I 

111TH CONGRESS 

1ST SESSION H. R. 1548 

To amend the Public Health Service Act to establish a pathway for the 

licensure of biosimilar biological products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 17, 2009 

Ms. ESHOO (for herself, Mr. INSLEE, Mr. BARTON of Texas, Mr. GENE

GREEN of Texas, Ms. BALDWIN, Mr. ROGERS of Michigan, Mrs. BONO

MACK, Mr. HILL, Mr. UPTON, Mr. BARROW, Mr. PITTS, Mr. THOMPSON

of California, Mr. CAPUANO, Mrs. DAVIS of California, Mr. BILBRAY, Mr. 

DREIER, Mr. ELLSWORTH, Mr. MCGOVERN, Mr. HERGER, Mr. DENT, 

Mr. GERLACH, Mr. BISHOP of New York, Ms. ZOE LOFGREN of California, Mr. PENCE, Mr. SOUDER, Mr. HONDA, Mrs. TAUSCHER, Mr. 

SCALISE, Mr. TOWNS, Mr. CROWLEY, Mr. ISSA, Mr. PATRICK J. MURPHY

of Pennsylvania, Ms. BEAN, Mr. DELAHUNT, Mr. SMITH of Washington, 

Mr. MCCARTHY of California, Mr. NEAL of Massachusetts, Mr. LYNCH, 

Mr. DONNELLY of Indiana, Mr. HALL of Texas, Mr. LANCE, Mr. HOLT, 

Mr. NUNES, and Mr. KIND) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to 

the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions 

as fall within the jurisdiction of the committee concerned 

A BILL 

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

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 ‘‘Pathway for 

3 Biosimilars Act’’. 

4 SEC. 2. TABLE OF CONTENTS. 

5 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—AMENDMENTS TO PUBLIC HEALTH SERVICE ACT 

Sec. 101. Approval pathway for biosimilar biological products. 

Sec. 102. Fees relating to biosimilar biological products. 

TITLE II—AMENDMENTS TO PATENT ACT 

Sec. 201. Amendments to certain patent provisions. 

6 TITLE I—AMENDMENTS TO 

7 PUBLIC HEALTH SERVICE ACT 

8 SEC. 101. LICENSURE PATHWAY FOR BIOSIMILAR BIOLOGI9 CAL PRODUCTS. 

10 (a) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO11 SIMILAR OR INTERCHANGEABLE.—Section 351 of the 

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

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

14 this subsection or subsection (k)’’ after ‘‘biologics li15 cense’’; and 

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

17 ‘‘(k) LICENSURE OF BIOLOGICAL PRODUCTS AS BIO18 SIMILAR.— 

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

20 application for licensure of a biological product 

21 under this subsection. 


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1 ‘‘(2) CONTENT.— 

2 ‘‘(A) REQUIRED INFORMATION.—An appli3 cation submitted under this subsection shall in4 clude information demonstrating that— 

5 ‘‘(i) the biological product is bio6 similar to a reference product based upon 

7 data derived from— 

8 ‘‘(I) analytical studies that dem9 onstrate that the biological product is 

10 highly similar to the reference product 

11 notwithstanding minor differences in 

12 clinically inactive components; 

13 ‘‘(II) animal studies (including 

14 the assessment of toxicity); and 

15 ‘‘(III) a clinical study or studies 

16 (including, but not limited to, the as17 sessment of immunogenicity and phar18 macokinetics or pharmacodynamics) 

19 that are sufficient to demonstrate 

20 safety, purity, and potency for each 

21 condition of use for which the ref22 erence product is approved; 

23 ‘‘(ii) the biological product and ref24 erence product utilize the same mechanism 

25 or mechanisms of action for the condition 


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1 or conditions of use prescribed, rec2 ommended, or suggested in the proposed 

3 labeling, but only to the extent the mecha4 nism or mechanisms of action are known 

5 for the reference product; 

6 ‘‘(iii) the condition or conditions of 

7 use prescribed, recommended, or suggested 

8 in the labeling proposed for the biological 

9 product have been previously approved for 

10 the reference product; 

11 ‘‘(iv) the route of administration, the 

12 dosage form, and the strength of the bio13 logical product are the same as those of 

14 the reference product; and 

15 ‘‘(v) the facility in which the biological 

16 product is manufactured, processed, 

17 packed, or held meets standards designed 

18 to assure that the biological product con19 tinues to be safe, pure, and potent. 

