I 

110TH CONGRESS 

1ST SESSION H. R. 1038 

To amend the Public Health Service Act to provide for the licensing of 

comparable and interchangeable biological products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 14, 2007 

Mr. WAXMAN (for himself, Mrs. EMERSON, Mr. PALLONE, Mr. EMANUEL, and 

Ms. HIRONO) 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 provide for 

the licensing of comparable and interchangeable 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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Life-Saving 

5 Medicine Act’’. 

6 SEC. 2. DEFINITIONS. 

7 (a) AMENDMENTS.—Section 351(i) of the Public 

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


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1 (1) by striking ‘‘In this section, the term ‘bio2 logical product’ means’’ and inserting the following: 

3 ‘‘In this section: 

4 ‘‘(1) The term ‘biological product’ means’’; and 

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

6 ‘‘(2) The term ‘abbreviated biological product 

7 application’ means an abbreviated application for a 

8 license of a biological product containing the same, 

9 or similar, active ingredient as a reference product. 

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

11 single licensed biological product, approved under 

12 subsection (a) or subsection (k), against which a bio13 logical product is evaluated for demonstration of 

14 safety, potency, or purity. 

15 ‘‘(4) The term ‘comparable’ or ‘comparability’ 

16 in reference to a biological product means the ab17 sence of clinically meaningful differences between 

18 the biological product and the reference product in 

19 terms of the safety, purity, and potency of the prod20 uct based upon— 

21 ‘‘(A) data derived from chemical, physical, 

22 and biological assays, and other non-clinical 

23 laboratory studies; and 

24 ‘‘(B) data from any necessary clinical 

25 study or studies sufficient to confirm safety, 


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1 purity, and potency in one or more appropriate 

2 conditions of use for which the reference prod3 uct is licensed and intended to be used. 

4 Any studies under subparagraph (B) shall be de5 signed to avoid duplicative and unethical clinical 

6 testing. 

7 ‘‘(5) The terms ‘interchangeable’ and ‘inter8 changeability’ mean, with respect to the condition of 

9 use involved, that the biological product— 

10 ‘‘(A) is comparable to the reference prod11 uct; and 

12 ‘‘(B) can be expected to produce the same 

13 clinical result as the reference product in any 

14 given patient. 

15 ‘‘(6) The term ‘thorough characterization’ 

16 means an analysis of structural features based upon 

17 appropriate analytical and functional testing suffi18 cient to identify differences between a biological 

19 product and reference product relevant to safety, pu20 rity or potency. 

21 ‘‘(7) The term ‘final action’ means, with respect 

22 to an abbreviated biological product application, the 

23 Secretary’s issuance of a final action letter to the 

24 sponsor of an abbreviated biological product applica25 tion which— 


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1 ‘‘(A) approves the application; or 

2 ‘‘(B) disapproves the application and sets 

3 forth in detail an enumeration of the specific 

4 deficiencies in the particular application and of 

5 the specific, enumerated actions the sponsor 

6 would be required to take in order for the spon7 sor to receive a final action letter that approves 

8 such application. 

9 ‘‘(8) The term ‘final action date’ means, with 

10 respect to an abbreviated biological product applica11 tion, the date by which the Secretary must take a 

12 final action on the application pursuant to sub13 section (k)(11). 

14 ‘‘(9) The term ‘reviewing division’ means the 

15 division responsible for the review of an application 

16 for approval of a biological product (including all sci17 entific and medical matters, chemistry, manufac18 turing, and controls).’’. 

19 (b) RULE OF CONSTRUCTION.—Nothing in this Act 

20 or the amendments made by this Act shall be construed 

21 to exclude an application for licensure of a biological prod22 uct under section 351(k) from the definition of a human 

23 drug application in section 735(1)(C) of the Federal Food, 

24 Drug, and Cosmetic Act (21 U.S.C. 379g(1)(C)). 


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1 SEC. 3. REGULATION OF COMPARABLE AND INTERCHANGE2 ABLE BIOLOGICAL PRODUCTS. 

3 (a) IN GENERAL.—Section 351 of the Public Health 

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

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

6 this subsection or subsection (k)’’ after ‘‘biologics li7 cense’’; and 

8 (2) by adding at the end the following sub9 section: 

10 ‘‘(k) REGULATION OF COMPARABLE AND INTER11 CHANGEABLE BIOLOGICAL PRODUCTS.— 

12 ‘‘(1) SUBMISSION OF AN ABBREVIATED BIO13 LOGICAL PRODUCT APPLICATION.—Any person may 

14 file with the Secretary an abbreviated biological 

15 product application. Any such application shall in16 clude the following: 

17 ‘‘(A) Data demonstrating that the biologi18 cal product is comparable to or interchangeable 

19 with the reference product. 

