Patent Term Extension, 56608-56609 [2016-19864]

Download as PDF 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 http:// 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: http:// 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: http://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 http://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