Interagency Patent Coordination and Improvement Act of 2023

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 Adminis- tration for purposes of sharing information and providing technical assistance with respect to patents, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •S 79 RS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Interagency Patent 2 Coordination and Improvement Act of 2023’’. 3 SEC. 2. FINDINGS. 4 Congress finds the following: 5 (1) Decisions by the United States Patent and 6 Trademark Office relating to patents may implicate, 7 or have relevance to, information housed at or in- 8 volving other Federal agencies. 9 (2) Entities submitting patent applications to 10 the United States Patent and Trademark Office may 11 also submit information to, or share information 12 with, other Federal agencies, necessitating accuracy 13 and consistency in those representations. 14 (3) Research has shown that patent examiners 15 may benefit from additional information that is 16 housed at, or is available to, Federal agencies other 17 than the United States Patent and Trademark Of- 18 fice in order to assess prior art and the state of 19 science and technology. 20 (4) The Under Secretary of Commerce for In- 21 tellectual Property and Director of the United States 22 Patent and Trademark Office is encouraged to work 23 with other Federal agencies. 24 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •S 79 RS SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE- 1 MARK OFFICE. 2 Not later than 4 years after the date of enactment 3 of this Act, the Under Secretary of Commerce for Intellec- 4 tual Property and Director of the United States Patent 5 and Trademark Office shall submit to the Committee on 6 the Judiciary of the Senate and the Committee on the Ju- 7 diciary of the House of Representatives a report that con- 8 tains— 9 (1) a description of the frequency with which— 10 (A) information is provided by the Food 11 and Drug Administration to the United States 12 Patent and Trademark Office through the 13 Interagency Task Force on Patents established 14 under section 15 of title 35, United States 15 Code, as added by section 4(a) of this Act, or 16 under processes established by that Task Force; 17 and 18 (B) the information described in subpara- 19 graph (A) is used in patent examinations; 20 (2) an identification of which methods of pro- 21 viding information, as described in paragraph 22 (1)(A), and types of information so shared, are most 23 useful to patent examiners; 24 (3) any recommendations for changes to be 25 made by Congress to the mandate, funding, or oper- 26 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •S 79 RS ations of the Task Force described in paragraph 1 (1)(A); and 2 (4) an identification of other Federal agencies 3 with which the Under Secretary of Commerce for In- 4 tellectual Property and Director of the United States 5 Patent and Trademark Office should explore oppor- 6 tunities for coordination that are similar to those 7 undertaken with the Food and Drug Administration 8 through the activities of the Task Force described in 9 paragraph (1)(A). 10 SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 11 (a) IN GENERAL.—Chapter 1 of title 35, United 12 States Code, is amended— 13 (1) in section 2(c), by adding at the end the fol- 14 lowing: 15 ‘‘(6)(A) In exercising the Director’s powers and du- 16 ties under this section relating to patents, and decisions 17 or actions involving patents, for human drugs and biologi- 18 cal products, the Director shall, through the Interagency 19 Task Force on Patents established under section 15, con- 20 sult with the Commissioner of Food and Drugs in the 21 manner described in that section. 22 ‘‘(B) For purposes of subparagraph (A), the term 23 ‘decisions or actions involving patents’ means decisions or 24 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •S 79 RS actions taken with respect to patents under this title.’’; 1 and 2 (2) by adding at the end the following: 3 ‘‘§ 15. Interagency Task Force on Patents 4 ‘‘(a) ESTABLISHMENT.—There is established an 5 interagency task force, to be known as the Interagency 6 Task Force on Patents (referred to in this section as the 7 ‘task force’), to coordinate efforts between the Director 8 and the Commissioner of Food and Drugs (referred to in 9 this section as the ‘Commissioner’) regarding communica- 10 tion about, evaluation of, and effective implementation of 11 the activities of the Office and the Food and Drug Admin- 12 istration with respect to patents, and decisions or actions 13 involving patents (as defined in section 2(c)(6)(B)), for 14 human drugs and biological products. 15 ‘‘(b) MEMORANDUM OF UNDERSTANDING.—The Di- 16 rector and the Commissioner shall enter into a memo- 17 randum of understanding, or update an existing memo- 18 randum of understanding, for the purposes of imple- 19 menting and carrying out the duties of the task force. 20 ‘‘(c) MEMBERSHIP.—The task force shall be com- 21 prised of employees of the Office, who shall be appointed 22 by the Director, and employees of the Food and Drug Ad- 23 ministration, who shall be appointed by the Commissioner, 24 who have appropriate expertise and decision-making au- 25 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •S 79 RS thority regarding operational, administrative, technical, 1 medical, pharmacological, clinical, and scientific matters 2 to carry out the functions of the task force. 3 ‘‘(d) ACTIVITIES.—The task force shall carry out the 4 following functions regarding interagency coordination to 5 promote reciprocal access of information: 6 ‘‘(1) Sharing information on the general proc- 7 esses of the Office and the Food and Drug Adminis- 8 tration, what each such agency considers in its re- 9 spective review of applications, and how each such 10 agency evaluates those applications, which may be 11 undertaken through routine and ongoing meetings, 12 workshops, and training sessions. 