available complaint 
                or other pleading. In the event that the reference 
                product sponsor does not file an infringement action by 
                the date specified in paragraph (6), the reference 
                product sponsor shall return or destroy all 
                confidential information received under this paragraph, 
                provided that if the reference product sponsor opts to 
                destroy such information, it will confirm destruction 
                in writing to the subsection (k) applicant.</DELETED>
                <DELETED>    ``(G) Rule of construction.--Nothing in 
                this paragraph shall be construed--</DELETED>
                        <DELETED>    ``(i) as an admission by the 
                        subsection (k) applicant regarding the 
                        validity, enforceability, or infringement of 
                        any patent; or</DELETED>
                        <DELETED>    ``(ii) an agreement or admission 
                        by the subsection (k) applicant with respect to 
                        the competency, relevance, or materiality of 
                        any confidential information.</DELETED>
                <DELETED>    ``(H) Effect of violation.--The disclosure 
                of any confidential information in violation of this 
                paragraph shall be deemed to cause the subsection (k) 
                applicant to suffer irreparable harm for which there is 
                no adequate legal remedy and the court shall consider 
                immediate injunctive relief to be an appropriate and 
                necessary remedy for any violation or threatened 
                violation of this paragraph.</DELETED>
        <DELETED>    ``(2) Subsection (k) application information.--Not 
        later than 20 days after the Secretary notifies the subsection 
        (k) applicant that the application has been accepted for 
        review, the subsection (k) applicant--</DELETED>
                <DELETED>    ``(A) shall provide to the reference 
                product sponsor a copy of the application submitted to 
                the Secretary under subsection (k), and such other 
                information that describes the process or processes 
                used to manufacture the biological product that is the 
                subject of such application; and</DELETED>
                <DELETED>    ``(B) may provide to the reference product 
                sponsor additional information requested by or on 
                behalf of the reference product sponsor.</DELETED>
        <DELETED>    ``(3) List and description of patents.--</DELETED>
                <DELETED>    ``(A) List by reference product sponsor.--
                Not later than 60 days after the receipt of the 
                application and information under paragraph (2), the 
                reference product sponsor shall provide to the 
                subsection (k) applicant--</DELETED>
                        <DELETED>    ``(i) a list of patents for which 
                        the reference product sponsor believes a claim 
                        of patent infringement could reasonably be 
                        asserted by the reference product sponsor if a 
                        person not licensed by the reference product 
                        sponsor engaged in the making, using, offering 
                        to sell, selling, or importing into the United 
                        States of the biological product that is the 
                        subject of the subsection (k) application; 
                        and</DELETED>
                        <DELETED>    ``(ii) an identification of the 
                        patents on such list that the reference product 
                        sponsor would be prepared to license to the 
                        subsection (k) applicant.</DELETED>
                <DELETED>    ``(B) List and description by subsection 
                (k) applicant.--Not later than 60 days after receipt of 
                the list under subparagraph (A), the subsection (k) 
                applicant--</DELETED>
                        <DELETED>    ``(i) may provide to the reference 
                        product sponsor a list of patents to which the 
                        subsection (k) applicant believes a claim of 
                        patent infringement could reasonably be 
                        asserted by the reference product sponsor if a 
                        person not licensed by the reference product 
                        sponsor engaged in the making, using, offering 
                        to sell, selling, or importing into the United 
                        States of the biological product that is the 
                        subject of the subsection (k) 
                        application;</DELETED>
                        <DELETED>    ``(ii) shall provide to the 
                        reference product sponsor, with respect to each 
                        patent listed by the reference product sponsor 
                        under subparagraph (A) or listed by the 
                        subsection (k) applicant under clause (i)--
                        </DELETED>
                                <DELETED>    ``(I) a detailed statement 
                                that describes, on a claim by claim 
                                basis, the factual and legal basis of 
                                the opinion of the subsection (k) 
                                applicant that such patent is invalid, 
                                unenforceable, or will not be infringed 
                                by the commercial marketing of the 
                                biological product that is the subject 
                                of the subsection (k) application; 
                                or</DELETED>
                                <DELETED>    ``(II) a statement that 
                                the subsection (k) applicant does not 
                                intend to begin commercial marketing of 
                                the biological product before the date 
                                that such patent expires; and</DELETED>
                        <DELETED>    ``(iii) shall provide to the 
                        reference product sponsor a response regarding 
                        each patent identified by the reference product 
                        sponsor under subparagraph (A)(ii).</DELETED>
                <DELETED>    ``(C) Description by reference product 
                sponsor.--Not later than 60 days after receipt of the 
                list and statement under subparagraph (B), the 
                reference product sponsor shall provide to the 
                subsection (k) applicant a detailed statement that 
                describes, with respect to each patent described in 
                subparagraph (B)(ii)(I), on a claim by claim basis, the 
                factual and legal basis of the opinion of the reference 
                product sponsor that such patent will be infringed by 
                the commercial marketing of the biological product that 
                is the subject of the subsection (k) application and a 
                response to the statement concerning validity and 
                enforceability provided under subparagraph 
                (B)(ii)(I).</DELETED>
        <DELETED>    ``(4) Patent resolution negotiations.--</DELETED>
                <DELETED>    ``(A) In general.--After receipt by the 
                subsection (k) applicant of the statement under 
                paragraph (3)(C), the reference product sponsor and the 
                subsection (k) applicant shall engage in good faith 
                negotiations to agree on which, if any, patents listed 
                under paragraph (3) by the subsection (k) applicant or 
                the reference product sponsor shall be the subject of 
                an action for patent infringement under paragraph 
                (6).</DELETED>
                <DELETED>    ``(B) Failure to reach agreement.--If, 
                within 15 days of beginning negotiations under 
                subparagraph (A), the subsection (k) applicant and the 
                reference product sponsor fail to agree on a final and 
                complete list of which, if any, patents listed under 
                paragraph (3) by the subsection (k) applicant or the 
                reference product sponsor shall be the subject of an 
                action for patent infringement under paragraph (6), the 
                provisions of paragraph (5) shall apply to the 
                parties.</DELETED>
        <DELETED>    ``(5) Patent resolution if no agreement.--
        </DELETED>
                <DELETED>    ``(A) Number of patents.--The subsection 
                (k) applicant shall notify the reference product 
                sponsor of the number of patents that such applicant 
                will provide to the reference product sponsor under 
                subparagraph (B)(i)(I).</DELETED>
                <DELETED>    ``(B) Exchange of patent lists.--
                </DELETED>
                        <DELETED>    ``(i) In general.--On a date 
                        agreed to by the subsection (k) applicant and 
                        the reference product sponsor, but in no case 
                        later than 5 days after the subsection (k) 
                        application notifies the reference product 
                        sponsor under subparagraph (A), the subsection 
                        (k) applicant and the reference product sponsor 
                        shall simultaneously exchange--</DELETED>
                                <DELETED>    ``(I) the list of patents 
                                that the subsection (k) applicant 
                                believes should be the subject of an 
                                action for patent infringement under 
                                paragraph (6); and</DELETED>
                                <DELETED>    ``(II) the list of 
                                patents, in accordance with clause 
                                (ii), that the reference product 
                                sponsor believes should be the subject 
                                of an action for patent infringement 
                                under paragraph (6).</DELETED>
                        <DELETED>    ``(ii) Number of patents listed by 
                        reference product sponsor.--</DELETED>
                                <DELETED>    ``(I) In general.--Subject 
                                to subclause (II), the number of 
                                patents listed by the reference product 
                                sponsor under clause (i)(II) may not 
                                exceed the number of patents listed by 
                                the subsection (k) applicant under 
                                clause (i)(I).</DELETED>
                                <DELETED>    ``(II) Exception.--If a 
                                subsection (k) applicant does not list 
                                any patent under clause (i)(I), the 
                                reference product sponsor may list 1 
                                patent under clause (i)(II).</DELETED>
        <DELETED>    ``(6) Immediate patent infringement action.--
        </DELETED>
                <DELETED>    ``(A) Action if agreement on patent 
                list.--If the subsection (k) applicant and the 
                reference product sponsor agree on patents as described 
                in paragraph (4), not later than 30 days after such 
                agreement, the reference product sponsor shall bring an 
                action for patent infringement with respect to each 
                such patent.</DELETED>
                <DELETED>    ``(B) Action if no agreement on patent 
                list.--If the provisions of paragraph (5) apply to the 
                parties as described in paragraph (4)(B), not later 
                than 30 days after the exchange of lists under 
                paragraph (5)(B), the reference product sponsor shall 
