[Federal Register Volume 66, Number 71 (Thursday, April 12, 2001)]
[Notices]
[Pages 18914-18916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9080]


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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)), and by the USPTO in the performance of its 
statutory functions of processing applications for patent term 
extension as required by the Federal Food, Drug and Cosmetic Act, 35 
U.S.C. 156, and processing requests for reconsideration or 
reinstatement of any patent term adjustment under 35 U.S.C. 154(b).

DATES: Written comments must be submitted on or before June 11, 2001.

ADDRESSES: Direct all written comments to Susan K. Brown, Records 
Officer, Office of Data Management, Data Administration Division, 
USPTO, Suite 310, 2231 Crystal Drive, Washington, DC 20231; by 
telephone 703-308-7400; by e-mail at [email protected]; or by 
facsimile at 703-308-7407.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to the attention of Karin L. Tyson, Office of Patent 
Legal Administration, United States Patent and Trademark Office, 
Washington, DC 20231; by telephone at 703-306-3159; or by facsimile 
transmission to 703-872-9411.

SUPPLEMENTARY INFORMATION:

I. Abstract

    The United States Patent and Trademark Office (USPTO), together 
with the Secretary of Health and Human Services and the Department of 
Agriculture, administers the Federal Food, Drug and Cosmetic Act, 35 
U.S.C. 156. This Act permits the 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 (the maximum of patent term that may be restored) 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, the 
claims of the patent that claim the approved product, a method of use 
of 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 statute (35 U.S.C. 156) requires the USPTO to extend the term 
of various patents past their original expiration dates, to grant 
interim extensions, to review applications for patent term extension 
and final eligibility decisions, to obtain additional information from 
the public that might influence the extension of the patent term, and 
to withdraw an application for a patent term extension.
    The USPTO administers 35 U.S.C. 156 through 37 CFR 1.705-1.791. 
These rules permit the public to submit applications to the USPTO to 
extend the term of a patent past its original expiration date; to 
petition for reviews of informal extensions of applications, final 
eligibility decisions, and interim extensions; and to withdraw an 
application requesting a patent term extension after it is submitted.
    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

[[Page 18915]]

Food, Drug and Cosmetic Act requires that an application for patent 
term extension be filed with the USPTO within 60 days of a product 
(approved product) that was subject to regulatory review receiving 
permission for commercial marketing or use 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 a patent for which an application for patent term extension has 
been submitted under 35 U.S.C. 156(d), and which is eligible for 
extension, would expire before a certificate of extension is issued.
    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,'' requires the USPTO to notify the 
applicant of the patent term adjustment in the notice of allowance, and 
gives the applicant an opportunity to request reconsideration of the 
USPTO's patent term adjustment determination and to request 
reinstatement of a reduction in patent term adjustment.
    The information supplied to the USPTO by an applicant requesting 
reconsideration of a USPTO patent term adjustment determination under 
35 U.S.C. 154(b) is used by the USPTO to determine whether the USPTO's 
determination of patent term adjustment under 35 U.S.C. 154(b) is 
correct, and to determine whether the applicant is entitled to 
reinstatement of reduced patent term adjustment.
    The subsequent application for interim extension under 37 CFR 1.790 
is part of the initial application for interim extension and has been 
reported as such in previous submissions of this collection. Because we 
are now reporting filing fees as part of the nonhour respondent cost 
burden, it became necessary to separate out this requirement as the 
filing fees are different for the two requirements.
    The information supplied to the USPTO by an applicant seeking a 
patent term extension under 35 U.S.C. 156 and a patent term adjustment 
under 35 U.S.C. 154(b) is used by the USPTO, the Department of Health 
and Human Services, and the Department of Agriculture to determine the 
eligibility of a patent for extension and to determine the period of 
any such extension.

II. Method of Collection

    By mail, facsimile, or hand carried to the USPTO when the applicant 
or agent files an application for a patent term extension with the 
USPTO, submits papers during the prosecution of the application, files 
a Petition for Reconsideration of Patent Term Adjustment Determination, 
files a Petition for Reinstatement of Patent Term Adjustment, or 
related papers during processing of a patent application.

