II 

Calendar No. 463 

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, Mr. GRASSLEY, Mr. LEAHY, Mr. 

COONS, and Mr. CORNYN) introduced the following bill; which was read 

twice and referred to the Committee on the Judiciary 

AUGUST 2, 2022 

Reported by Mr. DURBIN, with an amendment 

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

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 2022’’. 

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 

26 made by Congress to the mandate, funding, or operVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S4430.RS S4430

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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 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6401 E:\BILLS\S4430.RS S4430

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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 

25 by employees of the Office with responsiVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6401 E:\BILLS\S4430.RS S4430

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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 prescription drug or biological product 

16 sponsors that may not currently be subject 

17 to public disclosure, as appropriate and 

18 only to the extent necessary for the Office 

19 to carry out the responsibilities of the Of20 fice, including ensuring accurate represen21 tations and the enforcement of the limita22 tion on granting a patent because the 

23 claimed invention that would be the subject 

24 of the patent was on sale before the effecVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S4430.RS S4430

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1 tive filing date of the claimed invention, as 

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

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

4 Drug Administration in its ministerial role of 

5 listing appropriate and accurate descriptions of 

6 patents. 

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

8 appropriate circumstances, at the request of the Di9 rector, the Commissioner shall consult with or other10 wise furnish specific, available information to the Of11 fice with respect to certain applications, responses, 

12 or affidavits after rejections in order to assist patent 

13 examiners in carrying out the duties of those patent 

14 examiners. 

15 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in sub16 section (d)(3)(B) shall be construed as— 

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

18 delay the ministerial function of the Food and Drug 

19 Administration of listing patents; or 

20 ‘‘(2) indicating the position of the Office re21 garding the ability to assert a patent in infringement 

22 litigation. 

23 ‘‘(f) CONFIDENTIALITY.— 

24 ‘‘(1) IN GENERAL.—The task force shall estab25 lish appropriate protocols to safeguard confidenVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6401 E:\BILLS\S4430.RS S4430

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1 tiality and prevent the inappropriate disclosure of in2 formation when sharing information between the Of3 fice and the Food and Drug Administration. 

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

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

6 identify appropriate remedies for any potential in7 jury suffered when confidential information is made 

8 available, including inadvertently, through the shar9 ing of information described in that paragraph.’’. 

10 (b) TECHNICAL AND CONFORMING AMENDMENT.— 

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

12 States Code, is amended by adding at the end the fol13 lowing: 

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

14 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

15 are authorized to be appropriated to the Under Secretary 

16 of Commerce for Intellectual Property and Director of the 

17 United States Patent and Trademark Office and the Com18 missioner of Food and Drugs such sums as may be nec19 essary for the purposes of carrying out the functions of 

20 the Interagency Task Force on Patents established under 

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

22 subsection (a). 

23 SECTION 1. SHORT TITLE. 

24 This Act may be cited as the ‘‘Interagency Patent Co25 ordination 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 involv6 ing 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 Office 

16 in order to assess prior art and the state of science 

17 and technology. 

18 (4) The Under Secretary of Commerce for Intel19 lectual 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 of 

25 this Act, the Under Secretary of Commerce for Intellectual 

26 Property and Director of the United States Patent and 


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1 Trademark Office shall submit to the Committee on the Ju2 diciary of the Senate and the Committee on the Judiciary 

3 of the House of Representatives a report that contains— 

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

5 (A) information is provided by the Food 

6 and Drug Administration to the United States 

7 Patent and Trademark Office through the Inter8 agency Task Force on Patents established under 

9 section 15 of title 35, United States Code, as 

10 added by section 4(a) of this Act, or under proc11 esses established by that Task Force; and 

12 (B) the information described in subpara13 graph (A) is used in patent examinations; 

14 (2) an identification of which methods of pro15 viding information, as described in paragraph (1)(A), 

16 and types of information so shared, are most useful 

17 to patent examiners; 

18 (3) any recommendations for changes to be made 

19 by Congress to the mandate, funding, or operations of 

20 the Task Force described in paragraph (1)(A); and 

21 (4) an identification of other Federal agencies 

22 with which the Under Secretary of Commerce for In23 tellectual Property and Director of the United States 

24 Patent and Trademark Office should explore opportu25 nities for coordination that are similar to those unVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\S4430.RS S4430

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1 dertaken with the Food and Drug Administration 

2 through the activities of the Task Force described in 

3 paragraph (1)(A). 

