0651-0020-JustStmt-final

0651-0020-JustStmt-final.pdf

Patent Term Extension

OMB: 0651-0020

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SUPPORTING STATEMENT
United States Patent and Trademark Office
Patent Term Extension
OMB CONTROL NUMBER 0651-0020

JUSTIFICATION

Necessity of Information Collection

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, the claims included in the patent for the
approved product, and a method of use or manufacturing for 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 that 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 under 35 U.S.C. ' 156(d) would expire before a certificate of extension is issued.
Table 1 provides the specific statutes and regulations authorizing the USPTO to collect the
information discussed above:
Table 1: Information Requirements for Patent Term Extensions and Adjustments
Requirement

Statute

Rule

Application to Extend Patent Term under 35 U.S.C. ' 156

35 U.S.C. ' 156(d)(1)-(4)

37 CFR 1.740-1.741

Request for Interim Extension under 35 U.S.C. ' 156(e)(2)

35 U.S.C. ' 156(e)(2)

37 CFR 1.760

Petition to Review Final Eligibility Decision under 37 CFR 1.750

35 U.S.C. ' 156(d)

37 CFR 1.750

Initial Application for Interim Extension under 35 U.S.C. '
156(d)(5)

35 U.S.C. ' 156(d)(5)

37 CFR 1.790

Subsequent Application for Interim Extension under
37 CFR 1.790

35 U.S.C. ' 156(d)(5)

37 CFR 1.790

Response to Requirement to Elect

35 U.S.C. ' 156(c)(4)

37 CFR 1.785(b)

Response to Request to Identify Holder of Regulatory Approval

35 U.S.C. ' 156(d)(1)(E)

37 CFR 1.785(d)

Declaration to Withdraw an Application to Extend Patent Term

35 U.S.C. ' 156

37 CFR 1.770

Petition for Reconsideration of Patent Term Adjustment
Determination

35 U.S.C. ' 154(b)(3)(B)(ii)

37 CFR 1.705

Petition for Reinstatement of Reduced Patent Term Adjustment

35 U.S.C. ' 154(b)(3)(C)

37 CFR 1.705

Petition to Accord a Filing Date to an Application under 37 CFR
1.740 for Extension of a Patent Term

35 U.S.C. ' 156(d)(1)-(4)

37 CFR 1.741(b)

Needs and Uses

The public uses this information collection to file requests related to patent term extensions
and petitions for reconsideration or reinstatement of patent term adjustments. 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. There are no forms
associated with this collection.

The Information Quality Guidelines from Section 515 of Public Law 106-554, Treasury and
General Government Appropriations Act for Fiscal Year 2001, apply to this information
collection and comply with all applicable information quality guidelines, i.e. OMB and
specific operating unit guidelines.
This proposed collection of information will result in information that will be collected,
maintained, and used in a way consistent with all applicable OMB and USPTO Information
Quality Guidelines.
Table 2 outlines how this collection of information is used by the public and the USPTO:
Table 2: Needs and Uses of Information Collected for Patent Term Extensions and Adjustments
Form and Function

Form #

Needs and Uses

Application to Extend Patent Term
under 35 U.S.C. ' 156

No Form
Associated

C
C

Used by the public to apply for a patent term extension.
Used by the USPTO and the Department of Health and Human
Services or the Department of Agriculture to determine
eligibility of a patent for extension and to determine the period
of extension.

Request for Interim Extension under
35 U.S.C. ' 156(e)(2)

No Form
Associated

C
C

Used by the public to request an interim extension.
Used by the USPTO to trigger an interim extension before
processing of the application has been completed.

Petition to Review Final Eligibility
Decision under 37 CFR 1.750

No Form
Associated

Used by the public to petition the USPTO to review final
eligibility decisions.
Used by the USPTO to review final eligibility decisions, as long
as the petition is filed within a set time.

Initial Application for Interim Extension
under 35 U.S.C. ' 156(d)(5)

No Form
Associated

C
C

Used by the public to apply for an interim extension.
Used by the USPTO to determine eligibility of a patent for
interim extension.

Subsequent Application for Interim
Extension under 35 CFR 1.790

No Form
Associated

C
C

Used by the public to apply for a subsequent interim extension.
Used by the USPTO to determine eligibility of a patent for
subsequent interim extension.

