II 

110TH CONGRESS 

1ST 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, and Mr. ENZI) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, 

to promote innovation in the life sciences, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Biologics Price Com5 petition and Innovation Act of 2007’’. 

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1 SEC. 2. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL 

2 PRODUCTS. 

3 (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO4 SIMILAR OR INTERCHANGEABLE.—Section 351 of the 

5 Public Health Service Act (42 U.S.C. 262) is amended— 

6 (1) in subsection (a)(1)(A), by inserting ‘‘under 

7 this subsection or subsection (k)’’ after ‘‘biologics li8 cense’’; and 

9 (2) by adding at the end the following: 

10 ‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO11 SIMILAR OR INTERCHANGEABLE.— 

12 ‘‘(1) IN GENERAL.—Any person may submit an 

13 application for licensure of a biological product 

14 under this subsection. 

15 ‘‘(2) CONTENT.— 

16 ‘‘(A) IN GENERAL.— 

17 ‘‘(i) REQUIRED INFORMATION.—An 

18 application submitted under this subsection 

19 shall include information demonstrating 

20 that— 

21 ‘‘(I) the biological product is bio22 similar to a reference product based 

23 upon data derived from— 

24 ‘‘(aa) analytical studies that 

25 demonstrate that the biological 

26 product is highly similar to the 

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1 reference product notwith2 standing minor differences in 

3 clinically inactive components; 

4 ‘‘(bb) animal studies; and 

5 ‘‘(cc) a clinical study or 

6 studies (including the assessment 

7 of immunogenicity and pharma8 cokinetics or pharmacodynamics) 

9 that are— 

10 ‘‘(AA) sufficient to 

11 demonstrate safety, purity, 

12 and potency in 1 or more 

13 appropriate conditions of use 

14 for which the reference 

15 product is licensed and in16 tended to be used and for 

17 which licensure is sought for 

18 the biological product; and 

19 ‘‘(BB) designed to 

20 avoid needlessly duplicative 

21 or unethical clinical testing; 

22 ‘‘(II) the biological product and 

23 reference product utilize the same 

24 mechanism or mechanisms of action 

25 for the condition or conditions of use 

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1 prescribed, recommended, or sug2 gested in the proposed labeling, but 

3 only to the extent the mechanism or 

4 mechanisms of action are known for 

5 the reference product; 

6 ‘‘(III) the condition or conditions 

7 of use prescribed, recommended, or 

8 suggested in the labeling proposed for 

9 the biological product have been pre10 viously approved for the reference 

11 product; 

12 ‘‘(IV) the route of administra13 tion, the dosage form, and the 

14 strength of the biological product are 

15 the same as those of the reference 

16 product; and 

17 ‘‘(V) the facility in which the bio18 logical product is manufactured, proc19 essed, packed, or held meets stand20 ards designed to assure that the bio21 logical product continues to be safe, 

22 pure, and potent. 

23 ‘‘(ii) DETERMINATION BY SEC24 RETARY.—The Secretary may determine, 

25 in the Secretary’s discretion, that an elemstockstill on PROD1PC66 with BILLS

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1 ment described in clause (i)(I) is unneces2 sary in an application submitted under this 

3 subsection. 

4 ‘‘(iii) ADDITIONAL INFORMATION.— 

5 An application submitted under this sub6 section may include— 

7 ‘‘(I) at the applicant’s option, 

8 publicly-available information regard9 ing the Secretary’s previous deter10 mination that the reference product is 

11 safe, pure, and potent; and 

12 ‘‘(II) any additional information 

13 in support of the application, includ14 ing publicly-available information with 

15 respect to the reference product or an16 other biological product. 

17 ‘‘(B) INTERCHANGEABILITY.—An applica18 tion (or a supplement to an application) sub19 mitted under this subsection may include infor20 mation demonstrating that the biological prod21 uct is interchangeable with the reference prod22 uct. 

23 ‘‘(3) EVALUATION BY SECRETARY.—Upon re24 view of an application (or a supplement to an appli25 cation) submitted under this subsection, the Secmstockstill on PROD1PC66 with BILLS

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1 retary shall license the biological product under this 

2 subsection if the Secretary determines that the infor3 mation submitted in the application (or the supple4 ment) is sufficient to show that the biological prod5 uct— 

6 ‘‘(A) is biosimilar to the reference product; 

7 or 

8 ‘‘(B) is interchangeable with the reference 

9 product. 

10 ‘‘(4) SAFETY STANDARDS FOR DETERMINING

11 INTERCHANGEABILITY.—Upon review of an applica12 tion submitted under this subsection or any supple13 ment to such application, the Secretary shall deter14 mine the biological product to be interchangeable 

15 with the reference product if the Secretary deter16 mines that the information submitted in the applica17 tion (or a supplement to such application) is suffi18 cient to show that— 

19 ‘‘(A) the biological product— 

20 ‘‘(i) is biosimilar to the reference 

21 product; and 

22 ‘‘(ii) can be expected to produce the 

23 same clinical result as the reference prod24 uct in any given patient; and 

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1 ‘‘(B) for a biological product that is ad2 ministered more than once to an individual, the 

3 risk in terms of safety or diminished efficacy of 

4 alternating or switching between use of the bio5 logical product and the reference product is not 

6 greater than the risk of using the reference 

7 product without such alternation or switch. 

8 ‘‘(5) GENERAL RULES.— 

9 ‘‘(A) ONE REFERENCE PRODUCT PER AP10 PLICATION.—A biological product, in an appli11 cation submitted under this subsection, may not 

12 be evaluated against more than 1 reference 

13 product. 