20 ‘‘(B) Data demonstrating that the biologi21 cal product and reference product contain high22 ly similar principal molecular structural fea23 tures, notwithstanding minor differences in het24 erogeneity profile, impurities, or degradation 

25 patterns. The Secretary shall find the following 


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1 types of products to contain highly similar prin2 cipal molecular structural features: 

3 ‘‘(i) Two protein biological products 

4 with differences in structure between them 

5 solely due to post-translational events, infi6 delity of translation or transcription, or 

7 minor differences in amino acid sequence. 

8 ‘‘(ii) Two polysaccharide biological 

9 products with similar saccharide repeating 

10 units, even if the number of units differ 

11 and even if there are differences in post12 polymerization modifications. 

13 ‘‘(iii) Two glycosylated protein prod14 ucts with differences in structure between 

15 them solely due to post-translational 

16 events, infidelity of translation or tran17 scription, or minor differences in amino 

18 acid sequence, and if they had similar sac19 charide repeating units, even if the number 

20 of units differ and even if there were dif21 ferences in post-polymerization modifica22 tions. 

23 ‘‘(iv) Two polynucleotide biological 

24 products with identical sequence of purine 

25 and pyrimidine bases (or their derivatives) 


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1 bound to an identical sugar backbone (ri2 bose, deoxyribose, or modifications of these 

3 sugars). 

4 ‘‘(v) Closely related, complex partly 

5 definable biological products with similar 

6 therapeutic intent, such as two live viral 

7 products for the same indication. 

8 Two biological products not enumerated in the 

9 foregoing clauses may be demonstrated to con10 tain highly similar principal molecular struc11 tural features based upon such data and other 

12 information characterizing the two products as 

13 the Secretary determines to be necessary. 

14 ‘‘(C) Data demonstrating that the biologi15 cal product and reference product utilize the 

16 same mechanism or mechanisms of action for 

17 the condition or conditions of use prescribed, 

18 recommended, or suggested in the proposed la19 beling, but only to the extent the mechanism or 

20 mechanisms of action are known for the ref21 erence product. 

22 ‘‘(D) Information to show that the condi23 tion or conditions of use prescribed, rec24 ommended, or suggested in the labeling proVerDate Aug 31 2005 23:25 Feb 17, 2007 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1038.IH H1038

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1 posed for the biological product have been pre2 viously approved for the reference product. 

3 ‘‘(E) Information to show that the route of 

4 administration, the dosage form, and the 

5 strength of the biological product are the same 

6 as those of the reference product. 

7 ‘‘(F) Data demonstrating that the facility 

8 in which the biological product is manufactured, 

9 processed, packed, or held meets standards de10 signed to assure that the biological product con11 tinues to be safe, pure, and potent. 

12 ‘‘(G) At the applicant’s option, publicly13 available information regarding the Secretary’s 

14 previous determination that the reference prod15 uct is safe, pure, and potent. 

16 ‘‘(H) Any additional data and information 

17 in support of the application, including publicly18 available information with respect to the ref19 erence product or another biological product. 

20 ‘‘(2) OTHER APPLICATIONS.—Any person, in21 cluding a person who has not conducted and does 

22 not have a right of reference to the studies in the 

23 application for a reference product, may submit an 

24 application under this paragraph for a biological 

25 product that differs from, or incorporates a change 


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1 to, the reference product with respect to one or more 

2 characteristics described in subparagraphs (A) 

3 through (E) of paragraph (1), including a difference 

4 in safety, purity, or potency, so long as the applica5 tion contains sufficient information to establish the 

6 safety, purity, and potency of the biological product 

7 relative to the reference product for its proposed 

8 condition or conditions of use. 

9 ‘‘(3) FDA REVIEW OF ABBREVIATED BIOLOGI10 CAL PRODUCT APPLICATIONS.— 

11 ‘‘(A) GUIDANCE REGARDING REVIEW OF

12 APPLICATIONS.—The Secretary shall issue guid13 ance for the individuals who review applications 

14 submitted under paragraph (1) or (2), which 

15 shall relate to promptness in conducting the re16 view, technical excellence, lack of bias and con17 flict of interest, and knowledge of regulatory 

18 and scientific standards, and which shall apply 

19 equally to all individuals who review such appli20 cations. 

21 ‘‘(B) MEETINGS WITH SPONSORS AND AP22 PLICANTS.—The Secretary shall meet with a 

23 sponsor of an investigation or an applicant for 

24 approval of a comparable or interchangeable bi25 ological product under this subsection if the 


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1 sponsor or applicant makes a reasonable writ2 ten request for a meeting for the purpose of 

3 reaching agreement on the design and size of 

4 studies needed for approval of the application. 

5 The sponsor or applicant shall provide informa6 tion necessary for discussion and agreement on 

7 the design and size of such studies. Minutes of 

8 any such meeting shall be prepared by the Sec9 retary and made available to the sponsor or ap10 plicant. 

