Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Patent Term Extension and Adjustment, 5861-5862 [2023-01750]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[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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