14 ‘‘(B) REVIEW.—An application submitted 

15 under this subsection shall be reviewed by the 

16 division within the Food and Drug Administra17 tion that is responsible for the review and ap18 proval of the application under which the ref19 erence product is licensed. 

20 ‘‘(C) RISK EVALUATION AND MITIGATION

21 STRATEGIES.—The authority of the Secretary 

22 with respect to risk evaluation and mitigation 

23 strategies under the Federal Food, Drug, and 

24 Cosmetic Act shall apply to biological products 

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1 ner as such authority applies to biological prod2 ucts licensed under subsection (a). 

3 ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE4 ABLE BIOLOGICAL PRODUCT.—Upon review of an 

5 application submitted under this subsection relying 

6 on the same reference product for which a prior bio7 logical product has received a determination of inter8 changeability for any condition of use, the Secretary 

9 shall not make a determination under paragraph (4) 

10 that the second or subsequent biological product is 

11 interchangeable for any condition of use until the 

12 earlier of— 

13 ‘‘(A) 1 year after the first commercial 

14 marketing of the first interchangeable bio15 similar biological product to be approved as 

16 interchangeable for that reference product; 

17 ‘‘(B) 18 months after— 

18 ‘‘(i) a final court decision on all pat19 ents in suit in an action instituted under 

20 subsection (l)(6) against the applicant that 

21 submitted the application for the first ap22 proved interchangeable biosimilar biological 

23 product; or 

24 ‘‘(ii) the dismissal with or without 

25 prejudice of an action instituted under submstockstill on PROD1PC66 with BILLS

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1 section (l)(6) against the applicant that 

2 submitted the application for the first ap3 proved interchangeable biosimilar biological 

4 product; or 

5 ‘‘(C)(i) 42 months after approval of the 

6 first interchangeable biosimilar biological prod7 uct if the applicant that submitted such appli8 cation has been sued under subsection (l)(6) 

9 and such litigation is still ongoing within such 

10 36-month period; or 

11 ‘‘(ii) 18 months after approval of the first 

12 interchangeable biosimilar biological product if 

13 the applicant that submitted such application 

14 has not been sued under subsection (l)(6). 

15 For purposes of this paragraph, the term ‘final court 

16 decision’ means a final decision of a court from 

17 which no appeal (other than a petition to the United 

18 States Supreme Court for a writ of certiorari) has 

19 been or can be taken. 

20 ‘‘(7) EXCLUSIVITY FOR REFERENCE PROD21 UCT.— 

22 ‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP23 PLICATION APPROVAL.—Approval of an applica24 tion under this subsection may not be made ef25 fective by the Secretary until the date that is 

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1 12 years after the date on which the reference 

2 product was first licensed under subsection (a). 

3 ‘‘(B) FILING PERIOD.—An application 

4 under this subsection may not be submitted to 

5 the Secretary until the date that is 4 years 

6 after the date on which the reference product 

7 was first licensed under subsection (a). 

8 ‘‘(8) GUIDANCE DOCUMENTS.— 

9 ‘‘(A) IN GENERAL.—The Secretary may, 

10 after opportunity for public comment, issue 

11 guidance in accordance, except as provided in 

12 subparagraph (B)(i), with section 701(h) of the 

13 Federal Food, Drug, and Cosmetic Act with re14 spect to the process for the submission of appli15 cations for, and licensure of, a biological prod16 uct under this subsection. Any such guidance 

17 may be general or specific. 

18 ‘‘(B) PUBLIC COMMENT.— 

19 ‘‘(i) IN GENERAL.—The Secretary 

20 shall provide the public an opportunity to 

21 comment on any proposed guidance issued 

22 under subparagraph (A) before issuing 

23 final guidance. 

24 ‘‘(ii) INPUT REGARDING MOST VALU25 ABLE GUIDANCE.—The Secretary shall esmstockstill on PROD1PC66 with BILLS

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1 tablish a process through which the public 

2 may provide the Secretary with input re3 garding priorities for issuing guidance. 

4 ‘‘(C) NO REQUIREMENT FOR APPLICATION

5 CONSIDERATION.—The issuance (or non6 issuance) of guidance under subparagraph (A) 

7 shall not preclude the review of, or action on, 

8 an application submitted under this subsection. 

9 ‘‘(D) REQUIREMENT FOR PRODUCT CLASS10 SPECIFIC GUIDANCE.—If the Secretary issues 

11 product class-specific guidance under subpara12 graph (A), such guidance shall include a de13 scription of— 

14 ‘‘(i) the criteria that the Secretary will 

15 use to determine whether a biological prod16 uct is highly similar to a reference product 

17 in such product class; and 

18 ‘‘(ii) the criteria, if available, that the 

19 Secretary will use to determine whether a 

20 biological product meets the standards de21 scribed in paragraph (4). 

22 ‘‘(E) CERTAIN PRODUCT CLASSES.— 

23 ‘‘(i) GUIDANCE.—The Secretary may 

24 indicate in a guidance document that the 

25 science and experience, as of the date of 

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1 such guidance, with respect to a product or 

2 product class (not including any recom3 binant protein) does not allow approval of 

4 an application for a license as provided 

5 under this subsection for such product or 

6 product class. 

7 ‘‘(ii) MODIFICATION OR REVERSAL.— 

8 The Secretary may issue a subsequent 

9 guidance document under subparagraph 

10 (A) to modify or reverse a guidance docu11 ment under clause (i). 

12 ‘‘(iii) NO EFFECT ON ABILITY TO

13 DENY LICENSE.—Clause (i) shall not be 

14 construed to require the Secretary to ap15 prove a product with respect to which the 

16 Secretary has not indicated in a guidance 

17 document that the science and experience, 

18 as described in clause (i), does not allow 

19 approval of such an application. 

