[Federal Register Volume 69, Number 105 (Tuesday, June 1, 2004)]
[Notices]
[Pages 30884-30885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-12335]


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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 2, 2004.

ADDRESSES: You may submit comments by any of the following methods:
     E-mail: [email protected]. Include ``0651-0020 
comment'' in the subject line of the message.
     Fax: 703-308-7407, marked to the attention of Susan Brown.
     Mail: Susan K. Brown, Records Officer, Office of the Chief 
Information Officer, Office of Data Architecture and Services, Data 
Administration 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 J. Spar, Director, Office of Patent Legal 
Administration, U.S. Patent and Trademark Office, P.O. Box 1450, 
Alexandria, VA 22313-1450; by telephone at 703-308-5107; or by e-mail 
at [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 to a communication from 
the USPTO within three months of the mailing date of the communication. 
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 subpart 
F (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 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 under 35 U.S.C. 156(d) 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.
    This collection was previously approved by OMB in October 2001. The 
USPTO also submitted this collection in conjunction with a notice of 
proposed rulemaking entitled ``Changes to Support Implementation of the 
United States Patent and Trademark Office 21st Century Strategic Plan'' 
(RIN 0651-AB64), which was published in the Federal Register on 
September 12, 2003 (vol. 68, no. 177). The proposed rulemaking 
increased the filing fee for the Petition to Accord a Filing Date to an 
Application under 37 CFR 1.740 for Extension of a Patent Term, which 
was added to this collection. The proposed rulemaking would also allow 
applicants to use electronic signatures to sign documents that have 
been created with a word processor. The information collection package 
for 0651-0020 associated with this proposed rulemaking was approved by 
OMB in November 2003. The proposed changes related to patent term 
adjustments were finalized in the final rule notice entitled ``Revision 
of Patent Term Extension and Patent Term Adjustment Provisions'' (RIN 
0651-AB71), which was published in the Federal Register on April 22, 
2004.

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: Extension of a currently approved collection.
    Affected Public: Individuals or households; businesses or other 
for-profits; not-for-profit institutions; farms; the Federal 
government; and State, local or tribal governments.
    Estimated Number of Respondents: 26,859 responses per year.
    Estimated Time Per Response: The USPTO estimates that it will take 
the

[[Page 30885]]

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 applications, requests, and petitions 
included in this collection.
    Estimated Total Annual Respondent Burden Hours: 30,905 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: $8,838,830 per year. 
The USPTO expects that the information in this collection will be 
prepared by attorneys. Using the professional rate of $286 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 $8,838,830 per year.

----------------------------------------------------------------------------------------------------------------
                                                                                     Estimated       Estimated
                              Item                                Estimated time      annual       annual burden
                                                                   for response      responses         hours
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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: $5,986,978 
per year. 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       $1,120.00      $56,000.00
Request for Interim Extension 35 U.S.C. 156(e)(2)...............               1            0.00            0.00
Petition to Review Final Eligibility Decision under 37 CFR 1.750               1            0.00            0.00
Initial Application for Interim Extension under 35 U.S.C.                      1          420.00          420.00
 156(d)(5)......................................................
Subsequent Application for Interim Extension under 37 CFR 1.790.               1          220.00          220.00
Response to Requirement to Elect................................               2            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                    24,000          200.00    4,800,000.00
 Determination..................................................
Petition for Reinstatement of Reduced Patent Term Adjustment....           2,800          400.00    1,120,000.00
Petition to Accord a Filing Date to an Application under 37 CFR                1          400.00          400.00
 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 37 
cents and that up to 26,859 submissions will be mailed to the USPTO per 
year. The total estimated postage cost for this collection is $9,938 
per year.
    The total non-hour respondent cost burden for this collection in 
the form of filing fees and postage costs is $5,986,978 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: May 24, 2004.
Susan K. Brown,
Records Officer, USPTO, Office of the Chief Information Officer, Office 
of Data Architecture and Services, Data Administration Division.
[FR Doc. 04-12335 Filed 5-28-04; 8:45 am]
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