[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63857-63859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24953]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
Patent Term Extension
ACTION: Notice of renewal of information collection; request for
comment.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (USPTO), as
required by the Paperwork Reduction Act of 1995, invites comments on
the extension of an existing information collection: 0651-0020 (Patent
Term Extension).
DATES: Written comments must be submitted on or before January 21,
2020.
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 and Information Governance
Branch, Office of the Chief Administration 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 (Pub. 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.
The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-1.791.
This collection covers information gathered in patent term
extension applications submitted under 35 U.S.C. 156(d). Under this
provision, 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.
This collection also covers information gathered in requests for
interim extensions pursuant to 35 U.S.C. 156(e). Under this provision
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.
In addition, this collection covers requests for review of final
eligibility decisions, and to 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 under the
provisions at 35 U.S.C. 154 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 USPTO administers 35 U.S.C. 154 through 37 CFR
1.701-1.705. 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, allow the applicant an opportunity to
request reconsideration of the USPTO's patent term adjustment
determination. This collection covers information gathered in such a
request. In addition, this collection covers instances when the USPTO
may 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
[[Page 63858]]
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 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: Extension of a currently approved collection.
Affected Public: Businesses or other for-profits; not-for-profit
institutions.
Estimated Number of Respondents: 620 responses per year. The USPTO
estimates that approximately 25% (155) 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: 4,102 hours.
Estimated Total Annual Respondent (Hourly) Cost Burden:
$1,796,676.00. The USPTO expects that attorneys will complete these
applications. The professional hourly rate for intellectual property
attorneys is $438. The attorney rates are found in the 2017 Report of
the Economic Survey of the America Intellectual Property Law
Association (AIPLA). Using this hourly rate, the USPTO estimates that
the total respondent cost burden for this collection is $1,796,676.00
per year.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated time Estimated Estimated Total hourly
No. Item for response annual annual burden Rate ($/hr) cost burden ($/
(hours) responses hours hr)
(a) (b) (a) x (b) = (d) (c) x (d) =
(c) (e)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..................................... Application to Extend Patent 25 100 2,500 $438.00 $1,095,000.00
Term Under 35 U.S.C. 156.
2..................................... Request for Interim Extension 1 10 10 438.00 4,380.00
Under 35 U.S.C. 156(e)(2).
3..................................... Petition to Review Final 25 4 100 438.00 43,800.00
Eligibility Decision Under 37
CFR 1.750.
4..................................... Initial Application for Interim 20 2 40 438.00 17,520.00
Extension Under 37 CFR 1.790.
5..................................... Subsequent Application for 1 1 1 438.00 438.00
Interim Extension Under 37 CFR
1.790.
6..................................... Response to Requirement to Elect 1 35 35 438.00 15,330.00
7..................................... Response to Request to Identify 2 1 2 438.00 876.00
Holder of Regulatory Approval.
8..................................... Declaration to Withdraw an 2 1 2 438.00 876.00
Application to Extend Patent
Term.
9..................................... Petition for Reconsideration of 3 450 1,350 438.00 591,300.00
Patent Term Adjustment
Determination.
10.................................... Petition for Reinstatement of 4 15 60 438.00 26,280.00
Reduced Patent Term Adjustment.
11.................................... Petition to Accord a Filing Date 2 1 2 438.00 876.00
to an Application Under 37 CFR
1.740 for Extension of a Patent
Term.
-------------------------------------------------------------------------------
Total............................. ................................ .............. 620 4,102 .............. 1,796,676.00
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Total Annual (Non-hour) Respondent Cost Burden: $209,488.
There are no capital startup, maintenance, or operating fees associated
with this collection. There are, however, annual (non-hour) costs in
the form of postage costs and fees.
Filing Fees
There are filing fees associated with this collection. The items
with filing fees are listed in the table below.
----------------------------------------------------------------------------------------------------------------
Estimated Total non-hour
No. Item annual Filing fee ($) cost burden
responses ($)
(a) (b) (a) x (b) =
(c)
----------------------------------------------------------------------------------------------------------------
1................................. Filing an application for 450 $200 $90,000.00
patent term adjustment.
2................................. Request for reinstatement of 15 400 6,000.00
term reduced.
3................................. Extension of term of patent. 100 1,120 112,000.00
4................................. Initial application for 2 420 840.00
interim extension (see 37
CFR 1.790).
5................................. Subsequent application for 1 220 220.00
interim extension (see 37
CFR 1.790).
-----------------------------------------------
Total......................... ............................ .............. 2,360.00 209,060.00
----------------------------------------------------------------------------------------------------------------
[[Page 63859]]
Postage Costs
Customers may incur postage costs when submitting some of the items
covered by this collection to the USPTO by mail. The applications to
extend patent term under 35 U.S.C. 156 and the initial applications for
interim extension under 37 CFR 1.790 cannot be filed electronically.
The USPTO expects that 50 percent of these responses will be submitted
by mail, resulting in 51 mailed submissions. (The reminder of the
submission, in this category will be hand carried to USPTO.) The USPTO
expects that approximately 99 percent of the remaining responses in
this collection will be submitted electronically. Of the remaining 1
percent, the vast majority will be submitted by mail, resulting in 5
additional mailed submissions. Overall for this collection, 56 mailed
submissions are expected per year. The average USPS Priority Mail
postage cost for a legal flat rate envelope is estimated to be $7.65.
Therefore, the USPTO estimates that the postage costs for the mailed
submissions in this collection will total $428. Therefore, the USPTO
estimates that the total annual (non-hour) cost burden for this
collection, in the form of postage costs and fees is $209,488 per year.
IV. Request for Comments
Comments submitted in response to this notice will be summarized
and/or included in the request for OMB approval. All comments will
become a matter of public record.
USPTO invites public comments on:
(a) Whether the collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
(b) Accuracy of the agency's estimate of the burden (including
hours and cost) of the proposed collection of information, including
the validity of the methodology and assumptions used;
(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., including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Marcie Lovett,
Records and Information Governance Branch, Office of the Chief
Administrative Officer, USPTO.
[FR Doc. 2019-24953 Filed 11-18-19; 8:45 am]
BILLING CODE 1410-30-P