II 

109TH CONGRESS 

2D SESSION S. 2699 

To promote the research and development of drugs related to neglected 

and tropical diseases, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 2, 2006 

Mr. BROWNBACK (for himself and Mr. LIEBERMAN) introduced the following 

bill; which was read twice and referred to the Committee on the Judiciary 

A BILL 

To promote the research and development of drugs related 

to neglected and tropical diseases, 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 ‘‘Elimination of Ne5 glected Diseases Act of 2006’’. 

6 SEC. 2. PATENT EXTENSION AND RESTORATION. 

7 (a) IN GENERAL.—Chapter 14 of title 35, United 

8 States Code, is amended by inserting after section 156 the 

9 following: 


hmoore on PROD1PC68 with HMBILLS
2 

•S 2699 IS

1 ‘‘§ 156a. Extension and restoration of patent terms re2 lating to neglected and tropical diseases 

3 ‘‘(a) DEFINITIONS.—In this section, the term— 

4 ‘‘(1) ‘AIDS’ means the acquired immune defi5 ciency syndrome; 

6 ‘‘(2) ‘AIDS drug’ means a drug indicated for 

7 treating HIV; 

8 ‘‘(3) ‘eligible patent’ means a patent that— 

9 ‘‘(A) claims— 

10 ‘‘(i) an approved new molecular entity 

11 standard review drug; 

12 ‘‘(ii) an active ingredient of such new 

13 molecular entity standard review drug; 

14 ‘‘(iii) a process of making or using the 

15 new molecular entity standard review drug; 

16 or 

17 ‘‘(iv) a process of making an active in18 gredient of such new molecular entity 

19 standard review drug; and 

20 ‘‘(B) is owned by or licensed to a person 

21 that has filed and received approval of an appli22 cation described in section 505(b)(1) of the 

23 Federal Food, Drug, and Cosmetic Act (21 

24 U.S.C. 355(b)(1)), for a tropical disease prod25 uct; 


hmoore on PROD1PC68 with HMBILLS
3 

•S 2699 IS

1 ‘‘(4) ‘HIV’ means the human immunodeficiency 

2 virus, the pathogen that causes AIDS; 

3 ‘‘(5) ‘neglected or tropical disease’ means— 

4 ‘‘(A) HIV, malaria, tuberculosis, and re5 lated diseases; or 

6 ‘‘(B) any other infectious disease that dis7 proportionately affects poor and marginalized 

8 populations, including those diseases targeted 

9 by the Special Programme for Research and 

10 Training in Tropical Diseases cosponsored by 

11 the United Nations Development Program, 

12 UNICEF, the World Bank, and the World 

13 Health Organization; 

14 ‘‘(6) ‘new molecular entity standard review 

15 drug’— 

16 ‘‘(A) means a drug that— 

17 ‘‘(i) has never been marketed in the 

18 United States; 

19 ‘‘(ii) appears to have therapeutic 

20 qualities superior to the therapeutic quali21 ties of another drug that is marketed in 

22 the United States; and 

23 ‘‘(iii) is designated by the Secretary of 

24 Health and Human Services under section 

25 524 of the Federal Food, Drug, and CosVerDate Aug 31 2005 05:43 May 04, 2006 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2699.IS S2699

hmoore on PROD1PC68 with HMBILLS
4 

•S 2699 IS

1 metic Act as having a new molecular entity 

2 chemical type classification and standard 

3 review drug treatment potential classifica4 tion, other than drugs developed to treat 

5 serious or life-threatening diseases; and 

6 ‘‘(B) shall not include a subpart E drug or 

7 an AIDS drug; 

8 ‘‘(7) ‘regulatory review period’ means the period 

9 described under section 506(g)(1)(B); 

10 ‘‘(8) ‘subpart E drug’ means a drug developed 

11 or evaluated under special procedures for drugs to 

12 treat life-threatening or severely debilitating illnesses 

13 under subpart E of part 312 of title 21 of the Code 

14 of Federal Regulations; and 

15 ‘‘(9) ‘tropical disease product’ means a product 

16 that— 

17 ‘‘(A) is approved for use in the treatment 

18 of a neglected or tropical disease; 

19 ‘‘(B) is a new drug, antibiotic drug, bio20 logical product, device, diagnostic, or other tool 