4 SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 

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

6 Code, is amended— 

7 (1) in section 2(c), by adding at the end the fol8 lowing: 

9 ‘‘(6)(A) In exercising the Director’s powers and duties 

10 under this section relating to patents, and decisions or ac11 tions involving patents, for human drugs and biological 

12 products, the Director shall, through the Interagency Task 

13 Force on Patents established under section 15, consult with 

14 the Commissioner of Food and Drugs in the manner de15 scribed in that section. 

16 ‘‘(B) For purposes of subparagraph (A), the term ‘deci17 sions or actions involving patents’ means decisions or ac18 tions taken with respect to patents under this title.’’; and 

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

20 ‘‘§ 15. Interagency Task Force on Patents 

21 ‘‘(a) ESTABLISHMENT.—There is established an inter22 agency task force, to be known as the Interagency Task 

23 Force on Patents (referred to in this section as the ‘task 

24 force’), to coordinate efforts between the Director and the 

25 Commissioner of Food and Drugs (referred to in this section 


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1 as the ‘Commissioner’) regarding communication about, 

2 evaluation of, and effective implementation of the activities 

3 of the Office and the Food and Drug Administration with 

4 respect to patents, and decisions or actions involving pat5 ents (as defined in section 2(c)(6)(B)), for human drugs and 

6 biological products. 

7 ‘‘(b) MEMORANDUM OF UNDERSTANDING.—The Direc8 tor and the Commissioner shall enter into a memorandum 

9 of understanding, or update an existing memorandum of 

10 understanding, for the purposes of implementing and car11 rying out the duties of the task force. 

12 ‘‘(c) MEMBERSHIP.—The task force shall be comprised 

13 of employees of the Office, who shall be appointed by the 

14 Director, and employees of the Food and Drug Administra15 tion, who shall be appointed by the Commissioner, who have 

16 appropriate expertise and decision-making authority re17 garding operational, administrative, technical, medical, 

18 pharmacological, clinical, and scientific matters to carry 

19 out the functions of the task force. 

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

21 following functions regarding interagency coordination to 

22 promote reciprocal access of information: 

23 ‘‘(1) Sharing information on the general proc24 esses of the Office and the Food and Drug Adminis25 tration, what each such agency considers in its reVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\S4430.RS S4430

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1 spective review of applications, and how each such 

2 agency evaluates those applications, which may be 

3 undertaken through routine and ongoing meetings, 

4 workshops, and training sessions. 

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

6 patents, human drugs and biological products, new 

7 technologies and prior art (as appropriate on a case8 by-case basis), and scientific trends and developments. 

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

10 ‘‘(A) the Director to request from the Com11 missioner (and the Commissioner to provide to 

12 the Director, upon receiving such a request)— 

13 ‘‘(i) appropriate information for use 

14 by employees of the Office with responsi15 bility to examine patent applications under 

16 section 131 (referred to in this section as 

17 ‘patent examiners’) regarding when certain 

18 information relating to a human drug or 

19 biological product approval, which may in20 clude updates to a label or newly approved 

21 indications, is made publicly available, in22 cluding when such information is posted on23 line; and 

24 ‘‘(ii) appropriate access for patent ex25 aminers to relevant sources of product apVerDate Sep 11 2014 02:43 Aug 03, 2022 Jkt 029200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6203 E:\BILLS\S4430.RS S4430

