Patent Term Extension, 56608-56609 [2016-19864]
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56608
Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
telephone at 571–272–7728; or by email
to Raul.Tamayo@uspto.gov with ‘‘0651–
0020 comment’’ in the subject line.
Additional information about this
collection is also available at https://
www.reginfo.gov under ‘‘Information
Collection Review.’’
SUPPLEMENTARY INFORMATION:
Guam Coastal Management Program
Evaluation
You may participate or submit oral
comments at the public meeting
scheduled as follows:
Date: September 28, 2016.
Time: 5:30 p.m., local time.
Location: Sinajana Community
Center, 178 Chalan Guma Yu’os,
Sinajana, Guam 96910.
Written public comments must be
received on or before October 5, 2016.
Federal Domestic Assistance Catalog 11.419
Coastal Zone Management Program
Administration
Dated: August 5, 2016.
Josh Lott,
Policy Program Manager, Office for Coastal
Management, National Ocean Service,
National Oceanic and Atmospheric
Administration.
[FR Doc. 2016–19946 Filed 8–19–16; 8:45 am]
BILLING CODE 3510–08–P
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Patent Term Extension
ACTION:
Proposed collection; comment
request.
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 comment on the extension of
a 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 October 21,
2016.
SUMMARY:
You may submit comments
by any of the following methods:
• Email: InformationCollection@
uspto.gov. Include ‘‘0651–0020
comment’’ in the subject line of the
message.
• Federal Rulemaking Portal: https://
www.regulations.gov.
• Mail: Marcie Lovett, Records
Management Division Director, Office of
the Chief Information Officer, United
States Patent and Trademark Office,
P.O. Box 1450, Alexandria, VA 22313–
1450.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Raul Tamayo,
Senior Legal Advisor, Office of Patent
Legal Administration, United States
Patent and Trademark Office, P.O. Box
1450, Alexandria, VA 22313–1450; by
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:13 Aug 19, 2016
Jkt 238001
I. Abstract
The patent term restoration portion of
the Drug Price Competition and Patent
Term Restoration Act of 1984 (P.L. 98–
417), which is codified at 35 U.S.C. 156,
permits the United States Patent and
Trademark Office (USPTO) to extend
the term of protection under a patent to
compensate for delay during regulatory
review and approval by the Food and
Drug Administration (FDA) or
Department of Agriculture. Only patents
for drug products, medical devices, food
additives, or color additives are
potentially eligible for extension. The
maximum length that a patent may be
extended under 35 U.S.C. 156 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; and the claims
included in the patent that cover the
approved product, a method of using
the approved product, or a method of
manufacturing the approved product. 35
U.S.C. 156(d) also requires the
application for patent term extension to
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.
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.
Under 35 U.S.C. 156(d)(5), an interim
extension may be granted if the
applicable regulatory review period that
began for a product is reasonably
expected to extend beyond the
expiration of the patent term in effect.
The USPTO administers 35 U.S.C. 156
through 37 CFR 1.710–1.791. These
rules provide for the public to, inter
alia, submit 35 U.S.C. 156 patent term
extension applications to the USPTO,
request interim extensions and review
of final eligibility decisions, and
withdraw an application requesting a
patent term extension after it is
submitted.
Separate from the extension
provisions of 35 U.S.C. 156, the USPTO
may in some cases extend the term of an
original patent due to certain delays in
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
the prosecution of the patent
application, including delays caused by
interference proceedings, secrecy
orders, or appellate review by the Patent
Trial and Appeal Board 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
through 37 CFR 1.701–1.705.
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.
III. Data
OMB Number: 0651–0020.
IC Instruments and Forms: There are
no forms associated with this collection.
Type of Review: Revision of a
Previously Existing Information
Collection.
Affected Public: Businesses or other
for-profits; not-for-profit institutions.
Estimated Number of Respondents:
1,340 responses per year. The USPTO
estimates that approximately 25% of
these responses will be from small
entities.
Estimated Time per Response: The
USPTO estimates that it will take the
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
information to the USPTO.
Estimated Total Annual Respondent
Burden Hours: 6,187 hours.
E:\FR\FM\22AUN1.SGM
22AUN1
56609
Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
Estimated Total Annual Respondent
(Hourly) Cost Burden: $2,536,670.00.
The USPTO expects that attorneys will
complete these applications. The
professional hourly rate for attorneys is
$410. Using this hourly rate, the USPTO
estimates that the total respondent cost
burden for this collection is
$2,536,670.00 per year.
Estimated time for
response
(hours)
Estimated annual
responses
Estimated annual
burden hours
Rate
($/hr)
(a)
Item
(b)
(a) × (b) = (c)
(d)
1. Application to Extend Patent Term Under 35 U.S.C. § 156
2. Request for Interim Extension Under 35 U.S.C. § 156(e)(2)
3. Petition to Review Final Eligibility Decision Under 37 CFR
1.750 ....................................................................................