21 for treatment, as those terms are used in the 

22 Federal Food, Drug, and Cosmetic Act (21 

23 U.S.C. 301 et seq.) and the Public Health Serv24 ice Act (42 U.S.C. 201 et seq.); and 


hmoore on PROD1PC68 with HMBILLS
5 

•S 2699 IS

1 ‘‘(C) is certified by the Secretary of Health 

2 and Human Services under section 524 of the 

3 Federal Food, Drug, and Cosmetic Act . 

4 ‘‘(b) PATENT TERM EXTENSION.—The term of an el5 igible patent shall be extended by a period not to exceed 

6 2 years and not less than 6 months in duration if— 

7 ‘‘(1) an application in conformance with the re8 quirements of subsection (d) is submitted to the Di9 rector by either the owner of record of the patent or 

10 its agent on the later of— 

11 ‘‘(A) on or before the date specified under 

12 subsection (d)(3); or 

13 ‘‘(B) within 45 days after the date of 

14 issuance of the patent; 

15 ‘‘(2) the term of the eligible patent that is the 

16 basis of the application has not expired prior to the 

17 date that the application is submitted under sub18 section (d); 

19 ‘‘(3) the regulatory review period for the trop20 ical disease product has not been relied upon to sup21 port an application to extend the term of another 

22 patent under this section or under any other provi23 sion of law; and 


hmoore on PROD1PC68 with HMBILLS
6 

•S 2699 IS

1 ‘‘(4) the Food and Drug Administration has 

2 certified the eligibility of that tropical disease prod3 uct for patent extension. 

4 ‘‘(c) PATENT TERM RESTORATION.—The term of a 

5 patent for a tropical disease product shall be restored by 

6 a period equal to the number of days in the regulatory 

7 review period, if, with respect to the patent that is the 

8 basis for application— 

9 ‘‘(1) the owner of record of the patent or its 

10 agent submits an application to the Director on the 

11 later of— 

12 ‘‘(A) on or before the date specified under 

13 subsection (d)(3); or 

14 ‘‘(B) on or before 45 days after the date 

15 of issuance of the patent; 

16 ‘‘(2) the patent has not been previously restored 

17 or extended under this section; 

18 ‘‘(3) the term of the patent has not expired 

19 prior to the date that the owner of the record of the 

20 patent or its agent submits an application to the Di21 rector; 

22 ‘‘(4) the regulatory review period for the prod23 uct has not been relied upon to support an applica24 tion to extend the term of another patent under any 

25 section of this title; and 


hmoore on PROD1PC68 with HMBILLS
7 

•S 2699 IS

1 ‘‘(5) the Food and Drug Administration has 

2 certified the eligibility of that tropical disease prod3 uct for patent restoration. 

4 ‘‘(d) ADMINISTRATIVE PROVISIONS.— 

5 ‘‘(1) IN GENERAL.—To obtain an extension or 

6 restoration of the term of an eligible patent or pat7 ent of a tropical disease product under this section, 

8 the assigner of record and licensee of record of the 

9 eligible patent or tropical disease product or the 

10 agent of the assigner of record and licensee shall 

11 submit an application to the Director. 

12 ‘‘(2) CONTENT.—The application shall con13 tain— 

14 ‘‘(A) a description of the approved tropical 

15 disease product and the Federal statute under 

16 which regulatory review relating to such prod17 uct occurred; 

18 ‘‘(B) the identity of— 

19 ‘‘(i) the eligible patent for which an 

20 extension is sought under this section; or 

21 ‘‘(ii) the patent for a tropical disease 

22 product for which a restoration is sought 

23 under this section; 

24 ‘‘(C) an undertaking by the applicant to 

25 make publicly available independently audited 


hmoore on PROD1PC68 with HMBILLS
8 

•S 2699 IS

1 financial statements to verify commercialization 

2 of the approved tropical disease product; and 

3 ‘‘(D) such other information as the Direc4 tor may require including additional informa5 tion to establish that the eligible patent or trop6 ical disease product meets the requirements of 

7 this section. 

8 ‘‘(3) SUBMISSION OF APPLICATION.—Upon sub9 mission of the application for approval of the trop10 ical disease product to the Food and Drug Adminis11 tration, the sponsor shall give notice of which patent 

12 it would extend if the patent becomes eligible for the 

13 extension or restoration upon successfully completing 

14 the research. The Secretary of Health and Human 

15 Services shall publish the notice. 

16 ‘‘(4) IRREVOCABLE ELECTION.—The submis17 sion of an application under this section is an irrev18 ocable election of the application of this section to 

19 the eligible patent or patent for a tropical disease 

20 product that is the basis of the application. An eligi21 ble patent or patent for a tropical disease product 

22 that is the basis of an application submitted under 

23 this section may not be the subject of an application 

24 made under section 156 or any other provision of 

25 law. 


hmoore on PROD1PC68 with HMBILLS
9 

•S 2699 IS

1 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in 

2 this section shall be construed to prohibit an exten3 sion, under an application made under any other 

4 section of this title, of the term of a patent relating 

5 to a tropical disease product that, prior to the effec6 tive date of this section, was approved for commer7 cial marketing for a nontropical disease use. 

