I 

116TH CONGRESS 

1ST SESSION H. R. 1503 

To amend the Federal Food, Drug, and Cosmetic Act regarding the list 

under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, 

and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2019 

Ms. KELLY of Illinois 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 regarding the list under section 505(j)(7) of the Federal Food, 

Drug, and Cosmetic Act, 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 ‘‘Orange Book Trans5 parency Act of 2019’’. 

6 SEC. 2. ORANGE BOOK. 

7 (a) PATENTS.—Clause (iii) of section 505(j)(7)(A) of 

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

9 355(j)(7)) is amended to read as follows: 


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1 ‘‘(iii)(I) When patent information submitted under 

2 subsection (b) or (c) respecting a drug included on the 

3 list is to be published by the Secretary, the Secretary shall, 

4 in revisions made under clause (ii), include such informa5 tion for such drug. 

6 ‘‘(II) The Secretary— 

7 ‘‘(aa) shall include on the list, from such patent 

8 information respecting a drug, drug substance (in9 cluding active ingredient) patents, drug product (in10 cluding formulation and composition) patents, and 

11 method of use patents; and 

12 ‘‘(bb) may choose to include on the list addi13 tional patent information respecting the drug. 

14 ‘‘(III) The Secretary shall not include on the list any 

15 patent to the extent such patent claims a device that is 

16 used for the delivery of the drug. Notwithstanding the pre17 ceding sentence, the Secretary may require (under other 

18 applicable provisions of law) the holder of the approved 

19 application for a drug to submit, for purposes other than 

20 the list under this paragraph, patent information respect21 ing a device that is used for the delivery of the drug.’’. 

22 (b) LISTING OF EXCLUSIVITIES.—Subparagraph (A) 

23 of section 505(j)(7) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 355(j)(7)) is amended by adding at 

25 the end the following: 


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1 ‘‘(iv) For each drug included on the list, the Sec2 retary shall specify each exclusivity period that is applica3 ble and has not concluded under— 

4 ‘‘(I) clause (iii) or (iv) of subsection (c)(3)(E) 

5 of this section; 

6 ‘‘(II) clause (iv) or (v) of paragraph (5)(B) of 

7 this subsection; 

8 ‘‘(III) clause (iii) or (iv) of paragraph (5)(F) of 

9 this subsection; 

10 ‘‘(IV) section 505A; 

11 ‘‘(V) section 505E; or 

12 ‘‘(VI) section 527(a).’’. 

13 (c) REMOVAL OF INVALID PATENTS.— 

14 (1) IN GENERAL.—Section 505(j)(7) of the 

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

16 355(j)(7)) is amended by adding at the end the fol17 lowing: 

18 ‘‘(D)(i) The holder of an application approved under 

19 subsection (c) for a drug on the list shall promptly notify 

20 the Secretary in writing if either of the following occurs: 

21 ‘‘(I) The Patent Trial and Appeals Board issues 

22 a decision that a patent for such drug is invalid. 

23 ‘‘(II) A court issues a decision from which no 

24 appeal may be taken that a patent for such drug is 

25 invalid. 


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1 ‘‘(ii) The holder of an approved application shall in2 clude in any notification under clause (i) a copy of the 

3 decision described in subclause (I) or (II) of clause (i). 

4 ‘‘(iii) The Secretary shall remove from the list any 

5 patent that is determined to be invalid in a decision de6 scribed in subclause (I) or (II) of clause (i)— 

7 ‘‘(I) promptly; but 

8 ‘‘(II) not before the expiration of any 180-day 

9 exclusivity period under clause (iv) or (v) of para10 graph (5)(B) that relies on a certification described 

11 in paragraph (2)(A)(vii)(IV) that such patent was 

12 invalid.’’. 

13 (2) APPLICABILITY.—Subparagraph (D) of sec14 tion 505(j)(7) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355(j)(7)), as added by para16 graph (1), applies only with respect to a decision de17 scribed in such subparagraph that is issued on or 

18 after the date of enactment of this Act. 

19 (d) REVIEW AND REPORT.—Not later than one year 

20 after the date of enactment of this Act, the Secretary of 

21 Health and Human Services, acting through the Commis22 sioner of Food and Drugs, shall— 

23 (1) review the types of patent information that 

24 should be included on the list under section 


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1 507(j)(7) of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 355(j)(7)); and 

3 (2) report to the Congress on the results of 

4 such review, including any recommendations about 

5 the types of patent information that should be in6 cluded on or removed from such list. 

Æ 


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