II 

109TH CONGRESS 

2D SESSION S. 4016 

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

comparable biological products, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 29, 2006 

Mr. SCHUMER (for himself, Mrs. CLINTON, Mr. LEAHY, and Ms. STABENOW) 

introduced the following bill; which was read twice and referred to the 

Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to provide for 

the licensing of comparable 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 Section 351(i) of the Public Health Service Act (42 

8 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 ‘comparable 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 biological product 

10 for which a license has been approved under sub11 section (a). A comparable biologic application is a 

12 human drug application under section 735(1)(C) of 

13 the Federal Food, Drug, and Cosmetic Act. 

14 ‘‘(3) The term ‘reference product’ under this 

15 Act means the single licensed biological product, ap16 proved under subsection (a) or subsection (k), 

17 against which a comparable biological product is 

18 evaluated for demonstration of safety, potency, or 

19 purity. 

20 ‘‘(4) The term ‘comparable’ in reference to a 

21 comparable biological product application means the 

22 absence of clinically meaningful differences between 

23 the comparable biological product and the reference 

24 product in terms of the safety, purity, and potency 

25 of the product based upon— 


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

2 and biological assays, other non-clinical labora3 tory studies; and 

4 ‘‘(B) data from any necessary clinical 

5 study or studies sufficient to confirm safety, 

6 purity, and potency in one or more appropriate 

7 conditions of use for which the reference prod8 uct is licensed and intended to be used. 

9 Any studies described in subparagraph (B) shall be 

10 designed to avoid duplicative and unethical clinical 

11 testing. 

12 ‘‘(5) The term ‘thorough characterization’ 

13 means an analysis of structural features based upon 

14 appropriate analytical and functional testing suffi15 cient to identify differences between a new and ref16 erence biological product relevant to safety, purity or 

17 potency. 

18 ‘‘(6) The term ‘interchangeable’ means that a 

19 biological product contains an active ingredient or 

20 ingredients with principal molecular structural fea21 tures comparable to the reference product, and that 

22 the comparable biological product can be expected to 

23 produce the same clinical result as the reference 

24 product in any given patient in the condition or con25 ditions of use for which both products are labeled. 


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1 ‘‘(7) The term ‘process for the review of a com2 parable biological product application’ means, with 

3 respect to a comparable biological product applica4 tion, the procedural activities of the Secretary with 

5 respect to the review of human drug applications 

6 and supplements as defined in section 735(6) of the 

7 Federal Food, Drug, and Cosmetic Act, except as 

8 otherwise defined herein. 

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

10 to a comparable biological product application, the 

11 Secretary’s issuance on the final action date of a 

12 final action letter to the sponsor of a comparable bi13 ological product application under this Act which— 

14 ‘‘(A) approves the application, or 

15 ‘‘(B) disapproves the application and sets 

16 forth in detail an enumeration of the specific 

17 deficiencies in the particular application and of 

18 the specific, enumerated actions the sponsor 

19 would be required to take in order for the spon20 sor to receive a final action letter that approves 

21 such application. 

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

23 respect to an abbreviated comparable biological 

24 product application, the date that is eight calendar 

25 months following the sponsor’s submission of such 


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1 application, or 180 days following the Secretary’s 

2 notification of the sponsor that its application has 

3 been accepted for filing, whichever is earlier, except 

4 that the final action date hereunder may be ex5 tended for such period of time as is agreed to by the 

6 Secretary and the sponsor of such application in a 

7 jointly executed written agreement that is counter8 signed by the Secretary and the sponsor of such ap9 plication no later than 30 days prior to the final ac10 tion date provided for by this subsection. 

11 ‘‘(10) The term ‘reviewing division’ means the 

12 division responsible for the review of an application 

13 for approval of a biological product (including all sci14 entific and medical matters, chemistry, manufac15 turing, and controls).’’. 