13 ‘‘(2) Sharing information on new approvals of 14 patents, human drugs and biological products, new 15 technologies and prior art (as appropriate on a case- 16 by-case basis), and scientific trends and develop- 17 ments. 18 ‘‘(3) Establishing a process that requires— 19 ‘‘(A) the Director to request from the 20 Commissioner (and the Commissioner to pro- 21 vide to the Director, upon receiving such a re- 22 quest)— 23 ‘‘(i) appropriate information for use 24 by employees of the Office with responsi- 25 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •S 79 RS bility to examine patent applications under 1 section 131 (referred to in this section as 2 ‘patent examiners’) regarding when certain 3 information relating to a human drug or 4 biological product approval, which may in- 5 clude updates to a label or newly approved 6 indications, is made publicly available, in- 7 cluding when such information is posted 8 online; and 9 ‘‘(ii) appropriate access for patent ex- 10 aminers to relevant sources of product ap- 11 plication, approval, patent, and labeling in- 12 formation or communications between the 13 Food and Drug Administration and the 14 human drug or biological product sponsors 15 that may not currently be subject to public 16 disclosure, as appropriate and only to the 17 extent necessary for the Office to carry out 18 the responsibilities of the Office, such as 19 ensuring accurate representations and ac- 20 cess to information on whether the claimed 21 invention that would be the subject of the 22 patent was on sale before the effective fil- 23 ing date of the claimed invention, as de- 24 scribed in section 102(a)(1); and 25 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •S 79 RS ‘‘(B) the Office to assist the Food and 1 Drug Administration in its ministerial role of 2 listing patents. 3 ‘‘(4) Establishing a process to ensure that, in 4 appropriate circumstances, at the request of the Di- 5 rector, the Commissioner shall consult with or other- 6 wise furnish specific, available information to the Of- 7 fice with respect to certain applications, responses, 8 or affidavits after rejections in order to assist patent 9 examiners in carrying out the duties of those patent 10 examiners. 11 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in sub- 12 section (d)(3)(B) shall be construed as— 13 ‘‘(1) directing the Office to interfere with, 14 delay, or supersede the ministerial function of the 15 Food and Drug Administration of listing patents; 16 ‘‘(2) indicating the position of the Office re- 17 garding the ability to assert a patent in infringement 18 litigation; or 19 ‘‘(3) changing the ministerial function of the 20 Food and Drug Administration of listing patents. 21 ‘‘(f) CONFIDENTIALITY.— 22 ‘‘(1) IN GENERAL.—With respect to any record 23 or other information of the Food and Drug Adminis- 24 tration or the Office that is confidential, either such 25 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •S 79 RS agency may share any such information with the 1 other agency in furtherance of the activities de- 2 scribed in this section, which shall remain subject to 3 such protections as if the information were held by 4 the Food and Drug Administration. 5 ‘‘(2) PROTOCOLS.— 6 ‘‘(A) IN GENERAL.—The task force shall 7 establish appropriate protocols to safeguard 8 confidentiality and prevent the inappropriate 9 disclosure of information when sharing informa- 10 tion between the Office and the Food and Drug 11 Administration. 12 ‘‘(B) CONTENTS.—The protocols estab- 13 lished under subparagraph (A) shall provide 14 that— 15 ‘‘(i) before sharing any information 16 described in paragraph (1), the sponsor of 17 the human drug or biological product to 18 which that information relates shall be pro- 19 vided notice of that sharing by the applica- 20 ble agency and with a period of 30 days to 21 consult with the agency sharing that infor- 22 mation; and 23 ‘‘(ii) the Director shall, in order to 24 protect against the inadvertent disclosure 25 VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •S 79 RS of information, maintain any information 1 shared with the Director by the Commis- 2 sioner separate from pending patent appli- 3 cations and establish procedures for the 4 identification of confidential information. 5 ‘‘(C) POTENTIAL REMEDIES.—In estab- 6 lishing protocols under this paragraph, the task 7 force shall identify appropriate remedies for any 8 potential injury suffered when confidential in- 9 formation is made available, including inadvert- 10 ently, through the sharing of information de- 11 scribed in this subsection. 12 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 13 this subsection may be construed as superseding any 14 other remedy available for the unauthorized disclo- 15 sure of confidential information.’’. 16 (b) TECHNICAL AND CONFORMING AMENDMENT.— 17 The table of sections for chapter 1 of title 35, United 18 States Code, is amended by adding at the end the fol- 19 lowing: 20 ‘‘15. Interagency Task Force on Patents.’’. VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6211 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6211 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB Calendar No. 18 118TH CONGRESS 1ST SESSION S. 79 A BILL To amend title 35, United States Code, to establish an interagency task force between the United States Patent and Trademark Office and the Food and Drug Administration for purposes of sharing information and providing technical as- sistance with respect to patents, and for other purposes. MARCH 1, 2023 Reported without amendment VerDate Sep 11 2014 22:56 Mar 01, 2023 Jkt 039200 PO 00000 Frm 00012 Fmt 6651 Sfmt 6651 E:\BILLS\S79.RS S79 pbinns on DSKJLVW7X2PROD with $$_JOB