II 

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. 

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


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Biologics Price Com3 petition and Innovation Act of 2007’’. 

4 SEC. 2. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL 

5 PRODUCTS. 

6 (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO7 SIMILAR OR INTERCHANGEABLE.—Section 351 of the 

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

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

10 this subsection or subsection (k)’’ after ‘‘biologics li11 cense’’; and 

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

13 ‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO14 SIMILAR OR INTERCHANGEABLE.— 

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

16 application for licensure of a biological product 

17 under this subsection. 

18 ‘‘(2) CONTENT.— 

19 ‘‘(A) IN GENERAL.— 

20 ‘‘(i) REQUIRED INFORMATION.—An 

21 application submitted under this subsection 

22 shall include information demonstrating 

23 that— 

24 ‘‘(I) the biological product is bio25 similar to a reference product based 

26 upon data derived from— 


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1 ‘‘(aa) analytical studies that 

2 demonstrate that the biological 

3 product is highly similar to the 

4 reference product notwith5 standing minor differences in 

6 clinically inactive components; 

7 ‘‘(bb) animal studies; and 

8 ‘‘(cc) a clinical study or 

9 studies (including the assessment 

10 of immunogenicity and pharma11 cokinetics or pharmacodynamics) 

12 that are— 

13 ‘‘(AA) sufficient to 

14 demonstrate safety, purity, 

15 and potency in 1 or more 

16 appropriate conditions of use 

17 for which the reference 

18 product is licensed and in19 tended to be used and for 

20 which licensure is sought for 

21 the biological product; and 

22 ‘‘(BB) designed to 

23 avoid needlessly duplicative 

24 or unethical clinical testing; 


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1 ‘‘(II) the biological product and 

2 reference product utilize the same 

3 mechanism or mechanisms of action 

4 for the condition or conditions of use 

5 prescribed, recommended, or sug6 gested in the proposed labeling, but 

7 only to the extent the mechanism or 

8 mechanisms of action are known for 

9 the reference product; 

10 ‘‘(III) the condition or conditions 

11 of use prescribed, recommended, or 

12 suggested in the labeling proposed for 

13 the biological product have been pre14 viously approved for the reference 

15 product; 

16 ‘‘(IV) the route of administra17 tion, the dosage form, and the 

18 strength of the biological product are 

19 the same as those of the reference 

20 product; and 

21 ‘‘(V) the facility in which the bio22 logical product is manufactured, proc23 essed, packed, or held meets stand24 ards designed to assure that the bioVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6401 E:\BILLS\S1695.RS S1695

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1 logical product continues to be safe, 

2 pure, and potent. 

3 ‘‘(ii) DETERMINATION BY SEC4 RETARY.—The Secretary may determine, 

5 in the Secretary’s discretion, that an ele6 ment described in clause (i)(I) is unneces7 sary in an application submitted under this 

8 subsection. 

9 ‘‘(iii) ADDITIONAL INFORMATION.— 

10 An application submitted under this sub11 section may include— 

12 ‘‘(I) at the applicant’s option, 

13 publicly-available information regard14 ing the Secretary’s previous deter15 mination that the reference product is 

16 safe, pure, and potent; and 

17 ‘‘(II) any additional information 

18 in support of the application, includ19 ing publicly-available information with 

20 respect to the reference product or an21 other biological product. 

22 ‘‘(B) INTERCHANGEABILITY.—An applica23 tion (or a supplement to an application) sub24 mitted under this subsection may include infor25 mation demonstrating that the biological prodVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6401 E:\BILLS\S1695.RS S1695

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1 uct is interchangeable with the reference prod2 uct. 

3 ‘‘(3) EVALUATION BY SECRETARY.—Upon re4 view of an application (or a supplement to an appli5 cation) submitted under this subsection, the Sec6 retary shall license the biological product under this 

7 subsection if the Secretary determines that the infor8 mation submitted in the application (or the supple9 ment) is sufficient to show that the biological prod10 uct— 

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

12 or 

13 ‘‘(B) is interchangeable with the reference 

14 product. 

15 ‘‘(4) SAFETY STANDARDS FOR DETERMINING

16 INTERCHANGEABILITY.—Upon review of an applica17 tion submitted under this subsection or any supple18 ment to such application, the Secretary shall deter19 mine the biological product to be interchangeable 

20 with the reference product if the Secretary deter21 mines that the information submitted in the applica22 tion (or a supplement to such application) is suffi23 cient to show that— 

24 ‘‘(A) the biological product— 


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1 ‘‘(i) is biosimilar to the reference 

2 product; and 

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

4 same clinical result as the reference prod5 uct in any given patient; and 

6 ‘‘(B) for a biological product that is ad7 ministered more than once to an individual, the 

8 risk in terms of safety or diminished efficacy of 

9 alternating or switching between use of the bio10 logical product and the reference product is not 

11 greater than the risk of using the reference 

12 product without such alternation or switch. 

13 ‘‘(5) GENERAL RULES.— 

14 ‘‘(A) ONE REFERENCE PRODUCT PER AP15 PLICATION.—A biological product, in an appli16 cation submitted under this subsection, may not 

17 be evaluated against more than 1 reference 

18 product. 

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

20 under this subsection shall be reviewed by the 

21 division within the Food and Drug Administra22 tion that is responsible for the review and ap23 proval of the application under which the ref24 erence product is licensed. 


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1 ‘‘(C) RISK EVALUATION AND MITIGATION

2 STRATEGIES.—The authority of the Secretary 

3 with respect to risk evaluation and mitigation 

4 strategies under the Federal Food, Drug, and 

5 Cosmetic Act shall apply to biological products 

6 licensed under this subsection in the same man7 ner as such authority applies to biological prod8 ucts licensed under subsection (a). 

9 ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE10 ABLE BIOLOGICAL PRODUCT.—Upon review of an 

11 application submitted under this subsection relying 

12 on the same reference product for which a prior bio13 logical product has received a determination of inter14 changeability for any condition of use, the Secretary 

15 shall not make a determination under paragraph (4) 

16 that the second or subsequent biological product is 

17 interchangeable for any condition of use until the 

18 earlier of— 

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

20 marketing of the first interchangeable bio21 similar biological product to be approved as 

22 interchangeable for that reference product; 

23 ‘‘(B) 18 months after— 

24 ‘‘(i) a final court decision on all pat25 ents in suit in an action instituted under 


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

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

4 product; or 

5 ‘‘(ii) the dismissal with or without 

6 prejudice of an action instituted under sub7 section (l)(6) against the applicant that 

8 submitted the application for the first ap9 proved interchangeable biosimilar biological 

10 product; or 

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

12 first interchangeable biosimilar biological prod13 uct if the applicant that submitted such appli14 cation has been sued under subsection (l)(6) 

15 and such litigation is still ongoing within such 

16 36-month period; or 

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

18 interchangeable biosimilar biological product if 

19 the applicant that submitted such application 

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

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

22 decision’ means a final decision of a court from 

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

24 States Supreme Court for a writ of certiorari) has 

25 been or can be taken. 


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1 ‘‘(7) EXCLUSIVITY FOR REFERENCE PROD2 UCT.— 

3 ‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP4 PLICATION APPROVAL.—Approval of an applica5 tion under this subsection may not be made ef6 fective by the Secretary until the date that is 

7 12 years after the date on which the reference 

8 product was first licensed under subsection (a). 

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

10 under this subsection may not be submitted to 

11 the Secretary until the date that is 4 years 

12 after the date on which the reference product 

13 was first licensed under subsection (a). 

14 ‘‘(8) GUIDANCE DOCUMENTS.— 

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

16 after opportunity for public comment, issue 

17 guidance in accordance, except as provided in 

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

19 Federal Food, Drug, and Cosmetic Act with re20 spect to the process for the submission of appli21 cations for, and licensure of, a biological prod22 uct under this subsection. Any such guidance 

23 may be general or specific. 

24 ‘‘(B) PUBLIC COMMENT.— 


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1 ‘‘(i) IN GENERAL.—The Secretary 

2 shall provide the public an opportunity to 

3 comment on any proposed guidance issued 

4 under subparagraph (A) before issuing 

5 final guidance. 

6 ‘‘(ii) INPUT REGARDING MOST VALU7 ABLE GUIDANCE.—The Secretary shall es8 tablish a process through which the public 

9 may provide the Secretary with input re10 garding priorities for issuing guidance. 

11 ‘‘(C) NO REQUIREMENT FOR APPLICATION

12 CONSIDERATION.—The issuance (or non13 issuance) of guidance under subparagraph (A) 

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

15 an application submitted under this subsection. 

16 ‘‘(D) REQUIREMENT FOR PRODUCT CLASS17 SPECIFIC GUIDANCE.—If the Secretary issues 

18 product class-specific guidance under subpara19 graph (A), such guidance shall include a de20 scription of— 

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

22 use to determine whether a biological prod23 uct is highly similar to a reference product 

24 in such product class; and 


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

2 Secretary will use to determine whether a 

3 biological product meets the standards de4 scribed in paragraph (4). 

5 ‘‘(E) CERTAIN PRODUCT CLASSES.— 

6 ‘‘(i) GUIDANCE.—The Secretary may 

7 indicate in a guidance document that the 

8 science and experience, as of the date of 

9 such guidance, with respect to a product or 

10 product class (not including any recom11 binant protein) does not allow approval of 

12 an application for a license as provided 

13 under this subsection for such product or 

14 product class. 

15 ‘‘(ii) MODIFICATION OR REVERSAL.— 

16 The Secretary may issue a subsequent 

17 guidance document under subparagraph 

18 (A) to modify or reverse a guidance docu19 ment under clause (i). 

20 ‘‘(iii) NO EFFECT ON ABILITY TO

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

22 construed to require the Secretary to ap23 prove a product with respect to which the 

24 Secretary has not indicated in a guidance 

25 document that the science and experience, 


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

2 approval of such an application. 

3 ‘‘(l) PATENTS.— 

4 ‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION

5 (k) APPLICATION.— 

6 ‘‘(A) APPLICATION OF PARAGRAPH.—Un7 less otherwise agreed to by a person that sub8 mits an application under subsection (k) (re9 ferred to in this subsection as the ‘subsection 

10 (k) applicant’) and the sponsor of the applica11 tion for the reference product (referred to in 

12 this paragraph as the ‘reference product spon13 sor’), the provisions of this paragraph shall 

14 apply to the exchange of information described 

15 in this subsection. 

