I 
114TH CONGRESS 
1ST SESSION 
H. R. 971 
To amend the Federal Food, Drug, and Cosmetic Act to authorize a 6- 
month extension of certain exclusivity periods in the case of approved 
drugs that are subsequently approved for a new indication to prevent, 
diagnose, or treat a rare disease or condition, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 13, 2015 
Mr. BILIRAKIS (for himself, Mr. MCCAUL, and Mr. BUTTERFIELD) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
authorize a 6-month extension of certain exclusivity peri-
ods in the case of approved drugs that are subsequently 
approved for a new indication to prevent, diagnose, or 
treat a rare disease or condition, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Orphan Product Ex-
tensions Now Accelerating Cures and Treatments Act of 
2015’’. 
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SEC. 2. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG 
APPROVED FOR A NEW INDICATION FOR A 
RARE DISEASE OR CONDITION. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 505E of such Act (21 U.S.C. 355f) the following: 
‘‘SEC. 505F. EXTENSION OF EXCLUSIVITY PERIODS FOR A 
DRUG APPROVED FOR A NEW INDICATION 
FOR A RARE DISEASE OR CONDITION. 
‘‘(a) DESIGNATION.— 
‘‘(1) IN GENERAL.—The Secretary shall des-
ignate a drug as a drug approved for a new indica-
tion to prevent, diagnose, or treat a rare disease or 
condition for purposes of granting the extensions 
under subsection (b) if— 
‘‘(A) prior to approval of an application or 
supplemental application for the new indication, 
the drug was approved or licensed for mar-
keting under section 505(c) of this Act or sec-
tion 351(a) of the Public Health Service Act, 
but was not so approved or licensed for the new 
indication; 
‘‘(B) the sponsor of the approved or li-
censed drug files an application or a supple-
mental application for approval of the new indi-
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cation for use of the drug to prevent, diagnose, 
or treat the rare disease or condition; 
‘‘(C) the application or supplemental appli-
cation for the new indication contains— 
‘‘(i) a request for designation of the 
drug under this section; 
‘‘(ii) the consent of the applicant to 
notice being given by the Secretary under 
paragraph (4) respecting the designation 
of the drug; and 
‘‘(iii) in the case of a drug for which 
an extension is sought under subsection 
(b)(3), a list specifying each patent— 
‘‘(I) which claims the drug or a 
method of using the drug; and 
‘‘(II) with respect to which a 
claim of patent infringement could 
reasonably be asserted if a person not 
licensed by the owner engaged in the 
manufacture, use, or sale of the drug; 
and 
‘‘(D) the Secretary approves the applica-
tion or supplemental application. 
‘‘(2) REVOCATION OF DESIGNATION.— 
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‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), a designation under this 
subsection shall not be revoked for any reason. 
‘‘(B) EXCEPTION.—The Secretary may re-
voke a designation of a drug under paragraph 
(1) if the Secretary finds that the application or 
supplemental application resulting in such des-
ignation contained an untrue statement of ma-
terial fact. 
‘‘(3) NOTIFICATION PRIOR TO DISCONTINUANCE 
OF
PRODUCTION
FOR
SOLELY
COMMERCIAL
REA-
SONS.—A designation of a drug under paragraph (1) 
shall be subject to the condition that the sponsor of 
the drug will notify the Secretary of any discontinu-
ance of the production of the drug for solely com-
mercial reasons at least one year before such dis-
continuance. 
‘‘(4) NOTICE
TO
PUBLIC.—Notice respecting 
the designation of a drug under paragraph (1)— 
‘‘(A) shall be made available to the public; 
and 
‘‘(B) shall include any listing of patents 
under subsection (a)(1)(C)(iii). 
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‘‘(b) EXTENSION.—If the Secretary designates a 
drug as a drug approved for a new indication for a rare 
disease or condition, as described in subsection (a)(1)— 
‘‘(1)(A)(i) the 4-, 5-, and 71⁄2-year periods de-
scribed in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) 
of section 505, and the 3-year periods described in 
clauses (iii) and (iv) of subsection (c)(3)(E) and 
clauses (iii) and (iv) of subsection (j)(5)(F) of sec-
tion 505, as applicable, shall be extended by 6 
months; or 
‘‘(ii) the 4- and 12-year periods described in 
subparagraphs (A) and (B) of section 351(k)(7) of 
the Public Health Service Act, as applicable, shall be 
extended by 6 months; and 
‘‘(B) the 7-year period described in section 527, 
as applicable, shall be extended by 6 months; 
‘‘(2) if, at the time a drug is designated under 
subsection (a)(1)— 
‘‘(A) the drug is the subject of a listed pat-
ent for which a certification has been submitted 
under 
subsection 
(b)(2)(A)(ii) 
or 
(j)(2)(A)(vii)(II) of section 505 or a listed pat-
ent for which a certification has been submitted 
under 
subsections 
(b)(2)(A)(iii) 
or 
(j)(2)(A)(vii)(III) of section 505, the period 
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during which an application may not be ap-
proved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of 6 
months after the date the patent expires (in-
cluding any patent extensions); or 
‘‘(B) the drug is the subject of a listed 
patent for which a certification has been sub-
mitted 
under 
subsection 
(b)(2)(A)(iv) 
or 
(j)(2)(A)(vii)(IV) of section 505, and in the pat-
ent infringement litigation resulting from the 
certification the court determines that the pat-
ent is valid and would be infringed, the period 
during which an application may not be ap-
proved under section 505(c)(3) or section 
505(j)(5)(B) shall be extended by a period of 6 
months after the date the patent expires (in-
cluding any patent extensions); and 
‘‘(3) if the drug is a biological product, the Sec-
retary shall not grant final effective approval for any 
application submitted under section 351(k)(1) of the 
Public Health Service Act for a biosimilar biological 
product that cites such drug as its reference product 
until the date that is 6 months after the expiration 
of every patent that, as of the date on which the 
drug is designated under subsection (a)(1), is listed 
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