I 

115TH CONGRESS 

1ST SESSION H. R. 1223 

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. 

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. 

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 ‘‘Orphan Products Ex5 tension Now Accelerating Cures and Treatments Act of 

6 2017’’ or the ‘‘OPEN Act’’. 


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1 SEC. 2. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG 

2 APPROVED FOR A NEW INDICATION FOR A 

3 RARE DISEASE OR CONDITION. 

4 (a) IN GENERAL.—The Federal Food, Drug, and 

5 Cosmetic Act is amended by inserting after section 505F 

6 of such Act (21 U.S.C. 355g) the following: 

7 ‘‘SEC. 505G. EXTENSION OF EXCLUSIVITY PERIODS FOR A 

8 DRUG APPROVED FOR A NEW INDICATION 

9 FOR A RARE DISEASE OR CONDITION. 

10 ‘‘(a) DESIGNATION.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall des12 ignate a drug as a drug approved for a new indica13 tion to prevent, diagnose, or treat a rare disease or 

14 condition for purposes of granting the extensions 

15 under subsection (b) if— 

16 ‘‘(A) prior to approval of an application or 

17 supplemental application for the new indication, 

18 the drug was approved or licensed under section 

19 505(c) of this Act or section 351(a) of the Pub20 lic Health Service Act but was not so approved 

21 or licensed for the new indication; 

22 ‘‘(B)(i) the sponsor of the approved or li23 censed drug files an application or a supple24 mental application for approval of the new indi25 cation for use of the drug to prevent, diagnose, 

26 or treat the rare disease or condition; and 


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1 ‘‘(ii) the Secretary approves the application 

2 or supplemental application; and 

3 ‘‘(C) the application or supplemental appli4 cation for the new indication contains the con5 sent of the applicant to public notice under 

6 paragraph (4) with respect to the designation of 

7 the drug. 

8 ‘‘(2) REVOCATION OF DESIGNATION.— 

9 ‘‘(A) IN GENERAL.—Except as provided in 

10 subparagraph (B), a designation under para11 graph (1) shall not be revoked for any reason. 

12 ‘‘(B) EXCEPTION.—The Secretary may re13 voke a designation of a drug under paragraph 

14 (1) if the Secretary finds that the application or 

15 supplemental application resulting in such des16 ignation contained an untrue statement of ma17 terial fact. 

18 ‘‘(3) NOTICE TO PUBLIC.—The Secretary shall 

19 provide public notice of the designation of a drug 

20 under paragraph (1). 

21 ‘‘(b) EXTENSION.— 

22 ‘‘(1) IN GENERAL.—If the Secretary designates 

23 a drug as a drug approved for a new indication for 

24 a rare disease or condition, as described in sub25 section (a)(1)— 


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‘‘(A)(i) the 4-, 5-, and 71 1 ⁄2-year periods de2 scribed in subsections (c)(3)(E)(ii) and 

3 (j)(5)(F)(ii) of section 505, the 3-year periods 

4 described in clauses (iii) and (iv) of subsection 

5 (c)(3)(E) and clauses (iii) and (iv) of subsection 

6 (j)(5)(F) of section 505, and the 7-year period 

7 described in section 527, as applicable, shall be 

8 extended by 6 months; or 

9 ‘‘(ii) the 4- and 12-year periods described 

10 in subparagraphs (A) and (B) of section 

11 351(k)(7) of the Public Health Service Act and 

12 the 7-year period described in section 527, as 

13 applicable, shall be extended by 6 months; and 

14 ‘‘(B)(i) if the drug is the subject of a listed 

15 patent for which a certification has been sub16 mitted under subsection (b)(2)(A)(ii) or 

17 (j)(2)(A)(vii)(II) of section 505 or a listed pat18 ent for which a certification has been submitted 

19 under subsection (b)(2)(A)(iii) or 

20 (j)(2)(A)(vii)(III) of section 505, the period 

21 during which an application may not be ap22 proved under section 505(c)(3) or section 

23 505(j)(5)(B) shall be extended by a period of 6 

24 months after the date the patent expires (in25 cluding any patent extensions); or 


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1 ‘‘(ii) if the drug is the subject of a listed 

2 patent for which a certification has been sub3 mitted under subsection (b)(2)(A)(iv) or 

4 (j)(2)(A)(vii)(IV) of section 505, and in the pat5 ent infringement litigation resulting from the 

6 certification the court determines that the pat7 ent is valid and would be infringed, the period 

8 during which an application may not be ap9 proved under section 505(c)(3) or section 

10 505(j)(5)(B) shall be extended by a period of 6 

11 months after the date the patent expires (in12 cluding any patent extensions). 