11 ‘‘(C) AGREEMENTS.—Any agreement re12 garding the parameters of design and size of 

13 the studies of a biological product under this 

14 paragraph that is reached between the Sec15 retary and a sponsor or applicant shall be re16 duced to writing and made part of the adminis17 trative record by the Secretary. Such agreement 

18 shall not be changed after the testing begins, 

19 except— 

20 ‘‘(i) with the written agreement of the 

21 sponsor or applicant; or 

22 ‘‘(ii) pursuant to a decision, made in 

23 accordance with subparagraph (D) by the 

24 director of the reviewing division, that a 

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1 termining the safety, purity, and potency 

2 of the biological product has been identi3 fied after the testing has begun. 

4 ‘‘(D) PROCEDURE REGARDING CERTAIN

5 DECISIONS.—A decision under subparagraph 

6 (C)(ii) by the director shall be in writing and 

7 the Secretary shall provide to the sponsor or 

8 applicant an opportunity for a meeting at which 

9 the director and the sponsor or applicant will be 

10 present and at which the director will document 

11 the scientific issue involved. 

12 ‘‘(E) EFFECT OF DECISIONS.—The written 

13 decisions of the reviewing division shall be bind14 ing upon, and may not directly or indirectly be 

15 changed by, the field or compliance office per16 sonnel unless such field or compliance office 

17 personnel demonstrate to the reviewing division 

18 why such decision should be modified. 

19 ‘‘(F) DELAYS BY REVIEWING DIVISIONS.— 

20 No action by the reviewing division may be de21 layed because of the unavailability of informa22 tion from or action by field personnel unless the 

23 reviewing division determines that a delay is 

24 necessary to assure the marketing of a safe, 

25 pure, and potent biological product. 


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1 ‘‘(4) APPROVAL OF COMPARABLE OR INTER2 CHANGEABLE BIOLOGICAL PRODUCTS.— 

3 ‘‘(A) DETERMINATION OF COM4 PARABILITY.—Upon review of an application 

5 submitted under paragraph (1) or (2) for a bio6 logical product, the Secretary shall issue a com7 parable biological product license for all condi8 tions of use of the reference product sharing 

9 the same mechanism or mechanisms of action 

10 for which the applicant has demonstrated com11 parability for a single condition of use, or, if the 

12 mechanism or mechanisms of action are un13 known, for the condition or conditions of use 

14 for which the data submitted establishes com15 parability, unless the Secretary finds and in16 forms the applicant that— 

17 ‘‘(i) information submitted in the ap18 plication or any other information available 

19 to the Secretary is insufficient to show 

20 that the biological product is comparable 

21 to the reference product for the condition 

22 or conditions of use prescribed, rec23 ommended, or suggested in the labeling 

24 proposed in the application; 


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1 ‘‘(ii) information submitted in the ap2 plication or any other information available 

3 to the Secretary is insufficient to show 

4 that the biological product and the ref5 erence product contain highly similar prin6 cipal molecular structural features, not7 withstanding minor differences in hetero8 geneity profile, impurities, or degradation 

9 patterns; 

10 ‘‘(iii) information submitted in the ap11 plication or any other information available 

12 to the Secretary is insufficient to show 

13 that the biological product and reference 

14 product utilize the same mechanism or 

15 mechanisms of action for the conditions of 

16 use prescribed, recommended, or suggested 

17 in the labeling proposed for the biological 

18 product, unless the mechanism or mecha19 nisms of action are not known for the ref20 erence product for such condition or condi21 tions; 

22 ‘‘(iv) information submitted in the ap23 plication or any other information available 

24 to the Secretary is insufficient to show 

25 that the route of administration, the dosVerDate Aug 31 2005 23:25 Feb 17, 2007 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H1038.IH H1038

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1 age form, and the strength of the biological 

2 product are the same as those of the ref3 erence product; 

4 ‘‘(v) information submitted in the ap5 plication or any other information available 

6 to the Secretary is insufficient to show 

7 that the condition or conditions of use pre8 scribed, recommended, or suggested in the 

9 labeling proposed for the biological product 

10 are limited to one or more of the same use 

11 or uses as have been previously approved 

12 for the reference product; 

13 ‘‘(vi) information submitted in the ap14 plication or any other information available 

15 to the Secretary shows (I) the inactive in16 gredients of the biological product are un17 safe for use under the conditions pre18 scribed, recommended, or suggested in the 

19 labeling proposed for the biological prod20 uct, or (II) the composition of the biologi21 cal product is unsafe under such conditions 

22 because of the type or quantity of inactive 

23 ingredients included or the manner in 

24 which the inactive ingredients are included; 


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1 ‘‘(vii) information submitted in the 

2 application or any other information avail3 able to the Secretary fails to demonstrate 

4 that the facility in which the biological 

5 product is manufactured, processed, 

6 packed, or held meets standards designed 

7 to assure that the biological product con8 tinues to be safe, pure, and potent; 

9 ‘‘(viii) the Secretary has withdrawn or 

10 suspended the license of the reference 

11 product, for safety or effectiveness reasons, 

12 or has published a notice of opportunity 

13 for hearing to withdraw such license for 

14 safety or effectiveness reasons, or the Sec15 retary has determined that the reference 

16 product has been withdrawn from sale for 

17 safety or effectiveness reasons; or 

18 ‘‘(ix) the application contains an un19 true statement of material fact; and 

20 provides the applicant with a detailed expla21 nation for the decision. 

