In the Senate of the United States, 

December 7, 2020. 

Resolved, That the bill from the House of Representatives (H.R. 1503) entitled ‘‘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.’’, do pass with the following 

AMENDMENT: 

Strike all after the enacting clause and insert the 

following: 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Orange Book Trans3 parency Act of 2020’’. 

4 SEC. 2. ORANGE BOOK MODERNIZATION. 

5 (a) SUBMISSION OF PATENT INFORMATION FOR BRAND

6 NAME DRUGS.— 

7 (1) IN GENERAL.—Paragraph (1) of section 

8 505(b) of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355(b)) is amended to read as follows: 
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1 ‘‘(b)(1)(A) Any person may file with the Secretary an 

2 application with respect to any drug subject to the provi3 sions of subsection (a). Such persons shall submit to the 

4 Secretary as part of the application— 

5 ‘‘(i) full reports of investigations which have 

6 been made to show whether such drug is safe for use 

7 and whether such drug is effective in use; 

8 ‘‘(ii) a full list of the articles used as components 

9 of such drug; 

10 ‘‘(iii) a full statement of the composition of such 

11 drug; 

12 ‘‘(iv) a full description of the methods used in, 

13 and the facilities and controls used for, the manufac14 ture, processing, and packing of such drug; 

15 ‘‘(v) such samples of such drug and of the arti16 cles used as components thereof as the Secretary may 

17 require; 

18 ‘‘(vi) specimens of the labeling proposed to be 

19 used for such drug; 

20 ‘‘(vii) any assessments required under section 

21 505B; and 

22 ‘‘(viii) the patent number and expiration date of 

23 each patent for which a claim of patent infringement 

24 could reasonably be asserted if a person not licensed 
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1 by the owner of the patent engaged in the manufac2 ture, use, or sale of the drug, and that— 

3 ‘‘(I) claims the drug for which the applicant 

4 submitted the application and is a drug sub5 stance (active ingredient) patent or a drug prod6 uct (formulation or composition) patent; or 

7 ‘‘(II) claims a method of using such drug 

8 for which approval is sought or has been granted 

9 in the application. 

10 ‘‘(B) If an application is filed under this subsection 

11 for a drug, and a patent of the type described in subpara12 graph (A)(viii) is issued after the filing date but before ap13 proval of the application, the applicant shall amend the ap14 plication to include the patent number and expiration 

15 date.’’. 

16 (b) SUBSEQUENT SUBMISSION OF PATENT INFORMA17 TION.— 

18 (1) IN GENERAL.—Section 505(c)(2) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

20 355(c)(2)) is amended— 

21 (A) by inserting before the first sentence the 

22 following: ‘‘Not later than 30 days after the date 

23 of approval of an application submitted under 

24 subsection (b), the holder of the approved appli25 cation shall file with the Secretary the patent 
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1 number and the expiration date of any patent 

2 described in subsection (b)(1)(A)(viii), except 

3 that a patent that is identified as claiming a 

4 method of using such drug shall be filed only if 

5 the patent claims a method of use approved in 

6 the application. If a patent described in sub7 section (b)(1)(A)(viii) is issued after the date of 

8 approval of an application submitted under sub9 section (b), the holder of the approved applica10 tion shall, not later than 30 days after the date 

11 of issuance of the patent, file the patent number 

12 and the expiration date of the patent, except that 

13 a patent that claims a method of using such 

14 drug shall be filed only if approval for such use 

15 has been granted in the application.’’; 

16 (B) in the first sentence following the sen17 tences added by subparagraph (A), by striking 

18 ‘‘which claims the drug for which’’ and all that 

19 follows through ‘‘of the drug.’’ and inserting ‘‘de20 scribed in subsection (b)(1)(A)(viii).’’; 

21 (C) in the second sentence following the sen22 tences added by subparagraph (A), by inserting 

23 after ‘‘could not file patent information under 

24 subsection (b) because no patent’’ the following: 
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1 ‘‘of the type for which information is required to 

2 be submitted in subsection (b)(1)(A)(viii)’’; and 

3 (D) by adding at the end the following: 

4 ‘‘Patent information that is not the type of pat5 ent information required by subsection 

6 (b)(1)(A)(viii) shall not be submitted under this 

7 paragraph.’’. 

8 (2) UPDATING LIST.—Clause (iii) of section 

9 505(j)(7)(A) of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 355(j)(7)) is amended by striking ‘‘(b) 

11 or’’. 

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

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

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

15 the following: 

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

17 shall specify any exclusivity period that is applicable, for 

18 which the Secretary has determined the expiration date, 

19 and for which such period has not yet expired, under— 

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

21 (c)(3)(E); 

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

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

24 (5)(F); 

25 ‘‘(IV) section 505A; 
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1 ‘‘(V) section 505E; 

2 ‘‘(VI) section 527(a); or 

3 ‘‘(VII) subsection (u).’’. 