16 SEC. 3. REGULATION OF CERTAIN BIOLOGICAL PRODUCTS. 

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

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

19 (1) in subsection (a)(1)(A), by inserting after 

20 ‘‘biologics license’’ the following: ‘‘, or comparable 

21 biologics license,’’; and 

22 (2) by adding at the end the following sub23 section: 

24 ‘‘(k) REGULATION OF COMPARABLE BIOLOGICAL

25 PRODUCTS.— 


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1 ‘‘(1) SUBMISSION OF A COMPARABLE BIOLOGI2 CAL PRODUCT APPLICATION.—Any person may file 

3 with the Secretary an abbreviated comparable bio4 logical product application that includes the fol5 lowing: 

6 ‘‘(A) Data demonstrating that the com7 parable biological product is comparable to the 

8 reference product. 

9 ‘‘(B) Data demonstrating that the com10 parable biological product and reference product 

11 contain comparable principal molecular struc12 tural features as demonstrated by thorough 

13 characterization of the two products, notwith14 standing minor differences in heterogeneity pro15 file, impurities, or degradation patterns. The 

16 Secretary shall find the following types of prod17 ucts to contain comparable principal molecular 

18 structural features: 

19 ‘‘(i) Two protein biological products 

20 with differences in structure between them 

21 solely due to post-translational events, infi22 delity of translation or transcription, or 

23 minor differences in amino acid sequence. 

24 ‘‘(ii) Two polysaccharide biological 

25 products with similar saccharide repeating 


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1 units, even if the number of units differ 

2 and even if there are differences in post3 polymerization modifications. 

4 ‘‘(iii) Two glycosylated protein prod5 ucts with differences in structure between 

6 them solely due to post-translational 

7 events, infidelity of translation or tran8 scription, or minor differences in amino 

9 acid sequence, and if they had similar sac10 charide repeating units, even if the number 

11 of units differ and even if there were dif12 ferences in post-polymerization. 

13 ‘‘(iv) Two polynucleotide biological 

14 products with identical sequence of purine 

15 and pyrimidine bases (or their derivatives) 

16 bound to an identical sugar backbone (ri17 bose, deoxyribose, or modifications of these 

18 sugars). 

19 ‘‘(v) Closely related, complex partly 

20 definable biological products with similar 

21 therapeutic intent, such as two live viral 

22 products for the same indication. 

23 The principal molecular structural features of 

24 two biological products not enumerated in the 

25 foregoing clauses may be demonstrated to be 


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1 comparable based upon such data and other in2 formation characterizing the two products as 

3 the Secretary determines to be necessary. 

4 ‘‘(C) Data demonstrating that the com5 parable biological product and reference product 

6 utilize the same mechanism or mechanisms of 

7 action for the conditions of use prescribed, rec8 ommended, or suggested in the proposed label9 ing, but only to the extent the mechanism or 

10 mechanisms of action are known for the ref11 erence product. 

12 ‘‘(D) Information to show that the condi13 tion or conditions of use prescribed, rec14 ommended, or suggested in the labeling pro15 posed for the comparable biological product 

16 have been previously approved for the reference 

17 product. 

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

19 administration, the dosage form, and the 

20 strength of the comparable biological product 

21 are the same as those of the reference product. 

22 ‘‘(F) Data demonstrating that the facility 

23 in which the comparable biological product is 

24 manufactured, processed, packed, or held meets 

25 standards designed to assure that the comVerDate Aug 31 2005 23:47 Oct 04, 2006 Jkt 059196 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4016.IS S4016

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1 parable biological product continues to be safe, 

2 pure, and potent. 

3 ‘‘(G) At the applicant’s option, publicly4 available information regarding the Secretary’s 

5 previous determination that the reference prod6 uct is safe, pure, and potent. 

7 ‘‘(H) Any additional data and information 

8 in support of the application, including publicly9 available information with respect to the ref10 erence product or another biological product. 

11 ‘‘(2) OTHER APPLICATIONS.—A person who has 

12 not conducted and does not have a right of reference 

13 to the studies in the application for a reference prod14 uct may submit an application under this section for 

15 a biologic product that differs from, or incorporates 

16 a change to, the reference product with respect to 

17 one or more characteristics described in subpara18 graphs (A) through (E) of paragraph (1), including 

19 a difference in safety, purity, or potency, so long as 

20 the application contains sufficient information to es21 tablish the safety, purity, and potency of the biologi22 cal product relative to the reference product for its 

23 proposed condition or conditions of use. 

