Joint USPTO-FDA Collaboration Initiatives; Notice of Public Listening Session and Request for Comments, 67019-67022 [2022-24107]
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
entering either the title of the collection
or the OMB Control Number 0648–0613.
Sheleen Dumas,
Department PRA Clearance Officer, Office of
the Chief Information Officer, Commerce
Department.
[FR Doc. 2022–24211 Filed 11–4–22; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
Agency Information Collection
Activities; Submission to the Office of
Management and Budget (OMB) for
Review and Approval; Comment
Request; Designation of Fishery
Management Council Members and
Application for Reinstatement of State
Authority
National Oceanic &
Atmospheric Administration (NOAA),
Commerce.
AGENCY:
Notice of information collection,
request for comment.
ACTION:
The Department of
Commerce, in accordance with the
Paperwork Reduction Act of 1995
(PRA), invites the general public and
other Federal agencies to comment on
proposed and continuing information
collections, which helps us assess the
impact of our information collection
requirements and minimize the public’s
reporting burden. The purpose of this
notice is to allow for 60 days of public
comment preceding submission of the
collection to OMB.
SUMMARY:
To ensure consideration,
comments regarding this proposed
information collection must be received
on or before January 6, 2023.
DATES:
Interested persons are
invited to submit written comments to
Adrienne Thomas, NOAA PRA Officer,
at NOAA.PRA@noaa.gov. Please
reference OMB Control Number 0648–
0314 in the subject line of your
comments. Do not submit Confidential
Business Information or otherwise
sensitive or protected information.
ADDRESSES:
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FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
specific questions related to collection
activities should be directed to Morgan
Corey, Fishery Management Specialist,
Office of Sustainable Fisheries, 1315
East-West Highway, Silver Spring, MD
20910, (301) 427–8535, and
morgan.corey@noaa.gov.
SUPPLEMENTARY INFORMATION:
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I. Abstract
This request is for extension of a
currently approved information
collection. The Magnuson-Stevens
Fishery Conservation and Management
Act (Magnuson-Stevens Act) authorizes
the establishment of eight Regional
Fishery Management Councils to
manage fisheries within regional
jurisdictions. This collection pertains to
several sections of the MagnusonStevens Act related to the Councils.
Section 302(b) provides for appointment
of Council members nominated by State
Governors, Territorial Governors, or
Tribal Governments and for designation
of a principal state fishery official for
the purposes of the Magnuson-Stevens
Act. Section 306(b)(2) provides for a
request by a state for reinstatement of
state authority over a managed fishery.
Nominees for Council membership must
provide their State Governor, Territorial
Governor, or Tribal Government
leadership with background
documentation, which is then submitted
to NOAA, on behalf of the Secretary of
Commerce to review qualifications for
Council membership. The information
collected with these actions is used to
ensure that the requirements of the
Magnuson-Stevens Act are being met in
regards to Council membership and
state authority.
II. Method of Collection
State Governors, Territorial
Governors, and Tribal Governments
submit written nominations to the
Secretary of Commerce, together with
recommendations and statements of
candidates’ qualifications. Designations
of state officials and requests for
reinstatement of state authority are also
made in writing in response to
regulations. NMFS provides guidance
on what information to include in order
to comply with current regulations. See
50 CFR 600.215. No forms are used.
III. Data
OMB Control Number: 0648–0314.
Form Number(s): None.
Type of Review: Regular submission
(extension of a currently approved
collection).
Affected Public: State, local, or Tribal
government.
Estimated Number of Respondents:
275.
Estimated Time per Response: 80
hours for a nomination for Council
appointment; 16 hours for background
documentation for nominees; 1 hour to
designate a principal state fishery
official(s) or for a request to reinstate
authority.
Estimated Total Annual Burden
Hours: 4,607.
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Estimated Total Annual Cost to
Public: $0.
IV. Request for Comments
We are soliciting public comments to
permit the Department/Bureau to: (a)
Evaluate whether the proposed
information collection is necessary for
the proper functions of the Department,
including whether the information will
have practical utility; (b) Evaluate the
accuracy of our estimate of the time and
cost burden for this proposed collection,
including the validity of the
methodology and assumptions used; (c)
Evaluate ways to enhance the quality,
utility, and clarity of the information to
be collected; and (d) Minimize the
reporting burden on those who are to
respond, including the use of automated
collection techniques or other forms of
information technology.
Comments that you submit in
response to this notice are a matter of
public record. We will include, or
summarize, each comment in our
request to OMB to approve this ICR.
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you may ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Sheleen Dumas,
Department PRA Clearance Officer, Office of
the Chief Information Officer, Commerce
Department.
[FR Doc. 2022–24210 Filed 11–4–22; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO–P–2022–0037]
Joint USPTO–FDA Collaboration
Initiatives; Notice of Public Listening
Session and Request for Comments
United States Patent and
Trademark Office, U.S. Department of
Commerce.