Response to Requirement to Elect

No Form
Associated

Used by the public to elect which patent of more than one
patent to extend.
Used by the USPTO to determine which patent of more than
one patent to extend, or which regulatory review period of more
than one regulatory review period to use in the determination
of the length of patent term extension.

Response to Request to Identify
Holder of Regulatory Approval

No Form
Associated

Used by the public to declare eligibility to apply for a patent
term extension.
Used by the USPTO to determine eligibility of patent owner to
obtain an extension of a patent.

Declaration to Withdraw an
Application to Extend Patent Term

No Form
Associated

Used by the public to withdraw an application to extend a
patent term.
Used by the USPTO to avoid extending patents that the patent
owner no longer seeks to extend.

Petition for Reconsideration of Patent
Term Adjustment Determination

No Form
Associated

Used by the patentee to correct errors in the USPTO=s patent
term adjustment determination.
Used by the USPTO to determine whether its patent term
adjustment determination is in error.
Used by the USPTO to determine the correct patent term
adjustment.

C
C

Petition for Reinstatement of Reduced
Patent Term Adjustment

No Form
Associated

Used by the patentee to request reinstatement of reduced
patent term adjustment.
Used by the USPTO to determine whether the patentee is
entitled to reinstatement of reduced patent term adjustment.

Petition to Accord a Filing Date to an
Application under 37 CFR 1.740 for
Extension of a Patent Term

No Form
Associated

Used by the patentee to request review of a notice of an
incomplete application for extension of a patent term and to
request a filing date.
Used by the USPTO to determine the filing date for an
application for extension of a patent term.

Use of Information Technology

Currently, the USPTO does not use automated, electronic, mechanical, or other
technologies to collect the information for this collection. Customers may submit the
information in this collection to the USPTO by mail, facsimile, or hand delivery.
The USPTO’s latest electronic filing initiative, EFS-Web, was deployed in March 2006.
EFS-Web is a web-based patent application and document submission system that allows
customers to file applications and associated documents through their standard web
browser without downloading special software, changing their documentation preparation
tools, or altering their workflow processes. Applicants may create their patent applications
and associated documents using the tools and processes that they already use and then
convert those documents into standard PDF files that are submitted through EFS-Web to
the USPTO. EFS-Web uses standard web-based screens and prompts. Files are typically
submitted through EFS-Web within minutes, depending on the speed of the Internet
connection and the size of the PDF files. The USPTO has found that the time required for
these submissions is significantly less than that typically required for submissions through
the original EFS. In addition, EFS-Web can automatically validate whether the file types
and data entered into the web screens meet USPTO standards so that any problems can
be corrected before final submission.
At this time, the USPTO is not collecting information for patent term extensions or
adjustments electronically, though some follow-on papers may be filed using EFS-Web. As
the USPTO expands its electronic filing capabilities, it may become feasible in some cases
to allow the public to submit requests for patent term extensions and adjustments
electronically. If the USPTO determines that this information can be filed electronically, the
USPTO will develop associated electronic forms or formats and submit them to OMB for
review and approval as necessary.
The USPTO does currently disseminate some information to the public concerning patent
term extensions electronically. The USPTO publishes determinations on applications for
4

patent term extensions on the USPTO web site as required by the Freedom of Information
Act. The USPTO also provides secure access to information about patent applications
(including information about patent term adjustments) through the USPTO web site. Online
access to application status and history information is available only to authorized
individuals, while information for granted patents and published applications is available to
the general public.
4.

Efforts to Identify Duplication

This information is collected only when an applicant submits a request related to a patent
term extension or patent term adjustment. Requests for patent term extensions can only
be filed with the USPTO. The information needed by the USPTO, the Department of Health
and Human Resources, the Department of Agriculture, or other Federal government
agencies to consider such requests is not already available from any other source. This
information is not collected elsewhere and does not result in a duplication of effort.
5.

Minimizing Burden to Small Entities

The USPTO does not believe that this collection will have a significant economic impact on
a substantial number of small businesses or other small entities. Patent term extensions
under 35 U.S.C. ' 156 are only for patents for drug products, medical devices, food or color
additives, or methods of using or manufacturing such products, devices, or additives.
Patent term extensions are typically requested by large pharmaceutical companies
because of the expense required to develop and obtain marketing approval for such
inventions. The same information is required from every respondent, and this information
is not available from any other source.
6.