24 ‘‘(3) POSTMARKETING STUDIES.—If the Sec25 retary has agreed with the sponsor of the reference 


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1 product that the sponsor shall conduct one or more 

2 postmarketing safety studies, the applicant may 

3 agree with the Secretary to conduct a similar post4 marketing safety study or studies upon a reasonable 

5 showing that such study or studies would provide 

6 relevant information not available from the studies 

7 on the reference product. The Secretary shall not, as 

8 a condition of approval, propose any additional post9 marketing studies. 

10 ‘‘(4) FDA REVIEW OF COMPARABLE BIOLOGI11 CAL PRODUCT APPLICATIONS.— 

12 ‘‘(A) GUIDANCE REGARDING REVIEW OF

13 APPLICATIONS.—The Secretary shall issue guid14 ance for the individuals who review applications 

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

16 shall relate to promptness in conducting the re17 view, technical excellence, lack of bias and con18 flict of interest, and knowledge of regulatory 

19 and scientific standards, and which shall apply 

20 equally to all individuals who review such appli21 cations. 

22 ‘‘(B) MEETINGS WITH SPONSORS AND AP23 PLICANTS.—The Secretary shall meet with a 

24 sponsor of an investigation or an applicant for 

25 approval of a comparable biological product 


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1 under this subsection if the sponsor or appli2 cant makes a reasonable written request for a 

3 meeting for the purpose of reaching agreement 

4 on the design and size of studies needed for ap5 proval of such application. The sponsor or ap6 plicant shall provide information necessary for 

7 discussion and agreement on the design and 

8 size of such studies. Minutes of any such meet9 ing shall be prepared by the Secretary and 

10 made available to the sponsor or applicant. 

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 ‘‘(5) APPROVAL OF COMPARABLE BIOLOGICAL

2 PRODUCTS.—The Secretary shall review the informa3 tion submitted in the application and any other in4 formation available to the Secretary and shall issue, 

5 subject to paragraph (9), a comparable biological 

6 product license for all conditions of use of the ref7 erence product sharing the same mechanism of ac8 tion for which the applicant has demonstrated com9 parability for a single condition of use, or, if the 

10 mechanism of action is unknown, for the condition 

11 or conditions of use for which the data submitted es12 tablishes comparability, unless the Secretary finds 

13 and informs the applicant that— 

14 ‘‘(A) information submitted in the applica15 tion or any other information available to the 

16 Secretary is insufficient to show that the com17 parable biological product and the reference 

18 product contain comparable principal molecular 

19 structural features as demonstrated by thor20 ough characterization of the two products; 

21 ‘‘(B) information submitted in the applica22 tion or any other information available to the 

23 Secretary is insufficient to show that the com24 parable biological product is comparable to the 

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1 tions of use prescribed, recommended, or sug2 gested in the labeling proposed in the applica3 tion; 

4 ‘‘(C) information submitted in the applica5 tion or any other information available to the 

6 Secretary is insufficient to show that the com7 parable biological product and reference product 

8 utilize the same mechanism or mechanisms of 

9 action for the conditions of use prescribed, rec10 ommended, or suggested in the labeling pro11 posed for the comparable biological product, un12 less the mechanism or mechanisms of action are 

13 not known for the reference product for such 

14 condition or conditions; 

15 ‘‘(D) information submitted in the applica16 tion or any other information available to the 

17 Secretary is insufficient to show that the route 

18 of administration, the dosage form, and the 

19 strength of the comparable biological product 

20 are the same as those of the reference product; 

21 ‘‘(E) information submitted in the applica22 tion or any other information available to the 

23 Secretary is insufficient to show that the condi24 tion or conditions of use prescribed, rec25 ommended, or suggested in the labeling proVerDate Aug 31 2005 23:47 Oct 04, 2006 Jkt 059196 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S4016.IS S4016

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1 posed for the comparable biological product are 

2 limited to one or more of the same use or uses 

3 as have been previously approved for the ref4 erence product; 

5 ‘‘(F) information submitted in the applica6 tion or any other information available to the 

