[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70788-70791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25314]
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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 comment.
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SUMMARY: The United States Patent and Trademark Office (USPTO), 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 comment preceding submission of the
information collection to OMB.
DATES: To ensure consideration, comments regarding this information
collection must be received on or before January 20, 2023.
ADDRESSES: Interested persons are invited to submit written comments by
any of the following methods. Do not submit Confidential Business
[[Page 70789]]
Information or otherwise sensitive or protected information.
Email: [email protected]. Include ``0651-
0020 comment'' in the subject line of the message.
Federal Rulemaking Portal: https://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.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Parikha Mehta, Senior Legal Advisor, United
States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
22313-1450; by telephone at 571-272-3248; or by email at
[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 United States Patent and
Trademark Office (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.
Separate 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 information 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.
The title of this item has been changed from ``Patent Term
Extension'' to ``Patent term Extension and Adjustment'' to better
reflect the scope of actions available regarding Patent terms that are
a part of this information collection.
II. Method of Collection
Electronically, by mail, or 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; individuals or households.
Respondent's Obligation: Required to obtain or retain benefits.
Estimated Number of Annual Respondents: 915 respondents.
Estimated Number of Annual Responses: 915 responses.
Estimated Time per Response: The USPTO estimates that the responses
in this information collection will take the public approximately
between 1 hour and 25 hours to complete. This includes the time to
gather the necessary information, create the document, and submit the
completed item to the USPTO.
Estimated Total Annual Respondent Burden Hours: 6,113 hours.
Estimated Total Annual Respondent Hourly Cost Burden: $2,659,155.
Table 1--Total Burden Hours and Hourly Costs to Private Sector Respondents
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Estimated
Estimated Respondents Estimated time per Total annual Hourly cost Total annual
Item No. Item name annual per annual response hour burden burden rate cost for time
respondents respondent responses (hour) \1\ spent
................................ (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 146 1 146 25 3,650 $435 $1,587,750
Term Under 35 U.S.C. 156.
[[Page 70790]]
2............................................. Request for Interim Extension 29 1 29 1 29 435 12,615
Under 35 U.S.C. 156(e)(2).
3............................................. Petition to review final 2 1 2 25 50 435 21,750
Eligibility Decision Under 37
CFR 1.750.
4............................................. Initial Application for Interim 8 1 8 20 160 435 69,600
Extension Under 35 U.S.C.
156(d)(5).
5............................................. Subsequent Application for 7 1 7 1 7 435 3,045
Interim Extension Under 37 CFR
1.790.
6............................................. Response to Requirement to Elect 39 1 39 1 39 435 16,965
a Single Patent to Extend from
a Single Regulatory Review
Period.
7............................................. Response to Request to Identify 2 1 2 2 4 435 1,740
Holder of Regulatory Approval.
8............................................. Declaration to Withdraw an 1 1 1 2 2 435 870
Application to Extend Patent
Term.
9............................................. Petition for Reconsideration of 631 1 631 3 1,893 435 823,455
Patent Term Adjustment
Determination.
10............................................ Petition for Reinstatement of 14 1 14 4 56 435 24,360
Reduced Patent Term Adjustment.
11............................................ Petition to Accord a Filing Date 4 1 4 2 8 435 3,480
to an Application Under 37 CFR
1.740 for Extension of a Patent
Term.
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Totals.................................... ................................ 883 .............. 883 .............. 5,898 .............. 2,565,630
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Table 2--Total Burden Hours and Hourly Costs to Individual and Household Respondents
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Estimated
Estimated Respondents Estimated time per Total annual Hourly cost Total annual
Item No. Item name annual per annual response hour burden burden rate cost for time
respondents respondent responses (hour) \2\ spent
................................ (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 4 1 4 25 100 $435 $43,500
Term Under 35 U.S.C. 156.
2............................................. Request for Interim Extension 1 1 1 1 1 435 435
Under 35 U.S.C. 156(e)(2).
3............................................. Petition to review final 1 1 1 25 25 435 10,875
Eligibility Decision Under 37
CFR 1.750.
4............................................. Initial Application for Interim 1 1 1 20 20 435 8,700
Extension Under 35 U.S.C.
156(d)(5).
5............................................. Subsequent Application for 1 1 1 1 1 435 435
Interim Extension Under 37 CFR
1.790.
6............................................. Response to Requirement to Elect 1 1 1 1 1 435 435
7............................................. Response to Request to Identify 1 1 1 2 2 435 870
Holder of Regulatory Approval.
8............................................. Declaration to Withdraw an 1 1 1 2 2 435 870
Application to Extend Patent
Term.
9............................................. Petition for Reconsideration of 19 1 19 3 57 435 24,795
Patent Term Adjustment
Determination.
10............................................ Petition for Reinstatement of 1 1 1 4 4 435 1,740
Reduced Patent Term Adjustment.
11............................................ Petition to Accord a Filing Date 1 1 1 2 2 435 870
to an Application Under 37 CFR
1.740 for Extension of a Patent
Term.
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[[Page 70791]]
Totals.................................... ................................ 32 .............. 32 .............. 215 .............. 93,525
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Estimated Total Annual Respondent Non-hourly Cost Burden: $327,003.
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\1\ 2021 Report of the Economic Survey, published by the
Committee on Economics of Legal Practice of the American
Intellectual Property Law Association (AIPLA); pg. F-27. The USPTO
uses the average billing rate for intellectual property attorneys in
private firms which is $435 per hour.
\2\ Ibid.
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There are no maintenance costs, capital start-up costs, or
recordkeeping costs associated with this information collection.
However, the USPTO estimates that the total annual (non-hour) cost
burden for this information collection, in the form of filing fees
($326,920) and postage ($83), is $327,003.
Filing Fees
The items with filing fees are listed in the table below.
Table 3--Filing Fees
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Annual
Item No. Item estimated Filing fee Total cost
responses
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1.................................. Application to Extend 150 $1,180 $177,000
Patent Term Under 35
U.S.C. 156.
4.................................. Initial Application for 10 440 4,400
Interim Extension Under 35
U.S.C. 156(d)(5).
5.................................. Subsequent Application for 10 230 2,300
Interim Extension Under 37
CFR 1.790.
9.................................. Petition for 650 210 136,500
Reconsideration of Patent
Term Adjustment
Determination.
10................................. Petition for Reinstatement 15 420 6,300
of Reduced Patent Term
Adjustment.
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11................................. Petition to Accord a Filing 1 420 420
Date to an Application
Under 37 CFR 1.740 for
Extension of a Patent Term.
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Totals......................... ........................... 836 .............. 326,920
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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 (USPS). The USPTO expects
that approximately 1% of the 915 responses in this information
collection will be submitted in the mail, resulting in 9 mailed
submissions. The USPTO estimates that the average postage cost for a
mailed submission, using a Priority Mail 2-day flat rate legal
envelope, will be $9.25. Therefore, the USPTO estimates that the
postage costs for the mailed submissions in this information collection
will total $83.
IV. Request for Comments
The USPTO is soliciting public comments to:
(a) Evaluate whether the collection of information is necessary for
the proper 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. 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 aware that the entire
comment--including PII--may be made publicly available at any time.
While you may ask in your comment to withhold PII from public view,
USPTO cannot guarantee that it will be able to do so.
Justin Isaac,
Information Collections Officer, Office of the Chief Adminstrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2022-25314 Filed 11-18-22; 8:45 am]
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