I 

108TH CONGRESS 

2D SESSION H. R. 5306 

To amend the Federal Food, Drug, and Cosmetic Act with respect to market 

exclusivity for cancer drugs, and to amend title 35, United States Code, 

to provide for the extension of the patent term on such drugs equal 

to the regulatory review period for such drugs. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 8, 2004 

Mr. CARTER 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 Federal Food, Drug, and Cosmetic Act with 

respect to market exclusivity for cancer drugs, and to 

amend title 35, United States Code, to provide for the 

extension of the patent term on such drugs equal to 

the regulatory review period for such drugs. 

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 ‘‘New War on Cancer 

5 Act’’. 
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1 SEC. 2. NONPATENT MARKET EXCLUSIVITY FOR CANCER 

2 DRUGS. 

3 Chapter V of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 351 et seq.) is amended by adding at the 

5 end the following subchapter: 

6 ‘‘Subchapter G—Cancer Drugs 

7 ‘‘SEC. 575. RECOMMENDATIONS FOR INVESTIGATIONS OF 

8 CANCER DRUGS. 

9 ‘‘(a) REQUEST FOR RECOMMENDATIONS.—The spon10 sor of a drug intended for use for cancer (referred to in 

11 this subchapter as a ‘cancer drug’) may request the Sec12 retary to provide written recommendations for the nonclin13 ical and clinical investigations which must be conducted 

14 with the drug before— 

15 ‘‘(1) it may be approved for use for cancer 

16 under section 505; or 

17 ‘‘(2) if the drug is a biological product, it may 

18 be licensed for use for cancer under section 351 of 

19 the Public Health Service Act. 

20 ‘‘(b) RECOMMENDATIONS.—If the Secretary has rea21 son to believe that a drug for which a request is made 

22 under subsection (a) is a cancer drug, the Secretary shall 

23 provide the person making the request written rec24 ommendations for the nonclinical and clinical investiga25 tions which the Secretary believes, on the basis of informa-
3 

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1 tion available to the Secretary at the time of the request, 

2 would be necessary for— 

3 ‘‘(1) approval of such drug for use for cancer 

4 under section 505; or 

5 ‘‘(2) licensing of such drug for use for cancer 

6 under section 351 of the Public Health Service Act. 

7 ‘‘(c) REGULATIONS.—The Secretary shall by regula8 tion promulgate procedures for the implementation of sub9 sections (a) and (b). 

10 ‘‘SEC. 576. DESIGNATION OF CANCER DRUGS. 

11 ‘‘(a) REQUEST FOR DESIGNATION.—The sponsor of 

12 a drug may request the Secretary to designate the drug 

13 as a cancer drug. A request for designation of a drug shall 

14 be made before the submission of an application under sec15 tion 505(b) for the drug, or the submission of an applica16 tion for licensing of the drug under section 351 of the 

17 Public Health Service Act. Such a request shall contain 

18 the consent of the applicant to notice being given by the 

19 Secretary under subsection (c) respecting the designation 

20 of the drug. 

21 ‘‘(b) DESIGNATION.—In the case of a drug for which 

22 a request is submitted under subsection (a), the Secretary 

23 shall designate the drug as a cancer drug if the Secretary 

24 finds that the drug is being or will be investigated for use 

25 for cancer. 
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1 ‘‘(c) CONDITIONS.—A designation of a drug under 

2 subsection (b) shall be subject to the condition that— 

3 ‘‘(1) after an application is approved for the 

4 drug under section 505(b) or a license is issued for 

5 the drug under section 351 of the Public Health 

6 Service Act, the manufacturer of the drug will notify 

7 the Secretary of any discontinuance of the produc8 tion of the drug at least one year before discontinu9 ance; and 

10 ‘‘(2) before an application is approved for the 

11 drug under section 505(b) or a license is issued for 

12 the drug under section 351 of the Public Health 

13 Service Act, the sponsor of the drug will notify the 

14 Secretary of any decision to discontinue active pur15 suit of approval of an application under section 

16 505(b) or approval of a license under section 351 of 

17 the Public Health Service Act. 