7 Secretary shows (i) the inactive ingredients of 

8 the comparable biological product are unsafe for 

9 use under the conditions prescribed, rec10 ommended, or suggested in the labeling pro11 posed for the biological product, or (ii) the com12 position of the comparable biological product is 

13 unsafe under such conditions because of the 

14 type or quantity of inactive ingredients included 

15 or the manner in which the inactive ingredients 

16 are included; 

17 ‘‘(G) information submitted in the applica18 tion or any other information available to the 

19 Secretary fails to demonstrate that the facility 

20 in which the comparable biological product is 

21 manufactured, processed, packed, or held meets 

22 standards designed to assure that the com23 parable biological product continues to be safe, 

24 pure, and potent; 


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1 ‘‘(H) the Secretary has withdrawn or sus2 pended the license of the reference product, for 

3 safety or effectiveness reasons, or has published 

4 a notice of opportunity for hearing to withdraw 

5 such license for safety or effectiveness reasons, 

6 or the Secretary has determined that the ref7 erence product has been withdrawn from sale 

8 for safety or effectiveness reasons; or 

9 ‘‘(I) the application contains an untrue 

10 statement of material fact; and 

11 provides the applicant with a detailed explanation 

12 for the decision. 

13 ‘‘(6) OTHER APPROVAL PROVISIONS.—The Sec14 retary shall approve, under the provisions of para15 graph (5), an application for a license submitted 

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

17 approve such an application that would otherwise be 

18 disapproved by reason of one or more of subpara19 graphs (A) through (E) of paragraph (5), if the ap20 plication and any other information available to the 

21 Secretary contains sufficient information to establish 

22 the safety, purity, and potency of the comparable bi23 ological product relative to the reference product for 

24 the proposed condition or conditions of use for such 

25 product. 


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1 ‘‘(7) INTERCHANGEABILITY DETERMINATIONS

2 FOR COMPARABLE BIOLOGICAL PRODUCTS.—An ap3 plicant may request in an original application or 

4 supplement to an application that the Secretary 

5 make a determination as to the interchangeability of 

6 a comparable biological product and the reference 

7 product. An applicant may withdraw a request for a 

8 determination at any time. A request for an inter9 changeability determination submitted after the fil10 ing of an application shall be considered a major 

11 amendment to the application. In response to such 

12 a request, the Secretary shall, at such time as the 

13 application or supplement is approved, publish a 

14 therapeutic comparability evaluation code indicating 

15 either that the comparable biological product has 

16 been shown to be interchangeable with the reference 

17 product, or that interchangeability has not been es18 tablished. Nothing in this subsection shall be con19 strued to prohibit the Secretary from making a de20 termination of interchangeability at any time after 

21 approval. 

22 ‘‘(8) INTERCHANGEABILITY LABELING FOR

23 COMPARABLE BIOLOGICAL PRODUCTS.—Upon a de24 termination of interchangeability under paragraph 

25 (7), the label of the comparable biological product at 


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1 the time of licensure may include a statement, if re2 quested by the sponsor, that it is interchangeable 

3 with the biological reference product to which the 

4 sponsor of the comparable biological product applica5 tion has demonstrated comparability to the reference 

6 product for the conditions of use prescribed, rec7 ommended, or suggested in the labeling proposed for 

8 the comparable biological product. 

9 ‘‘(9) EXCLUSIVITY.— 

10 ‘‘(A) IN GENERAL.—Notwithstanding any 

11 other provision of law, the Secretary shall not 

12 approve a second or subsequent comparable bio13 logical product application, and no holder of a 

14 biologic product license approved under sub15 section (a) shall manufacture, market, sell, or 

16 distribute a rebranded interchangeable biologic, 

17 directly or indirectly, or authorize any other 

18 person to manufacture, market, sell, or dis19 tribute a rebranded interchangeable biologic 

20 that is interchangeable with the reference prod21 uct, until the earlier of— 

22 ‘‘(i) 180 days after the first commer23 cial marketing of the first interchangeable 

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1 proved as interchangeable for that same 

2 reference product; 

3 ‘‘(ii) one year after— 

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

5 patents in suit in an action instituted 

6 under paragraph (16)(C) against the 

7 applicant that submitted the applica8 tion for the first approved inter9 changeable comparable biological 

10 product; or 

11 ‘‘(II) the dismissal with or with12 out prejudice of an action instituted 

13 under paragraph (16)(C) against the 

14 applicant that submitted the applica15 tion for the first approved inter16 changeable comparable biological 

17 product; or 

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

19 the first interchangeable comparable bio20 logical product if the applicant has been 

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

22 litigation is still ongoing within such 36- 

23 month period; or 

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

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1 able comparable applicant has not been 

2 sued under paragraph (16)(C). 

