I 
115TH CONGRESS 
1ST SESSION H. R. 1223 
To amend the Federal Food, Drug, and Cosmetic Act to authorize an exten-
sion of exclusivity periods for certain drugs that are approved for a 
new indication for a rare disease or condition, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 27, 2017 
Mr. BILIRAKIS (for himself, Mr. BUTTERFIELD, and Mr. MCCAUL) 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 an extension of exclusivity periods for certain 
drugs that are approved for a new indication for 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 Products Ex-
tension Now Accelerating Cures and Treatments Act of 
2017’’ or the ‘‘OPEN Act’’. 
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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.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 505F 
of such Act (21 U.S.C. 355g) the following: 
‘‘SEC. 505G. 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 under section 
505(c) of this Act or section 351(a) of the Pub-
lic Health Service Act but was not so approved 
or licensed for the new indication; 
‘‘(B)(i) the sponsor of the approved or li-
censed drug files an application or a supple-
mental application for approval of the new indi-
cation for use of the drug to prevent, diagnose, 
or treat the rare disease or condition; and 
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‘‘(ii) the Secretary approves the application 
or supplemental application; and 
‘‘(C) the application or supplemental appli-
cation for the new indication contains the con-
sent of the applicant to public notice under 
paragraph (4) with respect to the designation of 
the drug. 
‘‘(2) REVOCATION OF DESIGNATION.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), a designation under para-
graph (1) 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) NOTICE TO PUBLIC.—The Secretary shall 
provide public notice of the designation of a drug 
under paragraph (1). 
‘‘(b) EXTENSION.— 
‘‘(1) IN GENERAL.—If the Secretary designates 
a drug as a drug approved for a new indication for 
a rare disease or condition, as described in sub-
section (a)(1)— 
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‘‘(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, 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 section 505, and the 7-year period 
described in section 527, 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 and 
the 7-year period described in section 527, as 
applicable, shall be extended by 6 months; and 
‘‘(B)(i) if the drug is the subject of a listed 
patent for which a certification has been sub-
mitted 
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 
subsection 
(b)(2)(A)(iii) 
or 
(j)(2)(A)(vii)(III) of section 505, 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); or 
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‘‘(ii) if 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). 
‘‘(2) RELATION TO PEDIATRIC AND QUALIFIED 
INFECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any 
extension under paragraph (1) of a period shall be 
in addition to any extension of the periods under 
sections 505A and 505E of this Act and section 
351(m) of the Public Health Service Act, as applica-
ble, with respect to the drug. 
‘‘(c) LIMITATIONS.—Any extension described in sub-
section (b)(1) shall not apply if the drug designated under 
subsection (a)(1) has previously received an extension by 
operation of subsection (b)(1). 
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