20 ‘‘(B) WAIVER REGARDING ANALYTICAL

21 STUDIES, ANIMAL STUDIES, AND CLINICAL

22 STUDIES.— 

23 ‘‘(i) IN GENERAL.—The Secretary 

24 may, in the Secretary’s discretion, deter25 mine that an element described in subVerDate Nov 24 2008 06:01 Mar 18, 2009 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1548.IH H1548

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1 clause (I), (II), or (III) of subparagraph 

2 (A)(i) is unnecessary and waive the re3 quirement that such element be submitted 

4 in an application under this subsection. 

5 ‘‘(ii) ASSESSMENTS OF

6 IMMUNOGENICITY.—Notwithstanding 

7 clause (i), the Secretary may determine 

8 that an assessment of immunogenicity de9 scribed in subparagraph (A)(i)(III) is un10 necessary and waive the requirement that 

11 such an assessment be submitted in an ap12 plication under this subsection only if the 

13 Secretary has published a final guidance, 

14 following receipt and consideration of pub15 lic comments on a draft guidance— 

16 ‘‘(I) advising that it is feasible in 

17 the current state of scientific knowl18 edge to make determinations on 

19 immunogenicity with respect to prod20 ucts in the product class to which the 

21 biological product belongs; and 

22 ‘‘(II) explaining the data that 

23 will be required to support such a de24 termination. 


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1 ‘‘(C) ADDITIONAL INFORMATION.—An ap2 plication submitted under this subsection— 

3 ‘‘(i) shall include publicly available in4 formation regarding the Secretary’s pre5 vious determination that the reference 

6 product is safe, pure, and potent; and 

7 ‘‘(ii) may include any additional infor8 mation in support of the application, in9 cluding publicly available information with 

10 respect to the reference product or another 

11 biological product. 

12 ‘‘(3) EVALUATION BY SECRETARY.—Upon re13 view of an application (or a supplement to an appli14 cation) submitted under this subsection, the Sec15 retary shall approve the application (or the supple16 ment) if— 

17 ‘‘(A) the Secretary determines that the in18 formation submitted in the application (or the 

19 supplement) is sufficient to show that the bio20 logical product is biosimilar to the reference 

21 product with respect to each condition of use 

22 for which the reference product is approved; 

23 and 

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

25 person) consents to the inspection of the facility 


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1 that is the subject of the application, in accord2 ance with subsection (c). 

3 ‘‘(4) SAFETY STANDARDS FOR DETERMINING

4 INTERCHANGEABILITY.— 

5 ‘‘(A) DETERMINATION.—Upon review of 

6 an application submitted under this subsection 

7 or any supplement to such application, the Sec8 retary shall determine the biological product to 

9 be interchangeable with the reference product if 

10 the Secretary determines that the information 

11 submitted in the application (or a supplement 

12 to such application) is sufficient to show that— 

13 ‘‘(i) the biological product— 

14 ‘‘(I) is biosimilar to the reference 

15 product and any biological product li16 censed under this subsection that has 

17 been determined to be interchangeable 

18 with the reference product; and 

19 ‘‘(II) can be expected to produce 

20 the same clinical result as the ref21 erence product in any given patient 

22 for each condition of use prescribed, 

23 recommended, or suggested in the la24 beling of the reference product; and 


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1 ‘‘(ii) for a biological product that is 

2 administered more than once to an indi3 vidual, the risk of alternating or switching 

4 between use of the biological product and 

5 the reference product (in terms of safety, 

6 diminished efficacy, and reduced or en7 hanced potency) is not greater than the 

8 risk of using the reference product without 

9 such alternation or switching. 