16 ‘‘(B) IN GENERAL.— 

17 ‘‘(i) PROVISION OF CONFIDENTIAL IN18 FORMATION.—When a subsection (k) ap19 plicant submits an application under sub20 section (k), such applicant shall provide to 

21 the persons described in clause (ii), subject 

22 to the terms of this paragraph, confidential 

23 access to the information required to be 

24 produced pursuant to paragraph (2) and 

25 any other information that the subsection 


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1 (k) applicant determines, in its sole discre2 tion, to be appropriate (referred to in this 

3 subsection as the ‘confidential informa4 tion’). 

5 ‘‘(ii) RECIPIENTS OF INFORMATION.— 

6 The persons described in this clause are 

7 the following: 

8 ‘‘(I) OUTSIDE COUNSEL.—One or 

9 more attorneys designated by the ref10 erence product sponsor who are em11 ployees of an entity other than the 

12 reference product sponsor (referred to 

13 in this paragraph as the ‘outside 

14 counsel’), provided that such attor15 neys do not engage, formally or infor16 mally, in patent prosecution relevant 

17 or related to the reference product. 

18 ‘‘(II) IN-HOUSE COUNSEL.—One 

19 attorney that represents the reference 

20 product sponsor who is an employee 

21 of the reference product sponsor, pro22 vided that such attorney does not en23 gage, formally or informally, in patent 

24 prosecution relevant or related to the 

25 reference product. 


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1 ‘‘(C) LIMITATION ON DISCLOSURE.—No 

2 person that receives confidential information 

3 pursuant to subparagraph (B) shall disclose 

4 any confidential information to any other per5 son or entity, including the reference product 

6 sponsor employees, outside scientific consult7 ants, or other outside counsel retained by the 

8 reference product sponsor, without the prior 

9 written consent of the subsection (k) applicant, 

10 which shall not be unreasonably withheld. 

11 ‘‘(D) USE OF CONFIDENTIAL INFORMA12 TION.—Confidential information shall be used 

13 for the sole and exclusive purpose of deter14 mining, with respect to each patent assigned to 

15 or exclusively licensed by the reference product 

16 sponsor, whether a claim of patent infringement 

17 could reasonably be asserted if the subsection 

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

19 offering for sale, sale, or importation into the 

20 United States of the biological product that is 

21 the subject of the application under subsection 

22 (k). 

23 ‘‘(E) OWNERSHIP OF CONFIDENTIAL IN24 FORMATION.—The confidential information dis25 closed under this paragraph is, and shall reVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6401 E:\BILLS\S1695.RS S1695

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1 main, the property of the subsection (k) appli2 cant. By providing the confidential information 

3 pursuant to this paragraph, the subsection (k) 

4 applicant does not provide the reference product 

5 sponsor or the outside counsel any interest in or 

6 license to use the confidential information, for 

7 purposes other than those specified in subpara8 graph (D). 

9 ‘‘(F) EFFECT OF INFRINGEMENT AC10 TION.—In the event that the reference product 

11 sponsor files a patent infringement suit, the use 

12 of confidential information shall continue to be 

13 governed by the terms of this paragraph until 

14 such time as a court enters a protective order 

15 regarding the information. Upon entry of such 

16 order, the subsection (k) applicant may redesig17 nate confidential information in accordance 

18 with the terms of that order. No confidential in19 formation shall be included in any publicly20 available complaint or other pleading. In the 

21 event that the reference product sponsor does 

22 not file an infringement action by the date spec23 ified in paragraph (6), the reference product 

24 sponsor shall return or destroy all confidential 

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1 vided that if the reference product sponsor opts 

2 to destroy such information, it will confirm de3 struction in writing to the subsection (k) appli4 cant. 

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

6 in this paragraph shall be construed— 

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

8 (k) applicant regarding the validity, en9 forceability, or infringement of any patent; 

10 or 

11 ‘‘(ii) an agreement or admission by 

12 the subsection (k) applicant with respect to 

13 the competency, relevance, or materiality 

14 of any confidential information. 

15 ‘‘(H) EFFECT OF VIOLATION.—The disclo16 sure of any confidential information in violation 

17 of this paragraph shall be deemed to cause the 

18 subsection (k) applicant to suffer irreparable 

19 harm for which there is no adequate legal rem20 edy and the court shall consider immediate in21 junctive relief to be an appropriate and nec22 essary remedy for any violation or threatened 

23 violation of this paragraph. 

24 ‘‘(2) SUBSECTION (k) APPLICATION INFORMA25 TION.—Not later than 20 days after the Secretary 


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1 notifies the subsection (k) applicant that the applica2 tion has been accepted for review, the subsection (k) 

3 applicant— 

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

5 sponsor a copy of the application submitted to 

6 the Secretary under subsection (k), and such 

7 other information that describes the process or 

8 processes used to manufacture the biological 

9 product that is the subject of such application; 

10 and 

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

12 sponsor additional information requested by or 

13 on behalf of the reference product sponsor. 

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

15 ‘‘(A) LIST BY REFERENCE PRODUCT SPON16 SOR.—Not later than 60 days after the receipt 

17 of the application and information under para18 graph (2), the reference product sponsor shall 

19 provide to the subsection (k) applicant— 

20 ‘‘(i) a list of patents for which the ref21 erence product sponsor believes a claim of 

22 patent infringement could reasonably be 

23 asserted by the reference product sponsor 

24 if a person not licensed by the reference 

25 product sponsor engaged in the making, 


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1 using, offering to sell, selling, or importing 

2 into the United States of the biological 

3 product that is the subject of the sub4 section (k) application; and 

5 ‘‘(ii) an identification of the patents 

6 on such list that the reference product 

7 sponsor would be prepared to license to the 

8 subsection (k) applicant. 

9 ‘‘(B) LIST AND DESCRIPTION BY SUB10 SECTION (k) APPLICANT.—Not later than 60 

11 days after receipt of the list under subpara12 graph (A), the subsection (k) applicant— 

13 ‘‘(i) may provide to the reference 

14 product sponsor a list of patents to which 

15 the subsection (k) applicant believes a 

16 claim of patent infringement could reason17 ably be asserted by the reference product 

18 sponsor if a person not licensed by the ref19 erence product sponsor engaged in the 

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

21 importing into the United States of the bi22 ological product that is the subject of the 

23 subsection (k) application; 

24 ‘‘(ii) shall provide to the reference 

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1 ent listed by the reference product sponsor 

2 under subparagraph (A) or listed by the 

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

4 ‘‘(I) a detailed statement that de5 scribes, on a claim by claim basis, the 

6 factual and legal basis of the opinion 

7 of the subsection (k) applicant that 

8 such patent is invalid, unenforceable, 

9 or will not be infringed by the com10 mercial marketing of the biological 

11 product that is the subject of the sub12 section (k) application; or 

13 ‘‘(II) a statement that the sub14 section (k) applicant does not intend 

15 to begin commercial marketing of the 

16 biological product before the date that 

17 such patent expires; and 

18 ‘‘(iii) shall provide to the reference 

19 product sponsor a response regarding each 

20 patent identified by the reference product 

21 sponsor under subparagraph (A)(ii). 

22 ‘‘(C) DESCRIPTION BY REFERENCE PROD23 UCT SPONSOR.—Not later than 60 days after 

24 receipt of the list and statement under subpara25 graph (B), the reference product sponsor shall 


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1 provide to the subsection (k) applicant a de2 tailed statement that describes, with respect to 

3 each patent described in subparagraph 

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

5 and legal basis of the opinion of the reference 

6 product sponsor that such patent will be in7 fringed by the commercial marketing of the bio8 logical product that is the subject of the sub9 section (k) application and a response to the 

10 statement concerning validity and enforceability 

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

12 ‘‘(4) PATENT RESOLUTION NEGOTIATIONS.— 

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

14 subsection (k) applicant of the statement under 

15 paragraph (3)(C), the reference product spon16 sor and the subsection (k) applicant shall en17 gage in good faith negotiations to agree on 

18 which, if any, patents listed under paragraph 

19 (3) by the subsection (k) applicant or the ref20 erence product sponsor shall be the subject of 

21 an action for patent infringement under para22 graph (6). 

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

24 If, within 15 days of beginning negotiations 

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1 plicant and the reference product sponsor fail to 

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

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

4 subsection (k) applicant or the reference prod5 uct sponsor shall be the subject of an action for 

6 patent infringement under paragraph (6), the 

7 provisions of paragraph (5) shall apply to the 

8 parties. 

9 ‘‘(5) PATENT RESOLUTION IF NO AGREE10 MENT.— 

11 ‘‘(A) NUMBER OF PATENTS.—The sub12 section (k) applicant shall notify the reference 

13 product sponsor of the number of patents that 

14 such applicant will provide to the reference 

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

16 ‘‘(B) EXCHANGE OF PATENT LISTS.— 

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

18 to by the subsection (k) applicant and the 

19 reference product sponsor, but in no case 

20 later than 5 days after the subsection (k) 

21 application notifies the reference product 

22 sponsor under subparagraph (A), the sub23 section (k) applicant and the reference 

24 product sponsor shall simultaneously ex25 change— 


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1 ‘‘(I) the list of patents that the 

2 subsection (k) applicant believes 

3 should be the subject of an action for 

4 patent infringement under paragraph 

5 (6); and 

6 ‘‘(II) the list of patents, in ac7 cordance with clause (ii), that the ref8 erence product sponsor believes should 

9 be the subject of an action for patent 

10 infringement under paragraph (6). 

11 ‘‘(ii) NUMBER OF PATENTS LISTED BY

12 REFERENCE PRODUCT SPONSOR.— 

13 ‘‘(I) IN GENERAL.—Subject to 

14 subclause (II), the number of patents 

15 listed by the reference product spon16 sor under clause (i)(II) may not ex17 ceed the number of patents listed by 

18 the subsection (k) applicant under 

19 clause (i)(I). 