3 Notwithstanding the foregoing provision, the 

4 sponsor of a subsequent comparable biological 

5 product application that has demonstrated 

6 interchangeability with the reference product 

7 may elect, at its option, to have the product ap8 proved as a non-interchangeable comparable bi9 ological product whose approval will not be de10 layed by operation of this paragraph. For pur11 poses of this paragraph, the term ‘final court 

12 decision’ means a final decision of a court from 

13 which no appeal (other than a petition to the 

14 United States Supreme Court for a writ of cer15 tiorari) has been or can be taken. 

16 ‘‘(B) REBRANDED INTERCHANGEABLE

17 BIOLOGIC.—For purposes of this subsection, the 

18 term ‘rebranded interchangeable biologic’— 

19 ‘‘(i) means any rebranded inter20 changeable version of a reference product 

21 that the holder of the biological product li22 cense approved under subsection (a) for 

23 that reference product seeks to commence 

24 marketing, selling, or distributing, directly 

25 or indirectly; and 


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

2 be marketed, sold, or distributed— 

3 ‘‘(I) by an entity eligible for ex4 clusivity with respect to such product 

5 under this paragraph; or 

6 ‘‘(II) after expiration of any ex7 clusivity with respect to such product 

8 under this paragraph. 

9 ‘‘(10) HEARING.—If the Secretary decides to 

10 disapprove a comparable biological product applica11 tion, the Secretary shall give the applicant notice of 

12 an opportunity for a hearing before the Secretary on 

13 the question of whether such application is approv14 able. If the applicant elects to accept the opportunity 

15 for hearing by written request within thirty days 

16 after such notice, such hearing shall commence not 

17 more than ninety days after the expiration of such 

18 thirty days unless the Secretary and the applicant 

19 otherwise agree. Any such hearing shall thereafter 

20 be conducted on an expedited basis and the Sec21 retary’s order thereon shall be issued within ninety 

22 days after the date fixed by the Secretary for filing 

23 final briefs. 


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1 ‘‘(11) FINAL ACTION DATE.—The Secretary 

2 shall take a final action on a comparable biological 

3 product application by the final action date. 

4 ‘‘(12) REQUEST FOR DELAY OF FINAL AC5 TION.—Notwithstanding any other provision of law, 

6 the Secretary shall not fail or refuse to take a final 

7 action on a comparable biological product application 

8 by the final action date on the basis that a person, 

9 other than the sponsor of the comparable biological 

10 product, has requested (in a petition or otherwise) 

11 that the Secretary refuse to take or otherwise defer 

12 such final action, and no court shall enjoin the Sec13 retary from taking final action or stay the effect of 

14 final action previously taken by the Secretary, except 

15 by issuance of a permanent injunction based upon 

16 an express finding of clear and convincing evidence 

17 that the person seeking to have the Secretary refuse 

18 to take or otherwise to deter final action by the final 

19 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 ‘‘(13) 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 of 

15 the joint execution of any such written agreement. 

16 ‘‘(14) REPORT ON FAILURE TO TAKE FINAL AC17 TION.—The Secretary shall prepare and submit an18 nually to the President, the Committee on Energy 

19 and Commerce of the House of Representatives, and 

20 the Committee on Health, Education, Labor, and 

21 Pensions of the Senate a report detailing the specific 

22 and particularized reasons enumerated by the Re23 viewing Division for each instance of the Secretary’s 

24 failure to take final action by the final action date 

25 in the previous year. 


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1 ‘‘(15) REGULATIONS.—The Secretary shall es2 tablish, by regulation within 2 years after the date 

3 of the enactment of this subsection, requirements for 

4 the efficient review, approval, suspension, and rev5 ocation of comparable biological product applications 

6 under this subsection. 

