Patent Term Extension, 35222-35224 [E7-12410]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[Federal Register Volume 72, Number 123 (Wednesday, June 27, 2007)]
[Notices]
[Pages 35222-35224]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12410]


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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 August 27, 2007.

ADDRESSES: You may submit comments by any of the following methods:
     E-mail: Susan.Fawcett@uspto.gov. Include ``0651-0020 
comment'' in the subject line of the message.
     Fax: 571-272-0112, marked to the attention of Susan 
Fawcett.
     Mail: Susan K. Fawcett, Records Officer, Office of the 
Chief Information Officer, Customer Information Services Group, Public 
Information Services Division, U.S. Patent and Trademark Office, P.O. 
Box 1450, Alexandria, VA 22313-1450.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Robert A. Clarke, Deputy Director, Office of 
Patent Legal Administration, U.S. Patent and Trademark Office, P.O. Box 
1450, Alexandria, VA 22313-1450; by telephone at 571-272-7735; or by e-
mail at Robert.Clarke@uspto.gov.

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, the claims included in the patent for the 
approved product, and a method of use or manufacturing for the approved 
product. In addition, the application for patent term extension must 
provide a brief description of the

[[Page 35223]]

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. There are no 
forms associated with this collection.

II. Method of Collection

    By mail, facsimile, or hand delivery 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: 26,859 responses per year.
    Estimated Time per Response: The USPTO estimates that it will take 
the public from one to 25 hours, depending on the complexity of the 
situation, to gather the necessary information, prepare the appropriate 
documents, and submit the applications, requests, and petitions 
included in this collection.
    Estimated Total Annual Respondent Burden Hours: 30,905 hours.
    Estimated Total Annual Respondent Cost Burden: $9,395,120. The 
USPTO expects that the information in this collection will be prepared 
by attorneys. Using the professional rate of $304 per hour for 
associate attorneys in private firms, the USPTO estimates that the 
respondent cost burden for submitting the information in this 
collection will be $9,395,120 per year.

----------------------------------------------------------------------------------------------------------------
                                                                  Estimated time     Estimated       Estimated
                              Item                                 for response       annual       annual burden
                                                                    (in hours)       responses         hours
----------------------------------------------------------------------------------------------------------------
Application to Extend Patent Term under 35 U.S.C. 156...........              25              50           1,250
Request for Interim Extension under 35 U.S.C. 156(e)(2).........               1               1               1
Petition to Review Final Eligibility Decision under 37 CFR 1.750              25               1              25
Initial Application for Interim Extension under 35 U.S.C.                     20               1              20
 156(d)(5)......................................................
Subsequent Application for Interim Extension under 37 CFR 1.790.               1               1               1
Response to Requirement to Elect................................               1               2               2
Response to Request to Identify Holder of Patent Term...........               2               1               2
Declaration to Withdraw an Application to Extend Patent Term....               2               1               2
Petition for Reconsideration of Patent Term Adjustment                         1          24,000          24,000
 Determination..................................................
Petition for Reinstatement of Reduced Patent Term Adjustment....               2           2,800           5,600
Petition to Accord a Filing Date to an Application under 37 CFR                2               1               2
 1.740 for Extension of a Patent Term...........................
                                                                 -----------------------------------------------
    Total.......................................................  ..............          26,859          30,905
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Non-hour Respondent Cost Burden: $5,988,052. 
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 filing fees and 
postage 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 costs associated with this collection 
will be $5,977,040 per year.

----------------------------------------------------------------------------------------------------------------
                                                                     Estimated                       Estimated
                              Item                                    annual        Fee amount     annual filing
                                                                     responses                         costs
----------------------------------------------------------------------------------------------------------------
Application to Extend Patent Term under 35 U.S.C. 156...........              50          $1,120         $56,000
Request for Interim Extension under 35 U.S.C. 156(e)(2).........               1               0               0
Petition to Review Final Eligibility Decision under 37 CFR 1.750               1               0               0
Initial Application for Interim Extension under 35 U.S.C.                      1             420             420
 156(d)(5)......................................................
Subsequent Application for Interim Extension under 37 CFR 1.790.               1             220             220
Response to Requirement to Elect................................               2               0               0
Response to Request to Identify Holder of Patent Term...........               1               0               0
Declaration to Withdraw an Application to Extend Patent Term....               1               0               0
Petition for Reconsideration of Patent Term Adjustment                    24,000             200       4,800,000
 Determination..................................................
Petition for Reinstatement of Reduced Patent Term Adjustment....           2,800             400       1,120,000
Petition to Accord a Filing Date to an Application under 37 CFR                1             400             400
 1.740 for Extension of a Patent Term...........................
                                                                 -----------------------------------------------
    Total.......................................................          26,859  ..............    5,977,040.00
----------------------------------------------------------------------------------------------------------------

    Customers may incur postage costs when submitting the information 
in this collection to the USPTO by mail. The USPTO estimates that the 
average first-class postage cost for a mailed submission will be 41 
cents and that up

[[Page 35224]]

to 26,859 submissions will be mailed to the USPTO per year. The total 
estimated postage cost for this collection is $11,012 per year.
    The total non-hour respondent cost burden for this collection in 
the form of filing fees and postage costs is estimated to be $5,988,052 
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: June 20, 2007.
Susan K. Fawcett,
Records Officer, USPTO, Office of the Chief Information Officer, 
Customer Information Services Group, Public Information Services 
Division.
[FR Doc. E7-12410 Filed 6-26-07; 8:45 am]
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