Interagency Patent Coordination and Improvement Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 1717 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 HOUSE OF REPRESENTATIVES MARCH 22, 2023 Mr. NEGUSE introduced the following bill; which was 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 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 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Interagency Patent 4 Coordination and Improvement Act of 2023’’. 5 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 1717 IH SEC. 2. FINDINGS. 1 Congress finds the following: 2 (1) Decisions by the United States Patent and 3 Trademark Office relating to patents may implicate, 4 or have relevance to, information housed at or in- 5 volving other Federal agencies. 6 (2) Entities submitting patent applications to 7 the United States Patent and Trademark Office may 8 also submit information to, or share information 9 with, other Federal agencies, necessitating accuracy 10 and consistency in those representations. 11 (3) Research has shown that patent examiners 12 may benefit from additional information that is 13 housed at, or is available to, Federal agencies other 14 than the United States Patent and Trademark Of- 15 fice in order to assess prior art and the state of 16 science and technology. 17 (4) The Under Secretary of Commerce for In- 18 tellectual Property and Director of the United States 19 Patent and Trademark Office is encouraged to work 20 with other Federal agencies. 21 SEC. 3. REPORT BY UNITED STATES PATENT AND TRADE- 22 MARK OFFICE. 23 Not later than 4 years after the date of enactment 24 of this Act, the Under Secretary of Commerce for Intellec- 25 tual Property and Director of the United States Patent 26 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 1717 IH and Trademark Office shall submit to the Committee on 1 the Judiciary of the Senate and the Committee on the Ju- 2 diciary of the House of Representatives a report that con- 3 tains— 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 8 Interagency Task Force on Patents established 9 under section 15 of title 35, United States 10 Code, as added by section 4(a) of this Act, or 11 under processes established by that Task Force; 12 and 13 (B) the information described in subpara- 14 graph (A) is used in patent examinations; 15 (2) an identification of which methods of pro- 16 viding information, as described in paragraph 17 (1)(A), and types of information so shared, are most 18 useful to patent examiners; 19 (3) any recommendations for changes to be 20 made by Congress to the mandate, funding, or oper- 21 ations of the Task Force described in paragraph 22 (1)(A); and 23 (4) an identification of other Federal agencies 24 with which the Under Secretary of Commerce for In- 25 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 1717 IH tellectual Property and Director of the United States 1 Patent and Trademark Office should explore oppor- 2 tunities for coordination that are similar to those 3 undertaken with the Food and Drug Administration 4 through the activities of the Task Force described in 5 paragraph (1)(A). 6 SEC. 4. INTERAGENCY TASK FORCE ON PATENTS. 7 (a) IN GENERAL.—Chapter 1 of title 35, United 8 States Code, is amended— 9 (1) in section 2(c), by adding at the end the fol- 10 lowing: 11 ‘‘(6)(A) In exercising the Director’s powers and du- 12 ties under this section relating to patents, and decisions 13 or actions involving patents, for human drugs and biologi- 14 cal products, the Director shall, through the Interagency 15 Task Force on Patents established under section 15, con- 16 sult with the Commissioner of Food and Drugs in the 17 manner described in that section. 18 ‘‘(B) For purposes of subparagraph (A), the term 19 ‘decisions or actions involving patents’ means decisions or 20 actions taken with respect to patents under this title.’’; 21 and 22 (2) by adding at the end the following: 23 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 1717 IH ‘‘§ 15. Interagency Task Force on Patents 1 ‘‘(a) ESTABLISHMENT.—There is established an 2 interagency task force, to be known as the Interagency 3 Task Force on Patents (referred to in this section as the 4 ‘task force’), to coordinate efforts between the Director 5 and the Commissioner of Food and Drugs (referred to in 6 this section as the ‘Commissioner’) regarding communica- 7 tion about, evaluation of, and effective implementation of 8 the activities of the Office and the Food and Drug Admin- 9 istration with respect to patents, and decisions or actions 10 involving patents (as defined in section 2(c)(6)(B)), for 11 human drugs and biological products. 12 ‘‘(b) MEMORANDUM OF UNDERSTANDING.—The Di- 13 rector and the Commissioner shall enter into a memo- 14 randum of understanding, or update an existing memo- 15 randum of understanding, for the purposes of imple- 16 menting and carrying out the duties of the task force. 17 ‘‘(c) MEMBERSHIP.—The task force shall be com- 18 prised of employees of the Office, who shall be appointed 19 by the Director, and employees of the Food and Drug Ad- 20 ministration, who shall be appointed by the Commissioner, 21 who have appropriate expertise and decision-making au- 22 thority regarding operational, administrative, technical, 23 medical, pharmacological, clinical, and scientific matters 24 to carry out the functions of the task force. 25 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 1717 IH ‘‘(d) ACTIVITIES.