7 ‘‘(16) PATENTS.— 

8 ‘‘(A) REQUEST FOR PATENT INFORMA9 TION.— 

10 ‘‘(i) IN GENERAL.—At any time, in11 cluding at the initial stages of develop12 ment, an applicant or a prospective appli13 cant may send a written request for patent 

14 information to the holder of the approved 

15 application for the reference product. 

16 Within 60 days of receipt of such request, 

17 the holder of the approved application for 

18 the reference product shall provide to the 

19 applicant or prospective applicant a list of 

20 all patents owned by, or licensed to, the 

21 holder of the approved application that the 

22 application holder in good faith believes re23 late to the reference product, including 

24 patents that claim the approved biologic 

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1 uct, any component of such product, or 

2 any method or process of manufacturing 

3 such product or component. 

4 ‘‘(ii) COSTS OF COMPLYING WITH RE5 QUEST.—The application holder may de6 mand payment not exceeding $1,000 to 

7 offset the cost of responding to the infor8 mation request. 

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

10 years from the date of the request for in11 formation, the holder of the approved ap12 plication for the reference product shall 

13 update its response to the request for in14 formation by identifying newly issued or li15 censed relevant patents. The updates must 

16 be provided within 30 days of patent 

17 issuance, for newly issued patents, and 

18 within 30 days of obtaining a license, for 

19 newly licensed patents. 

20 ‘‘(iv) ADDITIONAL REQUESTS.—The 

21 applicant may submit additional requests 

22 for patent information, subject to the re23 quirements of this paragraph, at any time. 

24 ‘‘(B) PATENT NOTIFICATIONS.—At any 

25 time after the submission of the application, the 


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1 applicant may provide a notice under this sub2 paragraph with respect to any one or more pat3 ents provided by the holder of the reference 

4 product provided in response to a request under 

5 this paragraph. An applicant may submit addi6 tional notices at any time, and each notice shall 

7 be subject to the provisions of this subpara8 graph. Each notice shall— 

9 ‘‘(i) be sent to the holder of approved 

10 application for the reference product and 

11 to the owner of the patent identified pursu12 ant to subparagraph (A)(i); 

13 ‘‘(ii) include a detailed statement of 

14 the factual and legal bases for the appli15 cant’s belief that the patents included in 

16 the notice are invalid, unenforceable, or 

17 will not be infringed by the commercial 

18 sale of the product for which approval is or 

19 has been sought; and 

20 ‘‘(iii) identify the judicial district or 

21 districts in which the applicant consents to 

22 suit being brought in response to the no23 tice. 

24 ‘‘(C) ACTION FOR INFRINGEMENT.— 


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1 ‘‘(i) TIMEFRAME FOR BRINGING AC2 TION.—Within 45 days of receipt of notice 

3 described in subparagraph (B), the holder 

4 of the approved application for the ref5 erence product, or the owner of the patent, 

6 may bring an action infringement solely 

7 with respect to the patent or patents in8 cluded in such notice. 

9 ‘‘(ii) APPROPRIATE JUDICIAL DIS10 TRICT.—Notwithstanding section 1391 of 

11 title 28, United States Code, an infringe12 ment action brought within the 45-day pe13 riod referenced in clause (i) may be 

14 brought only in the judicial district identi15 fied pursuant to subparagraph (B)(iii). 

16 ‘‘(D) LIMITATION ON DECLARATORY JUDG17 MENT ACTIONS.—No action may be brought 

18 under section 2201 of title 28, United States 

19 Code by the recipient of a notice under sub20 paragraph (B) for a declaration of infringe21 ment, validity, or enforceability with respect to 

22 any patent which was not identified in the no23 tice, and with respect to the application under 

24 which the notice was sent, or with respect to 

25 the product of that application, prior to the 


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1 commercial marketing of that product. With re2 spect to a patent identified in the notice, not3 withstanding section 1391 of title 28, any such 

4 action may be brought only in the judicial dis5 tricts identified in the notice. 

