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