—The task force shall carry out the 1 following functions regarding interagency coordination to 2 promote reciprocal access of information: 3 ‘‘(1) Sharing information on the general proc- 4 esses of the Office and the Food and Drug Adminis- 5 tration, what each such agency considers in its re- 6 spective review of applications, and how each such 7 agency evaluates those applications, which may be 8 undertaken through routine and ongoing meetings, 9 workshops, and training sessions. 10 ‘‘(2) Sharing information on new approvals of 11 patents, human drugs and biological products, new 12 technologies and prior art (as appropriate on a case- 13 by-case basis), and scientific trends and develop- 14 ments. 15 ‘‘(3) Establishing a process that requires— 16 ‘‘(A) the Director to request from the 17 Commissioner (and the Commissioner to pro- 18 vide to the Director, upon receiving such a re- 19 quest)— 20 ‘‘(i) appropriate information for use 21 by employees of the Office with responsi- 22 bility to examine patent applications under 23 section 131 (referred to in this section as 24 ‘patent examiners’) regarding when certain 25 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 1717 IH information relating to a human drug or 1 biological product approval, which may in- 2 clude updates to a label or newly approved 3 indications, is made publicly available, in- 4 cluding when such information is posted 5 online; and 6 ‘‘(ii) appropriate access for patent ex- 7 aminers to relevant sources of product ap- 8 plication, approval, patent, and labeling in- 9 formation or communications between the 10 Food and Drug Administration and the 11 human drug or biological product sponsors 12 that may not currently be subject to public 13 disclosure, as appropriate and only to the 14 extent necessary for the Office to carry out 15 the responsibilities of the Office, such as 16 ensuring accurate representations and ac- 17 cess to information on whether the claimed 18 invention that would be the subject of the 19 patent was on sale before the effective fil- 20 ing date of the claimed invention, as de- 21 scribed in section 102(a)(1); and 22 ‘‘(B) the Office to assist the Food and 23 Drug Administration in its ministerial role of 24 listing patents. 25 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 1717 IH ‘‘(4) Establishing a process to ensure that, in 1 appropriate circumstances, at the request of the Di- 2 rector, the Commissioner shall consult with or other- 3 wise furnish specific, available information to the Of- 4 fice with respect to certain applications, responses, 5 or affidavits after rejections in order to assist patent 6 examiners in carrying out the duties of those patent 7 examiners. 8 ‘‘(e) RULE OF CONSTRUCTION.—Nothing in sub- 9 section (d)(3)(B) shall be construed as— 10 ‘‘(1) directing the Office to interfere with, 11 delay, or supersede the ministerial function of the 12 Food and Drug Administration of listing patents; 13 ‘‘(2) indicating the position of the Office re- 14 garding the ability to assert a patent in infringement 15 litigation; or 16 ‘‘(3) changing the ministerial function of the 17 Food and Drug Administration of listing patents. 18 ‘‘(f) CONFIDENTIALITY.— 19 ‘‘(1) IN GENERAL.—With respect to any record 20 or other information of the Food and Drug Adminis- 21 tration or the Office that is confidential, either such 22 agency may share any such information with the 23 other agency in furtherance of the activities de- 24 scribed in this section, which shall remain subject to 25 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 1717 IH such protections as if the information were held by 1 the Food and Drug Administration. 2 ‘‘(2) PROTOCOLS.— 3 ‘‘(A) IN GENERAL.—The task force shall 4 establish appropriate protocols to safeguard 5 confidentiality and prevent the inappropriate 6 disclosure of information when sharing informa- 7 tion between the Office and the Food and Drug 8 Administration. 9 ‘‘(B) CONTENTS.—The protocols estab- 10 lished under subparagraph (A) shall provide 11 that— 12 ‘‘(i) before sharing any information 13 described in paragraph (1), the sponsor of 14 the human drug or biological product to 15 which that information relates shall be pro- 16 vided notice of that sharing by the applica- 17 ble agency and with a period of 30 days to 18 consult with the agency sharing that infor- 19 mation; and 20 ‘‘(ii) the Director shall, in order to 21 protect against the inadvertent disclosure 22 of information, maintain any information 23 shared with the Director by the Commis- 24 sioner separate from pending patent appli- 25 VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 1717 IH cations and establish procedures for the 1 identification of confidential information. 2 ‘‘(C) POTENTIAL REMEDIES.—In estab- 3 lishing protocols under this paragraph, the task 4 force shall identify appropriate remedies for any 5 potential injury suffered when confidential in- 6 formation is made available, including inadvert- 7 ently, through the sharing of information de- 8 scribed in this subsection. 9 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 10 this subsection may be construed as superseding any 11 other remedy available for the unauthorized disclo- 12 sure of confidential information.’’. 13 (b) TECHNICAL AND CONFORMING AMENDMENT.— 14 The table of sections for chapter 1 of title 35, United 15 States Code, is amended by adding at the end the fol- 16 lowing: 17 ‘‘15. Interagency Task Force on Patents.’’. Æ VerDate Sep 11 2014 23:40 Apr 05, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\H1717.IH H1717 kjohnson on DSK79L0C42PROD with BILLS