                bring an action for patent infringement with respect to 
                each patent that is included on such lists.</DELETED>
                <DELETED>    ``(C) Notification and publication of 
                complaint.--</DELETED>
                        <DELETED>    ``(i) Notification to secretary.--
                        Not later than 30 days after a complaint is 
                        served to a subsection (k) applicant in an 
                        action for patent infringement described under 
                        this paragraph, the subsection (k) applicant 
                        shall provide the Secretary with notice and a 
                        copy of such complaint.</DELETED>
                        <DELETED>    ``(ii) Publication by secretary.--
                        The Secretary shall publish in the Federal 
                        Register notice of a complaint received under 
                        clause (i).</DELETED>
        <DELETED>    ``(7) Newly issued or licensed patents.--In the 
        case of a patent that--</DELETED>
                <DELETED>    ``(A) is issued to, or exclusively 
                licensed by, the reference product sponsor after the 
                date that the reference product sponsor provided the 
                list to the subsection (k) applicant under paragraph 
                (3)(A); and</DELETED>
                <DELETED>    ``(B) the reference product sponsor 
                reasonably believes that, due to the issuance of such 
                patent, a claim of patent infringement could reasonably 
                be asserted by the reference product sponsor if a 
                person not licensed by the reference product sponsor 
                engaged in the making, using, offering to sell, 
                selling, or importing into the United States of the 
                biological product that is the subject of the 
                subsection (k) application,</DELETED>
        <DELETED>not later than 30 days after such issuance or 
        licensing, the reference product sponsor shall provide to the 
        subsection (k) applicant a supplement to the list provided by 
        the reference product sponsor under paragraph (3)(A) that 
        includes such patent, not later than 30 days after such 
        supplement is provided, the subsection (k) applicant shall 
        provide a statement to the reference product sponsor in 
        accordance with paragraph (3)(B), and such patent shall be 
        subject to paragraph (8).</DELETED>
        <DELETED>    ``(8) Notice of commercial marketing and 
        preliminary injunction.--</DELETED>
                <DELETED>    ``(A) Notice of commercial marketing.--The 
                subsection (k) applicant shall provide notice to the 
                reference product sponsor not later than 180 days 
                before the date of the first commercial marketing of 
                the biological product licensed under subsection 
                (k).</DELETED>
                <DELETED>    ``(B) Preliminary injunction.--After 
                receiving the notice under subparagraph (A) and before 
                such date of the first commercial marketing of such 
                biological product, the reference product sponsor may 
                seek a preliminary injunction prohibiting the 
                subsection (k) applicant from engaging in the 
                commercial manufacture or sale of such biological 
                product until the court decides the issue of patent 
                validity, enforcement, and infringement with respect to 
                any patent that is--</DELETED>
                        <DELETED>    ``(i) included in the list 
                        provided by the reference product sponsor under 
                        paragraph (3)(A) or in the list provided by the 
                        subsection (k) applicant under paragraph 
                        (3)(B); and</DELETED>
                        <DELETED>    ``(ii) not included, as 
                        applicable, on--</DELETED>
                                <DELETED>    ``(I) the list of patents 
                                described in paragraph (4); 
                                or</DELETED>
                                <DELETED>    ``(II) the lists of 
                                patents described in paragraph 
                                (5)(B).</DELETED>
                <DELETED>    ``(C) Reasonable cooperation.--If the 
                reference product sponsor has sought a preliminary 
                injunction under subparagraph (B), the reference 
                product sponsor and the subsection (k) applicant shall 
                reasonably cooperate to expedite such further discovery 
                as is needed in connection with the preliminary 
                injunction motion.</DELETED>
        <DELETED>    ``(9) Limitation on declaratory judgment action.--
        </DELETED>
                <DELETED>    ``(A) Subsection (k) application 
                provided.--If a subsection (k) applicant provides the 
                application and information required under paragraph 
                (2)(A), neither the reference product sponsor nor the 
                subsection (k) applicant may, prior to the date notice 
                is received under paragraph (8)(A), bring any action 
                under section 2201 of title 28, United States Code, for 
                a declaration of infringement, validity, or 
                enforceability of any patent that is described in 
                clauses (i) and (ii) of paragraph (8)(B).</DELETED>
                <DELETED>    ``(B) Subsequent failure to act by 
                subsection (k) applicant.--If a subsection (k) 
                applicant fails to complete an action required of the 
                subsection (k) applicant under paragraph (3)(B)(ii), 
                paragraph (5), paragraph (6)(C)(i), paragraph (7), or 
                paragraph (8)(A), the reference product sponsor, but 
                not the subsection (k) applicant, may bring an action 
                under section 2201 of title 28, United States Code, for 
                a declaration of infringement, validity, or 
                enforceability of any patent included in the list 
                described in paragraph (3)(A), including as provided 
                under paragraph (7).</DELETED>
                <DELETED>    ``(C) Subsection (k) application not 
                provided.--If a subsection (k) applicant fails to 
                provide the application and information required under 
                paragraph (2)(A), the reference product sponsor, but 
                not the subsection (k) applicant, may bring an action 
                under section 2201 of title 28, United States Code, for 
                a declaration of infringement, validity, or 
                enforceability of any patent that claims the biological 
                product or a use of the biological 
                product.''.</DELETED>
<DELETED>    (b) Definitions.--Section 351(i) of the Public Health 
Service Act (42 U.S.C. 262(i)) is amended--</DELETED>
        <DELETED>    (1) by striking ``In this section, the term 
        `biological product' means'' and inserting the following: ``In 
        this section:</DELETED>
        <DELETED>    ``(1) The term `biological product' 
        means'';</DELETED>
        <DELETED>    (2) in paragraph (1), as so designated, by 
        inserting ``protein (except any chemically synthesized 
        polypeptide),'' after ``allergenic product,''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
        <DELETED>    ``(2) The term `biosimilar' or `biosimilarity', in 
        reference to a biological product that is the subject of an 
        application under subsection (k), means there are no clinically 
        meaningful differences between the biological product and the 
        reference product in terms of the safety, purity, and potency 
        of the product.</DELETED>
        <DELETED>    ``(3) The term `interchangeable' or 
        `interchangeability', in reference to a biological product that 
        is the subject of an application under subsection (k), means 
        that the biological product may be substituted for the 
        reference product without the intervention of the health care 
        provider who prescribed the reference product.</DELETED>
        <DELETED>    ``(4) The term `reference product' means the 
        single biological product licensed under subsection (a) against 
        which a biological product is evaluated in an application 
        submitted under subsection (k).''.</DELETED>
<DELETED>    (c) Conforming Amendments Relating to Patents.--</DELETED>
        <DELETED>    (1) Patents.--Section 271(e) of title 35, United 
        States Code, is amended--</DELETED>
                <DELETED>    (A) in paragraph (2)--</DELETED>
                        <DELETED>    (i) in subparagraph (A), by 
                        striking ``or'' at the end;</DELETED>
                        <DELETED>    (ii) in subparagraph (B), by 
                        adding ``or'' at the end; and</DELETED>
                        <DELETED>    (iii) by inserting after 
                        subparagraph (B) the following:</DELETED>
        <DELETED>    ``(C)(i) with respect to a patent that is 
        identified in the list of patents described in section 
        351(l)(3) of the Public Health Service Act (including as 
        provided under section 351(l)(7) of such Act), an application 
        seeking approval of a biological product, or</DELETED>
        <DELETED>    ``(ii) if the applicant for the application fails 
        to provide the application and information required under 
        section 351(l)(2)(A) of such Act, an application seeking 
        approval of a biological product for a patent that could be 
        identified pursuant to section 351(l)(3)(A)(i) of such Act,''; 
        and</DELETED>
                        <DELETED>    (iv) in the matter following 
                        subparagraph (C) (as added by clause (iii)), by 
                        striking ``or veterinary biological product'' 
                        and inserting ``, veterinary biological 
                        product, or biological product'';</DELETED>
                <DELETED>    (B) in paragraph (4)--</DELETED>
                        <DELETED>    (i) in subparagraph (B), by--
                        </DELETED>
                                <DELETED>    (I) striking ``or 
                                veterinary biological product'' and 
                                inserting ``, veterinary biological 
                                product, or biological product''; 
                                and</DELETED>
                                <DELETED>    (II) striking ``and'' at 
                                the end;</DELETED>
                        <DELETED>    (ii) in subparagraph (C), by--
                        </DELETED>
                                <DELETED>    (I) striking ``or 
                                veterinary biological product'' and 
                                inserting ``, veterinary biological 
                                product, or biological product''; 
                                and</DELETED>
                                <DELETED>    (II) striking the period 
                                and inserting ``, and'';</DELETED>
                        <DELETED>    (iii) by inserting after 
                        subparagraph (C) the following:</DELETED>
        <DELETED>    ``(D) the court shall order a permanent injunction 
        prohibiting any infringement of the patent by the biological 
        product involved in the infringement until a date which is not 
        earlier than the date of the expiration of the patent that has 
        been infringed under paragraph (2)(C), provided the patent is 
        the subject of a final court decision, as defined in section 
        351(k)(6) of the Public Health Service Act, in an action for 
        infringement of the patent under section 351(l)(6) of such Act, 
        and the biological product has not yet been approved because of 
        section 351(k)(7) of such Act.''; and</DELETED>