22 ‘‘(B) DETERMINATIONS ON INTERCHANGE23 ABILITY.—Subject to subparagraph (C) and 

24 paragraph (10), upon issuing a product license 

25 for a biological product under subparagraph 


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1 (A), the Secretary shall make and publish one 

2 of the following determinations: 

3 ‘‘(i) Such product is interchangeable 

4 with the reference product for one or more 

5 specified conditions of use prescribed, rec6 ommended, or suggested in the labeling of 

7 the biological product. 

8 ‘‘(ii) Interchangeability has not been 

9 established. 

10 ‘‘(C) DETERMINATION OF INTERCHANGE11 ABILITY OF SUBSEQUENT BIOLOGICAL PROD12 UCT.—If the Secretary determines that an ap13 plication meets the approval requirements of 

14 subparagraph (A), and, prior to the issuance of 

15 a product license, the Secretary has made a de16 termination of interchangeability of another bio17 logical product and the reference product for 

18 which the exclusivity period under paragraph 

19 (10) has not expired, the Secretary shall— 

20 ‘‘(i) issue the product license for the 

21 subsequent biological product; and 

22 ‘‘(ii) defer issuing any determination 

23 of interchangeability as to the subsequent 

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1 uct until the exclusivity period under para2 graph (10) has expired. 

3 ‘‘(5) POSTMARKETING STUDIES FOR APPLICA4 TIONS SUBMITTED UNDER PARAGRAPH (1).—If the 

5 Secretary has agreed with the sponsor of the ref6 erence product, at the time of approval or any time 

7 thereafter, that the sponsor shall conduct one or 

8 more postmarketing safety studies, a person submit9 ting an application for a biological product under 

10 paragraph (1) may agree with the Secretary to con11 duct a similar postmarketing safety study or studies 

12 upon a reasonable showing that such study or stud13 ies would provide relevant information not available 

14 from the studies on the reference product. The Sec15 retary shall not, as a condition of approval, propose 

16 any additional postmarketing studies for such bio17 logical product. 

18 ‘‘(6) DESIGNATION OF OFFICIAL NAME.—If, 

19 pursuant to section 508 of the Federal Food, Drug, 

20 and Cosmetic Act, the Secretary determines that 

21 designation of an official name for a comparable bio22 logical product is necessary or desirable in the inter23 ests of usefulness or simplicity, the Secretary shall 

24 designate the same official name for the comparable 

25 biological product as the Secretary designated for 


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1 the reference product. This paragraph shall not 

2 apply to products approved under paragraph (7). 

3 ‘‘(7) OTHER APPROVAL PROVISIONS.—The Sec4 retary shall approve, under the provisions of para5 graph (4)(A), an application for a license submitted 

6 under paragraph (2), except that the Secretary shall 

7 approve such an application that would otherwise be 

8 disapproved by reason of one or more of subpara9 graphs (A) through (E) of paragraph (4)(A), if the 

10 application and any other information available to 

11 the Secretary are sufficient to establish the safety, 

12 purity, and potency of the comparable biological 

13 product relative to the reference product for the pro14 posed condition or conditions of use for such prod15 uct. 

16 ‘‘(8) ESTABLISHING INTERCHANGEABILITY FOR

17 COMPARABLE BIOLOGICAL PRODUCTS.— 

18 ‘‘(A) IN GENERAL.—In an original applica19 tion or a supplement to an application under 

20 this subsection, an applicant may submit infor21 mation to the Secretary to demonstrate the 

22 interchangeability of a comparable biological 

23 product and the reference product. An applicant 

24 may withdraw an interchangeability submission 

25 at any time. A request for an interchangeability 


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1 determination submitted after the filing of an 

2 application shall be considered a major amend3 ment to the application. Nothing in this sub4 section shall be construed to prohibit the Sec5 retary from making a determination of inter6 changeability at any time after approval. 

7 ‘‘(B) GUIDANCE.—Within one year after 

8 enactment of the Access to Life-Saving Medi9 cine Act, the Secretary shall issue guidance re10 garding standards and requirements for inter11 changeability. The Secretary may make deter12 minations of interchangeability under para13 graph (4)(B) prior to issuing guidance under 

14 this subparagraph. 

15 ‘‘(9) INTERCHANGEABILITY LABELING FOR

16 COMPARABLE BIOLOGICAL PRODUCTS.—Upon a de17 termination of interchangeability, the Secretary, if 

18 requested by the applicant, shall provide for the 

19 label of the comparable biological product to include 

20 a statement that the biological product is inter21 changeable with the reference product for the condi22 tions of use prescribed, recommended, or suggested 

23 in the labeling for which interchangeability has been 

24 established. 

