[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63857-63859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24953]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office


Patent Term Extension

ACTION: Notice of renewal 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 of an existing information collection: 0651-0020 (Patent 
Term Extension).

DATES: Written comments must be submitted on or before January 21, 
2020.

ADDRESSES: You may submit comments by any of the following methods:
     Email: [email protected]. Include ``0651-
0020 comment'' in the subject line of the message.
     Federal Rulemaking Portal: http://www.regulations.gov.
     Mail: Marcie Lovett, Records and Information Governance 
Branch, Office of the Chief Administration 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 Raul Tamayo, Senior Legal Advisor, Office of 
Patent Legal Administration, United States Patent and Trademark Office, 
P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7728; 
or by email to [email protected] with ``0651-0020 comment'' in the 
subject line. Additional information about this 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 Department of Agriculture. 
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 five years. 
The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-1.791.
    This 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 application 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 collection also covers information gathered in requests for 
interim extensions pursuant to 35 U.S.C. 156(e). Under this provision 
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. 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. 
In addition, this collection covers requests for review of final 
eligibility decisions, and 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 extend the term of an original patent under the 
provisions at 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 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 collection covers information gathered in such a 
request. In addition, this collection covers instances when the USPTO 
may reduce the amount of patent term adjustment granted if delays were 
caused by an applicant's failure to make a reasonable effort to respond 
within three months of the mailing date of a communication from the 
USPTO. Applicants may

[[Page 63858]]

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 information in this collection is used by the USPTO to consider 
whether an applicant is eligible for a patent term extension or 
reconsideration of a patent term adjustment and, if so, to determine 
the length of the patent term extension or adjustment.

II. Method of Collection

    By mail, facsimile, hand delivery, or electronically to the USPTO.

III. Data

    OMB Number: 0651-0020.
    IC Instruments and Forms: There are no forms associated with this 
collection.
    Type of Review: Extension of a currently approved collection.
    Affected Public: Businesses or other for-profits; not-for-profit 
institutions.
    Estimated Number of Respondents: 620 responses per year. The USPTO 
estimates that approximately 25% (155) of these responses will be from 
small entities.
    Estimated Time per Response: The USPTO estimates that it will take 
the public from 1 to 25 hours, depending on the complexity of the 
situation, to gather the necessary information, prepare the appropriate 
documents, and submit the information to the USPTO.
    Estimated Total Annual Respondent Burden Hours: 4,102 hours.
    Estimated Total Annual Respondent (Hourly) Cost Burden: 
$1,796,676.00. The USPTO expects that attorneys will complete these 
applications. The professional hourly rate for intellectual property 
attorneys is $438. The attorney rates are found in the 2017 Report of 
the Economic Survey of the America Intellectual Property Law 
Association (AIPLA). Using this hourly rate, the USPTO estimates that 
the total respondent cost burden for this collection is $1,796,676.00 
per year.