ACTION: Notice of public listening
session; request for comments.
AGENCY:
The United States Patent and
Trademark Office (USPTO), Department
of Commerce, in collaboration with the
United States Food and Drug
Administration (FDA), Department of
Health and Human Services, is
announcing a public listening session
SUMMARY:
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Federal Register / Vol. 87, No. 214 / Monday, November 7, 2022 / Notices
on January 19, 2023, titled ‘‘Listening
Session on Joint USPTO–FDA
Collaboration Initiatives.’’ The purpose
of the listening session is to seek public
comments on proposed initiatives for
collaboration between the agencies to
advance President Biden’s Executive
Order on ‘‘Promoting Competition in the
American Economy’’ and to promote
greater access to medicines for
American families. To assist in
gathering public input, the USPTO and
the FDA are announcing the
establishment of a docket to track
feedback received through this notice
and a request for comments on these
collaborative efforts.
DATES: The public listening session will
be held on Thursday, January 19, 2023,
from 10 a.m. to 5 p.m. ET. Persons
seeking to speak at the listening session
must register by 5 p.m. on January 5,
2023. Persons seeking to attend, either
in person or virtually, but not speak at
the event must register by January 17,
2023. Seating is limited for in-person
attendance. Written comments will be
accepted until February 6, 2023.
ADDRESSES:
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Public Listening Session
The public listening session will take
place in person in the Clara Barton
Auditorium at the USPTO, 600 Dulany
Street, Alexandria, VA 22313. The
session will also be available via live
feed for those wishing to attend
remotely. Registration is required for
both in-person and virtual attendance.
Information on registration is available
at www.uspto.gov/initiatives/uspto-fdacollaboration/engagements. Registrants
must indicate whether they are
registering as a listen-only attendee or as
a speaker participant.
Requests to participate as a speaker
must include:
1. The name of the person desiring to
participate;
2. The organization(s) that person
represents, if any;
3. Contact information (address,
telephone number, and email); and
4. Information on the specific topic(s)
of interest to the speaker (or their
organization) and identification of the
primary topic of interest.
Speaking slots are limited; preference
will be given to speakers wishing to
address one of the questions raised in
this request for comments. We will
attempt to group speakers by topic.
Topics and speakers will be announced
a few days prior to the public listening
session. Speakers must attend in person
and are required to submit their remarks
for the listening session in advance
through the Federal eRulemaking Portal
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at www.regulations.gov. We will inform
each speaker in advance of their
assigned time slot. If we receive more
requests to speak than time allows and
are unable to assign a time slot as
requested, we will invite the requestor
to submit written comments. Time slots
will be at least three minutes but may
be longer, depending on the number of
speakers registered. A panel of USPTO
and FDA personnel may reserve time to
ask questions of particular speakers after
the delivery of a speaker’s remarks.
Request for Comments
You may submit written comments as
follows. For reasons of Government
efficiency, comments must be submitted
through the Federal eRulemaking Portal
at www.regulations.gov. To submit
comments via the portal, enter docket
number PTO–P–2022–0037 on the
homepage and click ‘‘search.’’ The site
will provide a search results page listing
all documents associated with this
docket. Find a reference to this request
for comments and click on the
‘‘Comment Now!’’ icon, complete the
required fields, and enter or attach your
comments. Attachments to electronic
comments will be accepted in ADOBE®
portable document format (PDF) or
MICROSOFT WORD® format. Because
comments will be made available for
public inspection, information that the
submitter does not desire to make
public, such as an address or phone
number, should not be included in the
comments.
Visit the Federal eRulemaking Portal
for additional instructions on providing
comments via the portal. If electronic
submission of comments is not feasible
due to a lack of access to a computer
and/or the internet, please contact the
USPTO using the contact information
below for special instructions regarding
how to submit comments by mail or by
hand delivery.
FOR FURTHER INFORMATION CONTACT:
Linda Horner, Administrative Patent
Judge, USPTO, at 571–272–9797 or
USPTO-FDAcollaboration@uspto.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2021, President Biden
issued an Executive Order on
‘‘Promoting Competition in the
American Economy,’’ 86 FR 36987 (July
14, 2021) (Competition E.O.). To
advance the Biden Administration’s
goals of promoting greater access to
medicines for American families and
increasing competition in the
marketplace, section 5(p)(vi) of the
Competition E.O. directs the Secretary
of Health and Human Services,
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‘‘through the Commissioner of Food and
Drugs’’ and ‘‘not later than 45 days after
the date of this order,’’ to ‘‘write a letter
to the Under Secretary of Commerce for
Intellectual Property and Director of the
United States Patent and Trademark
Office enumerating and describing any
relevant concerns of the FDA,’’ in order
‘‘to help ensure that the patent system,
while incentivizing innovation, does not
also unjustifiably delay generic drug
and biosimilar competition beyond that
reasonably contemplated by applicable
law.’’