10 ‘‘(B) GUIDELINES.—Notwithstanding sub11 paragraph (A), the Secretary may not make a 

12 determination that a biological product licensed 

13 under this subsection is interchangeable with 

14 the reference product unless the Secretary has 

15 published a final guidance, following receipt and 

16 consideration of public comments on a draft 

17 guidance— 

18 ‘‘(i) advising that it is feasible in the 

19 current state of scientific knowledge to 

20 make such determinations with respect to 

21 products in the product class to which that 

22 biological product belongs; and 

23 ‘‘(ii) explaining the data that will be 

24 required to support such a determination. 


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1 ‘‘(C) PRESERVATION OF STATE AUTHOR2 ITY.—Nothing in this subsection shall be con3 strued as preempting or otherwise affecting the 

4 authority of a State to require or regulate pre5 scriptions. 

6 ‘‘(5) GENERAL RULES.— 

7 ‘‘(A) ONE REFERENCE PRODUCT PER AP8 PLICATION.—A biological product, in an appli9 cation submitted under this subsection, may not 

10 be evaluated against more than 1 reference 

11 product. 

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

13 under this subsection shall be reviewed by the 

14 division within the Food and Drug Administra15 tion that is responsible for the review and ap16 proval of the application under which the ref17 erence product is licensed. 

18 ‘‘(C) RISK EVALUATION AND MITIGATION

19 STRATEGIES.—The authority of the Secretary 

20 with respect to risk evaluation and mitigation 

21 strategies under the Federal Food, Drug, and 

22 Cosmetic Act shall apply to biological products 

23 licensed under this subsection in the same man24 ner as such authority applies to biological prod25 ucts licensed under subsection (a). 


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1 ‘‘(D) RESTRICTIONS ON BIOLOGICAL PROD2 UCTS CONTAINING DANGEROUS INGREDI3 ENTS.—If information in an application sub4 mitted under this subsection, in a supplement 

5 to such an application, or otherwise available to 

6 the Secretary shows that a biological product— 

7 ‘‘(i) is, bears, or contains a select 

8 agent or toxin listed in section 73.3 or 

9 73.4 of title 42, section 121.3 or 121.4 of 

10 title 9, or section 331.3 of title 7, Code of 

11 Federal Regulations (or any successor reg12 ulations); or 

13 ‘‘(ii) is, bears, or contains a controlled 

14 substance in schedule I or II of section 

15 202 of the Controlled Substances Act, as 

16 listed in part 1308 of title 21, Code of 

17 Federal Regulations (or any successor reg18 ulations); 

19 the Secretary shall not license the biological 

20 product under this subsection unless the Sec21 retary determines, after consultation with ap22 propriate national security and drug enforce23 ment agencies, that there would be no increased 

24 risk to the security or health of the public from 


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1 licensing such biological product under this sub2 section. 

3 ‘‘(6) EXCLUSIVITY FOR FIRST INTERCHANGE4 ABLE BIOLOGICAL PRODUCT.—The Secretary shall 

5 not make a determination under paragraph (4) that 

6 a second or subsequent biological product is inter7 changeable with the same reference product for 

8 which a prior biological product has received a deter9 mination of interchangeability until 24 months after 

10 the later of— 

11 ‘‘(A) the date of the first commercial mar12 keting of the first biosimilar biological product 

13 determined to be interchangeable for that ref14 erence product; or 

15 ‘‘(B) with respect to a product marketed 

16 before the date the product is determined to be 

17 interchangeable, the date that the product is 

18 determined to be interchangeable. 