20 ‘‘(II) EXCEPTION.—If a sub21 section (k) applicant does not list any 

22 patent under clause (i)(I), the ref23 erence product sponsor may list 1 pat24 ent under clause (i)(II). 


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1 ‘‘(6) IMMEDIATE PATENT INFRINGEMENT AC2 TION.— 

3 ‘‘(A) ACTION IF AGREEMENT ON PATENT

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

5 reference product sponsor agree on patents as 

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

7 days after such agreement, the reference prod8 uct sponsor shall bring an action for patent in9 fringement with respect to each such patent. 

10 ‘‘(B) ACTION IF NO AGREEMENT ON PAT11 ENT LIST.—If the provisions of paragraph (5) 

12 apply to the parties as described in paragraph 

13 (4)(B), not later than 30 days after the ex14 change of lists under paragraph (5)(B), the ref15 erence product sponsor shall bring an action for 

16 patent infringement with respect to each patent 

17 that is included on such lists. 

18 ‘‘(C) NOTIFICATION AND PUBLICATION OF

19 COMPLAINT.— 

20 ‘‘(i) NOTIFICATION TO SECRETARY.— 

21 Not later than 30 days after a complaint 

22 is served to a subsection (k) applicant in 

23 an action for patent infringement described 

24 under this paragraph, the subsection (k) 


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1 applicant shall provide the Secretary with 

2 notice and a copy of such complaint. 

3 ‘‘(ii) PUBLICATION BY SECRETARY.— 

4 The Secretary shall publish in the Federal 

5 Register notice of a complaint received 

6 under clause (i). 

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

8 In the case of a patent that— 

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

10 the reference product sponsor after the date 

11 that the reference product sponsor provided the 

12 list to the subsection (k) applicant under para13 graph (3)(A); and 

14 ‘‘(B) the reference product sponsor reason15 ably believes that, due to the issuance of such 

16 patent, a claim of patent infringement could 

17 reasonably be asserted by the reference product 

18 sponsor if a person not licensed by the ref19 erence product sponsor engaged in the making, 

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

21 the United States of the biological product that 

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

23 not later than 30 days after such issuance or licens24 ing, the reference product sponsor shall provide to 

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


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1 provided by the reference product sponsor under 

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

3 later than 30 days after such supplement is pro4 vided, the subsection (k) applicant shall provide a 

5 statement to the reference product sponsor in ac6 cordance with paragraph (3)(B), and such patent 

7 shall be subject to paragraph (8). 

8 ‘‘(8) NOTICE OF COMMERCIAL MARKETING AND

9 PRELIMINARY INJUNCTION.— 

10 ‘‘(A) NOTICE OF COMMERCIAL MAR11 KETING.—The subsection (k) applicant shall 

12 provide notice to the reference product sponsor 

13 not later than 180 days before the date of the 

14 first commercial marketing of the biological 

15 product licensed under subsection (k). 

16 ‘‘(B) PRELIMINARY INJUNCTION.—After 

17 receiving the notice under subparagraph (A) 

18 and before such date of the first commercial 

19 marketing of such biological product, the ref20 erence product sponsor may seek a preliminary 

21 injunction prohibiting the subsection (k) appli22 cant from engaging in the commercial manufac23 ture or sale of such biological product until the 

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1 forcement, and infringement with respect to any 

2 patent that is— 

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

4 the reference product sponsor under para5 graph (3)(A) or in the list provided by the 

6 subsection (k) applicant under paragraph 

7 (3)(B); and 

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

9 ‘‘(I) the list of patents described 

10 in paragraph (4); or 

11 ‘‘(II) the lists of patents de12 scribed in paragraph (5)(B). 

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

14 reference product sponsor has sought a prelimi15 nary injunction under subparagraph (B), the 

16 reference product sponsor and the subsection 

17 (k) applicant shall reasonably cooperate to ex18 pedite such further discovery as is needed in 

19 connection with the preliminary injunction mo20 tion. 

21 ‘‘(9) LIMITATION ON DECLARATORY JUDGMENT

22 ACTION.— 

23 ‘‘(A) SUBSECTION (k) APPLICATION PRO24 VIDED.—If a subsection (k) applicant provides 

25 the application and information required under 


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

2 sponsor nor the subsection (k) applicant may, 

3 prior to the date notice is received under para4 graph (8)(A), bring any action under section 

5 2201 of title 28, United States Code, for a dec6 laration of infringement, validity, or enforce7 ability of any patent that is described in clauses 

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

9 ‘‘(B) SUBSEQUENT FAILURE TO ACT BY

10 SUBSECTION (k) APPLICANT.—If a subsection 

11 (k) applicant fails to complete an action re12 quired of the subsection (k) applicant under 

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

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

15 the reference product sponsor, but not the sub16 section (k) applicant, may bring an action 

17 under section 2201 of title 28, United States 

18 Code, for a declaration of infringement, validity, 

19 or enforceability of any patent included in the 

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

21 provided under paragraph (7). 

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

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

24 to provide the application and information re25 quired under paragraph (2)(A), the reference 


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1 product sponsor, but not the subsection (k) ap2 plicant, may bring an action under section 2201 

3 of title 28, United States Code, for a declara4 tion of infringement, validity, or enforceability 

5 of any patent that claims the biological product 

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

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

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

9 (1) by striking ‘‘In this section, the term ‘bio10 logical product’ means’’ and inserting the following: 

11 ‘‘In this section: 

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

13 (2) in paragraph (1), as so designated, by in14 serting ‘‘protein (except any chemically synthesized 

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

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

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

18 reference to a biological product that is the subject 

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

20 are no clinically meaningful differences between the 

21 biological product and the reference product in 

22 terms of the safety, purity, and potency of the prod23 uct. 

24 ‘‘(3) The term ‘interchangeable’ or ‘inter25 changeability’, in reference to a biological product 


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1 that is the subject of an application under sub2 section (k), means that the biological product may 

3 be substituted for the reference product without the 

4 intervention of the health care provider who pre5 scribed the reference product. 

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

7 single biological product licensed under subsection 

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

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

10 (c) CONFORMING AMENDMENTS RELATING TO PAT11 ENTS.— 

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

13 United States Code, is amended— 

14 (A) in paragraph (2)— 

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

16 ‘‘or’’ at the end; 

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

18 ‘‘or’’ at the end; and 

19 (iii) by inserting after subparagraph 

20 (B) the following: 

21 ‘‘(C)(i) with respect to a patent that is identi22 fied in the list of patents described in section 

23 351(l)(3) of the Public Health Service Act (including 

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


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1 application seeking approval of a biological product, 

2 or 

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

4 provide the application and information required 

5 under section 351(l)(2)(A) of such Act, an applica6 tion seeking approval of a biological product for a 

7 patent that could be identified pursuant to section 

8 351(l)(3)(A)(i) of such Act,’’; and 

9 (iv) in the matter following subpara10 graph (C) (as added by clause (iii)), by 

11 striking ‘‘or veterinary biological product’’ 

12 and inserting ‘‘, veterinary biological prod13 uct, or biological product’’; 

14 (B) in paragraph (4)— 

15 (i) in subparagraph (B), by— 

16 (I) striking ‘‘or veterinary bio17 logical product’’ and inserting ‘‘, vet18 erinary biological product, or biologi19 cal product’’; and 

20 (II) striking ‘‘and’’ at the end; 

21 (ii) in subparagraph (C), by— 

22 (I) striking ‘‘or veterinary bio23 logical product’’ and inserting ‘‘, vet24 erinary biological product, or biologi25 cal product’’; and 


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1 (II) striking the period and in2 serting ‘‘, and’’; 

3 (iii) by inserting after subparagraph 

4 (C) the following: 

5 ‘‘(D) the court shall order a permanent injunc6 tion prohibiting any infringement of the patent by 

7 the biological product involved in the infringement 

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

9 expiration of the patent that has been infringed 

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

11 subject of a final court decision, as defined in sec12 tion 351(k)(6) of the Public Health Service Act, in 

13 an action for infringement of the patent under sec14 tion 351(l)(6) of such Act, and the biological prod15 uct has not yet been approved because of section 

16 351(k)(7) of such Act.’’; and 

17 (iv) in the matter following subpara18 graph (D) (as added by clause (iii)), by 

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

20 (D)’’; and 

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

22 ‘‘(6)(A) Subparagraph (B) applies, in lieu of para23 graph (4), in the case of a patent— 

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

25 of patents described in section 351(l)(4) of the PubVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6401 E:\BILLS\S1695.RS S1695

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1 lic Health Service Act or the lists of patents de2 scribed in section 351(l)(5)(B) of such Act with re3 spect to a biological product; and 

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

5 patent with respect to the biological product— 

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

7 the 30-day period described in subparagraph 

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

9 such Act; or 

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

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

12 but which was dismissed without prejudice or 

13 was not prosecuted to judgment in good faith. 

14 ‘‘(B) In an action for infringement of a patent de15 scribed in subparagraph (A), the sole and exclusive remedy 

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

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

18 the United States of the biological product that is the sub19 ject of the action infringed the patent, shall be a reason20 able royalty. 

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

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

23 the Public Health Service Act, including as provided under 

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

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


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1 action under this section for infringement of the patent 

2 with respect to the biological product.’’. 

3 (2) CONFORMING AMENDMENT UNDER TITLE

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

5 Code, is amended by inserting before the period the 

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

7 Service Act’’. 

8 (d) CONFORMING AMENDMENTS UNDER THE FED9 ERAL FOOD, DRUG, AND COSMETIC ACT.— 

10 (1) CONTENT AND REVIEW OF APPLICA11 TIONS.—Section 505(b)(5)(B) of the Federal Food, 

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

13 amended by inserting before the period at the end 

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

15 to an applicant for approval of a biological product 

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

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

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

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

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

21 following: 

22 ‘‘(i) NEW ACTIVE INGREDIENT.—A biological prod23 uct that is interchangeable with a reference product under 

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


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1 considered to have a new active ingredient under this sec2 tion.’’. 