In response to the Competition E.O.,
on September 10, 2021, the FDA sent a
letter to the USPTO outlining ideas for
further engagement with the USPTO
(FDA Letter). On July 6, 2022, the
USPTO sent a responsive letter (USPTO
Letter) discussing specific initiatives the
USPTO was exploring to collaborate
with the FDA to ensure that our patent
system properly and adequately protects
innovation while not unnecessarily
delaying getting generic, biosimilar, and
more affordable versions of
pharmaceuticals into the hands of
Americans who need them. The letters
are available at www.uspto.gov/
initiatives/fda-collaboration.
The FDA–USPTO exchange of letters
recognizes that, while the two agencies
have different missions and authorities,
we share a commitment to ensuring our
innovation system strikes the
appropriate balance—encouraging
meaningful innovation in drug
development while supporting a
competitive marketplace that can
promote greater access to medicines for
American families.
The United States is a global leader in
the development of drugs and biologics
due to its strong patent system, and the
USPTO Letter describes ongoing efforts
to further promote robust and reliable
patent rights across all technologies.
Robust and reliable patents are needed
to incentivize and protect the immense
research and development investment
that is essential to bringing life-saving
and life-altering products to market.
Patent rights can spur the collaboration
necessary for quick and speedy drug
and biological product development.
Congress also enacted laws to establish
approval pathways for generic and
biosimilar medicines, and these laws set
forth patent dispute resolution
mechanisms in the drug and biologic
innovation space to encourage generic
and biosimilar manufacturers to timely
resolve patent issues in order to enter
the market to increase competition.
The FDA Letter highlights the FDA’s
commitment to facilitating increased
drug competition through its
abbreviated pathways for the approval
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of generic drugs and biosimilars, which
play a foundational role in ensuring
access to high-quality, safe, effective,
and affordable medicines for American
patients. The FDA has a ministerial role
with regard to the patent listing
provisions of the Federal Food, Drug,
and Cosmetic Act. New drug application
sponsors are statutorily required to
submit certain patent information for
listing, and the FDA is statutorily
required to publish that information,
which it does in Approved Drug
Products with Therapeutic Equivalence
Evaluations (the Orange Book). Orange
Book-listed patents may impact the
timing of generic approval. In addition,
under section 351(l) of the Public Health
Service Act, if a reference product
sponsor (i.e., biologics license
application holder) provides a list of
patents to a biosimilar applicant within
the context of patent litigation, then the
FDA is statutorily required to publish
that patent list. The FDA publishes such
lists in the Purple Book Database of
Licensed Biological Products (the
Purple Book).
To further the objectives of the
Competition E.O., the letters the FDA
and the USPTO exchanged outline a
number of initiatives to execute the
President’s agenda, with a focus on
areas in which the agencies’ functions
overlap. The initiatives for collaboration
with the FDA, as discussed in paragraph
1 of the USPTO Letter, are reproduced
below.
1. Enhance collaboration with other
agencies on key technology areas,
including pharmaceuticals and
biologics. The USPTO will seek to
create formal mechanisms to collaborate
with other agencies such as the Food
and Drug Administration (FDA).1
Specifically, the USPTO will:
a. Continue discussions with the FDA
on this topic and the initiatives outlined
here and work collaboratively on these
and other initiatives.
b. Explore joint USPTO–FDA public
engagement through listening sessions,
dissemination of a Request for
Comments and other procedures for
collecting broader stakeholder input.
c. Provide examiners with training, in
collaboration with the FDA, on publicly
available FDA resources that can be
utilized in prior art searches and on the
state of the art in the pharmaceutical
and biopharma areas and provide
resources to the FDA to support its work
on matters influenced by patent law and
policy.
1 Although these initiatives focus mostly on
collaboration with the FDA, the USPTO is
interested in exploring further interagency
collaborations.
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d. Explore consistency in
representations made to the USPTO and
the FDA. The USPTO will work with
the FDA to evaluate consistency in
representations to the USPTO (made
both during prosecution of patent
applications and in America Invents Act
(AIA) and other post-issuance
proceedings) and the FDA. The USPTO
is also exploring initiatives to require
patent applicants to provide relevant
information to the USPTO that has been
submitted to other agencies and to
remind patent applicants of their
disclosure obligations and the
ramifications of failing to disclose
required information at the USPTO.2
The USPTO will explore with the FDA
whether other avenues exist to
determine whether patent applicants
have submitted inconsistent statements
between the agencies.
e. Engage in greater FDA collaboration
in AIA proceedings. In addition to
improving the robustness and reliability
of patents that are granted in the first
place, the USPTO will work with the
FDA on processes and procedures for (1)
notifying the FDA of AIA proceeding
filings on any Orange Book-listed
patents and/or Purple Book-listed
patents, and (2) potentially sharing more
information between the agencies. The
USPTO will also work with the FDA to
assess why there have been so few
filings of AIA proceedings on Orange
Book-listed patents and biologic patents
and why the number of AIA filings for
pharmaceutical patents has generally
declined.3
f. Revisit patent term extension
practice, required under 35 U.S.C. 156
due to the product being subject to an
FDA regulatory review period. Though
a recent report found that the USPTO
accurately and fairly grants patent term
extensions based on FDA regulatory
review periods, the USPTO will
collaborate with the FDA to determine
if there are any areas for improvement
through information sharing or
otherwise. The USPTO also is exploring
ways to facilitate public access to
information on patent term extension
applications and grants.
