IIB 

116TH CONGRESS 

1ST SESSION H. R. 1503 

IN THE SENATE OF THE UNITED STATES 

MAY 9, 2019 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Orange Book Trans3 parency Act of 2019’’. 

4 SEC. 2. ORANGE BOOK. 

5 (a) SUBMISSION OF PATENT INFORMATION FOR

6 BRAND NAME DRUGS.—Paragraph (1) of section 505(b) 

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

8 355(b)) is amended to read as follows: 

9 ‘‘(b)(1) Any person may file with the Secretary an 

10 application with respect to any drug subject to the provi11 sions of subsection (a). Such persons shall submit to the 

12 Secretary as part of the application— 

13 ‘‘(A) full reports of investigations which have 

14 been made to show whether or not such drug is safe 

15 for use and whether such drug is effective in use; 

16 ‘‘(B) a full list of the articles used as compo17 nents of such drug; 

18 ‘‘(C) a full statement of the composition of such 

19 drug; 

20 ‘‘(D) a full description of the methods used in, 

21 and the facilities and controls used for, the manufac22 ture, processing, and packing of such drug; 

23 ‘‘(E) such samples of such drug and of the arti24 cles used as components thereof as the Secretary 

25 may require; 


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1 ‘‘(F) specimens of the labeling proposed to be 

2 used for such drug; 

3 ‘‘(G) any assessments required under section 

4 505B; and 

5 ‘‘(H) patent information, with respect to each 

6 patent for which a claim of patent infringement 

7 could reasonably be asserted if a person not licensed 

8 by the owner engaged in the manufacture, use, or 

9 sale of the drug, and consistent with the following 

10 requirements: 

11 ‘‘(i) The applicant shall file with the appli12 cation the patent number and the expiration 

13 date of— 

14 ‘‘(I) any patent which claims the drug 

15 for which the applicant submitted the ap16 plication and is a drug substance (includ17 ing active ingredient) patent or a drug 

18 product (including formulation and com19 position) patent; and 

20 ‘‘(II) any patent which claims the 

21 method of using such drug. 

22 ‘‘(ii) If an application is filed under this 

23 subsection for a drug and a patent of the type 

24 described in clause (i) which claims such drug 

25 or a method of using such drug is issued after 


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1 the filing date but before approval of the appli2 cation, the applicant shall amend the applica3 tion to include such patent information. 

4 Upon approval of the application, the Secretary shall pub5 lish the information submitted under subparagraph (H). 

6 The Secretary shall, in consultation with the Director of 

7 the National Institutes of Health and with representatives 

8 of the drug manufacturing industry, review and develop 

9 guidance, as appropriate, on the inclusion of women and 

10 minorities in clinical trials required by subparagraph 

11 (A).’’. 

12 (b) CONFORMING CHANGES TO REQUIREMENTS FOR

13 SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 

14 Section 505(c)(2) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355(j)(7)) is amended— 

16 (1) by inserting after ‘‘the patent number and 

17 the expiration date of any patent which’’ the fol18 lowing: ‘‘fulfills the criteria in subsection (b) and’’; 

19 (2) by inserting after the first sentence the fol20 lowing: ‘‘Patent information that is not the type of 

21 patent information required by subsection (b) shall 

22 not be submitted.’’; and 

23 (3) by inserting after ‘‘could not file patent in24 formation under subsection (b) because no patent’’ 


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1 the following: ‘‘of the type required to be submitted 

2 in subsection (b)’’. 

3 (c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) 

4 of section 505(j)(7) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355(j)(7)) is amended by adding at 

6 the end the following: 

7 ‘‘(iv) For each drug included on the list, the Sec8 retary shall specify each exclusivity period that is applica9 ble and has not concluded under— 

10 ‘‘(I) clause (ii), (iii), or (iv) of subsection 

11 (c)(3)(E) of this section; 

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

13 this subsection; 

14 ‘‘(III) clause (ii), (iii), or (iv) of paragraph 

15 (5)(F) of this subsection; 

16 ‘‘(IV) section 505A; 

17 ‘‘(V) section 505E; or 

18 ‘‘(VI) section 527(a).’’. 