8 ‘‘(e) LIMITATION.—An eligible patent may not be ex9 tended under this section if— 

10 ‘‘(1) the tropical disease product was approved 

11 for commercial marketing prior to the date of enact12 ment of this section; or 

13 ‘‘(2) the eligible patent that is the basis of the 

14 application under this section expired prior to the 

15 date of enactment of this section.’’. 

16 (b) DESIGNATION FOR PATENT EXTENSION AND

17 RESTORATION.—Chapter V of the Federal Food, Drug, 

18 and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 

19 inserting after section 523 the following: 

20 ‘‘SEC. 524. DESIGNATION FOR PATENT EXTENSION AND 

21 RESTORATION. 

22 ‘‘(a) DEFINITIONS.—In this section: 

23 ‘‘(1) NEW MOLECULAR ENTITY STANDARD RE24 VIEW DRUG.—The term ‘new molecular entity standVerDate Aug 31 2005 05:43 May 04, 2006 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2699.IS S2699

hmoore on PROD1PC68 with HMBILLS
10 

•S 2699 IS

1 ard review drug’ has the meaning given that term in 

2 section 156a of title 35, United States Code. 

3 ‘‘(2) TROPICAL DISEASE PRODUCT.—The term 

4 ‘tropical disease product’ has the meaning given that 

5 term in section 156a of title 35, United States Code. 

6 ‘‘(b) NEW MOLECULAR ENTITY STANDARD REVIEW

7 DRUG.—The Secretary, acting through the Commissioner 

8 of Food and Drugs— 

9 ‘‘(1) shall designate a drug as a new molecular 

10 entity standard review drug for purposes of section 

11 156a of title 35, United States Code, if that drug— 

12 ‘‘(A) has a new molecular entity chemical 

13 type classification and standard review drug 

14 treatment potential classification; and 

15 ‘‘(B) is not a drug developed to treat seri16 ous or life-threatening diseases; 

17 ‘‘(2) shall apply the guidance issued in calendar 

18 year 2002 on serious or life-threatening diseases for 

19 purposes of paragraph (1)(B); 

20 ‘‘(3) shall maintain and annually update a clas21 sification list of serious and life-threatening diseases; 

22 and 

23 ‘‘(4) may remove the designation of a drug as 

24 a new molecular entity standard review drug as des25 ignated under paragraph (1). 


hmoore on PROD1PC68 with HMBILLS
11 

•S 2699 IS

1 ‘‘(c) TROPICAL DISEASE PRODUCTS.—The Secretary 

2 shall certify tropical disease products for purposes of sec3 tion 156a of title 35, United States Code.’’. 

4 (c) TECHNICAL AND CONFORMING AMENDMENT.— 

5 The table of sections for chapter 14 of title 35, United 

6 States Code, is amended by inserting after the item relat7 ing to section 156 the following: 

‘‘156a. Extension and restoration of patent terms relating to neglected and tropical diseases.’’. 

8 (d) STUDY AND REPORT.— 

9 (1) STUDY.—The Director of the United States 

10 Patent and Trademark Office, in conjunction with 

11 the Food and Drug Administration, the Department 

12 of Health and Human Services, and the United 

13 States Agency for International Development, shall 

14 conduct a study on the effect of patent extension 

15 and restoration on the ability of pharmaceutical 

16 companies to develop and distribute tropical disease 

17 products for poor and marginalized populations. 

18 (2) REPORT.—Not later than 1 year after the 

19 date of the enactment of this Act, the Director of 

20 the United States Patent and Trademark Office 

21 shall submit a report on the results of the study 

22 under paragraph (1) to— 


hmoore on PROD1PC68 with HMBILLS
12 

•S 2699 IS

1 (A) the Committee on Foreign Relations of 

2 the Senate and the Committee on Health, Edu3 cation, Labor, and Pensions of the Senate; and 

4 (B) the appropriate committees of the 

5 House of Representatives. 

Æ 


hmoore on PROD1PC68 with HMBILLS