Consequences of Less Frequent Collection

The information for a patent term or interim extension is collected only when the applicant
files an application with the USPTO. This information is not found elsewhere and therefore
could not be collected less frequently. If the information were not collected as provided in
35 U.S.C. ' 156(d)(1) or (d)(5), the Director of the USPTO, the Secretary of Health and
Human Services, and the Secretary of Agriculture would not have access to the information
required to determine whether the applicant is eligible for a patent term extension and, if so,
the period of the extension.
There is no requirement that any patent owner apply for an extension. However, if a
request for an extension is made, sufficient information is required by the agencies to
determine whether the statutory requirements for the special benefit have been met. There
is no set frequency of periodic intervals in which the information requested must be
supplied. The submission of a request for a patent term extension is at the discretion of the
patent owner and is normally limited to one submission within 60 days of approval of a
product for commercial use or sale by the Food and Drug Administration or the Department
of Agriculture.
5

The information for the petitions for reconsideration of patent term adjustment
determination and for reinstatement of reduced patent term adjustment is collected only as
requested and is not found elsewhere. If the information were not collected, the USPTO
would not be able to comply with the statute and regulations that permit applicants to
request reconsideration of a patent term adjustment determination.
7.

Special Circumstances in the Conduct of Information Collection

There are no special circumstances associated with this collection of information.
8.

Consultations Outside the Agency

The 60-Day Notice was published in the Federal Register on June 27, 2007 (72 Fed. Reg.
35222). The comment period ended on August 27, 2007. No public comments were
received.
The USPTO has long-standing relationships with groups from whom patent application
information is collected, such as the American Intellectual Property Law Association, as
well as patent bar associations, independent inventor groups, and users of our public
facilities. Their views are expressed in regularly scheduled meetings and considered in
developing proposals for information collection requirements. There have been no
comments or concerns expressed by these or similar organizations concerning the time to
provide the information required under this program.
9.

Payment or Gifts to Respondents

This information collection does not involve a payment or gift to any respondent.
10.

Assurance of Confidentiality

Confidentiality of patent applications is governed by statute (35 U.S.C. ' 122) and
regulation (37 CFR 1.11 and 1.14). The USPTO has a legal obligation to maintain the
confidentiality of the contents of unpublished patent applications and related documents.
Upon publication of an application or issuance of a patent, the patent application file is
made available to the public, subject to the provisions for providing only a redacted copy of
the file contents. Patent term extensions involve issued patents and therefore typically do
not have confidentiality issues, but there may be confidentiality considerations for patent
term adjustments.
The disclosure of the invention in the application is the quid pro quo for the property right
conferred by the patent grant, and the very means by which the patent statute achieves its
constitutional objective of "promot[ing] the progress of science and useful arts.@ The
prosecution history contained in the application file is critical to determining the scope of the
property right conferred by the patent grant.
6

11.

Justification for Sensitive Questions

None of the required information in this collection is considered to be sensitive.
12.

Estimate of Hour and Cost Burden to Respondents

Table 3 calculates the burden hours and costs of this information collection to the public,
based on the following factors:
$

Respondent Calculation Factors
The USPTO estimates that it will receive approximately 26,859 responses per year as
outlined in the table below.

Burden Hour Calculation Factors
The USPTO estimates that it will take the public from one to 25 hours, depending on the
complexity and type of filing, to gather the necessary information, prepare the appropriate
documents, and submit the applications, petitions, and requests included in this collection.

Cost Burden Calculation Factors
In 2005 the Committee on Economics of Legal Practice of the American Intellectual
Property Law Association published a report that summarized the results of a survey with
data on hourly billing rates. The professional rate of $304 per hour used in this submission
is the median rate for associate attorneys in private firms as published in that report. The
USPTO expects that the information in this collection will be prepared by attorneys. This
rate is a fully-loaded hourly rate.
As an illustration of the burden to the public, consider the hour and cost burden on the
applicant to file an application for a patent term extension. Based on an average of 25
hours of attorney time at a rate of $304 per hour, the average cost for an attorney to prepare
an application for patent term extension would be $7,600. While this is a significant amount,
it must be taken in the context of the $300 to $500 million that an organization may spend to
develop a new chemical entity before obtaining approval from the Food and Drug
Administration, which would give rise to eligibility for patent term extension. In addition,
extension of the term of a patent on a drug product may protect a domestic market worth
hundreds of millions, if not billions, of dollars per year.