                        <DELETED>    (iv) in the matter following 
                        subparagraph (D) (as added by clause (iii)), by 
                        striking ``and (C)'' and inserting ``(C), and 
                        (D)''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
<DELETED>    ``(6)(A) Subparagraph (B) applies, in lieu of paragraph 
(4), in the case of a patent--</DELETED>
        <DELETED>    ``(i) that is identified, as applicable, in the 
        list of patents described in section 351(l)(4) of the Public 
        Health Service Act or the lists of patents described in section 
        351(l)(5)(B) of such Act with respect to a biological product; 
        and</DELETED>
        <DELETED>    ``(ii) for which an action for infringement of the 
        patent with respect to the biological product--</DELETED>
                <DELETED>    ``(I) was brought after the expiration of 
                the 30-day period described in subparagraph (A) or (B), 
                as applicable, of section 351(l)(6) of such Act; 
                or</DELETED>
                <DELETED>    ``(II) was brought before the expiration 
                of the 30-day period described in subclause (I), but 
                which was dismissed without prejudice or was not 
                prosecuted to judgment in good faith.</DELETED>
<DELETED>    ``(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 making, using, offering to sell, 
selling, or importation into the United States of the biological 
product that is the subject of the action infringed the patent, shall 
be a reasonable royalty.</DELETED>
<DELETED>    ``(C) The owner of a patent that should have been included 
in the list described in section 351(l)(3)(A) of the Public Health 
Service Act, including as provided under section 351(l)(7) of such Act 
for a biological product, but was not timely included in such list, may 
not bring an action under this section for infringement of the patent 
with respect to the biological product.''.</DELETED>
        <DELETED>    (2) Conforming amendment under 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''.</DELETED>
<DELETED>    (d) Conforming Amendments Under the Federal Food, Drug, 
and Cosmetic Act.--</DELETED>
        <DELETED>    (1) Content and review of applications.--Section 
        505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(b)(5)(B)) is amended by inserting before the period 
        at the end of the first sentence the following: ``or, with 
        respect to an applicant for approval of a biological product 
        under section 351(k) of the Public Health Service Act, any 
        necessary clinical study or studies''.</DELETED>
        <DELETED>    (2) New active ingredient.--Section 505B of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is 
        amended by adding at the end the following:</DELETED>
<DELETED>    ``(i) New Active Ingredient.--A biological product that is 
interchangeable with a reference product under section 351 of the 
Public Health Service Act shall not be considered to have a new active 
ingredient under this section.''.</DELETED>
<DELETED>    (e) Products Previously Approved Under Section 505.--
</DELETED>
        <DELETED>    (1) Requirement to follow section 351.--Except as 
        provided in paragraph (2), an application for a biological 
        product shall be submitted under section 351 of the Public 
        Health Service Act (42 U.S.C. 262) (as amended by this 
        Act).</DELETED>
        <DELETED>    (2) Exception.--An application for a biological 
        product may be submitted under section 505 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355) if--</DELETED>
                <DELETED>    (A) such biological product is in a 
                product class for which a biological product in such 
                product class is the subject of an application approved 
                under such section 505 not later than the date of 
                enactment of this Act; and</DELETED>
                <DELETED>    (B) such application--</DELETED>
                        <DELETED>    (i) has been submitted to the 
                        Secretary of Health and Human Services 
                        (referred to in this Act as the ``Secretary'') 
                        before the date of enactment of this Act; 
                        or</DELETED>
                        <DELETED>    (ii) is submitted to the Secretary 
                        not later than the date that is 10 years after 
                        the date of enactment of this Act.</DELETED>
        <DELETED>    (3) Limitation.--Notwithstanding paragraph (2), an 
        application for a biological product may not be submitted under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) if there is another biological product approved 
        under subsection (a) of section 351 of the Public Health 
        Service Act that could be a reference product with respect to 
        such application (within the meaning of such section 351) if 
        such application were submitted under subsection (k) of such 
        section 351.</DELETED>
        <DELETED>    (4) Deemed approved under section 351.--An 
        approved application for a biological product under section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
        shall be deemed to be a license for the biological product 
        under such section 351 on the date that is 10 years after the 
        date of enactment of this Act.</DELETED>
        <DELETED>    (5) Definitions.--For purposes of this subsection, 
        the term ``biological product'' has the meaning given such term 
        under section 351 of the Public Health Service Act (42 U.S.C. 
        262) (as amended by this Act).</DELETED>
<DELETED>    (f) Follow-On Biologics User Fees.--</DELETED>
        <DELETED>    (1) Development of user fees for biosimilar 
        biological products.--</DELETED>
                <DELETED>    (A) In general.--Beginning not later than 
                October 1, 2010, the Secretary shall develop 
                recommendations to present to Congress with respect to 
                the goals, and plans for meeting the goals, for the 
                process for the review of biosimilar biological product 
                applications submitted under section 351(k) of the 
                Public Health Service Act (as added by this Act) for 
                the first 5 fiscal years after fiscal year 2012. In 
                developing such recommendations, the Secretary shall 
                consult with--</DELETED>
                        <DELETED>    (i) the Committee on Health, 
                        Education, Labor, and Pensions of the 
                        Senate;</DELETED>
                        <DELETED>    (ii) the Committee on Energy and 
                        Commerce of the House of 
                        Representatives;</DELETED>
                        <DELETED>    (iii) scientific and academic 
                        experts;</DELETED>
                        <DELETED>    (iv) health care 
                        professionals;</DELETED>
                        <DELETED>    (v) representatives of patient and 
                        consumer advocacy groups; and</DELETED>
                        <DELETED>    (vi) the regulated 
                        industry.</DELETED>
                <DELETED>    (B) Public review of recommendations.--
                After negotiations with the regulated industry, the 
                Secretary shall--</DELETED>
                        <DELETED>    (i) present the recommendations 
                        developed under subparagraph (A) to the 
                        Congressional committees specified in such 
                        subparagraph;</DELETED>
                        <DELETED>    (ii) publish such recommendations 
                        in the Federal Register;</DELETED>
                        <DELETED>    (iii) provide for a period of 30 
                        days for the public to provide written comments 
                        on such recommendations;</DELETED>
                        <DELETED>    (iv) hold a meeting at which the 
                        public may present its views on such 
                        recommendations; and</DELETED>
                        <DELETED>    (v) after consideration of such 
                        public views and comments, revise such 
                        recommendations as necessary.</DELETED>
                <DELETED>    (C) Transmittal of recommendations.--Not 
                later than January 15, 2012, the Secretary shall 
                transmit to Congress the revised recommendations under 
                subparagraph (B), a summary of the views and comments 
                received under such subparagraph, and any changes made 
                to the recommendations in response to such views and 
                comments.</DELETED>
        <DELETED>    (2) Establishment of user fee program.--It is the 
        sense of the Senate that, based on the recommendations 
        transmitted to Congress by the Secretary pursuant to paragraph 
        (1)(C), Congress should authorize a program, effective on 
        October 1, 2012, for the collection of user fees relating to 
        the submission of biosimilar biological product applications 
        under section 351(k) of the Public Health Service Act (as added 
        by this Act).</DELETED>
        <DELETED>    (3) Transitional provisions for user fees for 
        biosimilar biological products.--</DELETED>
                <DELETED>    (A) Application of the prescription drug 
                user fee provisions.--Section 735(1)(C) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)(C)) is 
                amended by striking ``section 351'' and inserting 
                ``subsection (a) or (k) of section 351''.</DELETED>
                <DELETED>    (B) Evaluation of costs of reviewing 
                biosimilar biological product applications.--During the 
                period beginning on the date of enactment of this Act 
                and ending on October 1, 2010, the Secretary shall 
                collect and evaluate data regarding the costs of 
                reviewing applications for biological products 
                submitted under section 351(k) of the Public Health 
                Service Act (as added by this Act) during such 
                period.</DELETED>
                <DELETED>    (C) Audit.--</DELETED>
                        <DELETED>    (i) In general.--On the date that 
                        is 2 years after first receiving a user fee 
                        applicable to an application for a biological 
                        product under section 351(k) of the Public 
                        Health Service Act (as added by this Act), and 
                        on a biennial basis thereafter until October 1, 
                        2013, the Secretary shall perform an audit of 
                        the costs of reviewing such applications under 
                        such section 351(k). Such an audit shall 
                        compare--</DELETED>
                                <DELETED>    (I) the costs of reviewing 
                                such applications under such section 
                                351(k) to the amount of the user fee 
                                applicable to such applications; 
                                and</DELETED>
                                <DELETED>    (II)(aa) such ratio 
                                determined under subclause (I); 
                                to</DELETED>
                                <DELETED>    (bb) the ratio of the 
                                costs of reviewing applications for 
                                biological products under section 
                                351(a) of such Act (as amended by this 
                                Act) to the amount of the user fee 
                                applicable to such applications under 
                                such section 351(a).</DELETED>
                        <DELETED>    (ii) Alteration of user fee.--If 
                        the audit performed under clause (i) indicates 
                        that the ratios compared under subclause (II) 
