81 FR 56608 - Patent Term Extension
DEPARTMENT OF COMMERCE
Patent and Trademark Office Federal Register Volume 81, Issue 162 (August 22, 2016)
Patent and Trademark Office
Federal Register Volume 81, Issue 162 (August 22, 2016)
| Page Range | 56608-56609 | |
| FR Document | 2016-19864 |
[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)] [Notices] [Pages 56608-56609] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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 [email protected] 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
![56608 Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices
Guam Coastal Management Program telephone at 571–272–7728; or by email the prosecution of the patent
Evaluation to Raul.Tamayo@uspto.gov with ‘‘0651– application, including delays caused by
You may participate or submit oral 0020 comment’’ in the subject line. interference proceedings, secrecy
comments at the public meeting Additional information about this orders, or appellate review by the Patent
scheduled as follows: collection is also available at http:// Trial and Appeal Board or a Federal
Date: September 28, 2016. www.reginfo.gov under ‘‘Information court in which the patent is issued
Time: 5:30 p.m., local time. Collection Review.’’ pursuant to a decision reversing an
Location: Sinajana Community SUPPLEMENTARY INFORMATION: adverse determination of patentability.
Center, 178 Chalan Guma Yu’os, The patent term provisions of 35 U.S.C.
I. Abstract
Sinajana, Guam 96910. 154(b), as amended by title IV, subtitle
Written public comments must be The patent term restoration portion of D of the Intellectual Property and
received on or before October 5, 2016. the Drug Price Competition and Patent Communications Omnibus Reform Act
Term Restoration Act of 1984 (P.L. 98– of 1999, require the USPTO to notify the
Federal Domestic Assistance Catalog 11.419 417), which is codified at 35 U.S.C. 156,
Coastal Zone Management Program
applicant of the patent term adjustment
permits the United States Patent and in the notice of allowance and give the
Administration
Trademark Office (USPTO) to extend applicant an opportunity to request
Dated: August 5, 2016. the term of protection under a patent to reconsideration of the USPTO’s patent
Josh Lott, compensate for delay during regulatory term adjustment determination.
Policy Program Manager, Office for Coastal review and approval by the Food and The USPTO may also reduce the
Management, National Ocean Service, Drug Administration (FDA) or amount of patent term adjustment
National Oceanic and Atmospheric Department of Agriculture. Only patents granted if delays were caused by an
Administration. for drug products, medical devices, food applicant’s failure to make a reasonable
[FR Doc. 2016–19946 Filed 8–19–16; 8:45 am] additives, or color additives are effort to respond within three months of
BILLING CODE 3510–08–P potentially eligible for extension. The the mailing date of a communication
maximum length that a patent may be from the USPTO. Applicants may
extended under 35 U.S.C. 156 is five petition for reinstatement of a reduction
DEPARTMENT OF COMMERCE years. in patent term adjustment with a
Under 35 U.S.C. 156(d), an showing that, in spite of all due care,
Patent and Trademark Office application for patent term extension the applicant was unable to respond to
must identify the approved product; the a communication from the USPTO
Patent Term Extension
patent to be extended; and the claims within the three-month period. The
ACTION: Proposed collection; comment included in the patent that cover the
USPTO administers 35 U.S.C. 154
request. approved product, a method of using
through 37 CFR 1.701–1.705.
the approved product, or a method of
The information in this collection is
SUMMARY: The United States Patent and manufacturing the approved product. 35
used by the USPTO to consider whether
Trademark Office (USPTO), as part of its U.S.C. 156(d) also requires the
an applicant is eligible for a patent term
continuing effort to reduce paperwork application for patent term extension to
provide a brief description of the extension or reconsideration of a patent
and respondent burden, invites the
activities undertaken by the applicant term adjustment and, if so, to determine
general public and other Federal
during the regulatory review period the length of the patent term extension
agencies to comment on the extension of
with respect to the approved product or adjustment.
a continuing information collection, as
required by the Paperwork Reduction and the significant dates of these II. Method of Collection
Act of 1995, Public Law 104–13 (44 activities.
Under 35 U.S.C. 156(e), an interim By mail, facsimile, hand delivery, or
U.S.C. 3506(c)(2)(A)). electronically to the USPTO.
DATES: Written comments must be extension may be granted if the term of
submitted on or before October 21, an eligible patent for which an III. Data
2016. application for patent term extension
has been submitted would expire before OMB Number: 0651–0020.
ADDRESSES: You may submit comments a certificate of extension is issued. IC Instruments and Forms: There are
by any of the following methods: Under 35 U.S.C. 156(d)(5), an interim no forms associated with this collection.
• Email: InformationCollection@ extension may be granted if the Type of Review: Revision of a
uspto.gov. Include ‘‘0651–0020 applicable regulatory review period that Previously Existing Information
comment’’ in the subject line of the began for a product is reasonably Collection.
message. expected to extend beyond the Affected Public: Businesses or other
• Federal Rulemaking Portal: http:// expiration of the patent term in effect. for-profits; not-for-profit institutions.
www.regulations.gov. The USPTO administers 35 U.S.C. 156 Estimated Number of Respondents:
• Mail: Marcie Lovett, Records through 37 CFR 1.710–1.791. These 1,340 responses per year. The USPTO
Management Division Director, Office of rules provide for the public to, inter estimates that approximately 25% of
the Chief Information Officer, United alia, submit 35 U.S.C. 156 patent term these responses will be from small
States Patent and Trademark Office, extension applications to the USPTO, entities.