13 ‘‘(2) RELATION TO PEDIATRIC AND QUALIFIED

14 INFECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any 

15 extension under paragraph (1) of a period shall be 

16 in addition to any extension of the periods under 

17 sections 505A and 505E of this Act and section 

18 351(m) of the Public Health Service Act, as applica19 ble, with respect to the drug. 

20 ‘‘(c) LIMITATIONS.—Any extension described in sub21 section (b)(1) shall not apply if the drug designated under 

22 subsection (a)(1) has previously received an extension by 

23 operation of subsection (b)(1). 


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1 ‘‘(d) DEFINITION.—In this section, the term ‘rare 

2 disease or condition’ has the meaning given to such term 

3 in section 526(a)(2).’’. 

4 (b) APPLICATION.—Section 505G of the Federal 

5 Food, Drug, and Cosmetic Act, as added by subsection 

6 (a), applies only with respect to a drug for which an appli7 cation or supplemental application described in subsection 

8 (a)(1)(B)(i) of such section 505G is first approved under 

9 section 505(c) of such Act (21 U.S.C. 355(c)) or section 

10 351(a) of the Public Health Service Act (42 U.S.C. 

11 262(a)) on or after the date of the enactment of this Act. 

12 (c) CONFORMING AMENDMENTS.— 

13 (1) RELATION TO PEDIATRIC EXCLUSIVITY FOR

14 DRUGS.—Section 505A of the Federal Food, Drug, 

15 and Cosmetic Act (21 U.S.C. 355a) is amended— 

16 (A) in subsection (b), by adding at the end 

17 the following: 

18 ‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG

19 APPROVED FOR A NEW INDICATION FOR A RARE DIS20 EASE OR CONDITION.—Notwithstanding the ref21 erences in paragraph (1) to the lengths of the exclu22 sivity periods after application of pediatric exclu23 sivity, the 6-month extensions described in para24 graph (1) shall be in addition to any extensions 

25 under section 505G.’’; and 


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1 (B) in subsection (c), by adding at the end 

2 the following: 

3 ‘‘(3) RELATION TO EXCLUSIVITY FOR A DRUG

4 APPROVED FOR A NEW INDICATION FOR A RARE DIS5 EASE OR CONDITION.—Notwithstanding the ref6 erences in paragraph (1) to the lengths of the exclu7 sivity periods after application of pediatric exclu8 sivity, the 6-month extensions described in para9 graph (1) shall be in addition to any extensions 

10 under section 505G.’’. 

11 (2) RELATION TO EXCLUSIVITY FOR NEW

12 QUALIFIED INFECTIOUS DISEASE PRODUCTS THAT

13 ARE DRUGS.—Subsection (b) of section 505E of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

15 355f) is amended— 

16 (A) by amending the subsection heading to 

17 read as follows: ‘‘RELATION TO PEDIATRIC EX18 CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP19 PROVED FOR A NEW INDICATION FOR A RARE

20 DISEASE OR CONDITION.—’’; and 

21 (B) by striking ‘‘any extension of the pe22 riod under section 505A’’ and inserting ‘‘any 

23 extension of the periods under sections 505A 

24 and 505G, as applicable,’’. 


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1 (3) RELATION TO PEDIATRIC EXCLUSIVITY FOR

2 BIOLOGICAL PRODUCTS.—Section 351(m) of the 

3 Public Health Service Act (42 U.S.C. 262(m)) is 

4 amended by adding at the end the following: 

5 ‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO6 LOGICAL PRODUCT APPROVED FOR A NEW INDICA7 TION FOR A RARE DISEASE OR CONDITION.—Not8 withstanding the references in paragraphs (2)(A), 

9 (2)(B), (3)(A), and (3)(B) to the lengths of the ex10 clusivity periods after application of pediatric exclu11 sivity, the 6-month extensions described in such 

12 paragraphs shall be in addition to any extensions 

13 under section 505G.’’. 

Æ 


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