25 ‘‘(10) EXCLUSIVITY.— 


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1 ‘‘(A) IN GENERAL.—Upon review of an ab2 breviated biological product application relying 

3 on the same reference product for which a prior 

4 biological product has received a determination 

5 of interchangeability for any condition of use, 

6 the Secretary shall not make a determination 

7 under paragraph (4)(B) that the second or sub8 sequent biological product is interchangeable for 

9 any condition of use, and no holder of a biologi10 cal product license approved under subsection 

11 (a) shall manufacture, market, sell, or dis12 tribute a rebranded interchangeable biological 

13 product, directly or indirectly, or authorize any 

14 other person to manufacture, market, sell, or 

15 distribute a rebranded interchangeable biologi16 cal product, for any condition of use, until the 

17 earlier of— 

18 ‘‘(i) 180 days after the first commer19 cial marketing of the first interchangeable 

20 comparable biological product to be ap21 proved as interchangeable for that ref22 erence product; 

23 ‘‘(ii) one year after— 

24 ‘‘(I) a final court decision on all 

25 patents in suit in an action instituted 


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1 under paragraph (17)(C) against the 

2 applicant that submitted the applica3 tion for the first approved inter4 changeable comparable biological 

5 product; or 

6 ‘‘(II) the dismissal with or with7 out prejudice of an action instituted 

8 under paragraph (17)(C) against the 

9 applicant that submitted the applica10 tion for the first approved inter11 changeable comparable biological 

12 product; or 

13 ‘‘(iii)(I) 36 months after approval of 

14 the first interchangeable comparable bio15 logical product if the applicant has been 

16 sued under paragraph (17)(C) and such 

17 litigation is still ongoing within such 36- 

18 month period; or 

19 ‘‘(II) one year after approval in the 

20 event that the first approved interchange21 able comparable applicant has not been 

22 sued under paragraph (17)(C). 

23 For purposes of this subparagraph, the term 

24 ‘final court decision’ means a final decision of 

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1 tition to the United States Supreme Court for 

2 a writ of certiorari) has been or can be taken. 

3 ‘‘(B) REBRANDED INTERCHANGEABLE BI4 OLOGICAL PRODUCT.—For purposes of this sub5 section, the term ‘rebranded interchangeable bi6 ological product’— 

7 ‘‘(i) means any rebranded inter8 changeable version of the reference product 

9 involved that the holder of the biological 

10 product license approved under subsection 

11 (a) for that reference product seeks to 

12 commence marketing, selling, or distrib13 uting, directly or indirectly; and 

14 ‘‘(ii) does not include any product to 

15 be marketed, sold, or distributed— 

16 ‘‘(I) by an entity eligible for ex17 clusivity with respect to such product 

18 under this paragraph; or 

19 ‘‘(II) after expiration of any ex20 clusivity with respect to such product 

21 under this paragraph. 

22 ‘‘(11) HEARING.—If the Secretary decides to 

23 disapprove an abbreviated biological product applica24 tion, the Secretary shall give the applicant notice of 

25 an opportunity for a hearing before the Secretary on 


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1 the question of whether such application is approv2 able. If the applicant elects to accept the opportunity 

3 for hearing by written request within thirty days 

4 after such notice, such hearing shall commence not 

5 more than ninety days after the expiration of such 

6 thirty days unless the Secretary and the applicant 

7 otherwise agree. Any such hearing shall thereafter 

8 be conducted on an expedited basis, and the Sec9 retary’s order thereon shall be issued within ninety 

10 days after the date fixed by the Secretary for filing 

11 final briefs. 

12 ‘‘(12) FINAL ACTION DATE.— 

13 ‘‘(A) IN GENERAL.—The Secretary shall 

14 take a final action on an abbreviated biological 

15 product application by the date that is 8 cal16 endar months following the sponsor’s submis17 sion of such application, or 180 days following 

18 the Secretary’s notification to the applicant that 

19 its application has been accepted for filing, 

20 whichever is earlier. 

21 ‘‘(B) EXTENSION.—The final action date 

22 provided by subparagraph (A) with respect to 

23 an application may be extended for such period 

24 of time as is agreed to by the Secretary and the 

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1 ment that is counter-signed by the Secretary 

2 and the applicant no later than 30 days prior 

3 to such date. 