                        of such clause differ by more than 5 percent, 
                        then the Secretary shall alter the user fee 
                        applicable to applications submitted under such 
                        section 351(k) to more appropriately account 
                        for the costs of reviewing such 
                        applications.</DELETED>
                        <DELETED>    (iii) Accounting standards.--The 
                        Secretary shall perform an audit under clause 
                        (i) in conformance with the accounting 
                        principles, standards, and requirements 
                        prescribed by the Comptroller General of the 
                        United States under section 3511 of title 31, 
                        United State Code, to ensure the validity of 
                        any potential variability.</DELETED>
        <DELETED>    (4) Authorization of appropriations.--There is 
        authorized to be appropriated to carry out this subsection such 
        sums as may be necessary for each of fiscal years 2008 through 
        2012.</DELETED>
<DELETED>    (g) Allocation of Savings; Special Reserve Fund.--
</DELETED>
        <DELETED>    (1) Determination of savings.--The Secretary of 
        the Treasury, in consultation with the Secretary, shall for 
        each fiscal year determine the amount of the savings to the 
        Federal Government as a result of the enactment of this Act and 
        shall transfer such amount to the Fund established under 
        paragraph (2) pursuant to a relevant appropriations 
        Act.</DELETED>
        <DELETED>    (2) Special reserve fund.--</DELETED>
                <DELETED>    (A) In general.--There is established in 
                the Treasury of the United States a fund to be 
                designated as the ``Biological Product Savings Fund'' 
                to be made available to the Secretary without fiscal 
                year limitation.</DELETED>
                <DELETED>    (B) Use of fund.--The amounts made 
                available to the Secretary through the Fund under 
                subparagraph (A) shall be expended on activities 
                authorized under the Public Health Service 
                Act.</DELETED>
        <DELETED>    (3) Authorization of appropriations.--There is 
        authorized to be appropriated for each fiscal year to the Fund 
        established under paragraph (2), the amount of the savings 
        determined for such fiscal year under paragraph (1).</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Biologics Price Competition and 
Innovation Act of 2007''.

SEC. 2. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL PRODUCTS.

    (a) Licensure of Biological Products as Biosimilar or 
Interchangeable.--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:
    ``(k) Licensure of Biological Products as Biosimilar or 
Interchangeable.--
            ``(1) In general.--Any person may submit an application for 
        licensure of a biological product under this subsection.
            ``(2) Content.--
                    ``(A) In general.--
                            ``(i) Required information.--An application 
                        submitted under this subsection shall include 
                        information demonstrating that--
                                    ``(I) the biological product is 
                                biosimilar to a reference product based 
                                upon data derived from--
                                            ``(aa) analytical studies 
                                        that demonstrate that the 
                                        biological product is highly 
                                        similar to the reference 
                                        product notwithstanding minor 
                                        differences in clinically 
                                        inactive components;
                                            ``(bb) animal studies 
                                        (including the assessment of 
                                        toxicity); and
                                            ``(cc) a clinical study or 
                                        studies (including the 
                                        assessment of immunogenicity 
                                        and pharmacokinetics or 
                                        pharmacodynamics) that are 
                                        sufficient to demonstrate 
                                        safety, purity, and potency in 
                                        1 or more appropriate 
                                        conditions of use for which the 
                                        reference product is licensed 
                                        and intended to be used and for 
                                        which licensure is sought for 
                                        the biological product;
                                    ``(II) 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;
                                    ``(III) 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;
                                    ``(IV) the route of administration, 
                                the dosage form, and the strength of 
                                the biological product are the same as 
                                those of the reference product; and
                                    ``(V) 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.
                            ``(ii) Determination by secretary.--The 
                        Secretary may determine, in the Secretary's 
                        discretion, that an element described in clause 
                        (i)(I) is unnecessary in an application 
                        submitted under this subsection.
                            ``(iii) Additional information.--An 
                        application submitted under this subsection--
                                    ``(I) shall include publicly-
                                available information regarding the 
                                Secretary's previous determination that 
                                the reference product is safe, pure, 
                                and potent; and
                                    ``(II) may include any additional 
                                information in support of the 
                                application, including publicly-
                                available information with respect to 
                                the reference product or another 
                                biological product.
                    ``(B) Interchangeability.--An application (or a 
                supplement to an application) submitted under this 
                subsection may include information demonstrating that 
                the biological product meets the standards described in 
                paragraph (4).
            ``(3) Evaluation by secretary.--Upon review of an 
        application (or a supplement to an application) submitted under 
        this subsection, the Secretary shall license the biological 
        product under this subsection if--
                    ``(A) the Secretary determines that the information 
                submitted in the application (or the supplement) is 
                sufficient to show that the biological product--
                            ``(i) is biosimilar to the reference 
                        product; or
                            ``(ii) meets the standards described in 
                        paragraph (4), and therefore is interchangeable 
                        with the reference product; and
                    ``(B) the applicant (or other appropriate person) 
                consents to the inspection of the facility that is the 
                subject of the application, in accordance with 
                subsection (c).
            ``(4) Safety standards for determining 
        interchangeability.--Upon review of an application submitted 
        under this subsection or any supplement to such application, 
        the Secretary shall determine the biological product to be 
        interchangeable with the reference product if the Secretary 
        determines that the information submitted in the application 
        (or a supplement to such application) is sufficient to show 
        that--
                    ``(A) the biological product--
                            ``(i) is biosimilar to the reference 
                        product; and
                            ``(ii) can be expected to produce the same 
                        clinical result as the reference product in any 
                        given patient; and
                    ``(B) for a biological product that is administered 
                more than once to an individual, the risk in terms of 
                safety or diminished efficacy of alternating or 
                switching between use of the biological product and the 
                reference product is not greater than the risk of using 
                the reference product without such alternation or 
                switch.
            ``(5) General rules.--
                    ``(A) One reference product per application.--A 
                biological product, in an application submitted under 
                this subsection, may not be evaluated against more than 
                1 reference product.
                    ``(B) Review.--An application submitted under this 
                subsection shall be reviewed by the division within the 
                Food and Drug Administration that is responsible for 
                the review and approval of the application under which 
                the reference product is licensed.
                    ``(C) Risk evaluation and mitigation strategies.--
                The authority of the Secretary with respect to risk 
                evaluation and mitigation strategies under the Federal 
                Food, Drug, and Cosmetic Act shall apply to biological 
                products licensed under this subsection in the same 
                manner as such authority applies to biological products 
                licensed under subsection (a).
            ``(6) Exclusivity for first interchangeable biological 
        product.--Upon review of an application submitted under this 
        subsection 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) that the 
        second or subsequent biological product is interchangeable for 
        any condition of use until the earlier of--
                    ``(A) 1 year after the first commercial marketing 
                of the first interchangeable biosimilar biological 
                product to be approved as interchangeable for that 
                reference product;
                    ``(B) 18 months after--
                            ``(i) a final court decision on all patents 
                        in suit in an action instituted under 
                        subsection (l)(6) against the applicant that 
                        submitted the application for the first 
                        approved interchangeable biosimilar biological 
                        product; or
                            ``(ii) the dismissal with or without 
                        prejudice of an action instituted under 
                        subsection (l)(6) against the applicant that 
                        submitted the application for the first 
                        approved interchangeable biosimilar biological 
                        product; or
                    ``(C)(i) 42 months after approval of the first 
                interchangeable biosimilar biological product if the 
                applicant that submitted such application has been sued 
                under subsection (l)(6) and such litigation is still 
                ongoing within such 36-month period; or
                    ``(ii) 18 months after approval of the first 
                interchangeable biosimilar biological product if the 
                applicant that submitted such application has not been 
                sued under subsection (l)(6).
