IB 

Union Calendar No. 25 

116TH CONGRESS 

1ST SESSION H. R. 1503 

[Report No. 116–47] 

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 

MAY 2, 2019 

Additional sponsors: Mr. RUIZ, Mr. RUSH, Mr. PALLONE, Mrs. DINGELL, Ms. 

ESHOO, Mr. KENNEDY, Ms. MATSUI, Mrs. CRAIG, Ms. CLARKE of New 

York, Mr. VAN DREW, Mr. WALDEN, Ms. SCHAKOWSKY, and Ms. 

MUCARSEL-POWELL

MAY 2, 2019 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on March 5, 2019] 


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•HR 1503 RH

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. 


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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) SUBMISSION OF PATENT INFORMATION FOR BRAND

8 NAME DRUGS.—Paragraph (1) of section 505(b) of the Fed9 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is 

10 amended to read as follows: 

11 ‘‘(b)(1) Any person may file with the Secretary an ap12 plication with respect to any drug subject to the provisions 

13 of subsection (a). Such persons shall submit to the Secretary 

14 as part of the application— 

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

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

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

18 ‘‘(B) a full list of the articles used as components 

19 of such drug; 

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

21 drug; 

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

23 and the facilities and controls used for, the manufac24 ture, processing, and packing of such drug; 


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1 ‘‘(E) such samples of such drug and of the arti2 cles used as components thereof as the Secretary may 

3 require; 

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

5 used for such drug; 

6 ‘‘(G) any assessments required under section 

7 505B; and 

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

9 patent for which a claim of patent infringement could 

10 reasonably be asserted if a person not licensed by the 

11 owner engaged in the manufacture, use, or sale of the 

12 drug, and consistent with the following requirements: 

13 ‘‘(i) The applicant shall file with the appli14 cation the patent number and the expiration 

15 date of— 

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

17 for which the applicant submitted the appli18 cation and is a drug substance (including 

19 active ingredient) patent or a drug product 

20 (including formulation and composition) 

21 patent; and 

22 ‘‘(II) any patent which claims the 

23 method of using such drug. 

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

25 subsection for a drug and a patent of the type 


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1 described in clause (i) which claims such drug or 

2 a method of using such drug is issued after the 

3 filing date but before approval of the applica4 tion, the applicant shall amend the application 

5 to include such patent information. 

6 Upon approval of the application, the Secretary shall pub7 lish the information submitted under subparagraph (H). 

8 The Secretary shall, in consultation with the Director of 

9 the National Institutes of Health and with representatives 

10 of the drug manufacturing industry, review and develop 

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

12 minorities in clinical trials required by subparagraph 

13 (A).’’. 

14 (b) CONFORMING CHANGES TO REQUIREMENTS FOR

15 SUBSEQUENT SUBMISSION OF PATENT INFORMATION.— 

16 Section 505(c)(2) of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 355(j)(7)) is amended— 

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

19 the expiration date of any patent which’’ the fol20 lowing: ‘‘fulfills the criteria in subsection (b) and’’; 

21 (2) by inserting after the first sentence the fol22 lowing: ‘‘Patent information that is not the type of 

23 patent information required by subsection (b) shall 

24 not be submitted.’’; and 


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1 (3) by inserting after ‘‘could not file patent in2 formation under subsection (b) because no patent’’ the 

3 following: ‘‘of the type required to be submitted in 

4 subsection (b)’’. 

5 (c) LISTING OF EXCLUSIVITIES.—Subparagraph (A) of 

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

7 Act (21 U.S.C. 355(j)(7)) is amended by adding at the end 

8 the following: 

9 ‘‘(iv) For each drug included on the list, the Secretary 

10 shall specify each exclusivity period that is applicable and 

11 has not concluded under— 

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

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

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

15 this subsection; 

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

17 (5)(F) of this subsection; 

18 ‘‘(IV) section 505A; 

19 ‘‘(V) section 505E; or 

20 ‘‘(VI) section 527(a).’’. 

21 (d) REMOVAL OF INVALID PATENTS.— 

22 (1) IN GENERAL.—Section 505(j)(7) of the Fed23 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

24 355(j)(7)) is amended by adding at the end the fol25 lowing: 


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

2 subsection (c) for a drug on the list shall notify within 14 

3 days the Secretary in writing if either of the following oc4 curs: 

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

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

7 taken that a patent for such drug is invalid. 

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

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

10 such drug is invalid. 

11 ‘‘(ii) The holder of an approved application shall in12 clude in any notification under clause (i) a copy of the deci13 sion described in subclause (I) or (II) of clause (i). 

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

15 patent that is determined to be invalid in a decision de16 scribed in subclause (I) or (II) of clause (i)— 

17 ‘‘(I) promptly; but 

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

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

20 relies on a certification described in paragraph 

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

22 (2) APPLICABILITY.—Subparagraph (D) of sec23 tion 505(j)(7) of the Federal Food, Drug, and Cos24 metic Act (21 U.S.C. 355(j)(7)), as added by para25 graph (1), applies only with respect to a decision deVerDate Sep 11 2014 20:31 May 02, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H1503.RH H1503

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1 scribed in such subparagraph that is issued on or 

2 after the date of enactment of this Act. 

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

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

5 Health and Human Services, acting through the Commis6 sioner of Food and Drugs, shall— 

7 (1) solicit public comment regarding the types of 

8 patent information that should be included on the list 

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

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

11 (2) transmit to the Congress an evaluation of 

12 such comments, including any recommendations 

13 about the types of patent information that should be 

14 included on or removed from such list. 

15 SEC. 3. GAO REPORT TO CONGRESS. 

16 (a) IN GENERAL.—Not later than one year after the 

17 date of enactment of this Act, the Comptroller General of 

18 the United States (referred to in this section as the ‘‘Comp19 troller General’’) shall submit to the Committee on Energy 

20 and Commerce of the House of Representatives a report on 

21 the patents included in the list published under section 

22 505(j)(7) of the Federal Food, Drug and Cosmetic Act (21 

23 U.S.C. 355(j)(7)), including an analysis and evaluation of 

24 the types of patents included in such list and the claims 

25 such patents make about the products they 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 Fed6 eral Food, Drug and Cosmetic Act (21 U.S.C. 

7 355(j)), that claim the active ingredient or for8 mulation of a drug in combination with a device 

9 that is used for delivery of the drug, together 

10 comprising the finished dosage form of the drug; 

11 and 

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

14 do not claim such device in combination with an 

15 active ingredient or formulation of a drug; 

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

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

18 patents under such list, as compared to patents that 

19 claim a method of using the drug in combination 

20 with a device; 

21 (3) an analysis regarding the impact of includ22 ing on the list under paragraph (7) of such section 

23 505(j) certain types of patent information for drug 

24 product applicants and approved application holders, 

25 including an analysis of whether— 


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1 (A) the listing of the patents described in 

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

3 one or more drugs approved under such section 

4 505(j); and 

5 (B) not listing the patents described in 

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

7 of one or more such drugs; and 

8 (4) recommendations about which kinds of pat9 ents relating to devices described in paragraph (1)(A) 

10 should be submitted to the Secretary of Health and 

11 Human Services for inclusion on the list under para12 graph (7) of such section 505(j) and which patents 

13 should not be required to be so submitted. 


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Union Calendar No. 25 

116TH CONGRESS 

1ST SESSION H. R. 1503 

[Report No. 116–47] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

for other purposes. the Federal Food, Drug, and Cosmetic Act, and Act regarding the list under section 505(j)(7) of 

MAY 2, 2019 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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