3 (e) PRODUCTS PREVIOUSLY APPROVED UNDER SEC4 TION 505.— 

5 (1) REQUIREMENT TO FOLLOW SECTION 351.— 

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

7 for a biological product shall be submitted under 

8 section 351 of the Public Health Service Act (42 

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

10 (2) EXCEPTION.—An application for a biologi11 cal product may be submitted under section 505 of 

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

13 U.S.C. 355) if— 

14 (A) such biological product is in a product 

15 class for which a biological product in such 

16 product class is the subject of an application 

17 approved under such section 505 not later than 

18 the date of enactment of this Act; and 

19 (B) such application— 

20 (i) has been submitted to the Sec21 retary of Health and Human Services (re22 ferred to in this Act as the ‘‘Secretary’’) 

23 before the date of enactment of this Act; 

24 or 


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1 (ii) is submitted to the Secretary not 

2 later than the date that is 10 years after 

3 the date of enactment of this Act. 

4 (3) LIMITATION.—Notwithstanding paragraph 

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

6 be submitted under section 505 of the Federal Food, 

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

8 another biological product approved under sub9 section (a) of section 351 of the Public Health Serv10 ice Act that could be a reference product with re11 spect to such application (within the meaning of 

12 such section 351) if such application were submitted 

13 under subsection (k) of such section 351. 

14 (4) DEEMED APPROVED UNDER SECTION

15 351.—An approved application for a biological prod16 uct under section 505 of the Federal Food, Drug, 

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

18 to be a license for the biological product under such 

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

20 date of enactment of this Act. 

21 (5) DEFINITIONS.—For purposes of this sub22 section, the term ‘‘biological product’’ has the mean23 ing given such term under section 351 of the Public 

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

25 this Act). 


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

2 (1) DEVELOPMENT OF USER FEES FOR BIO3 SIMILAR BIOLOGICAL PRODUCTS.— 

4 (A) IN GENERAL.—Beginning not later 

5 than October 1, 2010, the Secretary shall de6 velop recommendations to present to Congress 

7 with respect to the goals, and plans for meeting 

8 the goals, for the process for the review of bio9 similar biological product applications sub10 mitted under section 351(k) of the Public 

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

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

13 developing such recommendations, the Sec14 retary shall consult with— 

15 (i) the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate; 

17 (ii) the Committee on Energy and 

18 Commerce of the House of Representa19 tives; 

20 (iii) scientific and academic experts; 

21 (iv) health care professionals; 

22 (v) representatives of patient and con23 sumer advocacy groups; and 

24 (vi) the regulated industry. 


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1 (B) PUBLIC REVIEW OF RECOMMENDA2 TIONS.—After negotiations with the regulated 

3 industry, the Secretary shall— 

4 (i) present the recommendations de5 veloped under subparagraph (A) to the 

6 Congressional committees specified in such 

7 subparagraph; 

8 (ii) publish such recommendations in 

9 the Federal Register; 

10 (iii) provide for a period of 30 days 

11 for the public to provide written comments 

12 on such recommendations; 

13 (iv) hold a meeting at which the pub14 lic may present its views on such rec15 ommendations; and 

16 (v) after consideration of such public 

17 views and comments, revise such rec18 ommendations as necessary. 

19 (C) TRANSMITTAL OF RECOMMENDA20 TIONS.—Not later than January 15, 2012, the 

21 Secretary shall transmit to Congress the revised 

22 recommendations under subparagraph (B), a 

23 summary of the views and comments received 

24 under such subparagraph, and any changes 


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1 made to the recommendations in response to 

2 such views and comments. 

3 (2) ESTABLISHMENT OF USER FEE PRO4 GRAM.—It is the sense of the Senate that, based on 

5 the recommendations transmitted to Congress by the 

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

7 should authorize a program, effective on October 1, 

8 2012, for the collection of user fees relating to the 

9 submission of biosimilar biological product applica10 tions under section 351(k) of the Public Health 

11 Service Act (as added by this Act). 

12 (3) TRANSITIONAL PROVISIONS FOR USER FEES

13 FOR BIOSIMILAR BIOLOGICAL PRODUCTS.— 

14 (A) APPLICATION OF THE PRESCRIPTION

15 DRUG USER FEE PROVISIONS.—Section 

16 735(1)(C) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 379g(1)(C)) is amended 

18 by striking ‘‘section 351’’ and inserting ‘‘sub19 section (a) or (k) of section 351’’. 

20 (B) EVALUATION OF COSTS OF REVIEWING

21 BIOSIMILAR BIOLOGICAL PRODUCT APPLICA22 TIONS.—During the period beginning on the 

23 date of enactment of this Act and ending on 

24 October 1, 2010, the Secretary shall collect and 

25 evaluate data regarding the costs of reviewing 


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1 applications for biological products submitted 

2 under section 351(k) of the Public Health Serv3 ice Act (as added by this Act) during such pe4 riod. 

5 (C) AUDIT.— 

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

7 2 years after first receiving a user fee ap8 plicable to an application for a biological 

9 product under section 351(k) of the Public 

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

11 and on a biennial basis thereafter until Oc12 tober 1, 2013, the Secretary shall perform 

13 an audit of the costs of reviewing such ap14 plications under such section 351(k). Such 

15 an audit shall compare— 

16 (I) the costs of reviewing such 

17 applications under such section 

18 351(k) to the amount of the user fee 

19 applicable to such applications; and 

20 (II)(aa) such ratio determined 

21 under subclause (I); to 

22 (bb) the ratio of the costs of re23 viewing applications for biological 

24 products under section 351(a) of such 

25 Act (as amended by this Act) to the 


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1 amount of the user fee applicable to 

2 such applications under such section 

3 351(a). 

4 (ii) ALTERATION OF USER FEE.—If 

5 the audit performed under clause (i) indi6 cates that the ratios compared under sub7 clause (II) of such clause differ by more 

8 than 5 percent, then the Secretary shall 

9 alter the user fee applicable to applications 

10 submitted under such section 351(k) to 

11 more appropriately account for the costs of 

12 reviewing such applications. 

13 (iii) ACCOUNTING STANDARDS.—The 

14 Secretary shall perform an audit under 

15 clause (i) in conformance with the account16 ing principles, standards, and requirements 

17 prescribed by the Comptroller General of 

18 the United States under section 3511 of 

19 title 31, United State Code, to ensure the 

20 validity of any potential variability. 

21 (4) AUTHORIZATION OF APPROPRIATIONS.— 

22 There is authorized to be appropriated to carry out 

23 this subsection such sums as may be necessary for 

24 each of fiscal years 2008 through 2012. 


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1 (g) ALLOCATION OF SAVINGS; SPECIAL RESERVE

2 FUND.— 

3 (1) DETERMINATION OF SAVINGS.—The Sec4 retary of the Treasury, in consultation with the Sec5 retary, shall for each fiscal year determine the 

6 amount of the savings to the Federal Government as 

7 a result of the enactment of this Act and shall trans8 fer such amount to the Fund established under 

9 paragraph (2) pursuant to a relevant appropriations 

10 Act. 

11 (2) SPECIAL RESERVE FUND.— 

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

13 the Treasury of the United States a fund to be 

14 designated as the ‘‘Biological Product Savings 

15 Fund’’ to be made available to the Secretary 

16 without fiscal year limitation. 

17 (B) USE OF FUND.—The amounts made 

18 available to the Secretary through the Fund 

19 under subparagraph (A) shall be expended on 

20 activities authorized under the Public Health 

21 Service Act. 

22 (3) AUTHORIZATION OF APPROPRIATIONS.— 

23 There is authorized to be appropriated for each fis24 cal year to the Fund established under paragraph 


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

2 fiscal year under paragraph (1). 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Biologics Price Competi5 tion and Innovation Act of 2007’’. 

6 SEC. 2. APPROVAL PATHWAY FOR BIOSIMILAR BIOLOGICAL 

7 PRODUCTS. 

8 (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO9 SIMILAR OR INTERCHANGEABLE.—Section 351 of the Public 

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

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

12 this subsection or subsection (k)’’ after ‘‘biologics li13 cense’’; and 

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

15 ‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO16 SIMILAR OR INTERCHANGEABLE.— 

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

18 application for licensure of a biological product under 

19 this subsection. 

20 ‘‘(2) CONTENT.— 

21 ‘‘(A) IN GENERAL.— 

22 ‘‘(i) REQUIRED INFORMATION.—An ap23 plication submitted under this subsection 

24 shall include information demonstrating 

25 that— 


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1 ‘‘(I) the biological product is bio2 similar to a reference product based 

3 upon data derived from— 

4 ‘‘(aa) analytical studies that 

5 demonstrate that the biological 

6 product is highly similar to the 

7 reference product notwithstanding 

8 minor differences in clinically in9 active components; 

10 ‘‘(bb) animal studies (includ11 ing the assessment of toxicity); 

12 and 

13 ‘‘(cc) a clinical study or 

14 studies (including the assessment 

15 of immunogenicity and phar16 macokinetics or pharmaco17 dynamics) that are sufficient to 

18 demonstrate safety, purity, and 

19 potency in 1 or more appropriate 

20 conditions of use for which the ref21 erence product is licensed and in22 tended to be used and for which 

23 licensure is sought for the biologi24 cal product; 


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1 ‘‘(II) the biological product and 

2 reference product utilize the same 

3 mechanism or mechanisms of action 

4 for the condition or conditions of use 

5 prescribed, recommended, or suggested 

6 in the proposed labeling, but only to 

7 the extent the mechanism or mecha8 nisms of action are known for the ref9 erence product; 

10 ‘‘(III) the condition or conditions 

11 of use prescribed, recommended, or sug12 gested in the labeling proposed for the 

13 biological product have been previously 

14 approved for the reference product; 

15 ‘‘(IV) the route of administration, 

16 the dosage form, and the strength of the 

17 biological product are the same as 

18 those of the reference product; and 

19 ‘‘(V) the facility in which the bio20 logical product is manufactured, proc21 essed, packed, or held meets standards 

22 designed to assure that the biological 

23 product continues to be safe, pure, and 

24 potent. 


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1 ‘‘(ii) DETERMINATION BY SEC2 RETARY.—The Secretary may determine, in 

3 the Secretary’s discretion, that an element 

4 described in clause (i)(I) is unnecessary in 

5 an application submitted under this sub6 section. 