19 ‘‘(7) EXCLUSIVITY FOR REFERENCE PROD20 UCT.— 

21 ‘‘(A) EFFECTIVE DATE OF BIOSIMILAR AP22 PLICATION LICENSURE.—Subject to subpara23 graph (D) and paragraph (8), approval of an 

24 application under this subsection may not be 

25 made effective by the Secretary until the date 


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1 that is 12 years after the date on which the ref2 erence product was first licensed under sub3 section (a). 

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

5 under this subsection may not be submitted to 

6 the Secretary until the later of— 

7 ‘‘(i) the date of commencement of a 

8 proceeding for issuance of guidance pursu9 ant to paragraph (9) with respect to the 

10 product class within which the product 

11 that is the subject of such application falls; 

12 or 

13 ‘‘(ii) the date that is 4 years after the 

14 date on which the reference product was 

15 first licensed under subsection (a). 

16 ‘‘(C) FIRST LICENSURE.—For purposes of 

17 this paragraph, the date on which the reference 

18 product was first licensed under subsection (a) 

19 does not include the date of approval of a sup20 plement or of a subsequent application for a 

21 new indication, route of administration, dosage 

22 form, or strength for the previously licensed ref23 erence product. 

24 ‘‘(D) MEDICALLY SIGNIFICANT NEW INDI25 CATION.—If, during the 8-year period following 


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1 licensure of the reference product, the Secretary 

2 approves a supplement to the application for 

3 the reference product that seeks approval to 

4 market the reference product for a new indica5 tion that, if approved, would be a significant 

6 improvement, compared to marketed products, 

7 in the treatment, diagnosis, or prevention of 

8 disease, approval of an application submitted 

9 under this subsection may not be made effective 

10 by the Secretary until the date that is 14 years 

11 after the date on which the reference product 

12 was first licensed under subsection (a). 

13 ‘‘(8) PEDIATRIC STUDIES.— 

14 ‘‘(A) EXCLUSIVITY.—If, before or after li15 censure of the reference product under sub16 section (a) of this section, the Secretary deter17 mines that information relating to the use of 

18 such product in the pediatric population may 

19 produce health benefits in that population, the 

20 Secretary makes a written request for pediatric 

21 studies (which shall include a timeframe for 

22 completing such studies), the applicant or hold23 er of the approved application agrees to the re24 quest, such studies are completed using appro25 priate formulations for each age group for 


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1 which the study is requested within any such 

2 timeframe, and the reports thereof are sub3 mitted and accepted in accordance with section 

4 505A(d)(3) of the Federal Food, Drug, and 

5 Cosmetic Act— 

6 ‘‘(i) the period referred to in para7 graph (7)(A) of this subsection is deemed 

8 to be 12 years and 6 months rather than 

9 12 years; and 

10 ‘‘(ii) if paragraph (7)(D) of this sub11 section applies, the period referred to in 

12 such paragraph is deemed to be 14 years 

13 and 6 months rather than 14 years. 

14 ‘‘(B) EXCEPTION.—The Secretary shall 

15 not extend the period referred to in subpara16 graph (A)(i) or (A)(ii) of this paragraph if the 

17 determination under section 505A(d)(3) of the 

18 Federal Food, Drug, and Cosmetic Act is made 

19 later than 9 months prior to the expiration of 

20 such period. 

21 ‘‘(C) APPLICATION OF CERTAIN PROVI22 SIONS.—The provisions of subsections (a), (d), 

23 (e), (f), (h), (j), (k), and (l) of section 505A of 

24 the Federal Food, Drug, and Cosmetic Act 

25 shall apply with respect to the extension of a 


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1 period under subparagraph (A) of this para2 graph to the same extent and in the same man3 ner as such provisions apply with respect to the 

4 extension of a period under subsection (b) or 

5 (c) of section 505A of the Federal Food, Drug, 

6 and Cosmetic Act. 