20 ‘‘(l) PATENTS.— 

21 ‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION

22 (k) APPLICATION.— 

23 ‘‘(A) APPLICATION OF PARAGRAPH.—Un24 less otherwise agreed to by a person that sub25 mits an application under subsection (k) (remstockstill on PROD1PC66 with BILLS

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1 ferred to in this subsection as the ‘subsection 

2 (k) applicant’) and the sponsor of the applica3 tion for the reference product (referred to in 

4 this paragraph as the ‘reference product spon5 sor’), the provisions of this paragraph shall 

6 apply to the exchange of information described 

7 in this subsection. 

8 ‘‘(B) IN GENERAL.— 

9 ‘‘(i) PROVISION OF CONFIDENTIAL IN10 FORMATION.—When a subsection (k) ap11 plicant submits an application under sub12 section (k), such applicant shall provide to 

13 the persons described in clause (ii), subject 

14 to the terms of this paragraph, confidential 

15 access to the information required to be 

16 produced pursuant to paragraph (2) and 

17 any other information that the subsection 

18 (k) applicant determines, in its sole discre19 tion, to be appropriate (referred to in this 

20 subsection as the ‘confidential informa21 tion’). 

22 ‘‘(ii) RECIPIENTS OF INFORMATION.— 

23 The persons described in this clause are 

24 the following: 

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1 ‘‘(I) OUTSIDE COUNSEL.—One or 

2 more attorneys designated by the ref3 erence product sponsor who are em4 ployees of an entity other than the 

5 reference product sponsor (referred to 

6 in this paragraph as the ‘outside 

7 counsel’), provided that such attor8 neys do not engage, formally or infor9 mally, in patent prosecution relevant 

10 or related to the reference product. 

11 ‘‘(II) IN-HOUSE COUNSEL.—One 

12 attorney that represents the reference 

13 product sponsor who is an employee 

14 of the reference product sponsor, pro15 vided that such attorney does not en16 gage, formally or informally, in patent 

17 prosecution relevant or related to the 

18 reference product. 

19 ‘‘(C) LIMITATION ON DISCLOSURE.—No 

20 person that receives confidential information 

21 pursuant to subparagraph (B) shall disclose 

22 any confidential information to any other per23 son or entity, including the reference product 

24 sponsor employees, outside scientific consult25 ants, or other outside counsel retained by the 

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1 reference product sponsor, without the prior 

2 written consent of the subsection (k) applicant, 

3 which shall not be unreasonably withheld. 

4 ‘‘(D) USE OF CONFIDENTIAL INFORMA5 TION.—Confidential information shall be used 

6 for the sole and exclusive purpose of deter7 mining, with respect to each patent assigned to 

8 or exclusively licensed by the reference product 

9 sponsor, whether a claim of patent infringement 

10 could reasonably be asserted if the subsection 

11 (k) applicant engaged in the manufacture, use, 

12 offering for sale, sale, or importation into the 

13 United States of the biological product that is 

14 the subject of the application under subsection 

15 (k). 

16 ‘‘(E) OWNERSHIP OF CONFIDENTIAL IN17 FORMATION.—The confidential information dis18 closed under this paragraph is, and shall re19 main, the property of the subsection (k) appli20 cant. By providing the confidential information 

21 pursuant to this paragraph, the subsection (k) 

22 applicant does not provide the reference product 

23 sponsor or the outside counsel any interest in or 

24 license to use the confidential information, for 

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1 purposes other than those specified in subpara2 graph (D). 

3 ‘‘(F) EFFECT OF INFRINGEMENT AC4 TION.—In the event that the reference product 

5 sponsor files a patent infringement suit, the use 

6 of confidential information shall continue to be 

7 governed by the terms of this paragraph until 

8 such time as a court enters a protective order 

9 regarding the information. Upon entry of such 

10 order, the subsection (k) applicant may redesig11 nate confidential information in accordance 

12 with the terms of that order. No confidential in13 formation shall be included in any publicly14 available complaint or other pleading. In the 

15 event that the reference product sponsor does 

16 not file an infringement action by the date spec17 ified in paragraph (6), the reference product 

18 sponsor shall return or destroy all confidential 

19 information received under this paragraph, pro20 vided that if the reference product sponsor opts 

21 to destroy such information, it will confirm de22 struction in writing to the subsection (k) appli23 cant. 

24 ‘‘(G) RULE OF CONSTRUCTION.—Nothing 

25 in this paragraph shall be construed— 

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1 ‘‘(i) as an admission by the subsection 

2 (k) applicant regarding the validity, en3 forceability, or infringement of any patent; 

4 or 

5 ‘‘(ii) an agreement or admission by 

6 the subsection (k) applicant with respect to 

7 the competency, relevance, or materiality 

8 of any confidential information. 

9 ‘‘(H) EFFECT OF VIOLATION.—The disclo10 sure of any confidential information in violation 

11 of this paragraph shall be deemed to cause the 

12 subsection (k) applicant to suffer irreparable 

13 harm for which there is no adequate legal rem14 edy and the court shall consider immediate in15 junctive relief to be an appropriate and nec16 essary remedy for any violation or threatened 

17 violation of this paragraph. 

