II 

117TH CONGRESS 

2D SESSION S. 4430 

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 

JUNE 16, 2022 

Mr. DURBIN (for himself, Mr. TILLIS, and Mr. GRASSLEY) introduced the following bill; which was read twice and referred to the Committee on the 

Judiciary 

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, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Interagency Patent 

5 Coordination and Improvement Act of 2022’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds the following: 

3 (1) Decisions by the United States Patent and 

4 Trademark Office relating to patents may implicate, 

5 or have relevance to, information housed at or in6 volving other Federal agencies. 

7 (2) Entities submitting patent applications to 

8 the United States Patent and Trademark Office may 

9 also submit information to, or share information 

10 with, other Federal agencies, necessitating accuracy 

11 and consistency in those representations. 

12 (3) Research has shown that patent examiners 

13 may benefit from additional information that is 

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

15 than the United States Patent and Trademark Of16 fice in order to assess prior art and the state of 

17 science and technology. 

18 (4) The Under Secretary of Commerce for In19 tellectual Property and Director of the United States 

20 Patent and Trademark Office is encouraged to work 

21 with other Federal agencies. 

22 SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE23 MARK OFFICE. 

24 Not later than 4 years after the date of enactment 

25 of this Act, the Under Secretary of Commerce for Intellec26 tual Property and Director of the United States Patent 


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1 and Trademark Office shall submit to the Committee on 

2 the Judiciary of the Senate and the Committee on the Ju3 diciary of the House of Representatives a report that con4 tains— 

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

6 (A) information is provided by the Food 

7 and Drug Administration to the United States 

8 Patent and Trademark Office through the 

9 Interagency Task Force on Patents established 

10 under section 15 of title 35, United States 

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

12 under processes established by that Task Force; 

13 and 

14 (B) the information described in subpara15 graph (A) is used in patent examinations; 

16 (2) an identification of which methods of pro17 viding information, as described in paragraph 

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

19 useful to patent examiners; 

20 (3) any recommendations for changes to be 

21 made by Congress to the mandate, funding, or oper22 ations of the Task Force described in paragraph 

23 (1)(A); and 

24 (4) an identification of other Federal agencies 

25 with which the Under Secretary of Commerce for InVerDate Sep 11 2014 02:31 Jun 18, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4430.IS S4430

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1 tellectual Property and Director of the United States 

2 Patent and Trademark Office should explore oppor3 tunities for coordination that are similar to those 

4 undertaken with the Food and Drug Administration 

5 through the activities of the Task Force described in 

6 paragraph (1)(A). 

7 SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 

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

9 States Code, is amended— 

10 (1) in section 2(c), by adding at the end the fol11 lowing: 

12 ‘‘(6)(A) In exercising the Director’s powers and du13 ties under this section relating to patents, and decisions 

14 or actions involving patents, for human drugs and biologi15 cal products, the Director shall, through the Interagency 

16 Task Force on Patents established under section 15, con17 sult with the Commissioner of Food and Drugs in the 

18 manner described in that section. 

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

20 ‘decisions or actions involving patents’ means decisions or 

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

22 and 

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


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1 ‘‘§ 15. Interagency Task Force on Patents 

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

3 interagency task force, to be known as the Interagency 

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

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

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

7 this section as the ‘Commissioner’) regarding communica8 tion about, evaluation of, and effective implementation of 

9 the activities of the Office and the Food and Drug Admin10 istration with respect to patents, and decisions or actions 

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

12 human drugs and biological products. 

13 ‘‘(b) MEMORANDUM OF UNDERSTANDING.—The Di14 rector and the Commissioner shall enter into a memo15 randum of understanding, or update an existing memo16 randum of understanding, for the purposes of imple17 menting and carrying out the duties of the task force. 

18 ‘‘(c) MEMBERSHIP.—The task force shall be com19 prised of employees of the Office, who shall be appointed 

20 by the Director, and employees of the Food and Drug Ad21 ministration, who shall be appointed by the Commissioner, 

22 who have appropriate expertise and decision-making au23 thority regarding operational, administrative, technical, 

24 medical, pharmacological, clinical, and scientific matters 

25 to carry out the functions of the task force. 


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

2 following functions regarding interagency coordination to 

3 promote reciprocal access of information: 

4 ‘‘(1) Sharing information on the general proc5 esses of the Office and the Food and Drug Adminis6 tration, what each such agency considers in its re7 spective review of applications, and how each such 

8 agency evaluates those applications, which may be 

9 undertaken through routine and ongoing meetings, 

10 workshops, and training sessions. 

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

12 patents, human drugs and biological products, new 

13 technologies and prior art (as appropriate on a case14 by-case basis), and scientific trends and develop15 ments. 

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

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

18 Commissioner (and the Commissioner to pro19 vide to the Director, upon receiving such a re20 quest)— 

21 ‘‘(i) appropriate information for use 

22 by employees of the Office with responsi23 bility to examine patent applications under 

24 section 131 (referred to in this section as 

25 ‘patent examiners’) regarding when certain 


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1 information relating to a human drug or 

2 biological product approval, which may in3 clude updates to a label or newly approved 

4 indications, is made publicly available, in5 cluding when such information is posted 

6 online; and 

7 ‘‘(ii) appropriate access for patent ex8 aminers to relevant sources of product ap9 plication, approval, patent, and labeling in10 formation or communications between the 

11 Food and Drug Administration and the 

12 prescription drug or biological product 

13 sponsors that may not currently be subject 

14 to public disclosure, as appropriate and 

15 only to the extent necessary for the Office 

16 to carry out the responsibilities of the Of17 fice, including ensuring accurate represen18 tations and the enforcement of the limita19 tion on granting a patent because the 

20 claimed invention that would be the subject 

21 of the patent was on sale before the effec22 tive filing date of the claimed invention, as 

23 described in section 102(a)(1); and 

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

25 Drug Administration in its ministerial role of 


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1 listing appropriate and accurate descriptions of 

2 patents. 

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

4 appropriate circumstances, at the request of the Di5 rector, the Commissioner shall consult with or other6 wise furnish specific, available information to the Of7 fice with respect to certain applications, responses, 

8 or affidavits after rejections in order to assist patent 

9 examiners in carrying out the duties of those patent 

10 examiners. 

11 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in sub12 section (d)(3)(B) shall be construed as— 

13 ‘‘(1) directing the Office to interfere with or 

14 delay the ministerial function of the Food and Drug 

15 Administration of listing patents; or 

16 ‘‘(2) indicating the position of the Office re17 garding the ability to assert a patent in infringement 

18 litigation. 

19 ‘‘(f) CONFIDENTIALITY.— 

20 ‘‘(1) IN GENERAL.—The task force shall estab21 lish appropriate protocols to safeguard confiden22 tiality and prevent the inappropriate disclosure of in23 formation when sharing information between the Of24 fice and the Food and Drug Administration. 


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1 ‘‘(2) POTENTIAL REMEDIES.—In establishing 

2 protocols under paragraph (1), the task force shall 

3 identify appropriate remedies for any potential in4 jury suffered when confidential information is made 

5 available, including inadvertently, through the shar6 ing of information described in that paragraph.’’. 

7 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

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

9 States Code, is amended by adding at the end the fol10 lowing: 

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

11 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

12 are authorized to be appropriated to the Under Secretary 

13 of Commerce for Intellectual Property and Director of the 

14 United States Patent and Trademark Office and the Com15 missioner of Food and Drugs such sums as may be nec16 essary for the purposes of carrying out the functions of 

17 the Interagency Task Force on Patents established under 

18 section 15 of title 35, United States Code, as added by 

19 subsection (a). 

Æ 


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