[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Pages 56608-56609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19864]



Patent and Trademark Office

Patent Term Extension

ACTION: Proposed collection; comment request.


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 comment on the 
extension of a continuing information collection, as required by the 
Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 

DATES: Written comments must be submitted on or before October 21, 

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 Management Division Director, 
Office of the Chief Information 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 


I. Abstract

    The patent term restoration portion of the Drug Price Competition 
and Patent Term Restoration Act of 1984 (P.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 
    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. 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.
    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.

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 
    Type of Review: Revision of a Previously Existing Information 
    Affected Public: Businesses or other for-profits; not-for-profit 
    Estimated Number of Respondents: 1,340 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: 6,187 hours.

[[Page 56609]]

    Estimated Total Annual Respondent (Hourly) Cost Burden: 
$2,536,670.00. The USPTO expects that attorneys will complete these 
applications. The professional hourly rate for attorneys is $410. Using 
this hourly rate, the USPTO estimates that the total respondent cost 
burden for this collection is $2,536,670.00 per year.

                                        Estimated time
                Item                     for response     Estimated annual   Estimated annual     Rate ($/hr)
                                           (hours)           responses         burden hours
                                                    (a)                (b)    (a) x (b) = (c)                (d)
1. Application to Extend Patent Term                 25                 95              2,375               $410
 Under 35 U.S.C. Sec.   156.........
2. Request for Interim Extension                      1                 10                 10                410
 Under 35 U.S.C. Sec.   156(e)(2)...
3. Petition to Review Final                          25                  4                100                410
 Eligibility Decision Under 37 CFR
4. Initial Application for Interim                   20                  2                 40                410
 Extension Under 37 CFR 1.790.......
5. Subsequent Application for                         1                  1                  1                410
 Interim Extension Under 37 CFR
6. Response to Requirement to Elect.                  1                 15                 15                410
7. Response to Request to Identify                    2                  1                  2                410
 Holder of Regulatory Approval......
8. Declaration to Withdraw an                         2                  1                  2                410
 Application to Extend Patent Term..
9. Petition for Reconsideration of                    3              1,200              3,600                410
 Patent Term Adjustment
10. Petition for Reinstatement of                     4                 10                 40                410
 Reduced Patent Term Adjustment.....
11. Petition to Accord a Filing Date                  2                  1                  2                410
 to an Application Under 37 CFR
 1.740 for Extension of a Patent
    Total...........................  .................              1,340              6,187  .................

    Estimated Total Annual (Non-hour) Respondent Cost Burden: 
$351,505.08. 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.
    Customers may incur postage costs when submitting some of the items 
covered by this collection to the USPTO by mail. The USPTO expects that 
approximately 93 percent of the responses in this collection will be 
submitted electronically. Of the remaining 7 percent, the vast 
majority--98 percent--will be submitted by mail, for a total of 92 
mailed submissions. The average first class USPS postage cost for a 
mailed submission is 49 cents. Therefore, the USPTO estimates that the 
postage costs for the mailed submissions in this collection will total 
    The fees associated with this collection are being returned from 
their previous location in collection 0651-0072, which has been 
discontinued. These fees are listed in the accompanying table below.

                                                          Estimated annual                       Total non-hour
                          Item                               responses        Filing fee ($)    cost burden ($)
                                                                       (a)                (b)    (a) x (b) = (c)
1. Filing an application for patent term adjustment....              1,200                200         240,000.00
2. Request for reinstatement of term reduced...........                 10                400           4,000.00
3. Extension of term of patent.........................                 95              1,120         106,400.00
4. Initial application for interim extension (see 37                     2                420             840.00
 CFR 1.790)............................................
5. Subsequent application for interim extension (see 37                  1                220             220.00
 CFR 1.790)............................................
    Total..............................................  .................  .................         351,460.00

    Therefore, the USPTO estimates that the total annual (non-hour) 
cost burden for this collection, in the form of postage costs and fees 
is $351,505.08 per year.

IV. Request for Comments

    Comments are invited on:
    (a) Whether the proposed collection of information is necessary for 
the proper performance of the functions of the agency, including 
whether the information shall have practical utility;
    (b) the accuracy of the agency's estimate of the burden (including 
hours and cost) of the proposed collection of information;
    (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., the use of automated collection techniques or other 
forms of information technology.
    Comments submitted in response to this notice will be summarized or 
included in the request for OMB approval of this information 
collection; they also will become a matter of public record.

    Dated: August 16th 2016.
Marcie Lovett,
Records Management Division Director, OCIO United States Patent and 
Trademark Office.
[FR Doc. 2016-19864 Filed 8-19-16; 8:45 am]