        For purposes of this paragraph, the term `final court decision' 
        means a final decision of a court from which no appeal (other 
        than a petition to the United States Supreme Court for a writ 
        of certiorari) has been or can be taken.
            ``(7) Exclusivity for reference product.--
                    ``(A) Effective date of biosimilar application 
                approval.--Approval of an application under this 
                subsection may not be made effective by the Secretary 
                until the date that is 12 years after the date on which 
                the reference product was first licensed under 
                subsection (a).
                    ``(B) Filing period.--An application under this 
                subsection may not be submitted to the Secretary until 
                the date that is 4 years after the date on which the 
                reference product was first licensed under subsection 
                (a).
                    ``(C) First licensure.--The date on which the 
                reference product was first licensed under subsection 
                (a) does not include the date of approval of a 
                supplement or of a subsequent application for a new 
                indication, route of administration, dosage form, or 
                strength for the previously licensed reference product.
            ``(8) Guidance documents.--
                    ``(A) In general.--The Secretary may, after 
                opportunity for public comment, issue guidance in 
                accordance, except as provided in subparagraph (B)(i), 
                with section 701(h) of the Federal Food, Drug, and 
                Cosmetic Act with respect to the licensure of a 
                biological product under this subsection. Any such 
                guidance may be general or specific.
                    ``(B) Public comment.--
                            ``(i) In general.--The Secretary shall 
                        provide the public an opportunity to comment on 
                        any proposed guidance issued under subparagraph 
                        (A) before issuing final guidance.
                            ``(ii) Input regarding most valuable 
                        guidance.--The Secretary shall establish a 
                        process through which the public may provide 
                        the Secretary with input regarding priorities 
                        for issuing guidance.
                    ``(C) No requirement for application 
                consideration.--The issuance (or non-issuance) of 
                guidance under subparagraph (A) shall not preclude the 
                review of, or action on, an application submitted under 
                this subsection.
                    ``(D) Requirement for product class-specific 
                guidance.--If the Secretary issues product class-
                specific guidance under subparagraph (A), such guidance 
                shall include a description of--
                            ``(i) the criteria that the Secretary will 
                        use to determine whether a biological product 
                        is highly similar to a reference product in 
                        such product class; and
                            ``(ii) the criteria, if available, that the 
                        Secretary will use to determine whether a 
                        biological product meets the standards 
                        described in paragraph (4).
                    ``(E) Certain product classes.--
                            ``(i) Guidance.--The Secretary may indicate 
                        in a guidance document that the science and 
                        experience, as of the date of such guidance, 
                        with respect to a product or product class (not 
                        including any recombinant protein) does not 
                        allow approval of an application for a license 
                        as provided under this subsection for such 
                        product or product class.
                            ``(ii) Modification or reversal.--The 
                        Secretary may issue a subsequent guidance 
                        document under subparagraph (A) to modify or 
                        reverse a guidance document under clause (i).
                            ``(iii) No effect on ability to deny 
                        license.--Clause (i) shall not be construed to 
                        require the Secretary to approve a product with 
                        respect to which the Secretary has not 
                        indicated in a guidance document that the 
                        science and experience, as described in clause 
                        (i), does not allow approval of such an 
                        application.
    ``(l) Patents.--
            ``(1) Confidential access to subsection (k) application.--
                    ``(A) Application of paragraph.--Unless otherwise 
                agreed to by a person that submits an application under 
                subsection (k) (referred to in this subsection as the 
                `subsection (k) applicant') and the sponsor of the 
                application for the reference product (referred to in 
                this paragraph as the `reference product sponsor'), the 
                provisions of this paragraph shall apply to the 
                exchange of information described in this subsection.
                    ``(B) In general.--
                            ``(i) Provision of confidential 
                        information.--When a subsection (k) applicant 
                        submits an application under subsection (k), 
                        such applicant shall provide to the persons 
                        described in clause (ii), subject to the terms 
                        of this paragraph, confidential access to the 
                        information required to be produced pursuant to 
                        paragraph (2) and any other information that 
                        the subsection (k) applicant determines, in its 
                        sole discretion, to be appropriate (referred to 
                        in this subsection as the `confidential 
                        information').
                            ``(ii) Recipients of information.--The 
                        persons described in this clause are the 
                        following:
                                    ``(I) Outside counsel.--One or more 
                                attorneys designated by the reference 
                                product sponsor who are employees of an 
                                entity other than the reference product 
                                sponsor (referred to in this paragraph 
                                as the `outside counsel'), provided 
                                that such attorneys do not engage, 
                                formally or informally, in patent 
                                prosecution relevant or related to the 
                                reference product.
                                    ``(II) In-house counsel.--One 
                                attorney that represents the reference 
                                product sponsor who is an employee of 
                                the reference product sponsor, provided 
                                that such attorney does not engage, 
                                formally or informally, in patent 
                                prosecution relevant or related to the 
                                reference product.
                            ``(iii) Patent owner access.--A 
                        representative of the owner of a patent 
                        exclusively licensed to a reference product 
                        sponsor with respect to the reference product 
                        and who has retained a right to assert the 
                        patent or participate in litigation concerning 
                        the patent may be provided the confidential 
                        information, provided that the representative 
                        informs the reference product sponsor and the 
                        subsection (k) applicant of his or her 
                        agreement to be subject to the confidentiality 
                        provisions set forth in this paragraph, 
                        including those under clause (ii).
                    ``(C) Limitation on disclosure.--No person that 
                receives confidential information pursuant to 
                subparagraph (B) shall disclose any confidential 
                information to any other person or entity, including 
                the reference product sponsor employees, outside 
                scientific consultants, or other outside counsel 
                retained by the reference product sponsor, without the 
                prior written consent of the subsection (k) applicant, 
                which shall not be unreasonably withheld.
                    ``(D) Use of confidential information.--
                Confidential information shall be used for the sole and 
                exclusive purpose of determining, with respect to each 
                patent assigned to or exclusively licensed by the 
                reference product sponsor, whether a claim of patent 
                infringement could reasonably be asserted if the 
                subsection (k) applicant engaged in the manufacture, 
                use, offering for sale, sale, or importation into the 
                United States of the biological product that is the 
                subject of the application under subsection (k).
                    ``(E) Ownership of confidential information.--The 
                confidential information disclosed under this paragraph 
                is, and shall remain, the property of the subsection 
                (k) applicant. By providing the confidential 
                information pursuant to this paragraph, the subsection 
                (k) applicant does not provide the reference product 
                sponsor or the outside counsel any interest in or 
                license to use the confidential information, for 
                purposes other than those specified in subparagraph 
                (D).
                    ``(F) Effect of infringement action.--In the event 
                that the reference product sponsor files a patent 
                infringement suit, the use of confidential information 
                shall continue to be governed by the terms of this 
                paragraph until such time as a court enters a 
                protective order regarding the information. Upon entry 
                of such order, the subsection (k) applicant may 
                redesignate confidential information in accordance with 
                the terms of that order. No confidential information 
                shall be included in any publicly-available complaint 
                or other pleading. In the event that the reference 
                product sponsor does not file an infringement action by 
                the date specified in paragraph (6), the reference 
                product sponsor shall return or destroy all 
                confidential information received under this paragraph, 
                provided that if the reference product sponsor opts to 
                destroy such information, it will confirm destruction 
                in writing to the subsection (k) applicant.
                    ``(G) Rule of construction.--Nothing in this 
                paragraph shall be construed--
                            ``(i) as an admission by the subsection (k) 
                        applicant regarding the validity, 
                        enforceability, or infringement of any patent; 
                        or
                            ``(ii) an agreement or admission by the 
                        subsection (k) applicant with respect to the 
                        competency, relevance, or materiality of any 
                        confidential information.
                    ``(H) Effect of violation.--The disclosure of any 
                confidential information in violation of this paragraph 
                shall be deemed to cause the subsection (k) applicant 
                to suffer irreparable harm for which there is no 
                adequate legal remedy and the court shall consider 
                immediate injunctive relief to be an appropriate and 
                necessary remedy for any violation or threatened 
                violation of this paragraph.