7 ‘‘(9) GUIDANCE DOCUMENTS.— 

8 ‘‘(A) IN GENERAL.—The Secretary shall, 

9 after opportunity for public comment, issue 

10 final guidance with respect to the licensure 

11 under this subsection of a biological product or 

12 product class. Such guidance shall be issued in 

13 accordance, except as provided in subparagraph 

14 (B)(i), with section 701(h) of the Federal Food, 

15 Drug, and Cosmetic Act. 

16 ‘‘(B) PUBLIC COMMENT.— 

17 ‘‘(i) IN GENERAL.—Before issuing 

18 final guidance under subparagraph (A), 

19 the Secretary shall publish a proposed 

20 guidance, provide an opportunity for the 

21 public to comment on the proposed guid22 ance, and publish a response to comments 

23 received under this clause. 

24 ‘‘(ii) INPUT REGARDING MOST VALU25 ABLE GUIDANCE.—The Secretary shall esVerDate Nov 24 2008 06:01 Mar 18, 2009 Jkt 079200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H1548.IH H1548

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1 tablish a process through which the public 

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

4 ‘‘(C) CERTAIN PRODUCT CLASSES.— 

5 ‘‘(i) GUIDANCE.—The Secretary may 

6 indicate in a guidance document under 

7 subparagraph (A) that the Secretary will 

8 not license a product or product class (not 

9 including any recombinant protein) under 

10 this subsection because the science and ex11 perience, as of the date of such guidance, 

12 does not allow such licensure. 

13 ‘‘(ii) MODIFICATION OR REVERSAL.— 

14 The Secretary may issue a subsequent 

15 guidance document under subparagraph 

16 (A) to modify or reverse a guidance docu17 ment under clause (i). 

18 ‘‘(D) PETITION FOR INITIATION OF GUID19 ANCE FOR CERTAIN PRODUCTS.—In the case of 

20 a reference product that was licensed by the 

21 Secretary more than 7 years prior to the date 

22 of the enactment of the Pathway for 

23 Biosimilars Act, a person may petition the Sec24 retary at any time to commence the process for 

25 issuing final guidance under subparagraph (A) 


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1 for the product class to which the reference 

2 product belongs. Any such petition shall include 

3 a description of the scientific feasibility and ra4 tionale for the request. For guidance petitioned 

5 under this subparagraph, the Secretary shall, 

6 within 2 years of such petition, issue final guid7 ance with respect to that product class. 

8 ‘‘(E) REQUIREMENT FOR APPLICATION

9 CONSIDERATION.—The Secretary may not ac10 cept an application under this subsection until 

11 the Secretary has initiated a proceeding for 

12 issuance of guidance with respect to the product 

13 class within which the product that is the sub14 ject of the application falls. The Secretary may 

15 not approve an application under this sub16 section until the Secretary has completed the 

17 proceeding for issuance of guidance with re18 spect to the product class within which the 

19 product that is the subject of the application 

20 falls. 

21 ‘‘(F) REQUIREMENT FOR PRODUCT CLASS22 SPECIFIC GUIDANCE.—Product class-specific 

23 guidance issued under subparagraph (A) shall 

24 include a description of— 


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

2 use to determine whether a biological prod3 uct is biosimilar to a reference product in 

4 such product class; 

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

6 Secretary will use to determine whether a 

7 biological product meets the standards for 

8 interchangeability described in paragraph 

9 (4); and 

10 ‘‘(iii) the criteria, if available, that the 

11 Secretary will use to assess 

12 immunogenicity. 

13 ‘‘(10) NAMING.—The Secretary shall ensure 

14 that the labeling and packaging of each biological 

15 product licensed under this subsection bears a name 

16 that uniquely identifies the biological product and 

17 distinguishes it from the reference product and any 

18 other biological products licensed under this sub19 section following evaluation against such reference 

20 product. 