4. Initial Application for Interim Extension Under 37 CFR
1.790 ....................................................................................
5. Subsequent Application for Interim Extension Under 37
CFR 1.790 ............................................................................
6. Response to Requirement to Elect .....................................
7. Response to Request to Identify Holder of Regulatory Approval ....................................................................................
8. Declaration to Withdraw an Application to Extend Patent
Term .....................................................................................
9. Petition for Reconsideration of Patent Term Adjustment
Determination .......................................................................
10. Petition for Reinstatement of Reduced Patent Term Adjustment ................................................................................
11. Petition to Accord a Filing Date to an Application Under
37 CFR 1.740 for Extension of a Patent Term ....................
Total ..................................................................................
Estimated Total Annual (Non-hour)
Respondent Cost Burden: $351,505.08.
There are no capital startup,
maintenance, or operating fees
associated with this collection. There
are, however, annual (non-hour) costs in
the form of postage costs and fees.
Customers may incur postage costs
when submitting some of the items
covered by this collection to the USPTO
25
1
95
10
2,375
10
$410
410
25
4
100
410
20
2
40
410
1
1
1
15
1
15
410
410
2
1
2
410
2
1
2
410
3
1,200
3,600
410
4
10
40
410
2
1
2
410
..............................
1,340
6,187
..............................
by mail. The USPTO expects that
approximately 93 percent of the
responses in this collection will be
submitted electronically. Of the
remaining 7 percent, the vast majority—
98 percent—will be submitted by mail,
for a total of 92 mailed submissions. The
average first class USPS postage cost for
a mailed submission is 49 cents.
Therefore, the USPTO estimates that the
postage costs for the mailed submissions
in this collection will total $45.08.
The fees associated with this
collection are being returned from their
previous location in collection 0651–
0072, which has been discontinued.
These fees are listed in the
accompanying table below.
Estimated annual
responses
1.
2.
3.
4.
5.
Filing fee ($)
Total non-hour
cost burden ($)
(a)
Item
(b)
(a) × (b) = (c)
Filing an application for patent term adjustment ...................................................
Request for reinstatement of term reduced ..........................................................
Extension of term of patent ...................................................................................
Initial application for interim extension (see 37 CFR 1.790) .................................
Subsequent application for interim extension (see 37 CFR 1.790) ......................
1,200
10
95
2
1
200
400
1,120
420
220
240,000.00
4,000.00
106,400.00
840.00
220.00
Total ....................................................................................................................
..............................
..............................
351,460.00
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Therefore, the USPTO estimates that
the total annual (non-hour) cost burden
for this collection, in the form of postage
costs and fees is $351,505.08 per year.
(b) the accuracy of the agency’s
estimate of the burden (including hours
and cost) of the proposed collection of
information;
IV. Request for Comments
(c) ways to enhance the quality,
utility, and clarity of the information to
be collected; and
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;
VerDate Sep<11>2014
17:13 Aug 19, 2016
Jkt 238001
(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.
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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: August 16th 2016.
Marcie Lovett,
Records Management Division Director, OCIO
United States Patent and Trademark Office.
[FR Doc. 2016–19864 Filed 8–19–16; 8:45 am]
BILLING CODE P
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56608-56609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19864]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Patent Term Extension
ACTION: Proposed collection; comment request.
-----------------------------------------------------------------------
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 comment on the
extension of a 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 October 21,
2016.
ADDRESSES: You may submit comments by any of the following methods:
Email: InformationCollection@uspto.gov. Include ``0651-
0020 comment'' in the subject line of the message.
Federal Rulemaking Portal: https://www.regulations.gov.
Mail: Marcie Lovett, Records Management Division Director,
Office of the Chief Information Officer, United States Patent and
Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Raul Tamayo, Senior 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 email to Raul.Tamayo@uspto.gov with ``0651-0020 comment'' in the
subject line. Additional information about this collection is also
available at https://www.reginfo.gov under ``Information Collection
Review.''
SUPPLEMENTARY INFORMATION:
I. Abstract
The patent term restoration portion of the Drug Price Competition
and Patent Term Restoration Act of 1984 (P.L. 98-417), which is
codified at 35 U.S.C. 156, permits the United States Patent and
Trademark Office (USPTO) to extend the term of protection under a
patent to compensate for delay during regulatory review and approval by
the Food and Drug Administration (FDA) or Department of Agriculture.
Only patents for drug products, medical devices, food additives, or
color additives are potentially eligible for extension. The maximum
length that a patent may be extended under 35 U.S.C. 156 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; and the
claims included in the patent that cover the approved product, a method
of using the approved product, or a method of manufacturing the
approved product. 35 U.S.C. 156(d) also requires the application for
patent term extension to 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.