2 On July 29, 2022, the USPTO published a
Federal Register Notice clarifying the duty of
disclosure and the duty of reasonable inquiry,
including as to materials or statements material to
patentability, or statements made to the USPTO that
are inconsistent with statements submitted to the
FDA and other Government agencies. See Duties of
Disclosure and Reasonable Inquiry During
Examination, Reexamination, and Reissue, and for
Proceedings Before the Patent Trial and Appeal
Board, 87 FR 45764.
3 Orange Book patent/biologic patent study
update through June 2021, available at
www.uspto.gov/sites/default/files/documents/
PTABOBbiologicpatentstudy8.10.2021draftupdated
thruJune2021.pdf.
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g. Work with the FDA to understand
how else the agencies’ authorities and
responsibilities overlap, such as
exploring the policies surrounding the
use of ‘‘skinny labels,’’ the connection
between method of use patents and
associated use codes, and the patenting
of risk evaluation and mitigation
strategies that the FDA requires for
certain medications with serious safety
concerns. Where the agencies’ functions
overlap, the USPTO will work with FDA
to optimize information sharing and
policy within our respective frameworks
and legal restrictions.
h. Remain open to discussing with the
FDA, other agencies, the
Administration, and stakeholders the
FDA’s concerns over practices referred
to as ‘‘patent thickets,’’ ‘‘evergreening,’’
and ‘‘product hopping.’’
In this notice of public listening
session and request for comments, the
USPTO and the FDA seek public
comments on the proposed initiatives
outlined in the USPTO Letter (1(a)–1(h))
reproduced above.4
II. Purpose and Scope of the Listening
Session and Request for Comments
The purpose of this listening session
and request for comments is to obtain
public input on areas for USPTO–FDA
collaboration and engagement. We are
seeking feedback from a broad group of
stakeholders, including, but not limited
to, patients and their caregivers, patient
advocates, representatives from
regulated industry, including companies
that sell branded medicines, generics
drugs and biosimilars, healthcare
organizations, payors and insurers,
academic institutions, public interest
groups, and the general public.
To facilitate stakeholder feedback on
the initiatives listed above, we provide
the questions below. These questions
are not meant to be exhaustive. We
encourage interested stakeholders to
address these and/or other related issues
and to submit research and data that
inform their comments on these topics.
Commenters are welcome to respond to
any or all of the questions and are
encouraged to indicate which questions
their comments address.
1. What publicly available FDA
resources should be included when
training USPTO patent examiners on
tools they can use to assess the
patentability of claimed inventions?
2. What mechanisms could assist
patent examiners in determining
4 The USPTO is also working in parallel on the
other proposed initiatives described in the USPTO
Letter that are not the focus of this listening session
and request for comments. See, e.g., Request for
Comments on Initiatives Ensuring Robust and
Reliable Patents, 87 FR 60130 (October 4, 2022).
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whether patent applicants or patent
owners have submitted inconsistent
statements to the USPTO and the FDA?
Please explain whether such
mechanisms present confidentiality
concerns and, if so, how those concerns
could be addressed.
3. What are the opportunities and
challenges related to the use of AIA
proceedings to address the patentability
of claims in pharmaceutical and
biotechnological patents, including with
respect to how such proceedings may
intersect with Hatch-Waxman paragraph
IV disputes and the Biologics Price
Competition and Innovation Act ‘‘patent
dance’’ framework that biosimilar
applicants and reference product
sponsors use to address any patent
infringement concerns?
4. How can the USPTO and the FDA
reinforce their collaboration and
information exchange in relation to
determining whether a patent qualifies
for a patent term extension (PTE) and
the length of any extension under 35
U.S.C. 156, as described in the Manual
of Patent Examining Procedure § 2756?
Identify any specific areas for
improvement in the effectiveness of the
current USPTO–FDA process for
adjudicating applications for PTE and in
the opportunity for public comment on
such applications.
5. The FDA already publishes PTE
applications on www.regulations.gov,
and the USPTO publishes PTE
applications on its Patent Center portal
(https://patentcenter.uspto.gov/), which
replaced the Public Patent Application
Information Retrieval (PAIR) system.
The USPTO also recently provided
centralized access to a listing of PTE
applications filed during the last five
years at www.uspto.gov/patents/laws/
patent-term-extension/patent-termsextended-under-35-usc-156. This list
includes the patent application number,
patent number, link to the electronic file
wrapper in Patent Center, PTE
application filing date, and trade name
identified in the PTE application. The
status of each PTE application,
including disposition, may be
determined by reviewing the electronic
file wrapper in Patent Center. What
additional information would be useful
to include on this web page?