III. Data

    OMB Number: 0651-0020.
    Type of Review: Revision of a currently approved collection.
    Affected Public: Individuals or households; business or other for-
profit; not-for-profit institutions; farms; the Federal Government; and 
state, local or tribal governments.
    Estimated Number of Respondents: 26,858 responses per year.
    Estimated Time Per Response: The USPTO estimates that it will take 
the public anywhere from one to 25 hours, depending upon the complexity 
of the situation, to gather, prepare, and submit the applications, 
petitions, and various requests associated with the patent term and 
interim extensions, review of eligibility decisions, requirement to 
elect, requests to identify holders of regulatory approval, 
declarations to withdraw an application, petitions for reconsideration 
of a patent term adjustment determination, and petitions for 
reinstatement of reduced patent term adjustment with a showing that the 
applicant was unable to respond within three months in spite of all due 
care. There are no forms associated with this information collection.
    Estimated Total Annual Respondent Burden Hours: 30,903 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: Using the 
professional hourly rate of $175 per hour for associate attorneys in 
private firms, the USPTO estimates $5,408,025 per year for salary costs 
associated with respondents.

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                                                                  Estimated time     Estimated       Estimated
                              Item                                 for response   annual  burden      annual
                                                                    (in hours)         hours         responses
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Application to Extend Patent Term under 35 U.S.C. 156...........              25           1,250              50
Request for Interim Extension under 35 U.S.C. 156(e)(2).........               1               1               1
Petition to Review Final Eligibility Decision...................              25              25               1
Initial Application for Interim Extension under 35 U.S.C.                     20              20               1
 156(d)(5)......................................................
Subsequent Application for Interim Extension under 37 CFR 1.790.            1 D1               1
Response to Requirement to Elect................................               1               2               2
Response to Request to Identify Holder of Regulatory Approval...               2               2               1
Declaration to Withdraw an Application to Extend Patent Term....               2               2               1
Petition for Reconsideration of Patent Term Adjustment                         1          24,000          24,000
 Determination (35 U.S.C. 154(b))...............................
Petition for Reinstatement of Reduced Patent Term Adjustment (35               2           5,600           2,800
 U.S.C. 154(b)).................................................
                                                                 -----------------------------------------------
    Totals......................................................  ..............          30,903          26,858
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    Estimated Total Annual Nonhour Respondent Cost Burden: $5,976,770. 
(There are no capitol start-up or maintenance costs associated with 
this information collection.)
    There is annual nonhour cost burden in the way of filing fees 
associated with this collection. The filing fees related to this 
collection are considered part of the nonhour cost burden of the 
collection. Following is a chart listing these filing fees/nonhour cost 
burden. A zero means that there is no fee associated with that 
requirement. The total annual filing fees/nonhour cost burden is 
$5,976,770.

[[Page 18916]]



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                                                                                                      Total non-
                                                                            Responses   Filing fees   hour cost
                                   Item                                        (a)       ($)*  (b)   burden  (a)
                                                                                                        x  (b)
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Application to Extend Patent Term under 35 U.S.C. 156(d)(1)..............           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............................            1          130          130
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)......            1          420          420
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 Regulatory Approval............            1            0            0
Declaration to Withdraw an Application to Extend Patent Term.............            1            0            0
Petition for Reconsideration of Patent Term Adjustment Determination (35        24,000          200    4,800,000
 U.S.C. 154(b))..........................................................
Petition for Reinstatement of Reduced Patent Term Adjustment (35 U.S.C.          2,800          400    1,120,000
 154(b)).................................................................
                                                                          --------------------------------------
    Totals...............................................................       26,858        2,490   5,976,770
----------------------------------------------------------------------------------------------------------------
* Note: All fees listed are based on per class filing.

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, including through 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 will also become a matter of public record.

    Dated: April 3, 2001.
Susan K. Brown,
Records Officer, USPTO, Office of Data Management, Data Administration 
Division.
[FR Doc. 01-9080 Filed 4-11-01; 8:45 am]
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