P.O. Box 1450, Alexandria, VA 22313– request interim extensions and review Estimated Time per Response: The
asabaliauskas on DSK3SPTVN1PROD with NOTICES
1450. of final eligibility decisions, and USPTO estimates that it will take the
FOR FURTHER INFORMATION CONTACT: withdraw an application requesting a public from 1 to 25 hours, depending on
Requests for additional information patent term extension after it is the complexity of the situation, to gather
should be directed to Raul Tamayo, submitted. the necessary information, prepare the
Senior Legal Advisor, Office of Patent Separate from the extension appropriate documents, and submit the
Legal Administration, United States provisions of 35 U.S.C. 156, the USPTO information to the USPTO.
Patent and Trademark Office, P.O. Box may in some cases extend the term of an Estimated Total Annual Respondent
1450, Alexandria, VA 22313–1450; by original patent due to certain delays in Burden Hours: 6,187 hours.
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![Federal Register / Vol. 81, No. 162 / Monday, August 22, 2016 / Notices 56609
Estimated Total Annual Respondent complete these applications. The estimates that the total respondent cost
(Hourly) Cost Burden: $2,536,670.00. professional hourly rate for attorneys is burden for this collection is
The USPTO expects that attorneys will $410. Using this hourly rate, the USPTO $2,536,670.00 per year.
Estimated time for Estimated annual Estimated annual Rate
Item response responses burden hours ($/hr)
(hours)
(a) (b) (a) × (b) = (c) (d)
1. Application to Extend Patent Term Under 35 U.S.C. § 156 25 95 2,375 $410
2. Request for Interim Extension Under 35 U.S.C. § 156(e)(2) 1 10 10 410
3. Petition to Review Final Eligibility Decision Under 37 CFR
1.750 .................................................................................... 25 4 100 410
4. Initial Application for Interim Extension Under 37 CFR
1.790 .................................................................................... 20 2 40 410
5. Subsequent Application for Interim Extension Under 37
CFR 1.790 ............................................................................ 1 1 1 410
6. Response to Requirement to Elect ..................................... 1 15 15 410
7. Response to Request to Identify Holder of Regulatory Ap-
proval .................................................................................... 2 1 2 410
8. Declaration to Withdraw an Application to Extend Patent
Term ..................................................................................... 2 1 2 410
9. Petition for Reconsideration of Patent Term Adjustment
Determination ....................................................................... 3 1,200 3,600 410
10. Petition for Reinstatement of Reduced Patent Term Ad-
justment ................................................................................ 4 10 40 410
11. Petition to Accord a Filing Date to an Application Under
37 CFR 1.740 for Extension of a Patent Term .................... 2 1 2 410
Total .................................................................................. .............................. 1,340 6,187 ..............................
Estimated Total Annual (Non-hour) by mail. The USPTO expects that postage costs for the mailed submissions
Respondent Cost Burden: $351,505.08. approximately 93 percent of the in this collection will total $45.08.
There are no capital startup, responses in this collection will be The fees associated with this
maintenance, or operating fees submitted electronically. Of the
collection are being returned from their
associated with this collection. There remaining 7 percent, the vast majority—
previous location in collection 0651–
are, however, annual (non-hour) costs in 98 percent—will be submitted by mail,
the form of postage costs and fees. for a total of 92 mailed submissions. The 0072, which has been discontinued.
Customers may incur postage costs average first class USPS postage cost for These fees are listed in the
when submitting some of the items a mailed submission is 49 cents. accompanying table below.
covered by this collection to the USPTO Therefore, the USPTO estimates that the
Estimated annual Total non-hour
Item Filing fee ($)
responses cost burden ($)
(a) (b) (a) × (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 CFR 1.790) ................................. 2 420 840.00
5. Subsequent application for interim extension (see 37 CFR 1.790) ...................... 1 220 220.00
Total .................................................................................................................... .............................. .............................. 351,460.00
Therefore, the USPTO estimates that (b) the accuracy of the agency’s Comments submitted in response to
the total annual (non-hour) cost burden estimate of the burden (including hours this notice will be summarized or
for this collection, in the form of postage and cost) of the proposed collection of included in the request for OMB
costs and fees is $351,505.08 per year. information; approval of this information collection;
(c) ways to enhance the quality, they also will become a matter of public
asabaliauskas on DSK3SPTVN1PROD with NOTICES
IV. Request for Comments
utility, and clarity of the information to record.
Comments are invited on: be collected; and Dated: August 16th 2016.
(a) Whether the proposed collection of (d) ways to minimize the burden of Marcie Lovett,
information is necessary for the proper the collection of information on Records Management Division Director, OCIO
performance of the functions of the respondents, e.g., the use of automated United States Patent and Trademark Office.
agency, including whether the collection techniques or other forms of [FR Doc. 2016–19864 Filed 8–19–16; 8:45 am]
information shall have practical utility; information technology. BILLING CODE P
VerDate Sep<11>2014 17:13 Aug 19, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\22AUN1.SGM 22AUN1](https://thefederalregister.org/doc/81_FR_56770/page/2.svg)
Document Created: 2018-02-09 11:37:34
Document Modified: 2018-02-09 11:37:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Proposed collection; comment request. | |
| Dates | Written comments must be submitted on or before October 21, 2016. | |
| 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 [email protected] 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.'' | |
| FR Citation | 81 FR 56608 |
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