Patent Term Extension, 31885-31886 [2013-12620]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Notices]
[Pages 31885-31886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12620]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office


Patent Term Extension

ACTION: Proposed collection; comment request.

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SUMMARY: The United States Patent and Trademark Office (USPTO), as part 
of its continuing effort to reduce paperwork and respondent burden, 
invites the general public and other Federal agencies to take this 
opportunity to comment on the continuing information collection, as 
required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 
U.S.C. 3506(c)(2)(A)).

DATES: Written comments must be submitted on or before July 29, 2013.

ADDRESSES: You may submit comments by any of the following methods:
     Email: InformationCollection@uspto.gov. Include ``0651-
0020 comment'' in the subject line of the message.
     Mail: Susan K. Fawcett, Records Officer, Office of the 
Chief Information Officer, United States Patent and Trademark Office, 
P.O. Box 1450, Alexandria, VA 22313-1450.
     Federal Rulemaking Portal: https://www.regulations.gov.

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 Raul.Tamayo@uspto.gov. Additional information about this 
collection is also available at https://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.
    Under 35 U.S.C. 156(d), 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. Under 35 U.S.C. 156(e), 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.
    The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-1.791. 
These rules provide for the public to, inter alia, submit 35 U.S.C. 156 
patent term extension applications to the USPTO, request interim 
extensions and review of final eligibility decisions, and 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 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 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, require the USPTO to 
notify the applicant of the patent term adjustment in the notice of 
allowance and give the applicant an opportunity to request 
reconsideration of the USPTO's patent term adjustment determination.
    The USPTO may also 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 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 USPTO 
administers 35 U.S.C. 154 through 37 CFR 1.701-1.705.
    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.
    The USPTO is updating this information collection to remove one 
item, the Request for Recalculation of Patent Term Adjustment in View 
of Wyeth (PTO/SB/131), because the information is no longer being 
collected. The USPTO is also removing the fees associated with the 
information requirements in this collection because these fees have 
been moved into information collection 0651-0072, which was approved by 
OMB in January 2013 in conjunction with the USPTO rulemaking ``Setting 
and Adjusting Patent Fees'' (RIN 0651-AC54).

II. Method of Collection

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

III. Data

    OMB Number: 0651-0020.
    Form Number(s): None.
    Type of Review: Revision of a currently approved collection.
    Affected Public: Businesses or other for-profits; not-for-profit 
institutions.
    Estimated Number of Respondents: 1,950 responses per year. The 
USPTO estimates that approximately 25% 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: 7,252 hours.
    Estimated Total Annual Respondent Cost Burden: $2,690,492. The 
USPTO expects that the information in this collection will be prepared 
by attorneys at an estimated rate of $371 per hour. Therefore, the 
USPTO estimates that the respondent cost burden for this collection 
will be approximately $2,690,492 per year.

[[Page 31886]]



----------------------------------------------------------------------------------------------------------------
                                                                  Estimated time     Estimated       Estimated
                              Item                                 for response       annual       annual burden
                                                                      (hours)        responses         hours
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Application to Extend Patent Term Under 35 U.S.C. 156...........              25              60           1,500
Request for Interim Extension Under 35 U.S.C. 156(e)(2).........               1              10              10
Petition to Review Final Eligibility Decision Under 37 CFR 1.750              25               3              75
Initial Application for Interim Extension Under 35 U.S.C.                     20               3              60
 156(d)(5)......................................................
Subsequent Application for Interim Extension Under 37 CFR 1.790.               1               1               1
Response to Requirement to Elect................................               1              10              10
Response to Request to Identify Holder of Regulatory Approval...               2               1               2
Declaration to Withdraw an Application to Extend Patent Term....               2               1               2
Petition for Reconsideration of Patent Term Adjustment                         3           1,850           5,550
 Determination..................................................
Petition for Reinstatement of Reduced Patent Term Adjustment....               4              10              40
Petition to Accord a Filing Date to an Application Under 37 CFR                2               1               2
 1.740 for Extension of a Patent Term...........................
                                                                 -----------------------------------------------
    Totals......................................................  ..............           1,950           7,252
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    Estimated Total Annual Non-hour Respondent Cost Burden: $90. There 
are no capital start-up, maintenance, or recordkeeping costs associated 
with this information collection. However, this collection does have 
annual (non-hour) costs in the form of postage costs.
    There are fees associated with the requirements for patent term 
extension and patent term adjustment. These fees are covered under OMB 
control number 0651-0072. The fees are listed in the accompanying table 
for reference but will not be included in the annual (non-hour) cost 
burden for this collection.

------------------------------------------------------------------------
               Item                              Fee amount
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Application To Extend Patent Term   $1,120.00.
 Under 35 U.S.C. 156.
Request for Interim Extension       $0.00.
 Under 35 U.S.C. 156(e)(2).
Petition To Review Final            $0.00.
 Eligibility Decision Under 37 CFR
 1.750.
Initial Application for Interim     $420.00.
 Extension Under 35 U.S.C.
 156(d)(5).
Subsequent Application for Interim  $220.00.
 Extension Under 37 CFR 1.790.
Response to Requirement To Elect..  $0.00.
Response to Request to Identify     $0.00.
 Holder of Regulatory Approval.
Declaration To Withdraw an          $0.00.
 Application to Extend Patent Term.
Petition for Reconsideration of     $200.00.
 Patent Term Adjustment
 Determination.
Petition for Reinstatement of       $400.00.
 Reduced Patent Term Adjustment.
Petition To Accord a Filing Date    (large entity) $400.00.
 to an Application Under 37 CFR
 1.740 for Extension of a Patent
 Term.
                                    (small entity) $200.00.
                                    (micro entity) $100.00.
------------------------------------------------------------------------

    Customers may incur postage costs when submitting the information 
in this collection to the USPTO by mail. The USPTO expects that the 
Application to Extend Patent Term Under 35 U.S.C. 156, the Initial 
Application for Interim Extension Under 35 U.S.C. 156(d)(5), and 
approximately 7% of the other responses for this collection will be 
submitted by mail. The USPTO estimates that the average first-class 
postage cost for a mailed submission will be 46 cents and that up to 
195 submissions will be mailed to the USPTO per year, for a total 
estimated postage cost of $90 per year.
    The total annual (non-hour) respondent cost burden for this 
collection is estimated to be approximately $90 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.
    The USPTO is soliciting public comments to: (a) Evaluate whether 
the proposed 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 proposed 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.

    Dated: May 22, 2013.
Susan K. Fawcett,
Records Officer, USPTO, Office of the Chief Information Officer.
[FR Doc. 2013-12620 Filed 5-24-13; 8:45 am]
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