[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.
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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).
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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.
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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]
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