18 ‘‘(2) SUBSECTION (k) APPLICATION INFORMA19 TION.—Not later than 20 days after the Secretary 

20 notifies the subsection (k) applicant that the applica21 tion has been accepted for review, the subsection (k) 

22 applicant— 

23 ‘‘(A) shall provide to the reference product 

24 sponsor a copy of the application submitted to 

25 the Secretary under subsection (k), and such 

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1 other information that describes the process or 

2 processes used to manufacture the biological 

3 product that is the subject of such application; 

4 and 

5 ‘‘(B) may provide to the reference product 

6 sponsor additional information requested by or 

7 on behalf of the reference product sponsor. 

8 ‘‘(3) LIST AND DESCRIPTION OF PATENTS.— 

9 ‘‘(A) LIST BY REFERENCE PRODUCT SPON10 SOR.—Not later than 60 days after the receipt 

11 of the application and information under para12 graph (2), the reference product sponsor shall 

13 provide to the subsection (k) applicant— 

14 ‘‘(i) a list of patents for which the ref15 erence product sponsor believes a claim of 

16 patent infringement could reasonably be 

17 asserted by the reference product sponsor 

18 if a person not licensed by the reference 

19 product sponsor engaged in the making, 

20 using, offering to sell, selling, or importing 

21 into the United States of the biological 

22 product that is the subject of the sub23 section (k) application; and 

24 ‘‘(ii) an identification of the patents 

25 on such list that the reference product 

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1 sponsor would be prepared to license to the 

2 subsection (k) applicant. 

3 ‘‘(B) LIST AND DESCRIPTION BY SUB4 SECTION (k) APPLICANT.—Not later than 60 

5 days after receipt of the list under subpara6 graph (A), the subsection (k) applicant— 

7 ‘‘(i) may provide to the reference 

8 product sponsor a list of patents to which 

9 the subsection (k) applicant believes a 

10 claim of patent infringement could reason11 ably be asserted by the reference product 

12 sponsor if a person not licensed by the ref13 erence product sponsor engaged in the 

14 making, using, offering to sell, selling, or 

15 importing into the United States of the bi16 ological product that is the subject of the 

17 subsection (k) application; 

18 ‘‘(ii) shall provide to the reference 

19 product sponsor, with respect to each pat20 ent listed by the reference product sponsor 

21 under subparagraph (A) or listed by the 

22 subsection (k) applicant under clause (i)— 

23 ‘‘(I) a detailed statement that de24 scribes, on a claim by claim basis, the 

25 factual and legal basis of the opinion 

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1 of the subsection (k) applicant that 

2 such patent is invalid, unenforceable, 

3 or will not be infringed by the com4 mercial marketing of the biological 

5 product that is the subject of the sub6 section (k) application; or 

7 ‘‘(II) a statement that the sub8 section (k) applicant does not intend 

9 to begin commercial marketing of the 

10 biological product before the date that 

11 such patent expires; and 

12 ‘‘(iii) shall provide to the reference 

13 product sponsor a response regarding each 

14 patent identified by the reference product 

15 sponsor under subparagraph (A)(ii). 

16 ‘‘(C) DESCRIPTION BY REFERENCE PROD17 UCT SPONSOR.—Not later than 60 days after 

18 receipt of the list and statement under subpara19 graph (B), the reference product sponsor shall 

20 provide to the subsection (k) applicant a de21 tailed statement that describes, with respect to 

22 each patent described in subparagraph 

23 (B)(ii)(I), on a claim by claim basis, the factual 

24 and legal basis of the opinion of the reference 

25 product sponsor that such patent will be inmstockstill on PROD1PC66 with BILLS

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1 fringed by the commercial marketing of the bio2 logical product that is the subject of the sub3 section (k) application and a response to the 

4 statement concerning validity and enforceability 

5 provided under subparagraph (B)(ii)(I). 

6 ‘‘(4) PATENT RESOLUTION NEGOTIATIONS.— 

7 ‘‘(A) IN GENERAL.—After receipt by the 

8 subsection (k) applicant of the statement under 

9 paragraph (3)(C), the reference product spon10 sor and the subsection (k) applicant shall en11 gage in good faith negotiations to agree on 

12 which, if any, patents listed under paragraph 

13 (3) by the subsection (k) applicant or the ref14 erence product sponsor shall be the subject of 

15 an action for patent infringement under para16 graph (6). 

17 ‘‘(B) FAILURE TO REACH AGREEMENT.— 

18 If, within 15 days of beginning negotiations 

19 under subparagraph (A), the subsection (k) ap20 plicant and the reference product sponsor fail to 

21 agree on a final and complete list of which, if 

22 any, patents listed under paragraph (3) by the 

23 subsection (k) applicant or the reference prod24 uct sponsor shall be the subject of an action for 

25 patent infringement under paragraph (6), the 

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1 provisions of paragraph (5) shall apply to the 

2 parties. 

3 ‘‘(5) PATENT RESOLUTION IF NO AGREE4 MENT.— 

5 ‘‘(A) NUMBER OF PATENTS.—The sub6 section (k) applicant shall notify the reference 

7 product sponsor of the number of patents that 

8 such applicant will provide to the reference 

9 product sponsor under subparagraph (B)(i)(I). 

10 ‘‘(B) EXCHANGE OF PATENT LISTS.— 

11 ‘‘(i) IN GENERAL.—On a date agreed 

12 to by the subsection (k) applicant and the 

13 reference product sponsor, but in no case 

14 later than 5 days after the subsection (k) 

15 application notifies the reference product 

16 sponsor under subparagraph (A), the sub17 section (k) applicant and the reference 

18 product sponsor shall simultaneously ex19 change— 

20 ‘‘(I) the list of patents that the 

21 subsection (k) applicant believes 

22 should be the subject of an action for 

23 patent infringement under paragraph 

24 (6); and 

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1 ‘‘(II) the list of patents, in ac2 cordance with clause (ii), that the ref3 erence product sponsor believes should 

4 be the subject of an action for patent 

5 infringement under paragraph (6). 