21 ‘‘(l) PATENT NOTICES; RELATIONSHIP TO FINAL AP22 PROVAL.— 

23 ‘‘(1) DEFINITIONS.—For the purposes of this 

24 subsection, the term— 


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1 ‘‘(A) ‘biosimilar product’ means the bio2 logical product that is the subject of the appli3 cation under subsection (k); 

4 ‘‘(B) ‘relevant patent’ means a patent 

5 that— 

6 ‘‘(i) expires after the date specified in 

7 subsection (k)(7)(A) that applies to the 

8 reference product; and 

9 ‘‘(ii) could reasonably be asserted 

10 against the applicant due to the unauthor11 ized making, use, sale, or offer for sale 

12 within the United States, or the importa13 tion into the United States of the bio14 similar product, or materials used in the 

15 manufacture of the biosimilar product, or 

16 due to a use of the biosimilar product in 

17 a method of treatment that is indicated in 

18 the application; 

19 ‘‘(C) ‘reference product sponsor’ means the 

20 holder of an approved application or license for 

21 the reference product; and 

22 ‘‘(D) ‘interested third party’ means a per23 son other than the reference product sponsor 

24 that owns a relevant patent, or has the right to 


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1 commence or participate in an action for in2 fringement of a relevant patent. 

3 ‘‘(2) HANDLING OF CONFIDENTIAL INFORMA4 TION.—Any entity receiving confidential information 

5 pursuant to this subsection shall designate one or 

6 more individuals to receive such information. Each 

7 individual so designated shall execute an agreement 

8 in accordance with regulations promulgated by the 

9 Secretary. The regulations shall require each such 

10 individual to take reasonable steps to maintain the 

11 confidentiality of information received pursuant to 

12 this subsection and use the information solely for 

13 purposes authorized by this subsection. The obliga14 tions imposed on an individual who has received con15 fidential information pursuant to this subsection 

16 shall continue until the individual returns or de17 stroys the confidential information, a court imposes 

18 a protective order that governs the use or handling 

19 of the confidential information, or the party pro20 viding the confidential information agrees to other 

21 terms or conditions regarding the handling or use of 

22 the confidential information. 

23 ‘‘(3) PUBLIC NOTICE BY SECRETARY.—Within 

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1 cation filed under subsection (k), the Secretary shall 

2 publish a notice identifying— 

3 ‘‘(A) the reference product identified in the 

4 application; and 

5 ‘‘(B) the name and address of an agent 

6 designated by the applicant to receive notices 

7 pursuant to paragraph (4)(B). 

8 ‘‘(4) EXCHANGES CONCERNING PATENTS.— 

9 ‘‘(A) EXCHANGES WITH REFERENCE

10 PRODUCT SPONSOR.— 

11 ‘‘(i) Within 30 days of the date of ac12 ceptance of the application by the Sec13 retary, the applicant shall provide the ref14 erence product sponsor with a copy of the 

15 application and information concerning the 

16 biosimilar product and its production. This 

17 information shall include a detailed de18 scription of the biosimilar product, its 

19 method of manufacture, and the materials 

20 used in the manufacture of the product. 

21 ‘‘(ii) Within 60 days of the date of re22 ceipt of the information required to be pro23 vided under clause (i), the reference prod24 uct sponsor shall provide to the applicant 

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1 erence product sponsor, or in respect of 

2 which the reference product sponsor has 

3 the right to commence an action of in4 fringement or otherwise has an interest in 

5 the patent as such patent concerns the bio6 similar product. 

7 ‘‘(iii) If the reference product sponsor 

8 is issued or acquires an interest in a rel9 evant patent after the date on which the 

10 reference product sponsor provides the list 

11 required by clause (ii) to the applicant, the 

12 reference product sponsor shall identify 

13 that patent to the applicant within 30 days 

14 of the date of issue of the patent, or the 

15 date of acquisition of the interest in the 

16 patent, as applicable. 