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. Under 35 U.S.C. 156(d)(5), an interim extension
may be granted if the applicable regulatory review period that began
for a product is reasonably expected to extend beyond the expiration of
the patent term in effect.
The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-1.791.
These rules provide for the public to, inter alia, submit 35 U.S.C. 156
patent term extension applications to the USPTO, request interim
extensions and review of final eligibility decisions, and withdraw an
application requesting a patent term extension after it is submitted.
Separate from the extension provisions of 35 U.S.C. 156, 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 Patent Trial and Appeal Board 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 through 37 CFR 1.701-1.705.
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.
III. Data
OMB Number: 0651-0020.
IC Instruments and Forms: There are no forms associated with this
collection.
Type of Review: Revision of a Previously Existing Information
Collection.
Affected Public: Businesses or other for-profits; not-for-profit
institutions.
Estimated Number of Respondents: 1,340 responses per year. The
USPTO estimates that approximately 25% of these responses will be from
small entities.
Estimated Time per Response: The USPTO estimates that it will take
the 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 information to the USPTO.
Estimated Total Annual Respondent Burden Hours: 6,187 hours.
[[Page 56609]]
Estimated Total Annual Respondent (Hourly) Cost Burden:
$2,536,670.00. The USPTO expects that attorneys will complete these
applications. The professional hourly rate for attorneys is $410. Using
this hourly rate, the USPTO estimates that the total respondent cost
burden for this collection is $2,536,670.00 per year.
----------------------------------------------------------------------------------------------------------------
Estimated time
Item for response Estimated annual Estimated annual Rate ($/hr)
(hours) responses burden hours
(a) (b) (a) x (b) = (c) (d)
----------------------------------------------------------------------------------------------------------------
1. Application to Extend Patent Term 25 95 2,375 $410
Under 35 U.S.C. Sec. 156.........
2. Request for Interim Extension 1 10 10 410
Under 35 U.S.C. Sec. 156(e)(2)...
3. Petition to Review Final 25 4 100 410
Eligibility Decision Under 37 CFR
1.750..............................
4. Initial Application for Interim 20 2 40 410
Extension Under 37 CFR 1.790.......
5. Subsequent Application for 1 1 1 410
Interim Extension Under 37 CFR
1.790..............................
6. Response to Requirement to Elect. 1 15 15 410
7. Response to Request to Identify 2 1 2 410
Holder of Regulatory Approval......
8. Declaration to Withdraw an 2 1 2 410
Application to Extend Patent Term..
9. Petition for Reconsideration of 3 1,200 3,600 410
Patent Term Adjustment
Determination......................
10. Petition for Reinstatement of 4 10 40 410
Reduced Patent Term Adjustment.....
11. Petition to Accord a Filing Date 2 1 2 410
to an Application Under 37 CFR
1.740 for Extension of a Patent
Term...............................
---------------------------------------------------------------------------
Total........................... ................. 1,340 6,187 .................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual (Non-hour) Respondent Cost Burden:
$351,505.08. There are no capital startup, maintenance, or operating
fees associated with this collection. There are, however, annual (non-
hour) costs in the form of postage costs and fees.
Customers may incur postage costs when submitting some of the items
covered by this collection to the USPTO by mail. The USPTO expects that
approximately 93 percent of the responses in this collection will be
submitted electronically. Of the remaining 7 percent, the vast
majority--98 percent--will be submitted by mail, for a total of 92
mailed submissions. The average first class USPS postage cost for a
mailed submission is 49 cents. Therefore, the USPTO estimates that the
postage costs for the mailed submissions in this collection will total
$45.08.
The fees associated with this collection are being returned from
their previous location in collection 0651-0072, which has been
discontinued. These fees are listed in the accompanying table below.
----------------------------------------------------------------------------------------------------------------
Estimated annual Total non-hour
Item responses Filing fee ($) cost burden ($)
(a) (b) (a) x (b) = (c)
----------------------------------------------------------------------------------------------------------------
1. Filing an application for patent term adjustment.... 1,200 200 240,000.00
2. Request for reinstatement of term reduced........... 10 400 4,000.00
3. Extension of term of patent......................... 95 1,120 106,400.00
4. Initial application for interim extension (see 37 2 420 840.00
CFR 1.790)............................................
5. Subsequent application for interim extension (see 37 1 220 220.00
CFR 1.790)............................................
--------------------------------------------------------
Total.............................................. ................. ................. 351,460.00
----------------------------------------------------------------------------------------------------------------
Therefore, the USPTO estimates that the total annual (non-hour)
cost burden for this collection, in the form of postage costs and fees
is $351,505.08 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: August 16th 2016.
Marcie Lovett,
Records Management Division Director, OCIO United States Patent and
Trademark Office.
[FR Doc. 2016-19864 Filed 8-19-16; 8:45 am]
BILLING CODE P