6 ‘‘(E) DISCRETION OF APPLICANTS.—A 

7 comparable biological product applicant may 

8 not be compelled, by court order or otherwise, 

9 to initiate the procedures set forth in this para10 graph. The decision as to whether to invoke the 

11 procedures set forth in this paragraph is left 

12 entirely to the discretion of the applicant or 

13 prospective applicant. 

14 ‘‘(17) PETITIONS AND CIVIL ACTIONS REGARD15 ING APPROVAL OF CERTAIN APPLICATIONS.— 

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

17 pending application submitted under paragraph 

18 (1) or (2), if a petition is submitted to the Sec19 retary that seeks to have the Secretary take, or 

20 refrain from taking, any form of action relating 

21 to the approval of the application, including a 

22 delay in the effective date of the application, 

23 the following applies, subject to subparagraph 

24 (E): 


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1 ‘‘(i)(I) In the case of an application 

2 under paragraph (2), the Secretary may 

3 not, subject to subclause (III), consider the 

4 petition if it is submitted later than 180 

5 days prior to the date on which the ap6 proval of the application may first be made 

7 effective. 

8 ‘‘(II) In the case of an application 

9 under paragraph (1), the Secretary may 

10 not, subject to subclause (III), consider the 

11 petition if it is submitted later than 180 

12 days prior to the date on which the ap13 proval of the application may first be made 

14 effective. 

15 ‘‘(III) The restriction established in 

16 subclause (I) or (II) (as the case may be) 

17 does not apply to the petition if the Sec18 retary determines that the petitioner has 

19 shown good cause for the failure to submit 

20 the petition by the applicable date under 

21 such subclause. 

22 ‘‘(ii)(I) The Secretary may not, on the 

23 basis of the petition, delay approval of the 

24 application unless the Secretary determines 

25 that a delay is necessary to protect the 


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1 public health. Consideration of a petition 

2 shall be separate and apart from the re3 view and approval of the application. 

4 ‘‘(II) With respect to a determination 

5 by the Secretary under subclause (I) that 

6 a delay is necessary to protect the public 

7 health: 

8 ‘‘(aa) The Secretary shall publish 

9 on the Internet site of the Food and 

10 Drug Administration a statement pro11 viding the reasons underlying the de12 termination. 

13 ‘‘(bb) Not later than 10 days 

14 after making the determination, the 

15 Secretary shall provide notice to the 

16 sponsor of the application and an op17 portunity for a meeting with the Com18 missioner to discuss the determina19 tion. 

20 ‘‘(iii) The Secretary shall take final 

21 agency action on the petition not later 

22 than 180 days after the date on which the 

23 petition is submitted. The Secretary shall 

24 not extend such period, even with the con25 sent of the petitioner, for any reason, inVerDate Aug 31 2005 23:47 Oct 04, 2006 Jkt 059196 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\S4016.IS S4016

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1 cluding based upon the submission of com2 ments relating to the petition or supple3 mental information supplied by the peti4 tioner. 

5 ‘‘(iv) The Secretary may not consider 

6 the petition for review unless it is signed 

7 and contains the following verification: ‘I 

8 certify that, to my best knowledge and be9 lief: (a) this petition includes all informa10 tion and views upon which the petition re11 lies; (b) this petition includes representa12 tive data and/or information known to the 

13 petitioner which are unfavorable to the pe14 tition; and (c) I have taken reasonable 

15 steps to ensure that any representative 

16 data and/or information which are unfavor17 able to the petition were disclosed to me. 

18 I further certify that the information upon 

19 which I have based the action requested 

20 herein first became known to the party on 

21 whose behalf this petition is submitted on 

22 or about the following date: 

23 lllllll. I received or expect to 

24 receive payments, including cash and other 

25 forms of consideration, from the following 


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1 persons or organizations to file this peti2 tion: llllllll. I verify under 

3 penalty of perjury that the foregoing is 

4 true and correct.’. 

5 ‘‘(B) EXHAUSTION OF ADMINISTRATIVE

6 REMEDIES.— 

7 ‘‘(i) FINAL AGENCY ACTION WITHIN

8 180 DAYS.—The Secretary shall be consid9 ered to have taken final agency action on 

10 a petition referred to in subparagraph (A) 

11 if— 

12 ‘‘(I) during the 180-day period 

13 referred to in clause (iii) of such sub14 paragraph, the Secretary makes a 

15 final decision within the meaning of 

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

17 Federal Regulations; or 

18 ‘‘(II) such period expires without 

19 the Secretary having made such a 

20 final decision. 