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                                                                          Estimated time     Estimated       Estimated                     Total hourly
                  No.                                 Item                 for response       annual       annual burden    Rate ($/hr)   cost burden ($/
                                                                              (hours)        responses         hours                            hr)
                                                                                     (a)             (b)     (a) x (b) =             (d)     (c) x (d) =
                                                                                                                     (c)                             (e)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.....................................  Application to Extend Patent                  25             100           2,500         $438.00   $1,095,000.00
                                         Term Under 35 U.S.C. 156.
2.....................................  Request for Interim Extension                  1              10              10          438.00        4,380.00
                                         Under 35 U.S.C. 156(e)(2).
3.....................................  Petition to Review Final                      25               4             100          438.00       43,800.00
                                         Eligibility Decision Under 37
                                         CFR 1.750.
4.....................................  Initial Application for Interim               20               2              40          438.00       17,520.00
                                         Extension Under 37 CFR 1.790.
5.....................................  Subsequent Application for                     1               1               1          438.00          438.00
                                         Interim Extension Under 37 CFR
                                         1.790.
6.....................................  Response to Requirement to Elect               1              35              35          438.00       15,330.00
7.....................................  Response to Request to Identify                2               1               2          438.00          876.00
                                         Holder of Regulatory Approval.
8.....................................  Declaration to Withdraw an                     2               1               2          438.00          876.00
                                         Application to Extend Patent
                                         Term.
9.....................................  Petition for Reconsideration of                3             450           1,350          438.00      591,300.00
                                         Patent Term Adjustment
                                         Determination.
10....................................  Petition for Reinstatement of                  4              15              60          438.00       26,280.00
                                         Reduced Patent Term Adjustment.
11....................................  Petition to Accord a Filing Date               2               1               2          438.00          876.00
                                         to an Application Under 37 CFR
                                         1.740 for Extension of a Patent
                                         Term.
                                                                         -------------------------------------------------------------------------------
    Total.............................  ................................  ..............             620           4,102  ..............    1,796,676.00
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    Estimated Total Annual (Non-hour) Respondent Cost Burden: $209,488. 
There are no capital startup, maintenance, or operating fees associated 
with this collection. There are, however, annual (non-hour) costs in 
the form of postage costs and fees.

Filing Fees

    There are filing fees associated with this collection. The items 
with filing fees are listed in the table below.

----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                    Total non-hour
                No.                             Item                  annual      Filing fee ($)    cost burden
                                                                     responses                          ($)
                                                                             (a)             (b)     (a) x (b) =
                                                                                                             (c)
----------------------------------------------------------------------------------------------------------------
1.................................  Filing an application for                450            $200      $90,000.00
                                     patent term adjustment.
2.................................  Request for reinstatement of              15             400        6,000.00
                                     term reduced.
3.................................  Extension of term of patent.             100           1,120      112,000.00
4.................................  Initial application for                    2             420          840.00
                                     interim extension (see 37
                                     CFR 1.790).
5.................................  Subsequent application for                 1             220          220.00
                                     interim extension (see 37
                                     CFR 1.790).
                                                                 -----------------------------------------------
    Total.........................  ............................  ..............        2,360.00      209,060.00
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[[Page 63859]]

Postage Costs

    Customers may incur postage costs when submitting some of the items 
covered by this collection to the USPTO by mail. The applications to 
extend patent term under 35 U.S.C. 156 and the initial applications for 
interim extension under 37 CFR 1.790 cannot be filed electronically. 
The USPTO expects that 50 percent of these responses will be submitted 
by mail, resulting in 51 mailed submissions. (The reminder of the 
submission, in this category will be hand carried to USPTO.) The USPTO 
expects that approximately 99 percent of the remaining responses in 
this collection will be submitted electronically. Of the remaining 1 
percent, the vast majority will be submitted by mail, resulting in 5 
additional mailed submissions. Overall for this collection, 56 mailed 
submissions are expected per year. The average USPS Priority Mail 
postage cost for a legal flat rate envelope is estimated to be $7.65. 
Therefore, the USPTO estimates that the postage costs for the mailed 
submissions in this collection will total $428. Therefore, the USPTO 
estimates that the total annual (non-hour) cost burden for this 
collection, in the form of postage costs and fees is $209,488 per year.

IV. Request for Comments

    Comments submitted in response to this notice will be summarized 
and/or included in the request for OMB approval. All comments will 
become a matter of public record.
    USPTO invites public comments on:
    (a) 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) Accuracy of the agency's estimate of the burden (including 
hours and cost) of the proposed collection of information, including 
the validity of the methodology and assumptions used;
    (c) Ways to enhance the quality, utility, and clarity of the 
information to be collected; and
    (d) Ways to minimize the burden of the collection of information on 
respondents, e.g., 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.

Marcie Lovett,
Records and Information Governance Branch, Office of the Chief 
Administrative Officer, USPTO.
[FR Doc. 2019-24953 Filed 11-18-19; 8:45 am]
 BILLING CODE 1410-30-P