[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                     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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                                                                 ---------------------------------------------------------------------------------------------------------------
    Totals....................................  ................................             883  ..............             883  ..............           5,898  ..............       2,565,630
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                      Table 2--Total Burden Hours and Hourly Costs to Individual and Household Respondents
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                     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)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                                                                 ---------------------------------------------------------------------------------------------------------------

[[Page 70791]]

 
    Totals....................................  ................................              32  ..............              32  ..............             215  ..............          93,525
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Respondent Non-hourly Cost Burden: $327,003.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                                                                      Annual
              Item No.                           Item                estimated      Filing fee      Total cost
                                                                     responses
----------------------------------------------------------------------------------------------------------------
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.
                                                                 -----------------------------------------------
11.................................  Petition to Accord a Filing               1             420             420
                                      Date to an Application
                                      Under 37 CFR 1.740 for
                                      Extension of a Patent Term.
                                                                 -----------------------------------------------
    Totals.........................  ...........................             836  ..............         326,920
----------------------------------------------------------------------------------------------------------------

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]
BILLING CODE 3510-16-P