21 ‘‘(ii) DISMISSAL OF CERTAIN CIVIL

22 ACTIONS.—If a civil action is filed with re23 spect to a petition referred to in subpara24 graph (A) before final agency action within 

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


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1 court shall dismiss the action for failure to 

2 exhaust administrative remedies. 

3 ‘‘(C) APPLICABILITY OF CERTAIN REGULA4 TIONS.—The provisions of this section are in 

5 addition to the requirements for the submission 

6 of a petition to the Secretary that apply under 

7 section 10.30 or 10.35 of title 21, Code of Fed8 eral Regulations. 

9 ‘‘(D) ANNUAL REPORT ON DELAYS IN AP10 PROVALS PER PETITIONS.—The Secretary shall 

11 annually submit to the Congress a report that 

12 specifies— 

13 ‘‘(i) the number of applications under 

14 this subsection that were approved during 

15 the preceding 12-month period; 

16 ‘‘(ii) the number of such applications 

17 whose effective dates were delayed by peti18 tions referred to in subparagraph (A) dur19 ing such period; and 

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

21 applications were so delayed. 

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

23 not apply to a petition that is made by the 

24 sponsor of an application under this subsection 

25 and that seeks only to have the Secretary take 


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1 or refrain from taking any form of action with 

2 respect to that application. 

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

4 paragraph, the term ‘petition’ includes any re5 quest to the Secretary, without regard to 

6 whether the request is characterized as a peti7 tion.’’. 

8 (b) ADDITIONAL AMENDMENTS.—Section 271(e) of 

9 title 35, United States Code, is amended— 

10 (1) in paragraph (2)— 

11 (A) by striking ‘‘or’’ at the end of subpara12 graph (A); 

13 (B) by adding ‘‘or’’ at the end of subpara14 graph (B); 

15 (C) by inserting after subparagraph (B) 

16 the following: 

17 ‘‘(C) a notice described in section 

18 351(k)(16)(B) of the Public Health Service Act, but 

19 only with respect to a patent identified in such a no20 tice,’’; and 

21 (D) in the matter after and below subpara22 graph (C) (as inserted by clause (iii) of this 

23 subparagraph), by inserting before the period 

24 the following: ‘‘, or if the notice described in 

25 subparagraph (C) is provided in connection 


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1 with an application to obtain a license to en2 gage in the commercial manufacture, use, or 

3 sale of a biological product claimed in a patent 

4 or the use of which is claimed in a patent be5 fore the expiration of such patent’’ ; and 

6 (2) by adding at the end the following para7 graph: 

8 ‘‘(5) Notwithstanding the preceding subsection: 

9 ‘‘(A) A patent that is disclosed in a response to 

10 a request for patent information pursuant to sub11 paragraph (A) of section 351(k)(16) of the Public 

12 Health Service Act with respect to which a notice 

13 was provided pursuant to subparagraph (B) of such 

14 section, and for which an action for infringement of 

15 the patent was (I) brought after the expiration of 

16 the 45-day period described in such subparagraph, 

17 or (II) brought before the expiration of the 45-day 

18 period described in such section 351, but not main19 tained through a final court decision or a dismissal 

20 with prejudice regarding the validity, enforceability, 

21 and/or infringement, the sole and exclusive remedy 

22 which may be granted by a court upon a finding of 

23 infringement of such patent by the person who sub24 mitted the notice described in subclause (A), or any 


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1 person found to have induced or contributed to such 

2 infringement, shall be a reasonable royalty. 

3 ‘‘(B) No action for infringement can be brought 

4 under this section against an applicant that sent a 

5 request for patent information pursuant to subpara6 graph (A)(i) of section 351(k)(16) of the Public 

7 Health Service Act by the owner of a patent that 

8 should have been disclosed in response to such a re9 quest, but was not timely disclosed under that sub10 paragraph.’’. 

Æ 


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