6 ‘‘(ii) NUMBER OF PATENTS LISTED BY

7 REFERENCE PRODUCT SPONSOR.— 

8 ‘‘(I) IN GENERAL.—Subject to 

9 subclause (II), the number of patents 

10 listed by the reference product spon11 sor under clause (i)(II) may not ex12 ceed the number of patents listed by 

13 the subsection (k) applicant under 

14 clause (i)(I). 

15 ‘‘(II) EXCEPTION.—If a sub16 section (k) applicant does not list any 

17 patent under clause (i)(I), the ref18 erence product sponsor may list 1 pat19 ent under clause (i)(II). 

20 ‘‘(6) IMMEDIATE PATENT INFRINGEMENT AC21 TION.— 

22 ‘‘(A) ACTION IF AGREEMENT ON PATENT

23 LIST.—If the subsection (k) applicant and the 

24 reference product sponsor agree on patents as 

25 described in paragraph (4), not later than 30 

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1 days after such agreement, the reference prod2 uct sponsor shall bring an action for patent in3 fringement with respect to each such patent. 

4 ‘‘(B) ACTION IF NO AGREEMENT ON PAT5 ENT LIST.—If the provisions of paragraph (5) 

6 apply to the parties as described in paragraph 

7 (4)(B), not later than 30 days after the ex8 change of lists under paragraph (5)(B), the ref9 erence product sponsor shall bring an action for 

10 patent infringement with respect to each patent 

11 that is included on such lists. 

12 ‘‘(C) NOTIFICATION AND PUBLICATION OF

13 COMPLAINT.— 

14 ‘‘(i) NOTIFICATION TO SECRETARY.— 

15 Not later than 30 days after a complaint 

16 is served to a subsection (k) applicant in 

17 an action for patent infringement described 

18 under this paragraph, the subsection (k) 

19 applicant shall provide the Secretary with 

20 notice and a copy of such complaint. 

21 ‘‘(ii) PUBLICATION BY SECRETARY.— 

22 The Secretary shall publish in the Federal 

23 Register notice of a complaint received 

24 under clause (i). 

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1 ‘‘(7) NEWLY ISSUED OR LICENSED PATENTS.— 

2 In the case of a patent that— 

3 ‘‘(A) is issued to, or exclusively licensed by, 

4 the reference product sponsor after the date 

5 that the reference product sponsor provided the 

6 list to the subsection (k) applicant under para7 graph (3)(A); and 

8 ‘‘(B) the reference product sponsor reason9 ably believes that, due to the issuance of such 

10 patent, a claim of patent infringement could 

11 reasonably be asserted by the reference product 

12 sponsor if a person not licensed by the ref13 erence product sponsor engaged in the making, 

14 using, offering to sell, selling, or importing into 

15 the United States of the biological product that 

16 is the subject of the subsection (k) application, 

17 not later than 30 days after such issuance or licens18 ing, the reference product sponsor shall provide to 

19 the subsection (k) applicant a supplement to the list 

20 provided by the reference product sponsor under 

21 paragraph (3)(A) that includes such patent, not 

22 later than 30 days after such supplement is pro23 vided, the subsection (k) applicant shall provide a 

24 statement to the reference product sponsor in acmstockstill on PROD1PC66 with BILLS

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1 cordance with paragraph (3)(B), and such patent 

2 shall be subject to paragraph (8). 

3 ‘‘(8) NOTICE OF COMMERCIAL MARKETING AND

4 PRELIMINARY INJUNCTION.— 

5 ‘‘(A) NOTICE OF COMMERCIAL MAR6 KETING.—The subsection (k) applicant shall 

7 provide notice to the reference product sponsor 

8 not later than 180 days before the date of the 

9 first commercial marketing of the biological 

10 product licensed under subsection (k). 

11 ‘‘(B) PRELIMINARY INJUNCTION.—After 

12 receiving the notice under subparagraph (A) 

13 and before such date of the first commercial 

14 marketing of such biological product, the ref15 erence product sponsor may seek a preliminary 

16 injunction prohibiting the subsection (k) appli17 cant from engaging in the commercial manufac18 ture or sale of such biological product until the 

19 court decides the issue of patent validity, en20 forcement, and infringement with respect to any 

21 patent that is— 

22 ‘‘(i) included in the list provided by 

23 the reference product sponsor under para24 graph (3)(A) or in the list provided by the 

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1 subsection (k) applicant under paragraph 

2 (3)(B); and 

3 ‘‘(ii) not included, as applicable, on— 

4 ‘‘(I) the list of patents described 

5 in paragraph (4); or 

6 ‘‘(II) the lists of patents de7 scribed in paragraph (5)(B). 

8 ‘‘(C) REASONABLE COOPERATION.—If the 

9 reference product sponsor has sought a prelimi10 nary injunction under subparagraph (B), the 

11 reference product sponsor and the subsection 

12 (k) applicant shall reasonably cooperate to ex13 pedite such further discovery as is needed in 

14 connection with the preliminary injunction mo15 tion. 

16 ‘‘(9) LIMITATION ON DECLARATORY JUDGMENT

17 ACTION.— 

18 ‘‘(A) SUBSECTION (k) APPLICATION PRO19 VIDED.—If a subsection (k) applicant provides 

20 the application and information required under 

21 paragraph (2)(A), neither the reference product 

22 sponsor nor the subsection (k) applicant may, 

23 prior to the date notice is received under para24 graph (8)(A), bring any action under section 

25 2201 of title 28, United States Code, for a decmstockstill on PROD1PC66 with BILLS

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1 laration of infringement, validity, or enforce2 ability of any patent that is described in clauses 

3 (i) and (ii) of paragraph (8)(B). 