4 ‘‘(13) REQUEST FOR DELAY OF FINAL AC5 TION.—Notwithstanding paragraph (18) or any 

6 other provision of law, the Secretary shall not fail or 

7 refuse to take a final action on an abbreviated bio8 logical product application by the final action date 

9 on the basis that a person, other than the com10 parable biological product applicant, has requested 

11 (in a petition or otherwise) that the Secretary refuse 

12 to take or otherwise defer such final action, and no 

13 court shall enjoin the Secretary from taking final ac14 tion or stay the effect of final action previously 

15 taken by the Secretary, except by issuance of a per16 manent injunction based upon an express finding of 

17 clear and convincing evidence that the person seek18 ing to have the Secretary refuse to take or otherwise 

19 to defer final action by the final action date— 

20 ‘‘(A) has prevailed on the merits of the 

21 person’s complaint against the Secretary; 

22 ‘‘(B) will suffer imminent and actual irrep23 arable injury, constituting more than irrecover24 able economic loss, and that also will threaten 


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1 imminent destruction of such person’s business; 

2 and 

3 ‘‘(C) has an interest that outweighs the 

4 overwhelming interest that the public has in ob5 taining prompt access to a comparable biologi6 cal product. 

7 ‘‘(14) REPORT ON EXTENSIONS OF FINAL AC8 TION DATE.—The Secretary shall prepare and sub9 mit to the President, the Committee on Energy and 

10 Commerce of the House of Representatives, and the 

11 Committee on Health, Education, Labor, and Pen12 sions of the Senate a report regarding any jointly 

13 executed written agreement to extend the final ac14 tion date under this Act within 15 calendar days 

15 after the joint execution of any such written agree16 ment. 

17 ‘‘(15) REPORT ON FAILURE TO TAKE FINAL AC18 TION.—The Secretary shall prepare and submit an19 nually to the President, the Committee on Energy 

20 and Commerce of the House of Representatives, and 

21 the Committee on Health, Education, Labor, and 

22 Pensions of the Senate a report detailing the specific 

23 and particularized reasons enumerated by the re24 viewing division for each instance of the Secretary’s 


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1 failure to take final action by the final action date 

2 in the previous year. 

3 ‘‘(16) REGULATIONS.—The Secretary shall es4 tablish, by regulation within 2 years after the date 

5 of the enactment of this subsection, requirements for 

6 the efficient review, approval, suspension, and rev7 ocation of abbreviated biological product applications 

8 under this subsection. 

9 ‘‘(17) PATENTS.— 

10 ‘‘(A) REQUEST FOR PATENT INFORMA11 TION.— 

12 ‘‘(i) IN GENERAL.—At any time, in13 cluding at the initial stages of develop14 ment, an applicant or a prospective appli15 cant under this subsection may send a 

16 written request for patent information to 

17 the holder of the approved application for 

18 the reference product. The holder of the 

19 approved application for the reference 

20 product shall, not later than 60 days after 

21 the date on which the holder receives the 

22 request, provide to the applicant or pro23 spective applicant a list of all those patents 

24 owned by, or licensed to, the holder of the 

25 approved application that the holder beVerDate Aug 31 2005 23:25 Feb 17, 2007 Jkt 059200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H1038.IH H1038

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1 lieves in good faith relate to the reference 

2 product, including patents that claim the 

3 approved biological product, any method of 

4 using such product, any component of such 

5 product, or any method or process of man6 ufacturing such product or component. 

7 ‘‘(ii) COSTS OF COMPLYING WITH RE8 QUEST.—The application holder may de9 mand payment of not more than $1,000 to 

10 offset the cost of responding to the request 

11 for information. 

12 ‘‘(iii) UPDATES.—For a period of two 

13 years beginning on the date on which the 

14 holder of the approved application for the 

15 reference product receives the request for 

16 information, the holder shall send to the 

17 applicant or prospective applicant updates 

18 of its response to the request for informa19 tion by identifying all relevant patents 

20 issued or licensed to the holder after the 

21 initial response under clause (i). Any such 

22 update must be provided, in the case of a 

23 new patent, not later than 30 days after 

24 the date on which the patent is issued and, 

25 in the case of a license, not later than 30 


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1 days after the date on which the holder ob2 tains the license. 

3 ‘‘(iv) ADDITIONAL REQUESTS.—The 

4 applicant may submit additional requests 

5 for patent information, subject to the re6 quirements of this paragraph, at any time. 

7 ‘‘(B) PATENT NOTIFICATIONS.—At any 

8 time after submitting an application under this 

9 subsection, the applicant may provide a notice 

10 of the application with respect to any one or 

11 more patents identified by the holder of the ref12 erence product pursuant to subparagraph (A). 

13 An applicant may submit additional notices at 

14 any time, and each notice shall be subject to 

15 the provisions of this subparagraph. Each no16 tice shall— 

17 ‘‘(i) be sent to the holder of the ap18 proved application for the reference prod19 uct and to the owner of any patent identi20 fied by the holder pursuant to subpara21 graph (A); 

22 ‘‘(ii) include a detailed statement of 

23 the factual and legal bases for the appli24 cant’s belief that the patents included in 

25 the notice are invalid, are unenforceable, or 


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1 will not be infringed by the commercial 

2 sale of the product for which approval is 

3 being sought under this subsection; and 

4 ‘‘(iii) identify 1 or more judicial dis5 tricts in which the applicant consents to 

6 such suit being brought. 