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1 plication, approval, patent, and labeling in2 formation or communications between the 

3 Food and Drug Administration and the 

4 human drug or biological product sponsors 

5 that may not currently be subject to public 

6 disclosure, as appropriate and only to the 

7 extent necessary for the Office to carry out 

8 the responsibilities of the Office, such as en9 suring accurate representations and access 

10 to information on whether the claimed in11 vention that would be the subject of the pat12 ent was on sale before the effective filing 

13 date of the claimed invention, as described 

14 in section 102(a)(1); and 

15 ‘‘(B) the Office to assist the Food and Drug 

16 Administration in its ministerial role of listing 

17 appropriate and accurate descriptions of patents. 

18 ‘‘(4) Establishing a process to ensure that, in ap19 propriate circumstances, at the request of the Direc20 tor, the Commissioner shall consult with or otherwise 

21 furnish specific, available information to the Office 

22 with respect to certain applications, responses, or affi23 davits after rejections in order to assist patent exam24 iners in carrying out the duties of those patent exam25 iners. 


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1 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in subsection 

2 (d)(3)(B) shall be construed as— 

3 ‘‘(1) directing the Office to interfere with, delay, 

4 or supersede the ministerial function of the Food and 

5 Drug Administration of listing patents; or 

6 ‘‘(2) indicating the position of the Office regard7 ing the ability to assert a patent in infringement liti8 gation. 

9 ‘‘(f) CONFIDENTIALITY.— 

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

11 or other information of the Food and Drug Adminis12 tration or the Office that is confidential, either such 

13 agency may share any such information with the 

14 other agency in furtherance of the activities described 

15 in this section, which shall remain subject to such 

16 protections as if the information were held by the 

17 Food and Drug Administration. 

18 ‘‘(2) PROTOCOLS.— 

19 ‘‘(A) IN GENERAL.—The task force shall es20 tablish appropriate protocols to safeguard con21 fidentiality and prevent the inappropriate dis22 closure of information when sharing information 

23 between the Office and the Food and Drug Ad24 ministration. 


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1 ‘‘(B) CONTENTS.—The protocols established 

2 under subparagraph (A) shall provide that— 

3 ‘‘(i) before sharing any information de4 scribed in paragraph (1), the sponsor of the 

5 human drug or biological product to which 

6 that information relates shall be provided 

7 notice of that sharing by the applicable 

8 agency and with a period of 30 days to con9 sult with the agency sharing that informa10 tion; and 

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

12 protect against the inadvertent disclosure of 

13 information, maintain any information 

14 shared with the Director by the Commis15 sioner separate from pending patent appli16 cations and establish procedures for the 

17 identification of confidential information. 

18 ‘‘(C) POTENTIAL REMEDIES.—In estab19 lishing protocols under this paragraph, the task 

20 force shall identify appropriate remedies for any 

21 potential injury suffered when confidential infor22 mation is made available, including inadvert23 ently, through the sharing of information de24 scribed in this subsection. 


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1 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in this 

2 subsection may be construed as superseding any other 

3 remedy available for the unauthorized disclosure of 

4 confidential information.’’. 

5 (b) TECHNICAL AND CONFORMING AMENDMENT.—The 

6 table of sections for chapter 1 of title 35, United States 

7 Code, is amended by adding at the end the following: 

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

8 (c) AUTHORIZATION OF APPROPRIATIONS.—There are 

9 authorized to be appropriated to the Under Secretary of 

10 Commerce for Intellectual Property and Director of the 

11 United States Patent and Trademark Office and the Com12 missioner of Food and Drugs such sums as may be nec13 essary for the purposes of carrying out the functions of the 

14 Interagency Task Force on Patents established under sec15 tion 15 of title 35, United States Code, as added by sub16 section (a). 


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Calendar No. 463 

117TH CONGRESS 

2D SESSION S. 4430 

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 

AUGUST 2, 2022 

Reported with an amendment 


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