Table 3: Burden Hour/Cost to Respondents for Patent Term Extensions and Adjustments
Item

Application to Extend Patent Term under 35
U.S.C. ' 156

Hours
(a)

Responses
(yr)
(b)

Burden
(hrs/yr)
(c)
(a x b)

Rate
($/yr)
(d)

Total Cost
($/yr)
(e)
(d x e)

25.0

1,250

$304.00

$380,000.00

Request for Interim Extension under 35 U.S.C. '
156(e)(2)

1.0

$304.00

Petition to Review Final Eligibility Decision under
37 CFR 1.750

25.0

$304.00

$7,600.00

Initial Application for Interim Extension under
35 U.S.C. ' 156(d)(5)

20.0

$304.00

$6,080.00

Subsequent Application for Interim Extension
under 37 CFR 1.790

1.0

$304.00

Response to Requirement to Elect

1.0

$304.00

$608.00

Response to Request to Identify Holder of
Regulatory Approval

2.0

$304.00

$608.00

Declaration to Withdraw an Application to
Extend Patent Term

2.0

$304.00

$608.00

Petition for Reconsideration of Patent Term
Adjustment Determination

1.0

24,000

$304.00

$7,296,000.00

Petition for Reinstatement of Reduced Patent
Term Adjustment

2.0

2,800

5,600

$304.00

$1,702,400.00

Petition to Accord a Filing Date to an Application
under 37 CFR 1.740 for Extension of a Patent
Term

2.0

$304.00

$608.00

26,859

30,905

- - - - -

$9,395,120.00

Totals

13.

- - - -

Total Annualized Cost Burden

There are no capital start-up, maintenance, or recordkeeping costs associated with this
information collection. However, this collection does have annual (non-hour) costs in the
form of filing fees and postage 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 costs associated
with this collection will be $5,977,040 per year, as outlined in Table 4 below:
Table 4: Filing Costs to Respondents for Patent Term Extensions and Adjustments
Item

Responses
(a)

Filing
Fees ($)
(b)

Total Non-Hour
Cost Burden
(c)
(a) x (b)

Application to Extend Patent Term under 35 U.S.C. ' 156

$1,120.00

$56,000.00

Request for Interim Extension under 35 U.S.C. ' 156(e)(2)

$0.00

Petition to Review Final Eligibility Decision under 37 CFR 1.750

$0.00

Initial Application for Interim Extension under
35 U.S.C. ' 156(d)(5)

$420.00

Subsequent Application for Interim Extension under 37 CFR 1.790

$220.00

Response to Requirement to Elect

$0.00

Response to Request to Identify Holder of Regulatory Approval

$0.00

Declaration to Withdraw an Application to Extend Patent Term

$0.00

Petition for Reconsideration of Patent Term Adjustment Determination
Petition for Reinstatement of Reduced Patent Term Adjustment
Petition to Accord a Filing Date to an Application under 37 CFR 1.740
for Extension of a Patent Term
Totals

24,000

$200.00

$4,800,000.00

2,800

$400.00

$1,120,000.00

$400.00

26,859

......

$5,977,040.00

Customers may incur postage costs when submitting the information in this collection to the
USPTO by mail. The USPTO estimates that the average first-class postage cost for a
mailed submission will be 41 cents and that up to 26,859 submissions will be mailed to the
USPTO per year. The total estimated postage cost for this collection is $11,012 per year.
The total annual (non-hour) cost burden for this collection in the form of filing fees
($5,977,040) and postage costs ($11,012) is $5,988,052 per year.
14.