17 ‘‘(B) EXCHANGES WITH INTERESTED

18 THIRD PARTIES.— 

19 ‘‘(i) At any time after the date on 

20 which the Secretary publishes a notice for 

21 an application under paragraph (3), any 

22 interested third party may provide notice 

23 to the designated agent of the applicant 

24 that the interested third party owns or has 

25 rights under 1 or more patents that may 


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1 be relevant patents. The notice shall iden2 tify at least 1 patent and shall designate 

3 an individual who has executed an agree4 ment in accordance with paragraph (2) to 

5 receive confidential information from the 

6 applicant. 

7 ‘‘(ii) Within 30 days of the date of re8 ceiving notice pursuant to clause (i), the 

9 applicant shall send to the individual des10 ignated by the interested third party the 

11 information specified in subparagraph 

12 (A)(i), unless the applicant and interested 

13 third party otherwise agree. 

14 ‘‘(iii) Within 90 days of the date of 

15 receiving information pursuant to clause 

16 (ii), the interested third party shall provide 

17 to the applicant a list of relevant patents 

18 which the interested third party owns, or 

19 in respect of which the interested third 

20 party has the right to commence or partici21 pate in an action for infringement. 

22 ‘‘(iv) If the interested third party is 

23 issued or acquires an interest in a relevant 

24 patent after the date on which the inter25 ested third party provides the list required 


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1 by clause (iii), the interested third party 

2 shall identify that patent within 30 days of 

3 the date of issue of the patent, or the date 

4 of acquisition of the interest in the patent, 

5 as applicable. 

6 ‘‘(C) IDENTIFICATION OF BASIS FOR IN7 FRINGEMENT.—For any patent identified under 

8 clause (ii) or (iii) of subparagraph (A) or under 

9 clause (iii) or (iv) of subparagraph (B), the ref10 erence product sponsor or the interested third 

11 party, as applicable— 

12 ‘‘(i) shall explain in writing why the 

13 sponsor or the interested third party be14 lieves the relevant patent would be in15 fringed by the making, use, sale, or offer 

16 for sale within the United States, or im17 portation into the United States, of the 

18 biosimilar product or by a use of the bio19 similar product in treatment that is indi20 cated in the application; 

21 ‘‘(ii) may specify whether the relevant 

22 patent is available for licensing; and 

23 ‘‘(iii) shall specify the number and 

24 date of expiration of the relevant patent. 


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1 ‘‘(D) CERTIFICATION BY APPLICANT CON2 CERNING IDENTIFIED RELEVANT PATENTS.— 

3 Not later than 45 days after the date on which 

4 a patent is identified under clause (ii) or (iii) of 

5 subparagraph (A) or under clause (iii) or (iv) of 

6 subparagraph (B), the applicant shall send a 

7 written statement regarding each identified pat8 ent to the party that identified the patent. Such 

9 statement shall either— 

10 ‘‘(i) state that the applicant will not 

11 commence marketing of the biosimilar 

12 product and has requested the Secretary to 

13 not grant final approval of the application 

14 before the date of expiration of the noticed 

15 patent; or 

16 ‘‘(ii) provide a detailed written expla17 nation setting forth the reasons why the 

18 applicant believes— 

19 ‘‘(I) the making, use, sale, or 

20 offer for sale within the United 

21 States, or the importation into the 

22 United States, of the biosimilar prod23 uct, or the use of the biosimilar prod24 uct in a treatment indicated in the apVerDate Nov 24 2008 06:01 Mar 18, 2009 Jkt 079200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H1548.IH H1548

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1 plication, would not infringe the pat2 ent; or 

3 ‘‘(II) the patent is invalid or un4 enforceable. 

5 ‘‘(5) ACTION FOR INFRINGEMENT INVOLVING

6 REFERENCE PRODUCT SPONSOR.—If an action for 

7 infringement concerning a relevant patent identified 

8 by the reference product sponsor under clause (ii) or 

9 (iii) of paragraph (4)(A), or by an interested third 

10 party under clause (iii) or (iv) of paragraph (4)(B), 

11 is brought within 60 days of the date of receipt of 

12 a statement under paragraph (4)(D)(ii), and the 

13 court in which such action has been commenced de14 termines the patent is infringed prior to the date ap15 plicable under subsection (k)(7)(A), (k)(7)(D), or 

16 (k)(8) the Secretary shall make approval of the ap17 plication effective on the day after the date of expi18 ration of the patent that has been found to be in19 fringed. If more than one such patent is found to be 

20 infringed by the court, the approval of the applica21 tion shall be made effective on the day after the date 

22 that the last such patent expires. 