4 ‘‘(B) SUBSEQUENT FAILURE TO ACT BY

5 SUBSECTION (k) APPLICANT.—If a subsection 

6 (k) applicant fails to complete an action re7 quired of the subsection (k) applicant under 

8 paragraph (3)(B)(ii), paragraph (5), paragraph 

9 (6)(C)(i), paragraph (7), or paragraph (8)(A), 

10 the reference product sponsor, but not the sub11 section (k) applicant, may bring an action 

12 under section 2201 of title 28, United States 

13 Code, for a declaration of infringement, validity, 

14 or enforceability of any patent included in the 

15 list described in paragraph (3)(A), including as 

16 provided under paragraph (7). 

17 ‘‘(C) SUBSECTION (k) APPLICATION NOT

18 PROVIDED.—If a subsection (k) applicant fails 

19 to provide the application and information re20 quired under paragraph (2)(A), the reference 

21 product sponsor, but not the subsection (k) ap22 plicant, may bring an action under section 2201 

23 of title 28, United States Code, for a declara24 tion of infringement, validity, or enforceability 

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1 of any patent that claims the biological product 

2 or a use of the biological product.’’. 

3 (b) DEFINITIONS.—Section 351(i) of the Public 

4 Health Service Act (42 U.S.C. 262(i)) is amended— 

5 (1) by striking ‘‘In this section, the term ‘bio6 logical product’ means’’ and inserting the following: 

7 ‘‘In this section: 

8 ‘‘(1) The term ‘biological product’ means’’; 

9 (2) in paragraph (1), as so designated, by in10 serting ‘‘protein (except any chemically synthesized 

11 polypeptide),’’ after ‘‘allergenic product,’’; and 

12 (3) by adding at the end the following: 

13 ‘‘(2) The term ‘biosimilar’ or ‘biosimilarity’, in 

14 reference to a biological product that is the subject 

15 of an application under subsection (k), means there 

16 are no clinically meaningful differences between the 

17 biological product and the reference product in 

18 terms of the safety, purity, and potency of the prod19 uct. 

20 ‘‘(3) The term ‘interchangeable’ or ‘inter21 changeability’, in reference to a biological product 

22 that is the subject of an application under sub23 section (k), means that the biological product may 

24 be substituted for the reference product without the 

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1 intervention of the health care provider who pre2 scribed the reference product. 

3 ‘‘(4) The term ‘reference product’ means the 

4 single biological product licensed under subsection 

5 (a) against which a biological product is evaluated in 

6 an application submitted under subsection (k).’’. 

7 (c) CONFORMING AMENDMENTS RELATING TO PAT8 ENTS.— 

9 (1) PATENTS.—Section 271(e) of title 35, 

10 United States Code, is amended— 

11 (A) in paragraph (2)— 

12 (i) in subparagraph (A), by striking 

13 ‘‘or’’ at the end; 

14 (ii) in subparagraph (B), by adding 

15 ‘‘or’’ at the end; and 

16 (iii) by inserting after subparagraph 

17 (B) the following: 

18 ‘‘(C)(i) with respect to a patent that is identi19 fied in the list of patents described in section 

20 351(l)(3) of the Public Health Service Act (including 

21 as provided under section 351(l)(7) of such Act), an 

22 application seeking approval of a biological product, 

23 or 

24 ‘‘(ii) if the applicant for the application fails to 

25 provide the application and information required 

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1 under section 351(l)(2)(A) of such Act, an applica2 tion seeking approval of a biological product for a 

3 patent that could be identified pursuant to section 

4 351(l)(3)(A)(i) of such Act,’’; and 

5 (iv) in the matter following subpara6 graph (C) (as added by clause (iii)), by 

7 striking ‘‘or veterinary biological product’’ 

8 and inserting ‘‘, veterinary biological prod9 uct, or biological product’’; 

10 (B) in paragraph (4)— 

11 (i) in subparagraph (B), by— 

12 (I) striking ‘‘or veterinary bio13 logical product’’ and inserting ‘‘, vet14 erinary biological product, or biologi15 cal product’’; and 

16 (II) striking ‘‘and’’ at the end; 

17 (ii) in subparagraph (C), by— 

18 (I) striking ‘‘or veterinary bio19 logical product’’ and inserting ‘‘, vet20 erinary biological product, or biologi21 cal product’’; and 

22 (II) striking the period and in23 serting ‘‘, and’’; 

24 (iii) by inserting after subparagraph 

25 (C) the following: 

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1 ‘‘(D) the court shall order a permanent injunc2 tion prohibiting any infringement of the patent by 

3 the biological product involved in the infringement 

4 until a date which is not earlier than the date of the 

5 expiration of the patent that has been infringed 

6 under paragraph (2)(C), provided the patent is the 

7 subject of a final court decision, as defined in sec8 tion 351(k)(6) of the Public Health Service Act, in 

9 an action for infringement of the patent under sec10 tion 351(l)(6) of such Act, and the biological prod11 uct has not yet been approved because of section 

12 351(k)(7) of such Act.’’; and 

13 (iv) in the matter following subpara14 graph (D) (as added by clause (iii)), by 

15 striking ‘‘and (C)’’ and inserting ‘‘(C), and 

16 (D)’’; and 

17 (C) by adding at the end the following: 

18 ‘‘(6)(A) Subparagraph (B) applies, in lieu of para19 graph (4), in the case of a patent— 

20 ‘‘(i) that is identified, as applicable, in the list 

21 of patents described in section 351(l)(4) of the Pub22 lic Health Service Act or the lists of patents de23 scribed in section 351(l)(5)(B) of such Act with re24 spect to a biological product; and 

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1 ‘‘(ii) for which an action for infringement of the 

2 patent with respect to the biological product— 

3 ‘‘(I) was brought after the expiration of 

4 the 30-day period described in subparagraph 

5 (A) or (B), as applicable, of section 351(l)(6) of 

6 such Act; or 

7 ‘‘(II) was brought before the expiration of 

8 the 30-day period described in subclause (I), 

9 but which was dismissed without prejudice or 

10 was not prosecuted to judgment in good faith. 

