‘‘SEC. 577. MARKET PROTECTION FOR CANCER DRUGS. 
‘‘(a) IN GENERAL.—Except as provided in subsection 
(b), if the Secretary approves an application filed pursuant 
to section 505 for a drug designated under section 576 
as a cancer drug, or if the Secretary issues a license under 
section 351 of the Public Health Service Act for such a 
drug, the Secretary may not approve another application 
under section 505 or issue another license under section 
351 of the Public Health Service Act for such drug for 
a person who is not the holder of such approved applica-
tion or of such license until the expiration of seven years 
from the date of the approval of the approved application 
or the issuance of the license. Section 505(c)(2) does not 
apply to the refusal to approve an application under the 
preceding sentence. 
‘‘(b) EXCEPTION.—If an application filed pursuant to 
section 505 is approved for a drug designated under sec-
tion 576 as a cancer drug or if a license is issued under 
section 351 of the Public Health Service Act for such a 
drug, the Secretary may, during the seven-year period be-
ginning on the date of the application approval or of the 
issuance of the license, approve another application under 
section 505 or issue a license under section 351 of the 
Public Health Service Act for such drug for cancer for 
a person who is not the holder of such approved applica-
tion or of such license if—
‘‘(1) the Secretary finds, after providing the 
holder notice and opportunity for the submission of 
views, that in such period the holder of the approved 
application or of the license cannot assure the avail-
ability of sufficient quantities of the drug to meet 
the needs of persons with the cancer involved; or 
‘‘(2) such holder provides the Secretary in writ-
ing the consent of such holder for the approval of 
other applications or the issuance of other licenses 
before the expiration of such seven-year period. 
‘‘SEC. 578. OPEN PROTOCOLS FOR INVESTIGATIONS OF 
CANCER DRUGS. 
‘‘If a drug is designated under section 576 as a can-
cer drug and if notice of a claimed exemption under sec-
tion 505(i) or regulations issued thereunder is filed for 
such drug, the Secretary shall encourage the sponsor of 
such drug to design protocols for the drug which include 
persons with the cancer involved who need the drug to 
treat the cancer and who cannot be satisfactorily treated 
by available alternative drugs.’’.
SEC. 3. ABBREVIATED APPLICATIONS FOR NEW DRUGS; 
NONPATENT MARKET EXCLUSIVITY FOR CAN-
CER DRUGS. 
Section 505(j)(5)(F)(ii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(j)(5)(F)(ii)) is amend-
ed— 
(1) by striking ‘‘(ii)’’ and inserting ‘‘(ii)(I)’’; 
and 
(2) by adding at the end the following sub-
clause: 
‘‘(II) With respect to an application under subsection 
(b) for a drug referred to in subclause (I), in any case 
in which the drug is for use for cancer, the reference in 
such subclause to five years is deemed to be ten years, 
the reference to four years is deemed to be eight years, 
the reference to forty-eight months is deemed to be ninety- 
six months, and the reference to seven and one-half years 
is deemed to be twelve and one-half years.’’. 
SEC. 4. EXTENSION OF PATENT TERM ON CANCER DRUGS. 
Section 156(c) of title 35, United States Code, is 
amended by adding at the end the following flush sen-
tence: 
‘‘Paragraphs (2) and (3) shall not apply in the case of 
a drug approved for use for cancer.’’. 
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