7 ‘‘(iii) ADDITIONAL INFORMATION.—An 

8 application submitted under this sub9 section— 

10 ‘‘(I) shall include publicly-avail11 able information regarding the Sec12 retary’s previous determination that 

13 the reference product is safe, pure, and 

14 potent; and 

15 ‘‘(II) may include any additional 

16 information in support of the applica17 tion, including publicly-available in18 formation with respect to the reference 

19 product or another biological product. 

20 ‘‘(B) INTERCHANGEABILITY.—An applica21 tion (or a supplement to an application) sub22 mitted under this subsection may include infor23 mation demonstrating that the biological product 

24 meets the standards described in paragraph (4). 


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1 ‘‘(3) EVALUATION BY SECRETARY.—Upon review 

2 of an application (or a supplement to an application) 

3 submitted under this subsection, the Secretary shall 

4 license the biological product under this subsection 

5 if— 

6 ‘‘(A) the Secretary determines that the in7 formation submitted in the application (or the 

8 supplement) is sufficient to show that the biologi9 cal product— 

10 ‘‘(i) is biosimilar to the reference prod11 uct; or 

12 ‘‘(ii) meets the standards described in 

13 paragraph (4), and therefore is interchange14 able with the reference product; and 

15 ‘‘(B) the applicant (or other appropriate 

16 person) consents to the inspection of the facility 

17 that is the subject of the application, in accord18 ance with subsection (c). 

19 ‘‘(4) SAFETY STANDARDS FOR DETERMINING

20 INTERCHANGEABILITY.—Upon review of an applica21 tion submitted under this subsection or any supple22 ment to such application, the Secretary shall deter23 mine the biological product to be interchangeable with 

24 the reference product if the Secretary determines that 

25 the information submitted in the application (or a 


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1 supplement to such application) is sufficient to show 

2 that— 

3 ‘‘(A) the biological product— 

4 ‘‘(i) is biosimilar to the reference prod5 uct; and 

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

7 same clinical result as the reference product 

8 in any given patient; and 

9 ‘‘(B) for a biological product that is admin10 istered more than once to an individual, the risk 

11 in terms of safety or diminished efficacy of alter12 nating or switching between use of the biological 

13 product and the reference product is not greater 

14 than the risk of using the reference product with15 out such alternation or switch. 

16 ‘‘(5) GENERAL RULES.— 

17 ‘‘(A) ONE REFERENCE PRODUCT PER APPLI18 CATION.—A biological product, in an applica19 tion submitted under this subsection, may not be 

20 evaluated against more than 1 reference product. 

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

22 under this subsection shall be reviewed by the di23 vision within the Food and Drug Administra24 tion that is responsible for the review and apVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6203 E:\BILLS\S1695.RS S1695

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1 proval of the application under which the ref2 erence product is licensed. 

3 ‘‘(C) RISK EVALUATION AND MITIGATION

4 STRATEGIES.—The authority of the Secretary 

5 with respect to risk evaluation and mitigation 

6 strategies under the Federal Food, Drug, and 

7 Cosmetic Act shall apply to biological products 

8 licensed under this subsection in the same man9 ner as such authority applies to biological prod10 ucts licensed under subsection (a). 

11 ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGEABLE

12 BIOLOGICAL PRODUCT.—Upon review of an applica13 tion submitted under this subsection relying on the 

14 same reference product for which a prior biological 

15 product has received a determination of interchange16 ability for any condition of use, the Secretary shall 

17 not make a determination under paragraph (4) that 

18 the second or subsequent biological product is inter19 changeable for any condition of use until the earlier 

20 of— 

21 ‘‘(A) 1 year after the first commercial mar22 keting of the first interchangeable biosimilar bio23 logical product to be approved as interchangeable 

24 for that reference product; 

25 ‘‘(B) 18 months after— 


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1 ‘‘(i) a final court decision on all pat2 ents in suit in an action instituted under 

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

4 submitted the application for the first ap5 proved interchangeable biosimilar biological 

6 product; or 

7 ‘‘(ii) the dismissal with or without 

8 prejudice of an action instituted under sub9 section (l)(6) against the applicant that 

10 submitted the application for the first ap11 proved interchangeable biosimilar biological 

12 product; or 

13 ‘‘(C)(i) 42 months after approval of the first 

14 interchangeable biosimilar biological product if 

15 the applicant that submitted such application 

16 has been sued under subsection (l)(6) and such 

17 litigation is still ongoing within such 36-month 

18 period; or 

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

20 interchangeable biosimilar biological product if 

21 the applicant that submitted such application 

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

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

24 decision’ means a final decision of a court from which 

25 no appeal (other than a petition to the United States 


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1 Supreme Court for a writ of certiorari) has been or 

2 can be taken. 

3 ‘‘(7) EXCLUSIVITY FOR REFERENCE PRODUCT.— 

4 ‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP5 PLICATION APPROVAL.—Approval of an applica6 tion under this subsection may not be made ef7 fective by the Secretary until the date that is 12 

8 years after the date on which the reference prod9 uct was first licensed under subsection (a). 

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

11 under this subsection may not be submitted to 

12 the Secretary until the date that is 4 years after 

13 the date on which the reference product was first 

14 licensed under subsection (a). 

15 ‘‘(C) FIRST LICENSURE.—The date on 

16 which the reference product was first licensed 

17 under subsection (a) does not include the date of 

18 approval of a supplement or of a subsequent ap19 plication for a new indication, route of adminis20 tration, dosage form, or strength for the pre21 viously licensed reference product. 

22 ‘‘(8) GUIDANCE DOCUMENTS.— 

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

24 after opportunity for public comment, issue 

25 guidance in accordance, except as provided in 


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

2 Federal Food, Drug, and Cosmetic Act with re3 spect to the licensure of a biological product 

4 under this subsection. Any such guidance may be 

5 general or specific. 

6 ‘‘(B) PUBLIC COMMENT.— 

7 ‘‘(i) IN GENERAL.—The Secretary shall 

8 provide the public an opportunity to com9 ment on any proposed guidance issued 

10 under subparagraph (A) before issuing final 

11 guidance. 

12 ‘‘(ii) INPUT REGARDING MOST VALU13 ABLE GUIDANCE.—The Secretary shall es14 tablish a process through which the public 

15 may provide the Secretary with input re16 garding priorities for issuing guidance. 

17 ‘‘(C) NO REQUIREMENT FOR APPLICATION

18 CONSIDERATION.—The issuance (or non19 issuance) of guidance under subparagraph (A) 

20 shall not preclude the review of, or action on, an 

21 application submitted under this subsection. 

22 ‘‘(D) REQUIREMENT FOR PRODUCT CLASS23 SPECIFIC GUIDANCE.—If the Secretary issues 

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1 graph (A), such guidance shall include a descrip2 tion of— 

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

4 use to determine whether a biological prod5 uct is highly similar to a reference product 

6 in such product class; and 

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

8 Secretary will use to determine whether a 

9 biological product meets the standards de10 scribed in paragraph (4). 

11 ‘‘(E) CERTAIN PRODUCT CLASSES.— 

12 ‘‘(i) GUIDANCE.—The Secretary may 

13 indicate in a guidance document that the 

14 science and experience, as of the date of 

15 such guidance, with respect to a product or 

16 product class (not including any recom17 binant protein) does not allow approval of 

18 an application for a license as provided 

19 under this subsection for such product or 

20 product class. 

21 ‘‘(ii) MODIFICATION OR REVERSAL.— 

22 The Secretary may issue a subsequent guid23 ance document under subparagraph (A) to 

24 modify or reverse a guidance document 

25 under clause (i). 


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1 ‘‘(iii) NO EFFECT ON ABILITY TO DENY

2 LICENSE.—Clause (i) shall not be construed 

3 to require the Secretary to approve a prod4 uct with respect to which the Secretary has 

5 not indicated in a guidance document that 

6 the science and experience, as described in 

7 clause (i), does not allow approval of such 

8 an application. 

9 ‘‘(l) PATENTS.— 

10 ‘‘(1) CONFIDENTIAL ACCESS TO SUBSECTION (k) 

11 APPLICATION.— 

12 ‘‘(A) APPLICATION OF PARAGRAPH.—Unless 

13 otherwise agreed to by a person that submits an 

14 application under subsection (k) (referred to in 

15 this subsection as the ‘subsection (k) applicant’) 

16 and the sponsor of the application for the ref17 erence product (referred to in this paragraph as 

18 the ‘reference product sponsor’), the provisions of 

19 this paragraph shall apply to the exchange of in20 formation described in this subsection. 

21 ‘‘(B) IN GENERAL.— 

22 ‘‘(i) PROVISION OF CONFIDENTIAL IN23 FORMATION.—When a subsection (k) appli24 cant submits an application under sub25 section (k), such applicant shall provide to 


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1 the persons described in clause (ii), subject 

2 to the terms of this paragraph, confidential 

3 access to the information required to be pro4 duced pursuant to paragraph (2) and any 

5 other information that the subsection (k) 

6 applicant determines, in its sole discretion, 

7 to be appropriate (referred to in this sub8 section as the ‘confidential information’). 

9 ‘‘(ii) RECIPIENTS OF INFORMATION.— 

10 The persons described in this clause are the 

11 following: 

12 ‘‘(I) OUTSIDE COUNSEL.—One or 

13 more attorneys designated by the ref14 erence product sponsor who are em15 ployees of an entity other than the ref16 erence product sponsor (referred to in 

17 this paragraph as the ‘outside coun18 sel’), provided that such attorneys do 

19 not engage, formally or informally, in 

20 patent prosecution relevant or related 

21 to the reference product. 

22 ‘‘(II) IN-HOUSE COUNSEL.—One 

23 attorney that represents the reference 

24 product sponsor who is an employee of 

25 the reference product sponsor, provided 


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1 that such attorney does not engage, for2 mally or informally, in patent prosecu3 tion relevant or related to the reference 

4 product. 

5 ‘‘(iii) PATENT OWNER ACCESS.—A rep6 resentative of the owner of a patent exclu7 sively licensed to a reference product spon8 sor with respect to the reference product and 

9 who has retained a right to assert the pat10 ent or participate in litigation concerning 

11 the patent may be provided the confidential 

12 information, provided that the representa13 tive informs the reference product sponsor 

14 and the subsection (k) applicant of his or 

15 her agreement to be subject to the confiden16 tiality provisions set forth in this para17 graph, including those under clause (ii). 