11 ‘‘(B) In an action for infringement of a patent de12 scribed in subparagraph (A), the sole and exclusive remedy 

13 that may be granted by a court, upon a finding that the 

14 making, using, offering to sell, selling, or importation into 

15 the United States of the biological product that is the sub16 ject of the action infringed the patent, shall be a reason17 able royalty. 

18 ‘‘(C) The owner of a patent that should have been 

19 included in the list described in section 351(l)(3)(A) of 

20 the Public Health Service Act, including as provided under 

21 section 351(l)(7) of such Act for a biological product, but 

22 was not timely included in such list, may not bring an 

23 action under this section for infringement of the patent 

24 with respect to the biological product.’’. 

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1 (2) CONFORMING AMENDMENT UNDER TITLE

2 28.—Section 2201(b) of title 28, United States 

3 Code, is amended by inserting before the period the 

4 following: ‘‘, or section 351 of the Public Health 

5 Service Act’’. 

6 (d) CONFORMING AMENDMENTS UNDER THE FED7 ERAL FOOD, DRUG, AND COSMETIC ACT.— 

8 (1) CONTENT AND REVIEW OF APPLICA9 TIONS.—Section 505(b)(5)(B) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is 

11 amended by inserting before the period at the end 

12 of the first sentence the following: ‘‘or, with respect 

13 to an applicant for approval of a biological product 

14 under section 351(k) of the Public Health Service 

15 Act, any necessary clinical study or studies’’. 

16 (2) NEW ACTIVE INGREDIENT.—Section 505B 

17 of the Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 355c) is amended by adding at the end the 

19 following: 

20 ‘‘(i) NEW ACTIVE INGREDIENT.—A biological prod21 uct that is interchangeable with a reference product under 

22 section 351 of the Public Health Service Act shall not be 

23 considered to have a new active ingredient under this sec24 tion.’’. 

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1 (e) PRODUCTS PREVIOUSLY APPROVED UNDER SEC2 TION 505.— 

3 (1) REQUIREMENT TO FOLLOW SECTION 351.— 

4 Except as provided in paragraph (2), an application 

5 for a biological product shall be submitted under 

6 section 351 of the Public Health Service Act (42 

7 U.S.C. 262) (as amended by this Act). 

8 (2) EXCEPTION.—An application for a biologi9 cal product may be submitted under section 505 of 

10 the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 355) if— 

12 (A) such biological product is in a product 

13 class for which a biological product in such 

14 product class is the subject of an application 

15 approved under such section 505 not later than 

16 the date of enactment of this Act; and 

17 (B) such application— 

18 (i) has been submitted to the Sec19 retary of Health and Human Services (re20 ferred to in this Act as the ‘‘Secretary’’) 

21 before the date of enactment of this Act; 

22 or 

23 (ii) is submitted to the Secretary not 

24 later than the date that is 10 years after 

25 the date of enactment of this Act. 

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1 (3) LIMITATION.—Notwithstanding paragraph 

2 (2), an application for a biological product may not 

3 be submitted under section 505 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 355) if there is 

5 another biological product approved under sub6 section (a) of section 351 of the Public Health Serv7 ice Act that could be a reference product with re8 spect to such application (within the meaning of 

9 such section 351) if such application were submitted 

10 under subsection (k) of such section 351. 

11 (4) DEEMED APPROVED UNDER SECTION

12 351.—An approved application for a biological prod13 uct under section 505 of the Federal Food, Drug, 

14 and Cosmetic Act (21 U.S.C. 355) shall be deemed 

15 to be a license for the biological product under such 

16 section 351 on the date that is 10 years after the 

17 date of enactment of this Act. 

18 (5) DEFINITIONS.—For purposes of this sub19 section, the term ‘‘biological product’’ has the mean20 ing given such term under section 351 of the Public 

21 Health Service Act (42 U.S.C. 262) (as amended by 

22 this Act). 

23 (f) FOLLOW-ON BIOLOGICS USER FEES.— 

24 (1) DEVELOPMENT OF USER FEES FOR BIO25 SIMILAR BIOLOGICAL PRODUCTS.— 

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1 (A) IN GENERAL.—Beginning not later 

2 than October 1, 2010, the Secretary shall de3 velop recommendations to present to Congress 

4 with respect to the goals, and plans for meeting 

5 the goals, for the process for the review of bio6 similar biological product applications sub7 mitted under section 351(k) of the Public 

8 Health Service Act (as added by this Act) for 

9 the first 5 fiscal years after fiscal year 2012. In 

10 developing such recommendations, the Sec11 retary shall consult with— 

12 (i) the Committee on Health, Edu13 cation, Labor, and Pensions of the Senate; 

14 (ii) the Committee on Energy and 

15 Commerce of the House of Representa16 tives; 

17 (iii) scientific and academic experts; 

18 (iv) health care professionals; 

19 (v) representatives of patient and con20 sumer advocacy groups; and 

21 (vi) the regulated industry. 