18 ‘‘(d) PUBLIC AVAILABILITY OF NOTICE.—Notice re19 specting the designation of a drug under subsection (b) 

20 shall be made available to the public. 

21 ‘‘(e) REGULATIONS.—The Secretary shall by regula22 tion promulgate procedures for the implementation of sub23 sections (a) and (b). 
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1 ‘‘SEC. 577. MARKET PROTECTION FOR CANCER DRUGS. 

2 ‘‘(a) IN GENERAL.—Except as provided in subsection 

3 (b), if the Secretary approves an application filed pursuant 

4 to section 505 for a drug designated under section 576 

5 as a cancer drug, or if the Secretary issues a license under 

6 section 351 of the Public Health Service Act for such a 

7 drug, the Secretary may not approve another application 

8 under section 505 or issue another license under section 

9 351 of the Public Health Service Act for such drug for 

10 a person who is not the holder of such approved applica11 tion or of such license until the expiration of seven years 

12 from the date of the approval of the approved application 

13 or the issuance of the license. Section 505(c)(2) does not 

14 apply to the refusal to approve an application under the 

15 preceding sentence. 

16 ‘‘(b) EXCEPTION.—If an application filed pursuant to 

17 section 505 is approved for a drug designated under sec18 tion 576 as a cancer drug or if a license is issued under 

19 section 351 of the Public Health Service Act for such a 

20 drug, the Secretary may, during the seven-year period be21 ginning on the date of the application approval or of the 

22 issuance of the license, approve another application under 

23 section 505 or issue a license under section 351 of the 

24 Public Health Service Act for such drug for cancer for 

25 a person who is not the holder of such approved applica26 tion or of such license if— 
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1 ‘‘(1) the Secretary finds, after providing the 

2 holder notice and opportunity for the submission of 

3 views, that in such period the holder of the approved 

4 application or of the license cannot assure the avail5 ability of sufficient quantities of the drug to meet 

6 the needs of persons with the cancer involved; or 

7 ‘‘(2) such holder provides the Secretary in writ8 ing the consent of such holder for the approval of 

9 other applications or the issuance of other licenses 

10 before the expiration of such seven-year period. 

11 ‘‘SEC. 578. OPEN PROTOCOLS FOR INVESTIGATIONS OF 

12 CANCER DRUGS. 

13 ‘‘If a drug is designated under section 576 as a can14 cer drug and if notice of a claimed exemption under sec15 tion 505(i) or regulations issued thereunder is filed for 

16 such drug, the Secretary shall encourage the sponsor of 

17 such drug to design protocols for the drug which include 

18 persons with the cancer involved who need the drug to 

19 treat the cancer and who cannot be satisfactorily treated 

20 by available alternative drugs.’’. 
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1 SEC. 3. ABBREVIATED APPLICATIONS FOR NEW DRUGS; 

2 NONPATENT MARKET EXCLUSIVITY FOR CAN3 CER DRUGS. 

4 Section 505(j)(5)(F)(ii) of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 355(j)(5)(F)(ii)) is amend6 ed— 

7 (1) by striking ‘‘(ii)’’ and inserting ‘‘(ii)(I)’’; 

8 and 

9 (2) by adding at the end the following sub10 clause: 

11 ‘‘(II) With respect to an application under subsection 

12 (b) for a drug referred to in subclause (I), in any case 

13 in which the drug is for use for cancer, the reference in 

14 such subclause to five years is deemed to be ten years, 

15 the reference to four years is deemed to be eight years, 

16 the reference to forty-eight months is deemed to be ninety17 six months, and the reference to seven and one-half years 

18 is deemed to be twelve and one-half years.’’. 

19 SEC. 4. EXTENSION OF PATENT TERM ON CANCER DRUGS. 

20 Section 156(c) of title 35, United States Code, is 

21 amended by adding at the end the following flush sen22 tence: 

23 ‘‘Paragraphs (2) and (3) shall not apply in the case of 

24 a drug approved for use for cancer.’’. 

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