[Federal Register Volume 88, Number 19 (Monday, January 30, 2023)]
[Notices]
[Pages 5861-5862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01750]
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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
The United States Patent and Trademark Office (USPTO) will submit
the following information collection request to the Office of
Management and Budget (OMB) for review and clearance in accordance with
the Paperwork Reduction Act of 1995, on or after the date of
publication of this notice. The USPTO invites comment on this
information collection renewal, which helps the USPTO assess the impact
of its information collection requirements and minimize the public's
reporting burden. Public comments were previously requested via the
Federal Register on November 21, 2022 during a 60-day comment period.
This notice allows for an additional 30 days for public comments.
Agency: United States Patent and Trademark Office, Department of
Commerce.
Title: Patent Term Extension and Adjustment.
OMB Control Number: 0651-0020.
Needs and Uses: 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.
Form Number(s): 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.
Frequency: On occasion.
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 request to the USPTO.
Estimated Total Annual Respondent Burden Hours: 6,113 hours.
Estimated Total Annual Respondent Non-Hourly Cost Burden: $327,003.
This information collection request may be viewed at
www.reginfo.gov. Follow the instructions to view Department of
Commerce, USPTO information collections currently under review by OMB.
Written comments and recommendations for this information
collection should be submitted within 30 days of the publication of
this notice on the following website www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting ``Currently
under 30-day Review--Open for Public Comments'' or by using the search
function and entering either the title of
[[Page 5862]]
the information collection or the OMB Control Number 0651-0020.
Further information can be obtained by:
Email: [email protected]. Include ``0651-
0020 information request'' in the subject line of the message.
Mail: Justin Isaac, Office of the Chief Administrative
Officer, United States Patent and Trademark Office, P.O. Box 1450,
Alexandria, VA 22313-1450.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2023-01750 Filed 1-27-23; 8:45 am]
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