4 (d) ORANGE BOOK UPDATES WITH RESPECT TO IN5 VALIDATED PATENTS.— 

6 (1) AMENDMENT.—Section 505(j)(7) of the Fed7 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

8 355(j)(7)) is amended by adding at the end the fol9 lowing: 

10 ‘‘(D) In the case of a listed drug for which the list 

11 under subparagraph (A)(i) includes a patent for such drug, 

12 and any claim of the patent has been cancelled or invali13 dated pursuant to a final decision issued by the Patent 

14 Trial and Appeal Board of the United States Patent and 

15 Trademark Office or by a court, from which no appeal has 

16 been, or can be, taken, if the holder of the applicable appli17 cation approved under subsection (c) determines that a pat18 ent for such drug, or any patent information for such drug, 

19 no longer meets the listing requirements under this sec20 tion— 

21 ‘‘(i) the holder of such approved application 

22 shall notify the Secretary, in writing, within 14 days 

23 of such decision of such cancellation or invalidation 

24 and request that such patent or patent information, 

25 as applicable, be amended or withdrawn in accord-
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1 ance with the decision issued by the Patent Trial and 

2 Appeal Board or a court; 

3 ‘‘(ii) the holder of such approved application 

4 shall include in any notification under clause (i) in5 formation related to such patent cancellation or in6 validation decision and submit such information, in7 cluding a copy of such decision, to the Secretary; and 

8 ‘‘(iii) the Secretary shall, in response to a notifi9 cation under clause (i), amend or remove patent or 

10 patent information in accordance with the relevant 

11 decision from the Patent Trial and Appeals Board or 

12 court, as applicable, except that the Secretary shall 

13 not remove from the list any patent or patent infor14 mation before the expiration of any 180-day exclu15 sivity period under paragraph (5)(B)(iv) that relies 

16 on a certification described in paragraph 

17 (2)(A)(vii)(IV).’’. 

18 (2) APPLICABILITY.—Subparagraph (D) of sec19 tion 505(j)(7) of the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 355(j)(7)), as added by para21 graph (1), applies only with respect to a decision de22 scribed in such subparagraph that is issued on or 

23 after the date of enactment of this Act. 

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

25 the date of enactment of this Act, the Secretary of Health 
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1 and Human Services, acting through the Commissioner of 

2 Food and Drugs, shall— 

3 (1) solicit public comment regarding the types of 

4 patent information that should be included on, or re5 moved from, the list under section 507(j)(7) of the 

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

7 355(j)(7)); and 

8 (2) transmit to Congress a summary of such 

9 comments and actions the Food and Drug Adminis10 tration is considering taking, if any, in response to 

11 public comment pursuant to paragraph (1) about the 

12 types of patent information that should be included or 

13 removed from such list. 

14 (f) GAO REPORT TO CONGRESS.— 

15 (1) IN GENERAL.—Not later than 2 years after 

16 the date of enactment of this Act, the Comptroller 

17 General of the United States (referred to in this sec18 tion as the ‘‘Comptroller General’’) shall submit to the 

19 Committee on Health, Education, Labor, and Pen20 sions of the Senate and the Committee on Energy and 

21 Commerce of the House of Representatives a report on 

22 the patents included in the list published under sec23 tion 505(j)(7) of the Federal Food, Drug and Cos24 metic Act (21 U.S.C. 355(j)(7)) that claim an active 

25 ingredient or formulation of a drug in combination 
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1 with a device that is used for delivery of such drug, 

2 including an analysis of such patents and their 

3 claims. 

4 (2) CONTENT.—The Comptroller General shall 

5 include in the report under paragraph (1)— 

6 (A) data on— 

7 (i) the number of patents included in 

8 the list published under section 505(j)(7) of 

9 the Federal Food, Drug and Cosmetic Act 

10 (21 U.S.C. 355(j)(7)) that claim the active 

11 ingredient or formulation of a drug in com12 bination with a device that is used for de13 livery of the drug, and that together claim 

14 the finished dosage form of the drug; and 

15 (ii) the number of claims with respect 

16 to each patent included in the list published 

17 under such section 505(j)(7) that claim a 

18 device that is used for the delivery of the 

19 drug, but do not claim such device in com20 bination with an active ingredient or for21 mulation of a drug; 

22 (B) an analysis of the listing of patents de23 scribed in subparagraph (A)(ii), including the 

24 timing of listing such patents in relation to pat25 ents described in subparagraph (A)(i), and the 
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1 effect listing the patents described in subpara2 graph (A)(ii) has on market entry of one or more 

3 drugs approved under section 505(j) of the Fed4 eral Food, Drug, and Cosmetic Act as compared 

5 to the effect of not listing the patents described 

6 in subparagraph (A)(ii); and 

7 (C) recommendations about which kinds of 

8 patents relating to devices described in subpara9 graph (A)(i) should be submitted to the Secretary 

10 of Health and Human Services for inclusion on 

11 the list under section 505(j)(7) of the Federal 

12 Food, Drug, and Cosmetic Act and which patents 

13 should not be required to be so submitted in 

14 order to reduce barriers to approval and market 

15 entry. 

16 (g) CONFORMING AMENDMENTS.—Section 505 of the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 

18 amended— 

19 (1) in subsection (c)(3)(E), by striking ‘‘clause 

20 (A) of subsection (b)(1)’’ each place it appears and 

21 inserting ‘‘subsection (b)(1)(A)(i)’’; and 

22 (2) in subsection (j)(2)(A)(vi), by striking 

23 ‘‘clauses (B) through (F) of subsection (b)(1)’’ and in-
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1 serting ‘‘clauses (ii) through (vi) of subsection 

2 (b)(1)(A)’’. 

Attest: 

Secretary. 
116TH CONGRESS 

2D SESSION H.R. 1503 

AMENDMENT