II 

114TH CONGRESS 

1ST SESSION S. 1421 

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 SENATE OF THE UNITED STATES 

MAY 21, 2015 

Mr. HATCH (for himself and Ms. KLOBUCHAR) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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. 

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 Product Ex5 tensions Now Accelerating Cures and Treatments Act of 

6 2015’’. 


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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.—Chapter V of the Federal Food, 

5 Drug, and Cosmetic Act is amended by inserting after sec6 tion 505E the following: 

7 ‘‘SEC. 505F. 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 for mar19 keting under section 505(c) of this Act or sec20 tion 351(a) of the Public Health Service Act, 

21 but was not so approved or licensed for the new 

22 indication; 

23 ‘‘(B)(i) the sponsor of the approved or li24 censed drug files an application or a supple25 mental application for approval of the new indiVerDate Sep 11 2014 00:33 May 29, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1421.IS S1421

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1 cation for use of the drug to prevent, diagnose, 

2 or treat the rare disease or condition; and 

3 ‘‘(ii) the Secretary approves the application 

4 or supplemental application; and 

5 ‘‘(C) the application or supplemental appli6 cation for the new indication contains the con7 sent of the applicant to notice being given by 

8 the Secretary under paragraph (4) respecting 

9 the designation of the drug. 

10 ‘‘(2) REVOCATION OF DESIGNATION.— 

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

12 subparagraph (B), a designation under this 

13 subsection shall not be revoked for any reason. 

14 ‘‘(B) EXCEPTION.—The Secretary may re15 voke a designation of a drug under paragraph 

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

17 supplemental application resulting in such des18 ignation contained an untrue statement of ma19 terial fact. 

20 ‘‘(3) NOTIFICATION PRIOR TO DISCONTINUANCE

21 OF PRODUCTION FOR SOLELY COMMERCIAL REA22 SONS.—A designation of a drug under paragraph (1) 

23 shall be subject to the condition that the sponsor of 

24 the drug will notify the Secretary of any discontinu25 ance of the production of the drug for solely comVerDate Sep 11 2014 00:33 May 29, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1421.IS S1421

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1 mercial reasons at least one year before such dis2 continuance. 

3 ‘‘(4) NOTICE TO PUBLIC.—Notice respecting 

4 the designation of a drug under paragraph (1) shall 

5 be made available to the public. 

6 ‘‘(b) EXTENSION.—If the Secretary designates a 

7 drug as a drug approved for a new indication for a rare 

8 disease or condition, as described in subsection (a)(1)— 

‘‘(1)(A) the 4-, 5-, and 71 9 ⁄2-year periods de10 scribed in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) 

11 of section 505, the 3-year periods described in 

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

13 clauses (iii) and (iv) of subsection (j)(5)(F) of sec14 tion 505, and the 7-year period described in section 

15 527, as applicable, shall be extended by 6 months; 

16 or 

17 ‘‘(B) the 4- and 12-year periods described in 

18 subparagraphs (A) and (B) of section 351(k)(7) of 

19 the Public Health Service Act and the 7-year period 

20 described in section 527, as applicable, shall be ex21 tended by 6 months; and 

22 ‘‘(2)(A) if the drug is the subject of a listed 

23 patent for which a certification has been submitted 

24 under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of 

25 section 505 or a listed patent for which a certifiVerDate Sep 11 2014 00:33 May 29, 2015 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1421.IS S1421

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1 cation has been submitted under subsections 

2 (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, 

3 the period during which an application may not be 

4 approved under section 505(c)(3) or section 

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

6 months after the date the patent expires (including 

7 any patent extensions); or 

8 ‘‘(B) if the drug is the subject of a listed patent 

9 for which a certification has been submitted under 

10 subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of sec11 tion 505, and in the patent infringement litigation 

12 resulting from the certification the court determines 

13 that the patent is valid and would be infringed, the 

14 period during which an application may not be ap15 proved under section 505(c)(3) or section 

16 505(j)(5)(B) shall be extended by a period of 6 

17 months after the date the patent expires (including 

18 any patent extensions). 

19 ‘‘(c) RELATION TO PEDIATRIC AND QUALIFIED IN20 FECTIOUS DISEASE PRODUCT EXCLUSIVITY.—Any exten21 sion under subsection (b) of a period shall be in addition 

22 to any extension of the periods under sections 505A and 

23 505E of this Act and section 351(m) of the Public Health 

24 Service Act, as applicable, with respect to the drug. 


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1 ‘‘(d) LIMITATIONS.—The extension described in sub2 section (b) shall not apply if the drug designated under 

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

4 operation of subsection (b). 

5 ‘‘(e) DEFINITION.—In this section, the term ‘rare 

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

7 in section 526(a)(2).’’. 

8 (b) APPLICATION.—Section 505F of the Federal 

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

10 (a), applies only with respect to a drug for which an appli11 cation or supplemental application described in subsection 

12 (a)(1)(B)(i) of such section 505F is first approved under 

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

14 351(a) of the Public Health Service Act (42 U.S.C. 

15 262(a)) on or after the date of the enactment of this Act. 

16 (c) CONFORMING AMENDMENTS.— 

17 (1) RELATION TO PEDIATRIC EXCLUSIVITY FOR

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

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

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

21 the following: 

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

23 APPROVED FOR A NEW INDICATION FOR A RARE DIS24 EASE OR CONDITION.—Notwithstanding the ref25 erences in subsection (b)(1) to the lengths of the exVerDate Sep 11 2014 00:33 May 29, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1421.IS S1421

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1 clusivity periods after application of pediatric exclu2 sivity, the 6-month extensions described in sub3 section (b)(1) shall be in addition to any extensions 

4 under section 505F.’’; and 

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

6 the following: 

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

8 APPROVED FOR A NEW INDICATION FOR A RARE DIS9 EASE OR CONDITION.—Notwithstanding the ref10 erences in subsection (c)(1) to the lengths of the ex11 clusivity periods after application of pediatric exclu12 sivity, the 6-month extensions described in sub13 section (c)(1) shall be in addition to any extensions 

14 under section 505F.’’. 

15 (2) RELATION TO EXCLUSIVITY FOR NEW

16 QUALIFIED INFECTIOUS DISEASE PRODUCTS THAT

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

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

19 355f) is amended— 

20 (A) by amending the subsection heading to 

21 read as follows: ‘‘RELATION TO PEDIATRIC EX22 CLUSIVITY AND EXCLUSIVITY FOR A DRUG AP23 PROVED FOR A NEW INDICATION FOR A RARE

24 DISEASE OR CONDITION’’; and 


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1 (B) by striking ‘‘any extension of the pe2 riod under section 505A’’ and inserting ‘‘any 

3 extension of the periods under sections 505A 

4 and 505F, as applicable,’’. 

5 (3) RELATION TO PEDIATRIC EXCLUSIVITY FOR

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

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

8 amended by adding at the end the following: 

9 ‘‘(5) RELATION TO EXCLUSIVITY FOR A BIO10 LOGICAL PRODUCT APPROVED FOR A NEW INDICA11 TION FOR A RARE DISEASE OR CONDITION.—Not12 withstanding the references in paragraphs (2)(A), 

13 (2)(B), (3)(A), and (3)(B) to the lengths of the ex14 clusivity periods after application of pediatric exclu15 sivity, the 6-month extensions described in such 

16 paragraphs shall be in addition to any extensions 

17 under section 505F.’’. 

Æ 


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