7 ‘‘(C) ACTION FOR INFRINGEMENT.—With8 in 45 days after the date on which the holder 

9 of the approved application for the reference 

10 product, or the owner of a patent, receives a no11 tice under subparagraph (B), the holder or pat12 ent owner may bring an action for infringement 

13 only with respect to the patent or patents in14 cluded in the notice, and only in a judicial dis15 trict identified pursuant to subparagraph 

16 (B)(iii). 

17 ‘‘(D) LIMITATION ON DECLARATORY JUDG18 MENT ACTIONS.—With respect to any patent re19 lating to a product that is the subject of an ap20 plication under this subsection, the recipient of 

21 a notice under subparagraph (B) with respect 

22 to that application may not, prior to the com23 mercial marketing of the product, bring any ac24 tion under section 2201 of title 28, United 

25 States Code, for a declaration of infringement, 


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1 validity, or enforceability of any such patent 

2 that was not identified in the notice. With re3 spect to any such patent identified in the no4 tice, any such action may, notwithstanding 

5 chapter 87 of title 28, United States Code, be 

6 brought only in a judicial district identified in 

7 the notice. 

8 ‘‘(E) DISCRETION OF APPLICANTS.—An 

9 applicant or prospective applicant for a com10 parable biological product under this subsection 

11 may not be compelled, by court order or other12 wise, to initiate the procedures set forth in this 

13 paragraph. Nothing in this paragraph requires 

14 an applicant or a prospective applicant to in15 voke the procedures set forth in this paragraph. 

16 ‘‘(18) PETITIONS AND CIVIL ACTIONS REGARD17 ING APPROVAL OF CERTAIN APPLICATIONS.— 

18 ‘‘(A) IN GENERAL.—With respect to a 

19 pending application submitted under paragraph 

20 (1) or (2), if a petition is submitted to the Sec21 retary that seeks to have the Secretary take, or 

22 refrain from taking, any form of action relating 

23 to the approval of the application, including a 

24 delay in the effective date of the application, 


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1 the following applies, subject to subparagraph 

2 (E): 

3 ‘‘(i)(I) The Secretary may not, on the 

4 basis of the petition, delay approval of the 

5 application unless the Secretary deter6 mines, within 30 days after receiving the 

7 petition, that a delay is necessary to pro8 tect the public health. Consideration of a 

9 petition shall be separate and apart from 

10 the review and approval of the application. 

11 ‘‘(II) With respect to a determination 

12 by the Secretary under subclause (I) that 

13 a delay is necessary to protect the public 

14 health: 

15 ‘‘(aa) The Secretary shall publish 

16 on the Internet site of the Food and 

17 Drug Administration a statement pro18 viding the reasons underlying the de19 termination. 

20 ‘‘(bb) Not later than 10 days 

21 after making the determination, the 

22 Secretary shall provide notice to the 

23 sponsor of the application and an op24 portunity for a meeting with the ComVerDate Aug 31 2005 23:25 Feb 17, 2007 Jkt 059200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\H1038.IH H1038

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1 missioner to discuss the determina2 tion. 

3 ‘‘(ii) The Secretary shall take final 

4 agency action on the petition not later 

5 than 180 days after the date on which the 

6 petition is submitted. The Secretary shall 

7 not extend such period, even with the con8 sent of the petitioner, for any reason, in9 cluding based upon the submission of com10 ments relating to the petition or supple11 mental information supplied by the peti12 tioner. 

13 ‘‘(iii) The Secretary may not consider 

14 the petition for review unless it is signed 

15 and contains the following verification: ‘I 

16 certify that, to my best knowledge and be17 lief: (a) this petition includes all informa18 tion and views upon which the petition re19 lies; (b) this petition includes representa20 tive data and/or information known to the 

21 petitioner which are unfavorable to the pe22 tition; and (c) I have taken reasonable 

23 steps to ensure that any representative 

24 data and/or information which are unfavor25 able to the petition were disclosed to me. 


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1 I further certify that the information upon 

2 which I have based the action requested 

3 herein first became known to the party on 

4 whose behalf this petition is submitted on 

5 or about the following date: 

6 lllllll. I received or expect to 

7 receive payments, including cash and other 

8 forms of consideration, from the following 

9 persons or organizations to file this peti10 tion: llllllll. I verify under 

11 penalty of perjury that the foregoing is 

12 true and correct.’. 

13 ‘‘(B) EXHAUSTION OF ADMINISTRATIVE

14 REMEDIES.— 

15 ‘‘(i) FINAL AGENCY ACTION WITHIN

16 180 DAYS.—The Secretary shall be consid17 ered to have taken final agency action on 

18 a petition referred to in subparagraph (A) 

19 if— 

20 ‘‘(I) during the 180-day period 

21 referred to in clause (ii) of such sub22 paragraph, the Secretary makes a 

23 final decision within the meaning of 

24 section 10.45(d) of title 21, Code of 


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1 Federal Regulations (or any successor 

2 regulations); or 

3 ‘‘(II) such period expires without 

4 the Secretary having made such a 

5 final decision. 

