[Federal Register Volume 75, Number 75 (Tuesday, April 20, 2010)]
[Notices]
[Pages 20561-20563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9048]


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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 June 21, 2010.

ADDRESSES: You may submit comments by any of the following methods:
     E-mail: [email protected]. Include A0651-
0020 comment@ in the subject line of the message.
     Fax: 571-273-0112, marked to the attention of Susan 
Fawcett.
     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: http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Raul Tamayo, 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 e-mail to [email protected].

SUPPLEMENTARY INFORMATION:

I. Abstract

    The Federal Food, Drug, and Cosmetic Act at 35 U.S.C. 156 permits 
the United States Patent and Trademark Office (USPTO) to restore the 
patent term lost due to certain types of regulatory review by the 
Federal Food and Drug Administration or the Department of Agriculture. 
Only patents for drug products, medical devices, food additives, and 
color additives are eligible for extension. The maximum length that a 
patent may be extended in order to restore the lost portion of the 
patent term is five years.
    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 Board of Patent Appeals and Interferences 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 and 156 through 37 CFR 1.701-
1.791. These rules permit the public to submit applications to the 
USPTO to extend the term of a patent past its original expiration date, 
to request interim extensions and review of final eligibility 
decisions, and to withdraw an application requesting a patent term 
extension after it is submitted. 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

[[Page 20562]]

the patent that cover the approved product, a method of using the 
approved product, or a method of manufacturing the approved product. In 
addition, the application for patent term extension must 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.
    The term of a patent which claims a product, a method of using a 
product, or a method of manufacturing a product shall be extended if 
the term of the patent has not expired before an application is 
submitted. The Federal Food, Drug, and Cosmetic Act requires that an 
application for patent term extension be filed with the USPTO within 60 
days of the product receiving regulatory approval from the Federal Food 
and Drug Administration or the Department of Agriculture. 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 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. 
Electronic submissions are made through EFS-Web, the USPTO's online 
filing system for patent applications and related documents.

III. Data

    OMB Number: 0651-0020.
    Form Number(s): PTO/SB/131.
    Type of Review: Revision of a currently approved collection.
    Affected Public: Businesses or other for-profits; not-for-profit 
institutions.
    Estimated Number of Respondents: 13,586 responses per year.
    Estimated Time per Response: The USPTO estimates that it will take 
the public from 10 minutes (0.17 hours) to 25 hours, depending on the 
complexity of the situation, to gather the necessary information, 
prepare the appropriate documents, and submit the information in this 
collection to the USPTO.
    Estimated Total Annual Respondent Burden Hours: 7,808 hours.
    Estimated Total Annual Respondent Cost Burden: $2,537,600. The 
USPTO expects that the information in this collection will be prepared 
by attorneys. Using the professional rate of $325 per hour for 
attorneys in private firms, the USPTO estimates that the respondent 
cost burden for submitting the information in this collection will be 
$2,537,600 per year.

----------------------------------------------------------------------------------------------------------------
                                                                                   Estimated        Estimated
                    Item                         Estimated time for response         annual       annual burden
                                                                                   responses          hours
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Application to Extend Patent Term under 35    25 hours........................               40            1,000
 U.S.C. 156.
Request for Interim Extension under 35        1 hour..........................                1                1
 U.S.C. 156(e)(2).
Petition to Review Final Eligibility          25 hours........................                3               75
 Decision under 37 CFR 1.750.
Initial Application for Interim Extension     20 hours........................                3               60
 under 35 U.S.C. 156(d)(5).
Subsequent Application for Interim Extension  1 hour..........................                1                1
 under 37 CFR 1.790.
Response to Requirement to Elect............  1 hour..........................                5                5
Response to Request to Identify Holder of     2 hours.........................                1                2
 Patent Term.
Declaration to Withdraw an Application to     2 hours.........................                1                2
 Extend Patent Term.
Petition for Reconsideration of Patent Term   3 hours.........................            1,500            4,500
 Adjustment Determination.
Petition for Reinstatement of Reduced Patent  4 hours.........................               30              120
 Term Adjustment.
Petition to Accord a Filing Date to an        2 hours.........................                1                2
 Application under 37 CFR 1.740 for
 Extension of a Patent Term.
Request for Recalculation of Patent Term      10 minutes......................           12,000            2,040
 Adjustment in View of Wyeth (PTO/SB/131).
                                             -------------------------------------------------------------------
    Totals..................................  ................................           13,586            7,808
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    Estimated Total Annual Non-hour Respondent Cost Burden: $360,416. 
There are no capital start-up or maintenance costs associated with this 
information collection. However, this collection does have annual (non-
hour) costs in the form of filing fees, postage costs, and 
recordkeeping costs.
    This collection has filing fees associated with the requirements 
for patent term extension and patent term adjustment. The USPTO 
estimates that the total filing fees associated with this collection 
will be $358,680 per year.

----------------------------------------------------------------------------------------------------------------
                                                                  Estimated                         Estimated
                             Item                                   annual         Fee amount     annual filing
                                                                  responses                            fees
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Application to Extend Patent Term under 35 U.S.C. 156........               40        $1,120.00       $44,800.00
Request for Interim Extension under 35 U.S.C. 156(e)(2)......                1             0.00             0.00
Petition to Review Final Eligibility Decision under 37 CFR                   3             0.00             0.00
 1.750.......................................................
Initial Application for Interim Extension under 35 U.S.C.                    3           420.00         1,260.00
 156(d)(5)...................................................
Subsequent Application for Interim Extension under 37 CFR                    1           220.00           220.00
 1.790.......................................................
Response to Requirement to Elect.............................                5             0.00             0.00
Response to Request to Identify Holder of Patent Term........                1             0.00             0.00
Declaration to Withdraw an Application to Extend Patent Term.                1             0.00             0.00
Petition for Reconsideration of Patent Term Adjustment                   1,500           200.00       300,000.00
 Determination...............................................
Petition for Reinstatement of Reduced Patent Term Adjustment.               30           400.00        12,000.00
Petition to Accord a Filing Date to an Application under 37                  1           400.00           400.00
 CFR 1.740 for Extension of a Patent Term....................
Request for Recalculation of Patent Term Adjustment in View             12,000             0.00             0.00
 of Wyeth (PTO/SB/131).......................................
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[[Page 20563]]

 
    Totals...................................................           13,586  ...............       358,680.00
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    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 these 991 mailed submissions will be 44 cents each, 
for a total estimated postage cost of $436 per year.
    When submitting the information in this collection to the USPTO 
electronically, the customer is strongly urged to retain a copy of the 
acknowledgment receipt as evidence that the submission was received by 
the USPTO on the date noted. The USPTO estimates that it will take 5 
seconds (0.001 hours) to print and retain a copy of the acknowledgment 
receipt and that approximately 12,595 responses per year will be 
submitted electronically, for a total of approximately 13 hours per 
year for printing this receipt. Using the paraprofessional rate of $100 
per hour, the USPTO estimates that the recordkeeping cost associated 
with this collection will be $1,300 per year.
    The total non-hour respondent cost burden for this collection in 
the form of filing fees, postage costs, and recordkeeping costs is 
estimated to be $360,416 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: April 13, 2010.
Susan K. Fawcett,
Records Officer, USPTO, Office of the Chief Information Officer.
[FR Doc. 2010-9048 Filed 4-19-10; 8:45 am]
BILLING CODE 3510-16-P