[Federal Register Volume 90, Number 221 (Wednesday, November 19, 2025)]
[Notices]
[Pages 52043-52046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-20243]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the
Office of Management and Budget (OMB) for Review and Approval; Comment
Request; Patent Term Extension and Adjustment
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice of information collection; request for comments.
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SUMMARY: The United States Patent and Trademark Office (hereafter
``USPTO'' or ``Agency''), as required by the Paperwork Reduction Act of
1995, invites comments on the extension and revision of an existing
information collection: 0651-0020 (Patent Term Extension and
Adjustment). The purpose of this notice is to allow 60 days for public
comments preceding submission of the information collection to Office
of Management and Budget (OMB).
DATES: To ensure consideration, comments regarding this information
collection must be received on or before January 20, 2026.
ADDRESSES: Interested persons are invited to submit written comments by
any of the following methods. Do not submit Confidential Business
Information or otherwise sensitive or protected information.
Email: [email protected]. Include ``0651-
0020 comment'' in the subject line of the message.
Federal eRulemaking Portal: http://www.regulations.gov.
Mail: Justin Isaac, Office of the Chief Administrative
Officer, United States Patent and Trademark Office, P.O. Box 1450,
Alexandria, VA 22313-1450.
Telephone: Jeffrey West, Senior Legal Advisor, 571-272-
2226.
[[Page 52044]]
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to: Jeffrey West, Senior Legal Advisor, United
States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
22313-1450; 571-272-7728; or [email protected] with ``0651-0020
comment'' in the subject line. Additional information about this
information collection is also available at http://www.reginfo.gov
under ``Information Collection Review.''
SUPPLEMENTARY INFORMATION:
I. Abstract
The patent term restoration portion of the Drug Price Competition
and Patent Term Restoration Act of 1984 (Pub. L. 98-417), which is
codified at 35 U.S.C. 156, permits the USPTO to extend the term of
protection under a patent to compensate for delay during regulatory
review and approval by the Food and Drug Administration (FDA) or United
States Department of Agriculture (USDA). Only patents for drug
products, medical devices, food additives, or color additives are
potentially eligible for extension. The maximum length that a patent
may be extended under 35 U.S.C. 156 is 5 years. The USPTO administers
35 U.S.C. 156 through 37 CFR 1.710-1.791.
This information collection covers information gathered in patent
term extension applications submitted under 35 U.S.C. 156(d). Under
this provision, an application for patent term extension must: identify
the approved product; the patent to be extended; and the claims
included in the patent that cover the approved product, a method of
using the approved product, or a method of manufacturing the approved
product. 35 U.S.C. 156(d) also requires the submission of information
that enables the USPTO to determine the eligibility of the patent for
extension, and the rights that will be derived from the extension, and
information to enable the USPTO and the Secretary of Health and Human
Services or the Secretary of Agriculture to determine the period of the
extension. Additionally, 35 U.S.C. 156(d) requires the applicant for
patent term extension to provide a brief description of the activities
undertaken by the applicant during the regulatory review period with
respect to the approved product and the significant dates of these
activities.
This information collection also covers information gathered in
requests for interim extensions pursuant to 35 U.S.C. 156(d)(5) and
156(e)(2). Under 35 U.S.C. 156(d)(5), an interim extension may be
granted if the applicable regulatory review period that began for a
product is reasonably expected to extend beyond the expiration of the
patent term in effect. Under 35 U.S.C. 156(e)(2), an interim extension
may be granted if the term of an eligible patent for which an
application for patent term extension has been submitted would expire
before a certificate of extension is issued. In addition, this
information collection covers requests for review of final eligibility
decisions, and requests to withdraw an application requesting a patent
term extension after it is submitted.
Apart from the extension provisions of 35 U.S.C. 156, the USPTO may
in some cases adjust the term of an original patent under the
provisions of 35 U.S.C. 154 due to certain delays in the prosecution of
the patent application, including delays caused by interference
proceedings, secrecy orders, or appellate review by the Patent Trial
and Appeal Board or a Federal court in which the patent is issued
pursuant to a decision reversing an adverse USPTO determination of
patentability. The USPTO administers 35 U.S.C. 154 through 37 CFR
1.701-1.705. The patent term provisions of 35 U.S.C. 154(b), as amended
by Title IV, Subtitle D of the Intellectual Property and Communications
Omnibus Reform Act of 1999, allow the applicant an opportunity to
request reconsideration of the USPTO's patent term adjustment
determination. This information collection covers information gathered
in such a request.
In addition, this collection covers information collected when the
USPTO reduces the amount of a granted patent term adjustment if delays
were caused by an applicant's failure to make a reasonable effort to
respond to a communication from the USPTO within three months of the
communication's mailing date. Applicants may petition for reinstatement
of a reduction in patent term adjustment with a showing that, in spite
of all due care, the applicant was unable to respond to a communication
from the USPTO within the three-month period.
II. Method of Collection
Items in this information collection may be submitted
electronically, by mail, or by hand delivery to the USPTO.
III. Data
OMB Control Number: 0651-0020.
Forms: None.
Type of Review: Extension and revision of a currently approved
information collection.
Affected Public: Private sector.
Respondent's Obligation: Required to obtain or retain benefits.
Frequency: On occasion.
Estimated Number of Annual Respondents: 903 respondents.
Estimated Number of Annual Responses: 903 responses.