18 ‘‘(C) LIMITATION ON DISCLOSURE.—No per19 son that receives confidential information pursu20 ant to subparagraph (B) shall disclose any con21 fidential information to any other person or en22 tity, including the reference product sponsor em23 ployees, outside scientific consultants, or other 

24 outside counsel retained by the reference product 

25 sponsor, without the prior written consent of the 


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1 subsection (k) applicant, which shall not be un2 reasonably withheld. 

3 ‘‘(D) USE OF CONFIDENTIAL INFORMA4 TION.—Confidential information shall be used 

5 for the sole and exclusive purpose of determining, 

6 with respect to each patent assigned to or exclu7 sively licensed by the reference product sponsor, 

8 whether a claim of patent infringement could 

9 reasonably be asserted if the subsection (k) appli10 cant engaged in the manufacture, use, offering 

11 for sale, sale, or importation into the United 

12 States of the biological product that is the subject 

13 of the application under subsection (k). 

14 ‘‘(E) OWNERSHIP OF CONFIDENTIAL INFOR15 MATION.—The confidential information disclosed 

16 under this paragraph is, and shall remain, the 

17 property of the subsection (k) applicant. By pro18 viding the confidential information pursuant to 

19 this paragraph, the subsection (k) applicant does 

20 not provide the reference product sponsor or the 

21 outside counsel any interest in or license to use 

22 the confidential information, for purposes other 

23 than those specified in subparagraph (D). 

24 ‘‘(F) EFFECT OF INFRINGEMENT ACTION.— 

25 In the event that the reference product sponsor 


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1 files a patent infringement suit, the use of con2 fidential information shall continue to be gov3 erned by the terms of this paragraph until such 

4 time as a court enters a protective order regard5 ing the information. Upon entry of such order, 

6 the subsection (k) applicant may redesignate 

7 confidential information in accordance with the 

8 terms of that order. No confidential information 

9 shall be included in any publicly-available com10 plaint or other pleading. In the event that the 

11 reference product sponsor does not file an in12 fringement action by the date specified in para13 graph (6), the reference product sponsor shall re14 turn or destroy all confidential information re15 ceived under this paragraph, provided that if the 

16 reference product sponsor opts to destroy such in17 formation, it will confirm destruction in writing 

18 to the subsection (k) applicant. 

19 ‘‘(G) RULE OF CONSTRUCTION.—Nothing in 

20 this paragraph shall be construed— 

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

22 (k) applicant regarding the validity, en23 forceability, or infringement of any patent; 

24 or 


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1 ‘‘(ii) an agreement or admission by the 

2 subsection (k) applicant with respect to the 

3 competency, relevance, or materiality of any 

4 confidential information. 

5 ‘‘(H) EFFECT OF VIOLATION.—The disclo6 sure of any confidential information in violation 

7 of this paragraph shall be deemed to cause the 

8 subsection (k) applicant to suffer irreparable 

9 harm for which there is no adequate legal rem10 edy and the court shall consider immediate in11 junctive relief to be an appropriate and nec12 essary remedy for any violation or threatened 

13 violation of this paragraph. 

14 ‘‘(2) SUBSECTION (k) APPLICATION INFORMA15 TION.—Not later than 20 days after the Secretary no16 tifies the subsection (k) applicant that the application 

17 has been accepted for review, the subsection (k) appli18 cant— 

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

20 sponsor a copy of the application submitted to 

21 the Secretary under subsection (k), and such 

22 other information that describes the process or 

23 processes used to manufacture the biological 

24 product that is the subject of such application; 

25 and 


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

2 sponsor additional information requested by or 

3 on behalf of the reference product sponsor. 

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

5 ‘‘(A) LIST BY REFERENCE PRODUCT SPON6 SOR.—Not later than 60 days after the receipt of 

7 the application and information under para8 graph (2), the reference product sponsor shall 

9 provide to the subsection (k) applicant— 

10 ‘‘(i) a list of patents for which the ref11 erence product sponsor believes a claim of 

12 patent infringement could reasonably be as13 serted by the reference product sponsor, or 

14 by a patent owner that has granted an ex15 clusive license to the reference product spon16 sor with respect to the reference product, if 

17 a person not licensed by the reference prod18 uct sponsor engaged in the making, using, 

19 offering to sell, selling, or importing into 

20 the United States of the biological product 

21 that is the subject of the subsection (k) ap22 plication; and 

23 ‘‘(ii) an identification of the patents 

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1 sor would be prepared to license to the sub2 section (k) applicant. 

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

5 after receipt of the list under subparagraph (A), 

6 the subsection (k) applicant— 

7 ‘‘(i) may provide to the reference prod8 uct sponsor a list of patents to which the 

9 subsection (k) applicant believes a claim of 

10 patent infringement could reasonably be as11 serted by the reference product sponsor if a 

12 person not licensed by the reference product 

13 sponsor engaged in the making, using, offer14 ing to sell, selling, or importing into the 

15 United States of the biological product that 

16 is the subject of the subsection (k) applica17 tion; 

18 ‘‘(ii) shall provide to the reference 

19 product sponsor, with respect to each patent 

20 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 commer4 cial marketing of the biological product 

5 that is the subject of the subsection (k) 

6 application; or 

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

9 begin commercial marketing of the bio10 logical 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 re18 ceipt of the list and statement under subpara19 graph (B), the reference product sponsor shall 

20 provide to the subsection (k) applicant a detailed 

21 statement that describes, with respect to each 

22 patent described in subparagraph (B)(ii)(I), on 

23 a claim by claim basis, the factual and legal 

24 basis of the opinion of the reference product 

25 sponsor that such patent will be infringed by the 


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1 commercial marketing of the biological product 

2 that is the subject of the subsection (k) applica3 tion and a response to the statement concerning 

4 validity and enforceability provided under sub5 paragraph (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 sponsor 

10 and the subsection (k) applicant shall engage in 

11 good faith negotiations to agree on which, if any, 

12 patents listed under paragraph (3) by the sub13 section (k) applicant or the reference product 

14 sponsor shall be the subject of an action for pat15 ent infringement under paragraph (6). 

16 ‘‘(B) FAILURE TO REACH AGREEMENT.—If, 

17 within 15 days of beginning negotiations under 

18 subparagraph (A), the subsection (k) applicant 

19 and the reference product sponsor fail to agree on 

20 a final and complete list of which, if any, pat21 ents listed under paragraph (3) by the subsection 

22 (k) applicant or the reference product sponsor 

23 shall be the subject of an action for patent in24 fringement under paragraph (6), the provisions 

25 of paragraph (5) shall apply to the parties. 


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1 ‘‘(5) PATENT RESOLUTION IF NO AGREEMENT.— 

2 ‘‘(A) NUMBER OF PATENTS.—The subsection 

3 (k) applicant shall notify the reference product 

4 sponsor of the number of patents that such appli5 cant will provide to the reference product sponsor 

6 under subparagraph (B)(i)(I). 

7 ‘‘(B) EXCHANGE OF PATENT LISTS.— 

8 ‘‘(i) IN GENERAL.—On a date agreed 

9 to by the subsection (k) applicant and the 

10 reference product sponsor, but in no case 

11 later than 5 days after the subsection (k) 

12 application notifies the reference product 

13 sponsor under subparagraph (A), the sub14 section (k) applicant and the reference prod15 uct sponsor shall simultaneously exchange— 

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

17 subsection (k) applicant believes should 

18 be the subject of an action for patent 

19 infringement under paragraph (6); 

20 and 

21 ‘‘(II) the list of patents, in accord22 ance with clause (ii), that the reference 

23 product sponsor believes should be the 

24 subject of an action for patent in25 fringement under paragraph (6). 


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1 ‘‘(ii) NUMBER OF PATENTS LISTED BY

2 REFERENCE PRODUCT SPONSOR.— 

3 ‘‘(I) IN GENERAL.—Subject to 

4 subclause (II), the number of patents 

5 listed by the reference product sponsor 

6 under clause (i)(II) may not exceed the 

7 number of patents listed by the sub8 section (k) applicant under clause 

9 (i)(I). 

10 ‘‘(II) EXCEPTION.—If a subsection 

11 (k) applicant does not list any patent 

12 under clause (i)(I), the reference prod13 uct sponsor may list 1 patent under 

14 clause (i)(II). 

15 ‘‘(6) IMMEDIATE PATENT INFRINGEMENT AC16 TION.— 

17 ‘‘(A) ACTION IF AGREEMENT ON PATENT

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

19 reference product sponsor agree on patents as de20 scribed in paragraph (4), not later than 30 days 

21 after such agreement, the reference product spon22 sor shall bring an action for patent infringement 

23 with respect to each such patent. 

24 ‘‘(B) ACTION IF NO AGREEMENT ON PATENT

25 LIST.—If the provisions of paragraph (5) apply 


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1 to the parties as described in paragraph (4)(B), 

2 not later than 30 days after the exchange of lists 

3 under paragraph (5)(B), the reference product 

4 sponsor shall bring an action for patent in5 fringement with respect to each patent that is in6 cluded on such lists. 

7 ‘‘(C) NOTIFICATION AND PUBLICATION OF

8 COMPLAINT.— 

9 ‘‘(i) NOTIFICATION TO SECRETARY.— 

10 Not later than 30 days after a complaint is 

11 served to a subsection (k) applicant in an 

12 action for patent infringement described 

13 under this paragraph, the subsection (k) ap14 plicant shall provide the Secretary with no15 tice and a copy of such complaint. 

16 ‘‘(ii) PUBLICATION BY SECRETARY.— 

17 The Secretary shall publish in the Federal 

18 Register notice of a complaint received 

19 under clause (i). 