Annual Cost to the Federal Government

The USPTO estimates that it takes a GS-5, step 1 employee between 15 minutes and 2
hours to process the various applications, petitions, and requests associated with patent
term extensions and patent term adjustments, depending upon the situation. The hourly
rate for a GS-5, step 1 employee is currently $14.56. When 30% is added to account for a
fully-loaded hourly rate (benefits and overhead), the hourly rate for a GS-5, step 1 is $14.56
+ $4.37, for a rate of $18.93.
Table 5 calculates the burden hours and costs of this information collection to the Federal
Government:
Table 5: Burden Hour/Cost to the Federal Government for Patent Term Extensions and Adjustments
Item

Hours
(a)

Responses
(yr)
(b)

Burden
(hrs/yr)
(c)
(a x b)

Rate
($/yr)
(d)

Total Cost
($/yr)
(e)
(d x e)

Application to Extend Patent Term under 35
U.S.C. ' 156

2.00

100

$18.93

$1,893.00

Request for Interim Extension under 35 U.S.C. '
156(e)(2)

0.50

$18.93

$19.00

Petition to Review Final Eligibility Decision under
37 CFR 1.750

0.25

$18.93

$19.00

Initial Application for Interim Extension under
35 U.S.C. ' 156(d)(5)

0.50

$18.93

$19.00

Subsequent Application for Interim Extension
under 37 CFR 1.790

0.50

$18.93

$19.00

Response to Requirement to Elect

0.25

$18.93

$19.00

Response to Request to Identify Holder of
Regulatory Approval

0.25

$18.93

$19.00

Declaration to Withdraw an Application to
Extend Patent Term

0.25

$18.93

$19.00

Petition for Reconsideration of Patent Term
Adjustment Determination

1.00

24,000

$18.93

$454,320.00

Petition for Reinstatement of Reduced Patent
Term Adjustment

1.00

2,800

$18.93

$53,004.00

Petition to Accord a Filing Date to an Application
under 37 CFR 1.740 for Extension of a Patent
Term

0.25

$18.93

$19.00

26,859

26,908

- - - - -

$509,369.00

Totals

15.

- - - -

Reason for Change in Burden

Summary of Changes Since the Previous Renewal
This information collection was previously approved by OMB in October 2004 with a total of
26,859 responses and 30,905 burden hours per year. For this renewal, the USPTO is
maintaining these burden estimates for annual responses and hours.
The total annual (non-hour) cost burden for this renewal of $5,988,052 is an increase of
$1,074 from the currently approved total of $5,986,978 in annual costs for this collection.
This increase is due to administrative adjustments.
Change in Respondent Cost Burden
This collection was previously approved using an estimated hourly rate of $286 for
attorneys preparing the information in this collection. At the current estimated rate of $304
per hour for attorneys, the 30,905 burden hours estimated for this renewal yield a
respondent cost burden of $9,395,120, which is an increase of $556,290 over the currently
approved burden of $8,838,830. This increase in respondent cost burden is due to the
increase in the estimated hourly rate for attorneys from $286 to $304.
Changes in Responses and Burden Hours
For this renewal, the USPTO estimates that there will be no change in the total responses
and burden hours from the currently approved burden for this collection.
Changes in Annual (Non-hour) Costs
For this renewal, the USPTO estimates that the total annual (non-hour) costs will increase
by $1,074, from $5,986,978 to $5,988,052 per year. This increase is due to revising the
estimated postage costs for submitting the information in this collection to the USPTO by
mail. Therefore, this collection has an increase in annual (non-hour) cost burden of
$1,074 due to an administrative adjustment.
10

16.

Project Schedule

The USPTO does not plan to publish this information for statistical use or for any special
purpose. However, plant and utility patents granted are published weekly in the Official
Gazette of the United States Patent and Trademark Office-Patents (Official GazettePatents). The USPTO also publishes determinations on applications for patent term
extension on the USPTO web site as required by the Freedom of Information Act and lists
any certificates of extension granted in the Official Gazette-Patents. The Official GazettePatents is published in electronic format on the USPTO web site.
17.

Display of Expiration Date of OMB Approval

There are no forms associated with this collection. Therefore, the display of the expiration
date is not applicable.
18.

Exceptions to the Certificate Statement

This collection of information does not include any exceptions to the certificate statement.

COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

This collection of information does not employ statistical methods.

REFERENCES
A.
B.

The USPTO Information Quality Guidelines
60-Day Notice published in the Federal Register on June 27, 2007 (72 Fed. Reg.
35222)

File Type	application/pdf
File Title	0651-0020-JustStmt-final.doc
File Modified	2007-09-18
File Created	2007-09-18