6 ‘‘(ii) DISMISSAL OF CERTAIN CIVIL

7 ACTIONS.—If a civil action is filed with re8 spect to a petition referred to in subpara9 graph (A) before final agency action within 

10 the meaning of clause (i) has occurred, the 

11 court shall dismiss the action for failure to 

12 exhaust administrative remedies. 

13 ‘‘(C) APPLICABILITY OF CERTAIN REGULA14 TIONS.—The provisions of this section are in 

15 addition to the requirements for the submission 

16 of a petition to the Secretary that apply under 

17 section 10.30 or 10.35 of title 21, Code of Fed18 eral Regulations (or any successor regulations). 

19 ‘‘(D) ANNUAL REPORT ON DELAYS IN AP20 PROVALS PER PETITIONS.—The Secretary shall 

21 annually submit to the Congress a report that 

22 specifies— 

23 ‘‘(i) the number of applications under 

24 this subsection that were approved during 

25 the preceding 12-month period; 


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1 ‘‘(ii) the number of such applications 

2 whose effective dates were delayed by peti3 tions referred to in subparagraph (A) dur4 ing such period; and 

5 ‘‘(iii) the number of days by which the 

6 applications were so delayed. 

7 ‘‘(E) EXCEPTION.—This paragraph does 

8 not apply to a petition that is made by the 

9 sponsor of an application under this subsection 

10 and that seeks only to have the Secretary take 

11 or refrain from taking any form of action with 

12 respect to that application. 

13 ‘‘(F) DEFINITION.—For purposes of this 

14 paragraph, the term ‘petition’ includes any re15 quest to the Secretary, without regard to 

16 whether the request is characterized as a peti17 tion.’’. 

18 (b) ADDITIONAL AMENDMENTS.— 

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

20 United States Code, is amended— 

21 (A) in paragraph (2)— 

22 (i) by striking ‘‘or’’ at the end of sub23 paragraph (A); 

24 (ii) by adding ‘‘or’’ at the end of sub25 paragraph (B); 


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1 (iii) by inserting after subparagraph 

2 (B) the following: 

3 ‘‘(C) a notice described in section 

4 351(k)(17)(B) of the Public Health Service Act, but 

5 only with respect to a patent identified in such no6 tice,’’; and 

7 (iv) in the matter following subpara8 graph (C) (as inserted by clause (iii) of 

9 this subparagraph), by inserting before the 

10 period the following: ‘‘, or if the notice de11 scribed in subparagraph (C) is provided in 

12 connection with an application to obtain a 

13 license to engage in the commercial manu14 facture, use, or sale of a biological product 

15 claimed in a patent or the use of which is 

16 claimed in a patent before the expiration of 

17 such patent’’; and 

18 (B) by adding at the end the following 

19 paragraph: 

20 ‘‘(6) (A) This paragraph applies, in lieu of paragraph 

21 (4), in the case of a patent— 

22 ‘‘(i) which is disclosed in a response to a 

23 request for patent information pursuant to sub24 paragraph (A) of section 351(k)(17) of the 

25 Public Health Service Act; 


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1 ‘‘(ii) with respect to which a notice was 

2 provided pursuant to subparagraph (B) of such 

3 section; and 

4 ‘‘(iii) for which an action for infringement 

5 of the patent— 

6 ‘‘(I) was brought after the expiration 

7 of the 45-day period described in subpara8 graph (C) of such section; or 

9 ‘‘(II) was brought before the expira10 tion of the 45-day period described in sub11 clause (I), but which was dismissed with12 out prejudice or was not prosecuted to 

13 judgment in good faith. 

14 ‘‘(B) In an action for infringement of a patent 

15 described in subparagraph (A), the sole and exclu16 sive remedy that may be granted by a court, upon 

17 a finding that the person who submitted the notice 

18 described in subparagraph (A)(ii) infringed the pat19 ent, or that any person induced or contributed to in20 fringement of the patent, shall be a reasonable roy21 alty. 

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

23 been disclosed in response to a request for patent in24 formation made by an applicant pursuant to sub25 paragraph (A)(i) of section 351(k)(17) of the Public 


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1 Health Service Act, but that was not timely dis2 closed under that subparagraph, may not bring an 

3 action under this section for infringement of that 

4 patent.’’. 

5 (2) CONFORMING AMENDMENTS.— 

6 (A) TITLE 28.—Section 2201(b) of title 

7 28, United States Code, is amended by insert8 ing before the period the following: ‘‘, or section 

9 351 of the Public Health Service Act’’. 

10 (B) PUBLIC HEALTH SERVICE ACT.—Sub11 jection (j) of section 351 of the Public Health 

12 Service Act (42 U.S.C. 262) is amended by in13 serting ‘‘or subsection (k)’’ after ‘‘subsection 

14 (a)’’. 

Æ 


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