II 

Calendar No. 18 

118TH CONGRESS 

1ST SESSION S. 79 

To amend title 35, United States Code, to establish an interagency task 

force between the United States Patent and Trademark Office and the 

Food and Drug Administration for purposes of sharing information and 

providing technical assistance with respect to patents, and for other 

purposes. 

IN THE SENATE OF THE UNITED STATES 

JANUARY 25, 2023 

Mr. DURBIN (for himself, Mr. TILLIS, Mr. GRASSLEY, Mr. COONS, Mr. 

WELCH, and Mrs. FEINSTEIN) introduced the following bill; which was 

read twice and referred to the Committee on the Judiciary 

MARCH 1, 2023 

Reported by Mr. DURBIN, without amendment 

A BILL 

To amend title 35, United States Code, to establish an 

interagency task force between the United States Patent 

and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing 

technical assistance with respect to patents, 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 ‘‘Interagency Patent 

3 Coordination and Improvement Act of 2023’’. 

4 SEC. 2. FINDINGS. 

5 Congress finds the following: 

6 (1) Decisions by the United States Patent and 

7 Trademark Office relating to patents may implicate, 

8 or have relevance to, information housed at or in9 volving other Federal agencies. 

10 (2) Entities submitting patent applications to 

11 the United States Patent and Trademark Office may 

12 also submit information to, or share information 

13 with, other Federal agencies, necessitating accuracy 

14 and consistency in those representations. 

15 (3) Research has shown that patent examiners 

16 may benefit from additional information that is 

17 housed at, or is available to, Federal agencies other 

18 than the United States Patent and Trademark Of19 fice in order to assess prior art and the state of 

20 science and technology. 

21 (4) The Under Secretary of Commerce for In22 tellectual Property and Director of the United States 

23 Patent and Trademark Office is encouraged to work 

24 with other Federal agencies. 


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1 SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE2 MARK OFFICE. 

3 Not later than 4 years after the date of enactment 

4 of this Act, the Under Secretary of Commerce for Intellec5 tual Property and Director of the United States Patent 

6 and Trademark Office shall submit to the Committee on 

7 the Judiciary of the Senate and the Committee on the Ju8 diciary of the House of Representatives a report that con9 tains— 

10 (1) a description of the frequency with which— 

11 (A) information is provided by the Food 

12 and Drug Administration to the United States 

13 Patent and Trademark Office through the 

14 Interagency Task Force on Patents established 

15 under section 15 of title 35, United States 

16 Code, as added by section 4(a) of this Act, or 

17 under processes established by that Task Force; 

18 and 

19 (B) the information described in subpara20 graph (A) is used in patent examinations; 

21 (2) an identification of which methods of pro22 viding information, as described in paragraph 

23 (1)(A), and types of information so shared, are most 

24 useful to patent examiners; 

25 (3) any recommendations for changes to be 

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1 ations of the Task Force described in paragraph 

2 (1)(A); and 

3 (4) an identification of other Federal agencies 

4 with which the Under Secretary of Commerce for In5 tellectual Property and Director of the United States 

6 Patent and Trademark Office should explore oppor7 tunities for coordination that are similar to those 

8 undertaken with the Food and Drug Administration 

9 through the activities of the Task Force described in 

10 paragraph (1)(A). 

11 SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 

12 (a) IN GENERAL.—Chapter 1 of title 35, United 

13 States Code, is amended— 

14 (1) in section 2(c), by adding at the end the fol15 lowing: 

16 ‘‘(6)(A) In exercising the Director’s powers and du17 ties under this section relating to patents, and decisions 

18 or actions involving patents, for human drugs and biologi19 cal products, the Director shall, through the Interagency 

20 Task Force on Patents established under section 15, con21 sult with the Commissioner of Food and Drugs in the 

22 manner described in that section. 

23 ‘‘(B) For purposes of subparagraph (A), the term 

24 ‘decisions or actions involving patents’ means decisions or 


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1 actions taken with respect to patents under this title.’’; 

2 and 

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

4 ‘‘§ 15. Interagency Task Force on Patents 

5 ‘‘(a) ESTABLISHMENT.—There is established an 

6 interagency task force, to be known as the Interagency 

7 Task Force on Patents (referred to in this section as the 

8 ‘task force’), to coordinate efforts between the Director 

9 and the Commissioner of Food and Drugs (referred to in 

10 this section as the ‘Commissioner’) regarding communica11 tion about, evaluation of, and effective implementation of 

12 the activities of the Office and the Food and Drug Admin13 istration with respect to patents, and decisions or actions 

14 involving patents (as defined in section 2(c)(6)(B)), for 

15 human drugs and biological products. 

16 ‘‘(b) MEMORANDUM OF UNDERSTANDING.—The Di17 rector and the Commissioner shall enter into a memo18 randum of understanding, or update an existing memo19 randum of understanding, for the purposes of imple20 menting and carrying out the duties of the task force. 

21 ‘‘(c) MEMBERSHIP.—The task force shall be com22 prised of employees of the Office, who shall be appointed 

23 by the Director, and employees of the Food and Drug Ad24 ministration, who shall be appointed by the Commissioner, 

25 who have appropriate expertise and decision-making auVerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79

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1 thority regarding operational, administrative, technical, 

2 medical, pharmacological, clinical, and scientific matters 

3 to carry out the functions of the task force. 