            ``(2) Subsection (k) application information.--Not later 
        than 20 days after the Secretary notifies the subsection (k) 
        applicant that the application has been accepted for review, 
        the subsection (k) applicant--
                    ``(A) shall provide to the reference product 
                sponsor a copy of the application submitted to the 
                Secretary under subsection (k), and such other 
                information that describes the process or processes 
                used to manufacture the biological product that is the 
                subject of such application; and
                    ``(B) may provide to the reference product sponsor 
                additional information requested by or on behalf of the 
                reference product sponsor.
            ``(3) List and description of patents.--
                    ``(A) List by reference product sponsor.--Not later 
                than 60 days after the receipt of the application and 
                information under paragraph (2), the reference product 
                sponsor shall provide to the subsection (k) applicant--
                            ``(i) a list of patents for which the 
                        reference product sponsor believes a claim of 
                        patent infringement could reasonably be 
                        asserted by the reference product sponsor, or 
                        by a patent owner that has granted an exclusive 
                        license to the reference product sponsor with 
                        respect to the reference product, if a person 
                        not licensed by the reference product sponsor 
                        engaged in the making, using, offering to sell, 
                        selling, or importing into the United States of 
                        the biological product that is the subject of 
                        the subsection (k) application; and
                            ``(ii) an identification of the patents on 
                        such list that the reference product sponsor 
                        would be prepared to license to the subsection 
                        (k) applicant.
                    ``(B) List and description by subsection (k) 
                applicant.--Not later than 60 days after receipt of the 
                list under subparagraph (A), the subsection (k) 
                applicant--
                            ``(i) may provide to the reference product 
                        sponsor a list of patents to which the 
                        subsection (k) applicant believes a claim of 
                        patent infringement could reasonably be 
                        asserted by the reference product sponsor if a 
                        person not licensed by the reference product 
                        sponsor engaged in the making, using, offering 
                        to sell, selling, or importing into the United 
                        States of the biological product that is the 
                        subject of the subsection (k) application;
                            ``(ii) shall provide to the reference 
                        product sponsor, with respect to each patent 
                        listed by the reference product sponsor under 
                        subparagraph (A) or listed by the subsection 
                        (k) applicant under clause (i)--
                                    ``(I) a detailed statement that 
                                describes, on a claim by claim basis, 
                                the factual and legal basis of the 
                                opinion of the subsection (k) applicant 
                                that such patent is invalid, 
                                unenforceable, or will not be infringed 
                                by the commercial marketing of the 
                                biological product that is the subject 
                                of the subsection (k) application; or
                                    ``(II) a statement that the 
                                subsection (k) applicant does not 
                                intend to begin commercial marketing of 
                                the biological product before the date 
                                that such patent expires; and
                            ``(iii) shall provide to the reference 
                        product sponsor a response regarding each 
                        patent identified by the reference product 
                        sponsor under subparagraph (A)(ii).
                    ``(C) Description by reference product sponsor.--
                Not later than 60 days after receipt of the list and 
                statement under subparagraph (B), the reference product 
                sponsor shall provide to the subsection (k) applicant a 
                detailed statement that describes, with respect to each 
                patent described in subparagraph (B)(ii)(I), on a claim 
                by claim basis, the factual and legal basis of the 
                opinion of the reference product sponsor that such 
                patent will be infringed by the commercial marketing of 
                the biological product that is the subject of the 
                subsection (k) application and a response to the 
                statement concerning validity and enforceability 
                provided under subparagraph (B)(ii)(I).
            ``(4) Patent resolution negotiations.--
                    ``(A) In general.--After receipt by the subsection 
                (k) applicant of the statement under paragraph (3)(C), 
                the reference product sponsor and the subsection (k) 
                applicant shall engage in good faith negotiations to 
                agree on which, if any, patents listed under paragraph 
                (3) by the subsection (k) applicant or the reference 
                product sponsor shall be the subject of an action for 
                patent infringement under paragraph (6).
                    ``(B) Failure to reach agreement.--If, within 15 
                days of beginning negotiations under subparagraph (A), 
                the subsection (k) applicant and the reference product 
                sponsor fail to agree on a final and complete list of 
                which, if any, patents listed under paragraph (3) by 
                the subsection (k) applicant or the reference product 
                sponsor shall be the subject of an action for patent 
                infringement under paragraph (6), the provisions of 
                paragraph (5) shall apply to the parties.
            ``(5) Patent resolution if no agreement.--
                    ``(A) Number of patents.--The subsection (k) 
                applicant shall notify the reference product sponsor of 
                the number of patents that such applicant will provide 
                to the reference product sponsor under subparagraph 
                (B)(i)(I).
                    ``(B) Exchange of patent lists.--
                            ``(i) In general.--On a date agreed to by 
                        the subsection (k) applicant and the reference 
                        product sponsor, but in no case later than 5 
                        days after the subsection (k) application 
                        notifies the reference product sponsor under 
                        subparagraph (A), the subsection (k) applicant 
                        and the reference product sponsor shall 
                        simultaneously exchange--
                                    ``(I) the list of patents that the 
                                subsection (k) applicant believes 
                                should be the subject of an action for 
                                patent infringement under paragraph 
                                (6); and
                                    ``(II) the list of patents, in 
                                accordance with clause (ii), that the 
                                reference product sponsor believes 
                                should be the subject of an action for 
                                patent infringement under paragraph 
                                (6).
                            ``(ii) Number of patents listed by 
                        reference product sponsor.--
                                    ``(I) In general.--Subject to 
                                subclause (II), the number of patents 
                                listed by the reference product sponsor 
                                under clause (i)(II) may not exceed the 
                                number of patents listed by the 
                                subsection (k) applicant under clause 
                                (i)(I).
                                    ``(II) Exception.--If a subsection 
                                (k) applicant does not list any patent 
                                under clause (i)(I), the reference 
                                product sponsor may list 1 patent under 
                                clause (i)(II).
            ``(6) Immediate patent infringement action.--
                    ``(A) Action if agreement on patent list.--If the 
                subsection (k) applicant and the reference product 
                sponsor agree on patents as described in paragraph (4), 
                not later than 30 days after such agreement, the 
                reference product sponsor shall bring an action for 
                patent infringement with respect to each such patent.
                    ``(B) Action if no agreement on patent list.--If 
                the provisions of paragraph (5) apply to the parties as 
                described in paragraph (4)(B), not later than 30 days 
                after the exchange of lists under paragraph (5)(B), the 
                reference product sponsor shall bring an action for 
                patent infringement with respect to each patent that is 
                included on such lists.
                    ``(C) Notification and publication of complaint.--
                            ``(i) Notification to secretary.--Not later 
                        than 30 days after a complaint is served to a 
                        subsection (k) applicant in an action for 
                        patent infringement described under this 
                        paragraph, the subsection (k) applicant shall 
                        provide the Secretary with notice and a copy of 
                        such complaint.
                            ``(ii) Publication by secretary.--The 
                        Secretary shall publish in the Federal Register 
                        notice of a complaint received under clause 
                        (i).
            ``(7) Newly issued or licensed patents.--In the case of a 
        patent that--
                    ``(A) is issued to, or exclusively licensed by, the 
                reference product sponsor after the date that the 
                reference product sponsor provided the list to the 
                subsection (k) applicant under paragraph (3)(A); and
                    ``(B) the reference product sponsor reasonably 
                believes that, due to the issuance of such patent, a 
                claim of patent infringement could reasonably be 
                asserted by the reference product sponsor if a person 
                not licensed by the reference product sponsor engaged 
                in the making, using, offering to sell, selling, or 
                importing into the United States of the biological 
                product that is the subject of the subsection (k) 
                application,
        not later than 30 days after such issuance or licensing, the 
        reference product sponsor shall provide to the subsection (k) 
        applicant a supplement to the list provided by the reference 
        product sponsor under paragraph (3)(A) that includes such 
        patent, not later than 30 days after such supplement is 
        provided, the subsection (k) applicant shall provide a 
        statement to the reference product sponsor in accordance with 
        paragraph (3)(B), and such patent shall be subject to paragraph 
        (8).
            ``(8) Notice of commercial marketing and preliminary 
        injunction.--
                    ``(A) Notice of commercial marketing.--The 
                subsection (k) applicant shall provide notice to the 
                reference product sponsor not later than 180 days 
                before the date of the first commercial marketing of 
                the biological product licensed under subsection (k).