6. What policy considerations or
concerns should the USPTO and the
FDA explore as they relate to method of
use patents and, as applicable,
associated FDA use codes, including
with respect to generic drug, 505(b)(2),
and biosimilar applicants who do not
seek approval for (i.e., who seek to carve
out from their labeling) information
related to a patent-protected method of
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use (sometimes described as ‘‘skinny
labeling’’)?
7. What policy considerations or
concerns should the USPTO and the
FDA explore in relation to the patenting
of risk evaluation and mitigation
strategies associated with certain FDAapproved products? What other types of
patent claims associated with FDAregulated products raise policy
considerations or concerns for the
USPTO and the FDA to evaluate?
8. Apart from, or in conjunction with,
the initiatives set forth in the USPTO
Letter, what other steps could the
USPTO and the FDA take
collaboratively to address concerns
about the potential misuse of patents to
improperly delay competition or to
promote greater availability of generic
versions of scarce drugs that are no
longer covered by patents?
9. What additional input on any of the
initiatives listed in the USPTO Letter
(1(a)–1(h)), or any other related
suggestions for USPTO–FDA
collaboration, should the agencies
consider?
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2022–24107 Filed 11–4–22; 8:45 am]
BILLING CODE 3510–16–P
COMMODITY FUTURES TRADING
COMMISSION
Agency Information Collection
Activities: Notice of Intent To Extend
Collection 3038–0025, Practice by
Former Members and Employees of
the Commission
Commodity Futures Trading
Commission.
ACTION: Notice.
AGENCY:
The Commodity Futures
Trading Commission (‘‘CFTC’’ or
‘‘Commission’’) is announcing an
opportunity for public comment on the
proposed renewal of an information
collection by the agency. Under the
Paperwork Reduction Act (‘‘PRA’’),
Federal agencies are required to publish
notice in the Federal Register
concerning each proposed collection of
information, including proposed
extension of an existing collection of
information, and to allow 60 days for
public comment. This notice solicits
comments regarding the reporting
requirement imposed on former
members and employees of the
Commission who are employed or
retained by third parties to appear
before the Commission.
SUMMARY:
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Comments must be submitted on
or before January 6, 2023.
ADDRESSES: You may submit comments,
identified by ‘‘Practice by Former
Members and Employees of the
Commission, OMB Control No. 3038–
0025,’’ by any of the following methods:
• The Agency’s website, at https://
comments.cftc.gov/. Follow the
instructions for submitting comments
through the website.
• Mail: Christopher Kirkpatrick,
Secretary of the Commission,
Commodity Futures Trading
Commission, Three Lafayette Centre,
1155 21st Street NW, Washington, DC
20581.
• Hand Delivery/Courier: Same as
Mail above.
Please submit your comments using
only one method. All comments must be
submitted in English, or if not,
accompanied by an English translation.
Comments will be posted as received to
https://www.cftc.gov.
FOR FURTHER INFORMATION CONTACT:
Frank Walsh, Alternate Designated
Agency Ethics Official, Office of the
General Counsel, Commodity Futures
Trading Commission, (202) 418–6250;
email: fwalsh@cftc.gov, and refer to
OMB Control No. 3038–0025.
SUPPLEMENTARY INFORMATION: Under the
PRA, 44 U.S.C. 3501 et seq., Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of Information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR 1320.3
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA, 44 U.S.C.
3506(c)(2)(A), requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, the CFTC is publishing
notice of a proposed extension of the
currently approved information
collection listed below. An agency may
not conduct or sponsor, and a person is
not required to respond to, a collection
of information unless it displays a
currently valid OMB control number.1
Title: Practice by Former Members
and Employees of the Commission
(OMB Control No. 3038–0025). This is
a request for an extension of a currently
approved information collection.
DATES:
1 44 U.S.C. 3512, 5 CFR 1320.5(b)(2)(i) and 1320.8
(b)(3)(vi).
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Agencies
[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67019-67022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24107]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2022-0037]
Joint USPTO-FDA Collaboration Initiatives; Notice of Public
Listening Session and Request for Comments
AGENCY: United States Patent and Trademark Office, U.S. Department of
Commerce.
ACTION: Notice of public listening session; request for comments.
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SUMMARY: The United States Patent and Trademark Office (USPTO),
Department of Commerce, in collaboration with the United States Food
and Drug Administration (FDA), Department of Health and Human Services,
is announcing a public listening session
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on January 19, 2023, titled ``Listening Session on Joint USPTO-FDA
Collaboration Initiatives.'' The purpose of the listening session is to
seek public comments on proposed initiatives for collaboration between
the agencies to advance President Biden's Executive Order on
``Promoting Competition in the American Economy'' and to promote
greater access to medicines for American families. To assist in
gathering public input, the USPTO and the FDA are announcing the
establishment of a docket to track feedback received through this
notice and a request for comments on these collaborative efforts.