19 (d) REMOVAL OF INVALID PATENTS.— 

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

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

22 355(j)(7)) is amended by adding at the end the fol23 lowing: 

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

25 subsection (c) for a drug on the list shall notify within 


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1 14 days the Secretary in writing if either of the following 

2 occurs: 

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

4 a decision from which no appeal has been or can be 

5 taken that a patent for such drug is invalid. 

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

7 appeal has been or can be taken that a patent for 

8 such drug is invalid. 

9 ‘‘(ii) The holder of an approved application shall in10 clude in any notification under clause (i) a copy of the 

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

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

13 patent that is determined to be invalid in a decision de14 scribed in subclause (I) or (II) of clause (i)— 

15 ‘‘(I) promptly; but 

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

17 exclusivity period under paragraph (5)(B)(iv) that 

18 relies on a certification described in paragraph 

19 (2)(A)(vii)(IV) that such patent was invalid.’’. 

20 (2) APPLICABILITY.—Subparagraph (D) of sec21 tion 505(j)(7) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 355(j)(7)), as added by para23 graph (1), applies only with respect to a decision de24 scribed in such subparagraph that is issued on or 

25 after the date of enactment of this Act. 


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1 (e) REVIEW AND REPORT.—Not later than 1 year 

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

3 Health and Human Services, acting through the Commis4 sioner of Food and Drugs, shall— 

5 (1) solicit public comment regarding the types 

6 of patent information that should be included on the 

7 list under section 507(j)(7) of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)); and 

9 (2) transmit to the Congress an evaluation of 

10 such comments, including any recommendations 

11 about the types of patent information that should be 

12 included on or removed from such list. 

13 SEC. 3. GAO REPORT TO CONGRESS. 

14 (a) IN GENERAL.—Not later than 1 year after the 

15 date of enactment of this Act, the Comptroller General 

16 of the United States (referred to in this section as the 

17 ‘‘Comptroller General’’) shall submit to the Committee on 

18 Energy and Commerce of the House of Representatives 

19 a report on the patents included in the list published under 

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

21 Act (21 U.S.C. 355(j)(7)), including an analysis and eval22 uation of the types of patents included in such list and 

23 the claims such patents make about the products they 

24 claim. 


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1 (b) CONTENTS.—The Comptroller General shall in2 clude in the report under subsection (a)— 

3 (1) data on the number of— 

4 (A) patents included in the list published 

5 under paragraph (7) of section 505(j) of the 

6 Federal Food, Drug and Cosmetic Act (21 

7 U.S.C. 355(j)), that claim the active ingredient 

8 or formulation of a drug in combination with a 

9 device that is used for delivery of the drug, to10 gether comprising the finished dosage form of 

11 the drug; and 

12 (B) claims in each patent that claim a de13 vice that is used for the delivery of the drug, 

14 but do not claim such device in combination 

15 with an active ingredient or formulation of a 

16 drug; 

17 (2) data on the date of inclusion in the list 

18 under paragraph (7) of such section 505(j) for all 

19 patents under such list, as compared to patents that 

20 claim a method of using the drug in combination 

21 with a device; 

22 (3) an analysis regarding the impact of includ23 ing on the list under paragraph (7) of such section 

24 505(j) certain types of patent information for drug 


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1 product applicants and approved application holders, 

2 including an analysis of whether— 

3 (A) the listing of the patents described in 

4 paragraph (1)(A) delayed the market entry of 

5 one or more drugs approved under such section 

6 505(j); and 

7 (B) not listing the patents described in 

8 paragraph (1)(A) would delay the market entry 

9 of one or more such drugs; and 

10 (4) recommendations about which kinds of pat11 ents relating to devices described in paragraph 

12 (1)(A) should be submitted to the Secretary of 

13 Health and Human Services for inclusion on the list 

14 under paragraph (7) of such section 505(j) and 

15 which patents should not be required to be so sub16 mitted. 

Passed the House of Representatives May 8, 2019. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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