22 (B) PUBLIC REVIEW OF RECOMMENDA23 TIONS.—After negotiations with the regulated 

24 industry, the Secretary shall— 

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1 (i) present the recommendations de2 veloped under subparagraph (A) to the 

3 Congressional committees specified in such 

4 subparagraph; 

5 (ii) publish such recommendations in 

6 the Federal Register; 

7 (iii) provide for a period of 30 days 

8 for the public to provide written comments 

9 on such recommendations; 

10 (iv) hold a meeting at which the pub11 lic may present its views on such rec12 ommendations; and 

13 (v) after consideration of such public 

14 views and comments, revise such rec15 ommendations as necessary. 

16 (C) TRANSMITTAL OF RECOMMENDA17 TIONS.—Not later than January 15, 2012, the 

18 Secretary shall transmit to Congress the revised 

19 recommendations under subparagraph (B), a 

20 summary of the views and comments received 

21 under such subparagraph, and any changes 

22 made to the recommendations in response to 

23 such views and comments. 

24 (2) ESTABLISHMENT OF USER FEE PRO25 GRAM.—It is the sense of the Senate that, based on 

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1 the recommendations transmitted to Congress by the 

2 Secretary pursuant to paragraph (1)(C), Congress 

3 should authorize a program, effective on October 1, 

4 2012, for the collection of user fees relating to the 

5 submission of biosimilar biological product applica6 tions under section 351(k) of the Public Health 

7 Service Act (as added by this Act). 

8 (3) TRANSITIONAL PROVISIONS FOR USER FEES

9 FOR BIOSIMILAR BIOLOGICAL PRODUCTS.— 

10 (A) APPLICATION OF THE PRESCRIPTION

11 DRUG USER FEE PROVISIONS.—Section 

12 735(1)(C) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 379g(1)(C)) is amended 

14 by striking ‘‘section 351’’ and inserting ‘‘sub15 section (a) or (k) of section 351’’. 

16 (B) EVALUATION OF COSTS OF REVIEWING

17 BIOSIMILAR BIOLOGICAL PRODUCT APPLICA18 TIONS.—During the period beginning on the 

19 date of enactment of this Act and ending on 

20 October 1, 2010, the Secretary shall collect and 

21 evaluate data regarding the costs of reviewing 

22 applications for biological products submitted 

23 under section 351(k) of the Public Health Serv24 ice Act (as added by this Act) during such pe25 riod. 

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1 (C) AUDIT.— 

2 (i) IN GENERAL.—On the date that is 

3 2 years after first receiving a user fee ap4 plicable to an application for a biological 

5 product under section 351(k) of the Public 

6 Health Service Act (as added by this Act), 

7 and on a biennial basis thereafter until Oc8 tober 1, 2013, the Secretary shall perform 

9 an audit of the costs of reviewing such ap10 plications under such section 351(k). Such 

11 an audit shall compare— 

12 (I) the costs of reviewing such 

13 applications under such section 

14 351(k) to the amount of the user fee 

15 applicable to such applications; and 

16 (II)(aa) such ratio determined 

17 under subclause (I); to 

18 (bb) the ratio of the costs of re19 viewing applications for biological 

20 products under section 351(a) of such 

21 Act (as amended by this Act) to the 

22 amount of the user fee applicable to 

23 such applications under such section 

24 351(a). 

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1 (ii) ALTERATION OF USER FEE.—If 

2 the audit performed under clause (i) indi3 cates that the ratios compared under sub4 clause (II) of such clause differ by more 

5 than 5 percent, then the Secretary shall 

6 alter the user fee applicable to applications 

7 submitted under such section 351(k) to 

8 more appropriately account for the costs of 

9 reviewing such applications. 

10 (iii) ACCOUNTING STANDARDS.—The 

11 Secretary shall perform an audit under 

12 clause (i) in conformance with the account13 ing principles, standards, and requirements 

14 prescribed by the Comptroller General of 

15 the United States under section 3511 of 

16 title 31, United State Code, to ensure the 

17 validity of any potential variability. 

18 (4) AUTHORIZATION OF APPROPRIATIONS.— 

19 There is authorized to be appropriated to carry out 

20 this subsection such sums as may be necessary for 

21 each of fiscal years 2008 through 2012. 

22 (g) ALLOCATION OF SAVINGS; SPECIAL RESERVE

23 FUND.— 

24 (1) DETERMINATION OF SAVINGS.—The Sec25 retary of the Treasury, in consultation with the Secmstockstill on PROD1PC66 with BILLS

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1 retary, shall for each fiscal year determine the 

2 amount of the savings to the Federal Government as 

3 a result of the enactment of this Act and shall trans4 fer such amount to the Fund established under 

5 paragraph (2) pursuant to a relevant appropriations 

6 Act. 

7 (2) SPECIAL RESERVE FUND.— 

8 (A) IN GENERAL.—There is established in 

9 the Treasury of the United States a fund to be 

10 designated as the ‘‘Biological Product Savings 

11 Fund’’ to be made available to the Secretary 

12 without fiscal year limitation. 

13 (B) USE OF FUND.—The amounts made 

14 available to the Secretary through the Fund 

15 under subparagraph (A) shall be expended on 

16 activities authorized under the Public Health 

17 Service Act. 

18 (3) AUTHORIZATION OF APPROPRIATIONS.— 

19 There is authorized to be appropriated for each fis20 cal year to the Fund established under paragraph 

21 (2), the amount of the savings determined for such 

22 fiscal year under paragraph (1). 

Æ 

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