DATES: The public listening session will be held on Thursday, January
19, 2023, from 10 a.m. to 5 p.m. ET. Persons seeking to speak at the
listening session must register by 5 p.m. on January 5, 2023. Persons
seeking to attend, either in person or virtually, but not speak at the
event must register by January 17, 2023. Seating is limited for in-
person attendance. Written comments will be accepted until February 6,
2023.
ADDRESSES:
Public Listening Session
The public listening session will take place in person in the Clara
Barton Auditorium at the USPTO, 600 Dulany Street, Alexandria, VA
22313. The session will also be available via live feed for those
wishing to attend remotely. Registration is required for both in-person
and virtual attendance. Information on registration is available at
www.uspto.gov/initiatives/uspto-fda-collaboration/engagements.
Registrants must indicate whether they are registering as a listen-only
attendee or as a speaker participant.
Requests to participate as a speaker must include:
1. The name of the person desiring to participate;
2. The organization(s) that person represents, if any;
3. Contact information (address, telephone number, and email); and
4. Information on the specific topic(s) of interest to the speaker
(or their organization) and identification of the primary topic of
interest.
Speaking slots are limited; preference will be given to speakers
wishing to address one of the questions raised in this request for
comments. We will attempt to group speakers by topic. Topics and
speakers will be announced a few days prior to the public listening
session. Speakers must attend in person and are required to submit
their remarks for the listening session in advance through the Federal
eRulemaking Portal at www.regulations.gov. We will inform each speaker
in advance of their assigned time slot. If we receive more requests to
speak than time allows and are unable to assign a time slot as
requested, we will invite the requestor to submit written comments.
Time slots will be at least three minutes but may be longer, depending
on the number of speakers registered. A panel of USPTO and FDA
personnel may reserve time to ask questions of particular speakers
after the delivery of a speaker's remarks.
Request for Comments
You may submit written comments as follows. For reasons of
Government efficiency, comments must be submitted through the Federal
eRulemaking Portal at www.regulations.gov. To submit comments via the
portal, enter docket number PTO-P-2022-0037 on the homepage and click
``search.'' The site will provide a search results page listing all
documents associated with this docket. Find a reference to this request
for comments and click on the ``Comment Now!'' icon, complete the
required fields, and enter or attach your comments. Attachments to
electronic comments will be accepted in ADOBE[supreg] portable document
format (PDF) or MICROSOFT WORD[supreg] format. Because comments will be
made available for public inspection, information that the submitter
does not desire to make public, such as an address or phone number,
should not be included in the comments.
Visit the Federal eRulemaking Portal for additional instructions on
providing comments via the portal. If electronic submission of comments
is not feasible due to a lack of access to a computer and/or the
internet, please contact the USPTO using the contact information below
for special instructions regarding how to submit comments by mail or by
hand delivery.
FOR FURTHER INFORMATION CONTACT: Linda Horner, Administrative Patent
Judge, USPTO, at 571-272-9797 or [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On July 9, 2021, President Biden issued an Executive Order on
``Promoting Competition in the American Economy,'' 86 FR 36987 (July
14, 2021) (Competition E.O.). To advance the Biden Administration's
goals of promoting greater access to medicines for American families
and increasing competition in the marketplace, section 5(p)(vi) of the
Competition E.O. directs the Secretary of Health and Human Services,
``through the Commissioner of Food and Drugs'' and ``not later than 45
days after the date of this order,'' to ``write a letter to the Under
Secretary of Commerce for Intellectual Property and Director of the
United States Patent and Trademark Office enumerating and describing
any relevant concerns of the FDA,'' in order ``to help ensure that the
patent system, while incentivizing innovation, does not also
unjustifiably delay generic drug and biosimilar competition beyond that
reasonably contemplated by applicable law.''
In response to the Competition E.O., on September 10, 2021, the FDA
sent a letter to the USPTO outlining ideas for further engagement with
the USPTO (FDA Letter). On July 6, 2022, the USPTO sent a responsive
letter (USPTO Letter) discussing specific initiatives the USPTO was
exploring to collaborate with the FDA to ensure that our patent system
properly and adequately protects innovation while not unnecessarily
delaying getting generic, biosimilar, and more affordable versions of
pharmaceuticals into the hands of Americans who need them. The letters
are available at www.uspto.gov/initiatives/fda-collaboration.
The FDA-USPTO exchange of letters recognizes that, while the two
agencies have different missions and authorities, we share a commitment
to ensuring our innovation system strikes the appropriate balance--
encouraging meaningful innovation in drug development while supporting
a competitive marketplace that can promote greater access to medicines
for American families.