                    ``(B) Preliminary injunction.--After receiving the 
                notice under subparagraph (A) and before such date of 
                the first commercial marketing of such biological 
                product, the reference product sponsor may seek a 
                preliminary injunction prohibiting the subsection (k) 
                applicant from engaging in the commercial manufacture 
                or sale of such biological product until the court 
                decides the issue of patent validity, enforcement, and 
                infringement with respect to any patent that is--
                            ``(i) included in the list provided by the 
                        reference product sponsor under paragraph 
                        (3)(A) or in the list provided by the 
                        subsection (k) applicant under paragraph 
                        (3)(B); and
                            ``(ii) not included, as applicable, on--
                                    ``(I) the list of patents described 
                                in paragraph (4); or
                                    ``(II) the lists of patents 
                                described in paragraph (5)(B).
                    ``(C) Reasonable cooperation.--If the reference 
                product sponsor has sought a preliminary injunction 
                under subparagraph (B), the reference product sponsor 
                and the subsection (k) applicant shall reasonably 
                cooperate to expedite such further discovery as is 
                needed in connection with the preliminary injunction 
                motion.
            ``(9) Limitation on declaratory judgment action.--
                    ``(A) Subsection (k) application provided.--If a 
                subsection (k) applicant provides the application and 
                information required under paragraph (2)(A), neither 
                the reference product sponsor nor the subsection (k) 
                applicant may, prior to the date notice is received 
                under paragraph (8)(A), bring any action under section 
                2201 of title 28, United States Code, for a declaration 
                of infringement, validity, or enforceability of any 
                patent that is described in clauses (i) and (ii) of 
                paragraph (8)(B).
                    ``(B) Subsequent failure to act by subsection (k) 
                applicant.--If a subsection (k) applicant fails to 
                complete an action required of the subsection (k) 
                applicant under paragraph (3)(B)(ii), paragraph (5), 
                paragraph (6)(C)(i), paragraph (7), or paragraph 
                (8)(A), the reference product sponsor, but not the 
                subsection (k) applicant, may bring an action under 
                section 2201 of title 28, United States Code, for a 
                declaration of infringement, validity, or 
                enforceability of any patent included in the list 
                described in paragraph (3)(A), including as provided 
                under paragraph (7).
                    ``(C) Subsection (k) application not provided.--If 
                a subsection (k) applicant fails to provide the 
                application and information required under paragraph 
                (2)(A), the reference product sponsor, but not the 
                subsection (k) applicant, may bring an action under 
                section 2201 of title 28, United States Code, for a 
                declaration of infringement, validity, or 
                enforceability of any patent that claims the biological 
                product or a use of the biological product.''.
    (b) Definitions.--Section 351(i) of the Public Health Service Act 
(42 U.S.C. 262(i)) is amended--
            (1) by striking ``In this section, the term `biological 
        product' means'' and inserting the following: ``In this 
        section:
            ``(1) The term `biological product' means'';
            (2) in paragraph (1), as so designated, by inserting 
        ``protein (except any chemically synthesized polypeptide),'' 
        after ``allergenic product,''; and
            (3) by adding at the end the following:
            ``(2) The term `biosimilar' or `biosimilarity', in 
        reference to a biological product that is the subject of an 
        application under subsection (k), means--
                    ``(A) that the biological product is highly similar 
                to the reference product notwithstanding minor 
                differences in clinically inactive components; and
                    ``(B) there are no clinically meaningful 
                differences between the biological product and the 
                reference product in terms of the safety, purity, and 
                potency of the product.
            ``(3) The term `interchangeable' or `interchangeability', 
        in reference to a biological product that is shown to meet the 
        standards described in subsection (k)(4), means that the 
        biological product may be substituted for the reference product 
        without the intervention of the health care provider who 
        prescribed the reference product.
            ``(4) The term `reference product' means the single 
        biological product licensed under subsection (a) against which 
        a biological product is evaluated in an application submitted 
        under subsection (k).''.
    (c) Conforming Amendments Relating to Patents.--
            (1) Patents.--Section 271(e) of title 35, United States 
        Code, is amended--
                    (A) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``or'' 
                        at the end;
                            (ii) in subparagraph (B), by adding ``or'' 
                        at the end; and
                            (iii) by inserting after subparagraph (B) 
                        the following:
            ``(C)(i) with respect to a patent that is identified in the 
        list of patents described in section 351(l)(3) of the Public 
        Health Service Act (including as provided under section 
        351(l)(7) of such Act), an application seeking approval of a 
        biological product, or
            ``(ii) if the applicant for the application fails to 
        provide the application and information required under section 
        351(l)(2)(A) of such Act, an application seeking approval of a 
        biological product for a patent that could be identified 
        pursuant to section 351(l)(3)(A)(i) of such Act,''; and
                            (iv) in the matter following subparagraph 
                        (C) (as added by clause (iii)), by striking 
                        ``or veterinary biological product'' and 
                        inserting ``, veterinary biological product, or 
                        biological product'';
                    (B) in paragraph (4)--
                            (i) in subparagraph (B), by--
                                    (I) striking ``or veterinary 
                                biological product'' and inserting ``, 
                                veterinary biological product, or 
                                biological product''; and
                                    (II) striking ``and'' at the end;
                            (ii) in subparagraph (C), by--
                                    (I) striking ``or veterinary 
                                biological product'' and inserting ``, 
                                veterinary biological product, or 
                                biological product''; and
                                    (II) striking the period and 
                                inserting ``, and'';
                            (iii) by inserting after subparagraph (C) 
                        the following:
            ``(D) the court shall order a permanent injunction 
        prohibiting any infringement of the patent by the biological 
        product involved in the infringement until a date which is not 
        earlier than the date of the expiration of the patent that has 
        been infringed under paragraph (2)(C), provided the patent is 
        the subject of a final court decision, as defined in section 
        351(k)(6) of the Public Health Service Act, in an action for 
        infringement of the patent under section 351(l)(6) of such Act, 
        and the biological product has not yet been approved because of 
        section 351(k)(7) of such Act.''; and
                            (iv) in the matter following subparagraph 
                        (D) (as added by clause (iii)), by striking 
                        ``and (C)'' and inserting ``(C), and (D)''; and
                    (C) by adding at the end the following:
    ``(6)(A) Subparagraph (B) applies, in lieu of paragraph (4), in the 
case of a patent--
            ``(i) that is identified, as applicable, in the list of 
        patents described in section 351(l)(4) of the Public Health 
        Service Act or the lists of patents described in section 
        351(l)(5)(B) of such Act with respect to a biological product; 
        and
            ``(ii) for which an action for infringement of the patent 
        with respect to the biological product--
                    ``(I) was brought after the expiration of the 30-
                day period described in subparagraph (A) or (B), as 
                applicable, of section 351(l)(6) of such Act; or
                    ``(II) was brought before the expiration of the 30-
                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 making, using, offering to sell, 
selling, or importation into the United States of the biological 
product that is the subject of the action infringed the patent, shall 
be a reasonable royalty.
    ``(C) The owner of a patent that should have been included in the 
list described in section 351(l)(3)(A) of the Public Health Service 
Act, including as provided under section 351(l)(7) of such Act for a 
biological product, but was not timely included in such list, may not 
bring an action under this section for infringement of the patent with 
respect to the biological product.''.
            (2) Conforming amendment under 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''.
    (d) Conforming Amendments Under the Federal Food, Drug, and 
Cosmetic Act.--
            (1) Content and review of applications.--Section 
        505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(b)(5)(B)) is amended by inserting before the period 
        at the end of the first sentence the following: ``or, with 
        respect to an applicant for approval of a biological product 
        under section 351(k) of the Public Health Service Act, any 
        necessary clinical study or studies''.
            (2) New active ingredient.--Section 505B of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended by 
        adding at the end the following:
    ``(i) New Active Ingredient.--
            ``(1) Non-interchangeable biosimilar biological product.--A 
        biological product that is biosimilar to a reference product 
        under section 351 of the Public Health Service Act, and that 
        the Secretary has not determined to meet the standards 
        described in subsection (k)(4) of such section for 
        interchangeability with the reference product, shall be 
        considered to have a new active ingredient under this section.
            ``(2) Interchangeable biosimilar biological product.--A 
        biological product that is interchangeable with a reference 
        product under section 351 of the Public Health Service Act 
        shall not be considered to have a new active ingredient under 
        this section.''.
    (e) Products Previously Approved Under Section 505.--
            (1) Requirement to follow section 351.--Except as provided 
        in paragraph (2), an application for a biological product shall 
        be submitted under section 351 of the Public Health Service Act 
        (42 U.S.C. 262) (as amended by this Act).