4 ‘‘(d) ACTIVITIES.—The task force shall carry out the 

5 following functions regarding interagency coordination to 

6 promote reciprocal access of information: 

7 ‘‘(1) Sharing information on the general proc8 esses of the Office and the Food and Drug Adminis9 tration, what each such agency considers in its re10 spective review of applications, and how each such 

11 agency evaluates those applications, which may be 

12 undertaken through routine and ongoing meetings, 

13 workshops, and training sessions. 

14 ‘‘(2) Sharing information on new approvals of 

15 patents, human drugs and biological products, new 

16 technologies and prior art (as appropriate on a case17 by-case basis), and scientific trends and develop18 ments. 

19 ‘‘(3) Establishing a process that requires— 

20 ‘‘(A) the Director to request from the 

21 Commissioner (and the Commissioner to pro22 vide to the Director, upon receiving such a re23 quest)— 

24 ‘‘(i) appropriate information for use 

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1 bility to examine patent applications under 

2 section 131 (referred to in this section as 

3 ‘patent examiners’) regarding when certain 

4 information relating to a human drug or 

5 biological product approval, which may in6 clude updates to a label or newly approved 

7 indications, is made publicly available, in8 cluding when such information is posted 

9 online; and 

10 ‘‘(ii) appropriate access for patent ex11 aminers to relevant sources of product ap12 plication, approval, patent, and labeling in13 formation or communications between the 

14 Food and Drug Administration and the 

15 human drug or biological product sponsors 

16 that may not currently be subject to public 

17 disclosure, as appropriate and only to the 

18 extent necessary for the Office to carry out 

19 the responsibilities of the Office, such as 

20 ensuring accurate representations and ac21 cess to information on whether the claimed 

22 invention that would be the subject of the 

23 patent was on sale before the effective fil24 ing date of the claimed invention, as de25 scribed in section 102(a)(1); and 


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1 ‘‘(B) the Office to assist the Food and 

2 Drug Administration in its ministerial role of 

3 listing patents. 

4 ‘‘(4) Establishing a process to ensure that, in 

5 appropriate circumstances, at the request of the Di6 rector, the Commissioner shall consult with or other7 wise furnish specific, available information to the Of8 fice with respect to certain applications, responses, 

9 or affidavits after rejections in order to assist patent 

10 examiners in carrying out the duties of those patent 

11 examiners. 

12 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in sub13 section (d)(3)(B) shall be construed as— 

14 ‘‘(1) directing the Office to interfere with, 

15 delay, or supersede the ministerial function of the 

16 Food and Drug Administration of listing patents; 

17 ‘‘(2) indicating the position of the Office re18 garding the ability to assert a patent in infringement 

19 litigation; or 

20 ‘‘(3) changing the ministerial function of the 

21 Food and Drug Administration of listing patents. 

22 ‘‘(f) CONFIDENTIALITY.— 

23 ‘‘(1) IN GENERAL.—With respect to any record 

24 or other information of the Food and Drug Adminis25 tration or the Office that is confidential, either such 


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1 agency may share any such information with the 

2 other agency in furtherance of the activities de3 scribed in this section, which shall remain subject to 

4 such protections as if the information were held by 

5 the Food and Drug Administration. 

6 ‘‘(2) PROTOCOLS.— 

7 ‘‘(A) IN GENERAL.—The task force shall 

8 establish appropriate protocols to safeguard 

9 confidentiality and prevent the inappropriate 

10 disclosure of information when sharing informa11 tion between the Office and the Food and Drug 

12 Administration. 

13 ‘‘(B) CONTENTS.—The protocols estab14 lished under subparagraph (A) shall provide 

15 that— 

16 ‘‘(i) before sharing any information 

17 described in paragraph (1), the sponsor of 

18 the human drug or biological product to 

19 which that information relates shall be pro20 vided notice of that sharing by the applica21 ble agency and with a period of 30 days to 

22 consult with the agency sharing that infor23 mation; and 

24 ‘‘(ii) the Director shall, in order to 

25 protect against the inadvertent disclosure 


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1 of information, maintain any information 

2 shared with the Director by the Commis3 sioner separate from pending patent appli4 cations and establish procedures for the 

5 identification of confidential information. 

6 ‘‘(C) POTENTIAL REMEDIES.—In estab7 lishing protocols under this paragraph, the task 

8 force shall identify appropriate remedies for any 

9 potential injury suffered when confidential in10 formation is made available, including inadvert11 ently, through the sharing of information de12 scribed in this subsection. 

13 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 

14 this subsection may be construed as superseding any 

15 other remedy available for the unauthorized disclo16 sure of confidential information.’’. 

17 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

18 The table of sections for chapter 1 of title 35, United 

19 States Code, is amended by adding at the end the fol20 lowing: 

‘‘15. Interagency Task Force on Patents.’’. 


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Calendar No. 18 

118TH CONGRESS 

1ST SESSION S. 79 

A BILL 

To amend title 35, United States Code, to establish 

purposes. sistance with respect to patents, and for other sharing information and providing technical asFood and Drug Administration for purposes of States Patent and Trademark Office and the an interagency task force between the United 

MARCH 1, 2023 

Reported without amendment 


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