The United States is a global leader in the development of drugs
and biologics due to its strong patent system, and the USPTO Letter
describes ongoing efforts to further promote robust and reliable patent
rights across all technologies. Robust and reliable patents are needed
to incentivize and protect the immense research and development
investment that is essential to bringing life-saving and life-altering
products to market. Patent rights can spur the collaboration necessary
for quick and speedy drug and biological product development. Congress
also enacted laws to establish approval pathways for generic and
biosimilar medicines, and these laws set forth patent dispute
resolution mechanisms in the drug and biologic innovation space to
encourage generic and biosimilar manufacturers to timely resolve patent
issues in order to enter the market to increase competition.
The FDA Letter highlights the FDA's commitment to facilitating
increased drug competition through its abbreviated pathways for the
approval
[[Page 67021]]
of generic drugs and biosimilars, which play a foundational role in
ensuring access to high-quality, safe, effective, and affordable
medicines for American patients. The FDA has a ministerial role with
regard to the patent listing provisions of the Federal Food, Drug, and
Cosmetic Act. New drug application sponsors are statutorily required to
submit certain patent information for listing, and the FDA is
statutorily required to publish that information, which it does in
Approved Drug Products with Therapeutic Equivalence Evaluations (the
Orange Book). Orange Book-listed patents may impact the timing of
generic approval. In addition, under section 351(l) of the Public
Health Service Act, if a reference product sponsor (i.e., biologics
license application holder) provides a list of patents to a biosimilar
applicant within the context of patent litigation, then the FDA is
statutorily required to publish that patent list. The FDA publishes
such lists in the Purple Book Database of Licensed Biological Products
(the Purple Book).
To further the objectives of the Competition E.O., the letters the
FDA and the USPTO exchanged outline a number of initiatives to execute
the President's agenda, with a focus on areas in which the agencies'
functions overlap. The initiatives for collaboration with the FDA, as
discussed in paragraph 1 of the USPTO Letter, are reproduced below.
1. Enhance collaboration with other agencies on key technology
areas, including pharmaceuticals and biologics. The USPTO will seek to
create formal mechanisms to collaborate with other agencies such as the
Food and Drug Administration (FDA).\1\ Specifically, the USPTO will:
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\1\ Although these initiatives focus mostly on collaboration
with the FDA, the USPTO is interested in exploring further
interagency collaborations.
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a. Continue discussions with the FDA on this topic and the
initiatives outlined here and work collaboratively on these and other
initiatives.
b. Explore joint USPTO-FDA public engagement through listening
sessions, dissemination of a Request for Comments and other procedures
for collecting broader stakeholder input.
c. Provide examiners with training, in collaboration with the FDA,
on publicly available FDA resources that can be utilized in prior art
searches and on the state of the art in the pharmaceutical and
biopharma areas and provide resources to the FDA to support its work on
matters influenced by patent law and policy.
d. Explore consistency in representations made to the USPTO and the
FDA. The USPTO will work with the FDA to evaluate consistency in
representations to the USPTO (made both during prosecution of patent
applications and in America Invents Act (AIA) and other post-issuance
proceedings) and the FDA. The USPTO is also exploring initiatives to
require patent applicants to provide relevant information to the USPTO
that has been submitted to other agencies and to remind patent
applicants of their disclosure obligations and the ramifications of
failing to disclose required information at the USPTO.\2\ The USPTO
will explore with the FDA whether other avenues exist to determine
whether patent applicants have submitted inconsistent statements
between the agencies.
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\2\ On July 29, 2022, the USPTO published a Federal Register
Notice clarifying the duty of disclosure and the duty of reasonable
inquiry, including as to materials or statements material to
patentability, or statements made to the USPTO that are inconsistent
with statements submitted to the FDA and other Government agencies.
See Duties of Disclosure and Reasonable Inquiry During Examination,
Reexamination, and Reissue, and for Proceedings Before the Patent
Trial and Appeal Board, 87 FR 45764.
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e. Engage in greater FDA collaboration in AIA proceedings. In
addition to improving the robustness and reliability of patents that
are granted in the first place, the USPTO will work with the FDA on
processes and procedures for (1) notifying the FDA of AIA proceeding
filings on any Orange Book-listed patents and/or Purple Book-listed
patents, and (2) potentially sharing more information between the
agencies. The USPTO will also work with the FDA to assess why there
have been so few filings of AIA proceedings on Orange Book-listed
patents and biologic patents and why the number of AIA filings for
pharmaceutical patents has generally declined.\3\
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\3\ Orange Book patent/biologic patent study update through June
2021, available at www.uspto.gov/sites/default/files/documents/PTABOBbiologicpatentstudy8.10.2021draftupdatedthruJune2021.pdf.
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f. Revisit patent term extension practice, required under 35 U.S.C.
156 due to the product being subject to an FDA regulatory review
period. Though a recent report found that the USPTO accurately and
fairly grants patent term extensions based on FDA regulatory review
periods, the USPTO will collaborate with the FDA to determine if there
are any areas for improvement through information sharing or otherwise.