20 ‘‘(7) NEWLY ISSUED OR LICENSED PATENTS.—In 

21 the case of a patent that— 

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

23 the reference product sponsor after the date that 

24 the reference product sponsor provided the list to 


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1 the subsection (k) applicant under paragraph 

2 (3)(A); and 

3 ‘‘(B) the reference product sponsor reason4 ably believes that, due to the issuance of such 

5 patent, a claim of patent infringement could rea6 sonably be asserted by the reference product 

7 sponsor if a person not licensed by the reference 

8 product sponsor engaged in the making, using, 

9 offering to sell, selling, or importing into the 

10 United States of the biological product that is 

11 the subject of the subsection (k) application, 

12 not later than 30 days after such issuance or licens13 ing, the reference product sponsor shall provide to the 

14 subsection (k) applicant a supplement to the list pro15 vided by the reference product sponsor under para16 graph (3)(A) that includes such patent, not later than 

17 30 days after such supplement is provided, the sub18 section (k) applicant shall provide a statement to the 

19 reference product sponsor in accordance with para20 graph (3)(B), and such patent shall be subject to 

21 paragraph (8). 

22 ‘‘(8) NOTICE OF COMMERCIAL MARKETING AND

23 PRELIMINARY INJUNCTION.— 

24 ‘‘(A) NOTICE OF COMMERCIAL MAR25 KETING.—The subsection (k) applicant shall proVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6203 E:\BILLS\S1695.RS S1695

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1 vide notice to the reference product sponsor not 

2 later than 180 days before the date of the first 

3 commercial marketing of the biological product 

4 licensed under subsection (k). 

5 ‘‘(B) PRELIMINARY INJUNCTION.—After re6 ceiving the notice under subparagraph (A) and 

7 before such date of the first commercial mar8 keting of such biological product, the reference 

9 product sponsor may seek a preliminary injunc10 tion prohibiting the subsection (k) applicant 

11 from engaging in the commercial manufacture or 

12 sale of such biological product until the court de13 cides the issue of patent validity, enforcement, 

14 and infringement with respect to any patent that 

15 is— 

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

17 the reference product sponsor under para18 graph (3)(A) or in the list provided by the 

19 subsection (k) applicant under paragraph 

20 (3)(B); and 

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

22 ‘‘(I) the list of patents described 

23 in paragraph (4); or 

24 ‘‘(II) the lists of patents described 

25 in paragraph (5)(B). 


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

2 reference product sponsor has sought a prelimi3 nary injunction under subparagraph (B), the 

4 reference product sponsor and the subsection (k) 

5 applicant shall reasonably cooperate to expedite 

6 such further discovery as is needed in connection 

7 with the preliminary injunction motion. 

8 ‘‘(9) LIMITATION ON DECLARATORY JUDGMENT

9 ACTION.— 

10 ‘‘(A) SUBSECTION (k) APPLICATION PRO11 VIDED.—If a subsection (k) applicant provides 

12 the application and information required under 

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

14 sponsor nor the subsection (k) applicant may, 

15 prior to the date notice is received under para16 graph (8)(A), bring any action under section 

17 2201 of title 28, United States Code, for a dec18 laration of infringement, validity, or enforce19 ability of any patent that is described in clauses 

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

21 ‘‘(B) SUBSEQUENT FAILURE TO ACT BY

22 SUBSECTION (k) APPLICANT.—If a subsection (k) 

23 applicant fails to complete an action required of 

24 the subsection (k) applicant under paragraph 

25 (3)(B)(ii), paragraph (5), paragraph (6)(C)(i), 


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1 paragraph (7), or paragraph (8)(A), the ref2 erence product sponsor, but not the subsection (k) 

3 applicant, may bring an action under section 

4 2201 of title 28, United States Code, for a dec5 laration of infringement, validity, or enforce6 ability of any patent included in the list de7 scribed in paragraph (3)(A), including as pro8 vided under paragraph (7). 

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

10 PROVIDED.—If a subsection (k) applicant fails to 

11 provide the application and information re12 quired under paragraph (2)(A), the reference 

13 product sponsor, but not the subsection (k) appli14 cant, may bring an action under section 2201 of 

15 title 28, United States Code, for a declaration of 

16 infringement, validity, or enforceability of any 

17 patent that claims the biological product or a use 

18 of the biological product.’’. 

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

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

21 (1) by striking ‘‘In this section, the term ‘biologi22 cal product’ means’’ and inserting the following: ‘‘In 

23 this section: 

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


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1 (2) in paragraph (1), as so designated, by insert2 ing ‘‘protein (except any chemically synthesized 

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

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

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

6 reference to a biological product that is the subject of 

7 an application under subsection (k), means— 

8 ‘‘(A) that the biological product is highly 

9 similar to the reference product notwithstanding 

10 minor differences in clinically inactive compo11 nents; and 

12 ‘‘(B) there are no clinically meaningful dif13 ferences between the biological product and the 

14 reference product in terms of the safety, purity, 

15 and potency of the product. 

16 ‘‘(3) The term ‘interchangeable’ or ‘interchange17 ability’, in reference to a biological product that is 

18 shown to meet the standards described in subsection 

19 (k)(4), means that the biological product may be sub20 stituted for the reference product without the interven21 tion of the health care provider who prescribed the 

22 reference product. 

23 ‘‘(4) The term ‘reference product’ means the sin24 gle biological product licensed under subsection (a) 


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1 against which a biological product is evaluated in an 

2 application submitted under subsection (k).’’. 

3 (c) CONFORMING AMENDMENTS RELATING TO PAT4 ENTS.— 

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

6 States Code, is amended— 

7 (A) in paragraph (2)— 

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

9 ‘‘or’’ at the end; 

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

11 ‘‘or’’ at the end; and 

12 (iii) by inserting after subparagraph 

13 (B) the following: 

14 ‘‘(C)(i) with respect to a patent that is identified 

15 in the list of patents described in section 351(l)(3) of 

16 the Public Health Service Act (including as provided 

17 under section 351(l)(7) of such Act), an application 

18 seeking approval of a biological product, or 

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

20 provide the application and information required 

21 under section 351(l)(2)(A) of such Act, an application 

22 seeking approval of a biological product for a patent 

23 that could be identified pursuant to section 

24 351(l)(3)(A)(i) of such Act,’’; and 


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1 (iv) in the matter following subpara2 graph (C) (as added by clause (iii)), by 

3 striking ‘‘or veterinary biological product’’ 

4 and inserting ‘‘, veterinary biological prod5 uct, or biological product’’; 

6 (B) in paragraph (4)— 

7 (i) in subparagraph (B), by— 

8 (I) striking ‘‘or veterinary biologi9 cal product’’ and inserting ‘‘, veteri10 nary biological product, or biological 

11 product’’; and 

12 (II) striking ‘‘and’’ at the end; 

13 (ii) in subparagraph (C), by— 

14 (I) striking ‘‘or veterinary biologi15 cal product’’ and inserting ‘‘, veteri16 nary biological product, or biological 

17 product’’; and 

18 (II) striking the period and in19 serting ‘‘, and’’; 

20 (iii) by inserting after subparagraph 

21 (C) the following: 

22 ‘‘(D) the court shall order a permanent injunc23 tion prohibiting any infringement of the patent by 

24 the biological product involved in the infringement 

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


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1 expiration of the patent that has been infringed under 

2 paragraph (2)(C), provided the patent is the subject 

3 of a final court decision, as defined in section 

4 351(k)(6) of the Public Health Service Act, in an ac5 tion for infringement of the patent under section 

6 351(l)(6) of such Act, and the biological product has 

7 not yet been approved because of section 351(k)(7) of 

8 such Act.’’; and 

9 (iv) in the matter following subpara10 graph (D) (as added by clause (iii)), by 

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

12 (D)’’; and 

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

14 ‘‘(6)(A) Subparagraph (B) applies, in lieu of para15 graph (4), in the case of a patent— 

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

17 of patents described in section 351(l)(4) of the Public 

18 Health Service Act or the lists of patents described in 

19 section 351(l)(5)(B) of such Act with respect to a bio20 logical product; and 

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

22 patent with respect to the biological product— 

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

24 30-day period described in subparagraph (A) or 


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1 (B), as applicable, of section 351(l)(6) of such 

2 Act; or 

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

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

5 which was dismissed without prejudice or was 

6 not prosecuted to judgment in good faith. 

7 ‘‘(B) In an action for infringement of a patent de8 scribed in subparagraph (A), the sole and exclusive remedy 

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

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

11 the United States of the biological product that is the subject 

12 of the action infringed the patent, shall be a reasonable roy13 alty. 

14 ‘‘(C) The owner of a patent that should have been in15 cluded in the list described in section 351(l)(3)(A) of the 

16 Public Health Service Act, including as provided under sec17 tion 351(l)(7) of such Act for a biological product, but was 

18 not timely included in such list, may not bring an action 

19 under this section for infringement of the patent with re20 spect to the biological product.’’. 

21 (2) CONFORMING AMENDMENT UNDER TITLE

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

23 is amended by inserting before the period the fol24 lowing: ‘‘, or section 351 of the Public Health Service 

25 Act’’. 


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1 (d) CONFORMING AMENDMENTS UNDER THE FEDERAL

2 FOOD, DRUG, AND COSMETIC ACT.— 

3 (1) CONTENT AND REVIEW OF APPLICATIONS.— 

4 Section 505(b)(5)(B) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by 

6 inserting before the period at the end of the first sen7 tence the following: ‘‘or, with respect to an applicant 

8 for approval of a biological product under section 

9 351(k) of the Public Health Service Act, any nec10 essary clinical study or studies’’. 

11 (2) NEW ACTIVE INGREDIENT.—Section 505B of 

12 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 355c) is amended by adding at the end the following: 

14 ‘‘(i) NEW ACTIVE INGREDIENT.— 

15 ‘‘(1) NON-INTERCHANGEABLE BIOSIMILAR BIO16 LOGICAL PRODUCT.—A biological product that is bio17 similar to a reference product under section 351 of the 

18 Public Health Service Act, and that the Secretary has 

19 not determined to meet the standards described in 

20 subsection (k)(4) of such section for interchangeability 

21 with the reference product, shall be considered to have 

22 a new active ingredient under this section. 

23 ‘‘(2) INTERCHANGEABLE BIOSIMILAR BIOLOGICAL

24 PRODUCT.—A biological product that is interchange25 able with a reference product under section 351 of the 


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1 Public Health Service Act shall not be considered to 

2 have a new active ingredient under this section.’’. 