            (2) Exception.--An application for a biological product may 
        be submitted under section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) if--
                    (A) such biological product is in a product class 
                for which a biological product in such product class is 
                the subject of an application approved under such 
                section 505 not later than the date of enactment of 
                this Act; and
                    (B) such application--
                            (i) has been submitted to the Secretary of 
                        Health and Human Services (referred to in this 
                        Act as the ``Secretary'') before the date of 
                        enactment of this Act; or
                            (ii) is submitted to the Secretary not 
                        later than the date that is 10 years after the 
                        date of enactment of this Act.
            (3) Limitation.--Notwithstanding paragraph (2), an 
        application for a biological product may not be submitted under 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) if there is another biological product approved 
        under subsection (a) of section 351 of the Public Health 
        Service Act that could be a reference product with respect to 
        such application (within the meaning of such section 351) if 
        such application were submitted under subsection (k) of such 
        section 351.
            (4) Deemed approved under section 351.--An approved 
        application for a biological product under section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) shall be 
        deemed to be a license for the biological product under such 
        section 351 on the date that is 10 years after the date of 
        enactment of this Act.
            (5) Definitions.--For purposes of this subsection, the term 
        ``biological product'' has the meaning given such term under 
        section 351 of the Public Health Service Act (42 U.S.C. 262) 
        (as amended by this Act).
    (f) Follow-on Biologics User Fees.--
            (1) Development of user fees for biosimilar biological 
        products.--
                    (A) In general.--Beginning not later than October 
                1, 2010, the Secretary shall develop recommendations to 
                present to Congress with respect to the goals, and 
                plans for meeting the goals, for the process for the 
                review of biosimilar biological product applications 
                submitted under section 351(k) of the Public Health 
                Service Act (as added by this Act) for the first 5 
                fiscal years after fiscal year 2012. In developing such 
                recommendations, the Secretary shall consult with--
                            (i) the Committee on Health, Education, 
                        Labor, and Pensions of the Senate;
                            (ii) the Committee on Energy and Commerce 
                        of the House of Representatives;
                            (iii) scientific and academic experts;
                            (iv) health care professionals;
                            (v) representatives of patient and consumer 
                        advocacy groups; and
                            (vi) the regulated industry.
                    (B) Public review of recommendations.--After 
                negotiations with the regulated industry, the Secretary 
                shall--
                            (i) present the recommendations developed 
                        under subparagraph (A) to the Congressional 
                        committees specified in such subparagraph;
                            (ii) publish such recommendations in the 
                        Federal Register;
                            (iii) provide for a period of 30 days for 
                        the public to provide written comments on such 
                        recommendations;
                            (iv) hold a meeting at which the public may 
                        present its views on such recommendations; and
                            (v) after consideration of such public 
                        views and comments, revise such recommendations 
                        as necessary.
                    (C) Transmittal of recommendations.--Not later than 
                January 15, 2012, the Secretary shall transmit to 
                Congress the revised recommendations under subparagraph 
                (B), a summary of the views and comments received under 
                such subparagraph, and any changes made to the 
                recommendations in response to such views and comments.
            (2) Establishment of user fee program.--It is the sense of 
        the Senate that, based on the recommendations transmitted to 
        Congress by the Secretary pursuant to paragraph (1)(C), 
        Congress should authorize a program, effective on October 1, 
        2012, for the collection of user fees relating to the 
        submission of biosimilar biological product applications under 
        section 351(k) of the Public Health Service Act (as added by 
        this Act).
            (3) Transitional provisions for user fees for biosimilar 
        biological products.--
                    (A) Application of the prescription drug user fee 
                provisions.--Section 735(1)(C) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 379g(1)(C)) is 
                amended by striking ``section 351'' and inserting 
                ``subsection (a) or (k) of section 351''.
                    (B) Evaluation of costs of reviewing biosimilar 
                biological product applications.--During the period 
                beginning on the date of enactment of this Act and 
                ending on October 1, 2010, the Secretary shall collect 
                and evaluate data regarding the costs of reviewing 
                applications for biological products submitted under 
                section 351(k) of the Public Health Service Act (as 
                added by this Act) during such period.
                    (C) Audit.--
                            (i) In general.--On the date that is 2 
                        years after first receiving a user fee 
                        applicable to an application for a biological 
                        product under section 351(k) of the Public 
                        Health Service Act (as added by this Act), and 
                        on a biennial basis thereafter until October 1, 
                        2013, the Secretary shall perform an audit of 
                        the costs of reviewing such applications under 
                        such section 351(k). Such an audit shall 
                        compare--
                                    (I) the costs of reviewing such 
                                applications under such section 351(k) 
                                to the amount of the user fee 
                                applicable to such applications; and
                                    (II)(aa) such ratio determined 
                                under subclause (I); to
                                    (bb) the ratio of the costs of 
                                reviewing applications for biological 
                                products under section 351(a) of such 
                                Act (as amended by this Act) to the 
                                amount of the user fee applicable to 
                                such applications under such section 
                                351(a).
                            (ii) Alteration of user fee.--If the audit 
                        performed under clause (i) indicates that the 
                        ratios compared under subclause (II) of such 
                        clause differ by more than 5 percent, then the 
                        Secretary shall alter the user fee applicable 
                        to applications submitted under such section 
                        351(k) to more appropriately account for the 
                        costs of reviewing such applications.
                            (iii) Accounting standards.--The Secretary 
                        shall perform an audit under clause (i) in 
                        conformance with the accounting principles, 
                        standards, and requirements prescribed by the 
                        Comptroller General of the United States under 
                        section 3511 of title 31, United State Code, to 
                        ensure the validity of any potential 
                        variability.
            (4) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection such sums as 
        may be necessary for each of fiscal years 2008 through 2012.
    (g) Allocation of Savings; Special Reserve Fund.--
            (1) Determination of savings.--The Secretary of the 
        Treasury, in consultation with the Secretary, shall for each 
        fiscal year determine the amount of the savings to the Federal 
        Government as a result of the enactment of this Act and shall 
        transfer such amount to the Fund established under paragraph 
        (2) pursuant to a relevant appropriations Act.
            (2) Special reserve fund.--
                    (A) In general.--There is established in the 
                Treasury of the United States a fund to be designated 
                as the ``Biological Product Savings Fund'' to be made 
                available to the Secretary without fiscal year 
                limitation.
                    (B) Use of fund.--The amounts made available to the 
                Secretary through the Fund under subparagraph (A) shall 
                be expended on activities authorized under the Public 
                Health Service Act.
            (3) Authorization of appropriations.--There is authorized 
        to be appropriated for each fiscal year to the Fund established 
        under paragraph (2), the amount of the savings determined for 
        such fiscal year under paragraph (1).
    (h) Government Accountability Office Study.--
            (1) In general.--Not later than 3 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall study and report to Congress regarding--
                    (A) the extent to which pediatric studies of 
                biological products are being required under the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
                seq.); and
                    (B) any pediatric needs not being met under 
                existing authority.
            (2) Content of study.--The study under paragraph (1) shall 
        review and assess--
                    (A) the extent to which pediatric studies of 
                biological products are required under subsections (a) 
                and (b) of section 505B of the Federal Food, Drug and 
                Cosmetic Act (21 U.S.C. 355c);
                    (B) the extent to which pediatric studies of 
                biological products are required as part of risk 
                evaluation and mitigation strategies under such Act;
                    (C) the number, importance, and prioritization of 
                any biological products that are not being tested for 
                pediatric use; and
                    (D) recommendations for ensuring pediatric testing 
                of products identified in subparagraph (C), including 
                the consideration of any incentives, such as those 
                provided under the Best Pharmaceuticals for Children 
                Act.
    (i) Orphan Products.--If a reference product, as defined in section 
351 of the Public Health Service Act (42 U.S.C. 262) (as amended by 
this Act) has been designated under section 526 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bb) for a rare disease or 
condition, a biological product seeking approval for such disease or 
condition under subsection (k) of such section 351 as biosimilar to, or 
interchangeable with, such reference product may be licensed by the 
Secretary only after the expiration for such reference product of the 
later of--
            (1) the 7-year period described in section 527(a) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)); and
            (2) the 12-year period described in subsection (k)(7) of 
        such section 351.
                                                      Calendar No. 1127

110th CONGRESS

  2d Session

                                S. 1695

_______________________________________________________________________

                                 A BILL

 To amend the Public Health Service Act to establish a pathway for the 
 licensure of biosimilar biological products, to promote innovation in 
               the life sciences, and for other purposes.

_______________________________________________________________________

                           November 19, 2008

                       Reported with an amendment
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