The USPTO also is exploring ways to facilitate public access to
information on patent term extension applications and grants.
g. Work with the FDA to understand how else the agencies'
authorities and responsibilities overlap, such as exploring the
policies surrounding the use of ``skinny labels,'' the connection
between method of use patents and associated use codes, and the
patenting of risk evaluation and mitigation strategies that the FDA
requires for certain medications with serious safety concerns. Where
the agencies' functions overlap, the USPTO will work with FDA to
optimize information sharing and policy within our respective
frameworks and legal restrictions.
h. Remain open to discussing with the FDA, other agencies, the
Administration, and stakeholders the FDA's concerns over practices
referred to as ``patent thickets,'' ``evergreening,'' and ``product
hopping.''
In this notice of public listening session and request for
comments, the USPTO and the FDA seek public comments on the proposed
initiatives outlined in the USPTO Letter (1(a)-1(h)) reproduced
above.\4\
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\4\ The USPTO is also working in parallel on the other proposed
initiatives described in the USPTO Letter that are not the focus of
this listening session and request for comments. See, e.g., Request
for Comments on Initiatives Ensuring Robust and Reliable Patents, 87
FR 60130 (October 4, 2022).
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II. Purpose and Scope of the Listening Session and Request for Comments
The purpose of this listening session and request for comments is
to obtain public input on areas for USPTO-FDA collaboration and
engagement. We are seeking feedback from a broad group of stakeholders,
including, but not limited to, patients and their caregivers, patient
advocates, representatives from regulated industry, including companies
that sell branded medicines, generics drugs and biosimilars, healthcare
organizations, payors and insurers, academic institutions, public
interest groups, and the general public.
To facilitate stakeholder feedback on the initiatives listed above,
we provide the questions below. These questions are not meant to be
exhaustive. We encourage interested stakeholders to address these and/
or other related issues and to submit research and data that inform
their comments on these topics. Commenters are welcome to respond to
any or all of the questions and are encouraged to indicate which
questions their comments address.
1. What publicly available FDA resources should be included when
training USPTO patent examiners on tools they can use to assess the
patentability of claimed inventions?
2. What mechanisms could assist patent examiners in determining
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whether patent applicants or patent owners have submitted inconsistent
statements to the USPTO and the FDA? Please explain whether such
mechanisms present confidentiality concerns and, if so, how those
concerns could be addressed.
3. What are the opportunities and challenges related to the use of
AIA proceedings to address the patentability of claims in
pharmaceutical and biotechnological patents, including with respect to
how such proceedings may intersect with Hatch-Waxman paragraph IV
disputes and the Biologics Price Competition and Innovation Act
``patent dance'' framework that biosimilar applicants and reference
product sponsors use to address any patent infringement concerns?
4. How can the USPTO and the FDA reinforce their collaboration and
information exchange in relation to determining whether a patent
qualifies for a patent term extension (PTE) and the length of any
extension under 35 U.S.C. 156, as described in the Manual of Patent
Examining Procedure Sec. 2756? Identify any specific areas for
improvement in the effectiveness of the current USPTO-FDA process for
adjudicating applications for PTE and in the opportunity for public
comment on such applications.
5. The FDA already publishes PTE applications on
www.regulations.gov, and the USPTO publishes PTE applications on its
Patent Center portal (https://patentcenter.uspto.gov/), which replaced
the Public Patent Application Information Retrieval (PAIR) system. The
USPTO also recently provided centralized access to a listing of PTE
applications filed during the last five years at www.uspto.gov/patents/laws/patent-term-extension/patent-terms-extended-under-35-usc-156. This
list includes the patent application number, patent number, link to the
electronic file wrapper in Patent Center, PTE application filing date,
and trade name identified in the PTE application. The status of each
PTE application, including disposition, may be determined by reviewing
the electronic file wrapper in Patent Center. What additional
information would be useful to include on this web page?
6. What policy considerations or concerns should the USPTO and the
FDA explore as they relate to method of use patents and, as applicable,
associated FDA use codes, including with respect to generic drug,
505(b)(2), and biosimilar applicants who do not seek approval for
(i.e., who seek to carve out from their labeling) information related
to a patent-protected method of use (sometimes described as ``skinny
labeling'')?
7. What policy considerations or concerns should the USPTO and the
FDA explore in relation to the patenting of risk evaluation and
mitigation strategies associated with certain FDA-approved products?
What other types of patent claims associated with FDA-regulated
products raise policy considerations or concerns for the USPTO and the
FDA to evaluate?
8. Apart from, or in conjunction with, the initiatives set forth in
the USPTO Letter, what other steps could the USPTO and the FDA take
collaboratively to address concerns about the potential misuse of
patents to improperly delay competition or to promote greater
availability of generic versions of scarce drugs that are no longer
covered by patents?
9. What additional input on any of the initiatives listed in the
USPTO Letter (1(a)-1(h)), or any other related suggestions for USPTO-
FDA collaboration, should the agencies consider?
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2022-24107 Filed 11-4-22; 8:45 am]
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