3 (e) PRODUCTS PREVIOUSLY APPROVED UNDER SEC4 TION 505.— 

5 (1) REQUIREMENT TO FOLLOW SECTION 351.— 

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

7 for a biological product shall be submitted under sec8 tion 351 of the Public Health Service Act (42 U.S.C. 

9 262) (as amended by this Act). 

10 (2) EXCEPTION.—An application for a biological 

11 product may be submitted under section 505 of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 355) if— 

14 (A) such biological product is in a product 

15 class for which a biological product in such 

16 product class is the subject of an application ap17 proved under such section 505 not later than the 

18 date of enactment of this Act; and 

19 (B) such application— 

20 (i) has been submitted to the Secretary 

21 of Health and Human Services (referred to 

22 in this Act as the ‘‘Secretary’’) before the 

23 date of enactment of this Act; or 


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1 (ii) is submitted to the Secretary not 

2 later than the date that is 10 years after the 

3 date of enactment of this Act. 

4 (3) LIMITATION.—Notwithstanding paragraph 

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

6 be submitted under section 505 of the Federal Food, 

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

8 another biological product approved under subsection 

9 (a) of section 351 of the Public Health Service Act 

10 that could be a reference product with respect to such 

11 application (within the meaning of such section 351) 

12 if such application were submitted under subsection 

13 (k) of such section 351. 

14 (4) DEEMED APPROVED UNDER SECTION 351.— 

15 An approved application for a biological product 

16 under section 505 of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 355) shall be deemed to be 

18 a license for the biological product under such section 

19 351 on the date that is 10 years after the date of en20 actment of this Act. 

21 (5) DEFINITIONS.—For purposes of this sub22 section, the term ‘‘biological product’’ has the mean23 ing given such term under section 351 of the Public 

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

25 this Act). 


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

2 (1) DEVELOPMENT OF USER FEES FOR BIO3 SIMILAR BIOLOGICAL PRODUCTS.— 

4 (A) IN GENERAL.—Beginning not later than 

5 October 1, 2010, the Secretary shall develop rec6 ommendations to present to Congress with re7 spect to the goals, and plans for meeting the 

8 goals, for the process for the review of biosimilar 

9 biological product applications submitted under 

10 section 351(k) of the Public Health Service Act 

11 (as added by this Act) for the first 5 fiscal years 

12 after fiscal year 2012. In developing such rec13 ommendations, the Secretary shall consult 

14 with— 

15 (i) the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate; 

17 (ii) the Committee on Energy and 

18 Commerce of the House of Representatives; 

19 (iii) scientific and academic experts; 

20 (iv) health care professionals; 

21 (v) representatives of patient and con22 sumer advocacy groups; and 

23 (vi) the regulated industry. 


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1 (B) PUBLIC REVIEW OF RECOMMENDA2 TIONS.—After negotiations with the regulated in3 dustry, the Secretary shall— 

4 (i) present the recommendations devel5 oped under subparagraph (A) to the Con6 gressional committees specified in such sub7 paragraph; 

8 (ii) publish such recommendations in 

9 the Federal Register; 

10 (iii) provide for a period of 30 days for 

11 the public to provide written comments on 

12 such recommendations; 

13 (iv) hold a meeting at which the public 

14 may present its views on such recommenda15 tions; and 

16 (v) after consideration of such public 

17 views and comments, revise such rec18 ommendations as necessary. 

19 (C) TRANSMITTAL OF RECOMMENDA20 TIONS.—Not later than January 15, 2012, the 

21 Secretary shall transmit to Congress the revised 

22 recommendations under subparagraph (B), a 

23 summary of the views and comments received 

24 under such subparagraph, and any changes 


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1 made to the recommendations in response to such 

2 views and comments. 

3 (2) ESTABLISHMENT OF USER FEE PROGRAM.— 

4 It is the sense of the Senate that, based on the rec5 ommendations transmitted to Congress by the Sec6 retary pursuant to paragraph (1)(C), Congress should 

7 authorize a program, effective on October 1, 2012, for 

8 the collection of user fees relating to the submission of 

9 biosimilar biological product applications under sec10 tion 351(k) of the Public Health Service Act (as 

11 added by this Act). 

12 (3) TRANSITIONAL PROVISIONS FOR USER FEES

13 FOR BIOSIMILAR BIOLOGICAL PRODUCTS.— 

14 (A) APPLICATION OF THE PRESCRIPTION

15 DRUG USER FEE PROVISIONS.—Section 

16 735(1)(C) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 379g(1)(C)) is amended by 

18 striking ‘‘section 351’’ and inserting ‘‘subsection 

19 (a) or (k) of section 351’’. 

20 (B) EVALUATION OF COSTS OF REVIEWING

21 BIOSIMILAR BIOLOGICAL PRODUCT APPLICA22 TIONS.—During the period beginning on the date 

23 of enactment of this Act and ending on October 

24 1, 2010, the Secretary shall collect and evaluate 

25 data regarding the costs of reviewing applicaVerDate Aug 31 2005 23:31 Nov 19, 2008 Jkt 079200 PO 00000 Frm 00081 Fmt 6652 Sfmt 6203 E:\BILLS\S1695.RS S1695

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1 tions for biological products submitted under sec2 tion 351(k) of the Public Health Service Act (as 

3 added by this Act) during such period. 

4 (C) AUDIT.— 

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

6 2 years after first receiving a user fee appli7 cable to an application for a biological 

8 product under section 351(k) of the Public 

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

10 and on a biennial basis thereafter until Oc11 tober 1, 2013, the Secretary shall perform 

12 an audit of the costs of reviewing such ap13 plications under such section 351(k). Such 

14 an audit shall compare— 

15 (I) the costs of reviewing such ap16 plications under such section 351(k) to 

17 the amount of the user fee applicable to 

18 such applications; and 

19 (II)(aa) such ratio determined 

20 under subclause (I); to 

21 (bb) the ratio of the costs of re22 viewing applications for biological 

23 products under section 351(a) of such 

24 Act (as amended by this Act) to the 

25 amount of the user fee applicable to 


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1 such applications under such section 

2 351(a). 

3 (ii) ALTERATION OF USER FEE.—If the 

4 audit performed under clause (i) indicates 

5 that the ratios compared under subclause 

6 (II) of such clause differ by more than 5 

7 percent, then the Secretary shall alter the 

8 user fee applicable to applications sub9 mitted under such section 351(k) to more 

10 appropriately account for the costs of re11 viewing such applications. 

12 (iii) ACCOUNTING STANDARDS.—The 

13 Secretary shall perform an audit under 

14 clause (i) in conformance with the account15 ing principles, standards, and requirements 

16 prescribed by the Comptroller General of the 

17 United States under section 3511 of title 31, 

18 United State Code, to ensure the validity of 

19 any potential variability. 

20 (4) AUTHORIZATION OF APPROPRIATIONS.— 

21 There is authorized to be appropriated to carry out 

22 this subsection such sums as may be necessary for 

23 each of fiscal years 2008 through 2012. 

24 (g) ALLOCATION OF SAVINGS; SPECIAL RESERVE

25 FUND.— 


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1 (1) DETERMINATION OF SAVINGS.—The Sec2 retary of the Treasury, in consultation with the Sec3 retary, shall for each fiscal year determine the 

4 amount of the savings to the Federal Government as 

5 a result of the enactment of this Act and shall trans6 fer such amount to the Fund established under para7 graph (2) pursuant to a relevant appropriations Act. 

8 (2) SPECIAL RESERVE FUND.— 

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

10 the Treasury of the United States a fund to be 

11 designated as the ‘‘Biological Product Savings 

12 Fund’’ to be made available to the Secretary 

13 without fiscal year limitation. 

14 (B) USE OF FUND.—The amounts made 

15 available to the Secretary through the Fund 

16 under subparagraph (A) shall be expended on ac17 tivities authorized under the Public Health Serv18 ice Act. 

19 (3) AUTHORIZATION OF APPROPRIATIONS.— 

20 There is authorized to be appropriated for each fiscal 

21 year to the Fund established under paragraph (2), the 

22 amount of the savings determined for such fiscal year 

23 under paragraph (1). 

24 (h) GOVERNMENT ACCOUNTABILITY OFFICE STUDY.— 


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1 (1) IN GENERAL.—Not later than 3 years after 

2 the date of enactment of this Act, the Comptroller 

3 General of the United States shall study and report 

4 to Congress regarding— 

5 (A) the extent to which pediatric studies of 

6 biological products are being required under the 

7 Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 301 et seq.); and 

9 (B) any pediatric needs not being met 

10 under existing authority. 

11 (2) CONTENT OF STUDY.—The study under para12 graph (1) shall review and assess— 

13 (A) the extent to which pediatric studies of 

14 biological products are required under sub15 sections (a) and (b) of section 505B of the Fed16 eral Food, Drug and Cosmetic Act (21 U.S.C. 

17 355c); 

18 (B) the extent to which pediatric studies of 

19 biological products are required as part of risk 

20 evaluation and mitigation strategies under such 

21 Act; 

22 (C) the number, importance, and 

23 prioritization of any biological products that are 

24 not being tested for pediatric use; and 


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1 (D) recommendations for ensuring pediatric 

2 testing of products identified in subparagraph 

3 (C), including the consideration of any incen4 tives, such as those provided under the Best 

5 Pharmaceuticals for Children Act. 

6 (i) ORPHAN PRODUCTS.—If a reference product, as de7 fined in section 351 of the Public Health Service Act (42 

8 U.S.C. 262) (as amended by this Act) has been designated 

9 under section 526 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 360bb) for a rare disease or condition, a 

11 biological product seeking approval for such disease or con12 dition under subsection (k) of such section 351 as biosimilar 

13 to, or interchangeable with, such reference product may be 

14 licensed by the Secretary only after the expiration for such 

15 reference product of the later of— 

16 (1) the 7-year period described in section 527(a) 

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

18 U.S.C. 360cc(a)); and 

19 (2) the 12-year period described in subsection 

20 (k)(7) of such section 351. 


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Calendar No. 1127 

110TH CONGRESS 

2D SESSION S. 1695 

A BILL 

To amend the Public Health Service Act to estabsciences, and for other purposes. logical products, to promote innovation in the life lish a pathway for the licensure of biosimilar bioNOVEMBER 19, 2008 

Reported with an amendment 


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