23 ‘‘(6) LIMITATIONS ON ACTIONS FOR DECLARA24 TORY JUDGMENT.—With respect to a patent that is 

25 the subject of an explanation under paragraph 


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1 (4)(D)(ii), no action for a declaratory judgment that 

2 the patent is invalid, unenforceable, or not infringed 

3 may be brought under section 2201 of title 28, 

4 United States Code, by an applicant prior to the 

5 date that is the later of— 

6 ‘‘(A) 3 years prior to the date applicable 

7 under subsection (k)(7)(A); or 

8 ‘‘(B) 120 days after such explanation has 

9 been provided.’’. 

10 (b) PRODUCTS PREVIOUSLY APPROVED UNDER SEC11 TION 505.— 

12 (1) REQUIREMENT TO FOLLOW SECTION 351.— 

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

14 for a biological product shall be submitted under 

15 section 351 of the Public Health Service Act (42 

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

17 (2) EXCEPTION.—An application for a biologi18 cal product may be submitted under section 505 of 

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

20 U.S.C. 355) if— 

21 (A) such biological product is in a product 

22 class for which a biological product in such 

23 product class is the subject of an application 

24 approved under such section 505 not later than 

25 the date of enactment of this Act; and 


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1 (B) such application— 

2 (i) has been submitted to the Sec3 retary of Health and Human Services (re4 ferred to in this Act as the ‘‘Secretary’’) 

5 before the date of enactment of this Act; 

6 or 

7 (ii) is submitted to the Secretary not 

8 later than the date that is 10 years after 

9 the date of enactment of this Act. 

10 (3) LIMITATION.—Notwithstanding paragraph 

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

12 be submitted under section 505 of the Federal Food, 

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

14 another biological product approved under sub15 section (a) of section 351 of the Public Health Serv16 ice Act that could be a reference product with re17 spect to such application (within the meaning of 

18 such section 351) if such application were submitted 

19 under subsection (k) of such section 351. 

20 (4) DEEMED APPROVED UNDER SECTION 351.— 

21 An approved application for a biological product 

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

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

24 a license for the biological product under such secVerDate Nov 24 2008 06:01 Mar 18, 2009 Jkt 079200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H1548.IH H1548

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1 tion 351 on the date that is 10 years after the date 

2 of enactment of this Act. 

3 (5) DEFINITIONS.—For purposes of this sub4 section, the term ‘‘biological product’’ has the mean5 ing given such term under section 351 of the Public 

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

7 this Act). 

8 SEC. 102. FEES RELATING TO BIOSIMILAR BIOLOGICAL 

9 PRODUCTS. 

10 Subparagraph (B) of section 735(1) of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)) is 

12 amended by inserting ‘‘, including licensure of a biological 

13 product under section 351(k) of such Act’’ before the pe14 riod at the end. 

15 TITLE II—AMENDMENTS TO 

16 PATENT ACT 

17 SEC. 201. AMENDMENTS TO CERTAIN PATENT PROVISIONS. 

18 Section 271(e)(2) of title 35, United States Code is 

19 amended— 

20 (1) in subparagraph (A), by striking ‘‘or’’ after 

21 ‘‘patent’’; 

22 (2) in subparagraph (B), by adding ‘‘or’’ after 

23 the comma at the end; and 

24 (3) by inserting the following after subpara25 graph (B): 


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1 ‘‘(C) a statement under section 

2 351(l)(4)(D)(ii) of the Public Health Service 

3 Act,’’. 

Æ 


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