Estimated Time per Response: The USPTO estimates that the responses
in this information collection will take the public approximately 1 to
25 hours to complete. This includes the time to gather the necessary
information, create the document, and submit the completed item(s) to
the USPTO.
Estimated Total Annual Respondent Burden Hours: 6,807 hours.
Estimated Total Annual Respondent Hourly Cost Burden: $3,042,729.
Table 1--Total Burden Hours and Hourly Costs to Private Sector Respondents
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Estimated
Estimated Respondents Estimated Estimated time Estimated Rate \1\ ($/ annual
Item No. Item name annual per respondent annual per response burden (hour/ hour) respondent
respondents responses (hours) year) cost burden
(a) (b) (a) x (b) = (d) (c) x (d) = (f) (e) x (f) =
(c) (e) (g)
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1............................................. Application to Extend Patent 134 1 134 25 3,350 $447 $1,497,450
Term Under 35 U.S.C. 156.
2............................................. Request for Interim Extension 24 1 24 1 24 447 10,728
Under 35 U.S.C. 156(e)(2).
3............................................. Petition to review final 56 1 56 25 1,400 447 625,800
Eligibility Decision Under 37
CFR 1.750.
4............................................. Initial Application for Interim 4 1 4 20 80 447 35,760
Extension Under 35 U.S.C.
156(d)(5).
[[Page 52045]]
5............................................. Subsequent Application for 3 1 3 1 3 447 1,341
Interim Extension Under 37 CFR
1.790.
6............................................. Response to Requirement to Elect 38 1 38 1 38 447 16,986
a Single Patent to Extend from
a Single Regulatory Review
Period.
7............................................. Response to Request to Identify 19 1 19 2 38 447 16,986
Holder of Regulatory Approval.
8............................................. Declaration to Withdraw an 1 1 1 2 2 447 894
Application to Extend Patent
Term.
9............................................. Petition for Reconsideration of 622 1 622 3 1,866 447 834,102
Patent Term Adjustment
Determination.
10............................................ Petition for Reinstatement of 1 1 1 4 4 447 1,788
Reduced Patent Term Adjustment.
11............................................ Petition to Accord a Filing Date 1 1 1 2 2 447 894
to an Application Under 37 CFR
1.740 for Extension of a Patent
Term.
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Totals.................................... ................................ 903 .............. 903 .............. 6,807 .............. 3,042,729
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\1\ 2023 Report of the Economic Survey, published by the Committee on Economics of Legal Practice of the American Intellectual Property Law Association, pg. F-41. The USPTO uses the average
billing rate for intellectual property work in all firms, which is $447 per hour (www.aipla.org/home/news-publications/economic-survey).
Estimated Total Annual Respondent Non-hourly Cost Burden: $489,431.
There are no capital startup costs, maintenance costs, or recordkeeping
costs associated with this information collection. However, the USPTO
estimates that the total annual non-hourly cost burden for this
information collection, in the form of filing fees and postage, is
$489,431.
Filing Fees
The items with filing fees are listed in the table below.
Table 2--Filing Fees
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Annual
Item No. Fee code(s) Item estimated Filing fee Total cost
responses
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1........................................ 1457/2457/3457............. Application to Extend Patent 134 $2,500 $335,000
Term Under 35 U.S.C. 156.
4........................................ 1458/2458/3458............. Initial Application for Interim 4 1,320 5,280
Extension Under 35 U.S.C.
156(d)(5).
5........................................ 1459/2459/3459............. Subsequent Application for 3 680 2,040
Interim Extension Under 37 CFR
1.790.
9........................................ 1455/2455/3455............. Petition for Reconsideration of 622 226 140,572
Patent Term Adjustment
Determination.
9........................................ 1465/2465/3465............. Supplemental Redetermination 4 1,440 5,760
After Notice of Final
Determination.
10....................................... 1456/2456/3456............. Petition for Reinstatement of 1 452 452
Reduced Patent Term Adjustment.
11....................................... 1455/2455/3455............. Petition to Accord a Filing Date 1 226 226
to an Application Under 37 CFR
1.740 for Extension of a Patent
Term.
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Totals............................... ........................... ................................ 769 .............. 489,330
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Postage
Although the USPTO prefers that the items in this information
collection be submitted electronically, responses may be submitted by
mail through the United States Postal Service. The USPTO estimates that
1% of the 903 items in this information collection will be submitted in
the mail, resulting in 9 mailed items. The USPTO estimates that the
average postage cost for a mailed submission, using a Priority Mail
legal flat-rate envelope, will be $11.20. Therefore, the USPTO
estimates the total mailing costs for this information collection at
$101.
IV. Request for Comments
The USPTO is soliciting public comments to:
(a) Evaluate whether the collection of information is necessary for
the proper
[[Page 52046]]
performance of the functions of the Agency, including whether the
information will have practical utility;
(b) Evaluate the accuracy of the Agency's estimate of the burden of
the collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected; and
(d) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
All comments submitted in response to this notice are a matter of
public record. The USPTO will include or summarize each comment in the
request to OMB to approve this information collection. Before including
an address, phone number, email address, or other personally
identifiable information (PII) in a comment, be advised that the entire
comment--including PII--may be made publicly available at any time.
While one may request to withhold PII from public view, the USPTO
cannot guarantee that it will be able to do so.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2025-20243 Filed 11-18-25; 8:45 am]
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