Patent Term Extension

Forms and Documents

Document Name	Status
Form PTO/SB/131 Request for Recalculation of Patent Term Adjustment in View of Wyeth Form and Instruction	New
0651-0020-emergencyclearancememo-Jan2010.pdf Supplementary Document	2010-01-22
0651-0020-justificationforemergencyclearance-Jan2010-final.pdf Supplementary Document	2010-01-22
0651-0020-JustStmt-final.pdf Supporting Statement A	2007-09-26
USPTO-newinfoqualityguide.pdf Supplementary Document	2007-09-26

IC Document Collections

IC ID	Document Title	Status
4686	Application to Extend Patent Term under 35 U.S.C. 156	Unchanged
191833	Request for Recalculation of Patent Term Adjustment in View of Wyeth Form and Instruction	New
182039	Petition to Accord a Filing Date to an Application under 37 CFR 1.740 for Extension of a Patent Term	Unchanged
182038	Petition for Reinstatement of Reduced Patent Term Adjustment	Unchanged
182037	Petition for Reconsideration of Patent Term Adjustment Determination	Unchanged
182036	Declaration to Withdraw an Application to Extend Patent Term	Unchanged
182035	Response to Request to Identify Holder of Regulatory Approval	Unchanged
182034	Response to Requirement to Elect	Unchanged
182033	Subsequent Application for Interim Extension under 37 CFR 1.790	Unchanged
182032	Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)	Unchanged
182031	Petition to Review Final Eligibility Decision under 37 CFR 1.750	Modified
182030	Request for Interim Extension under 35 U.S.C. 156(e)(2)	Modified

ICR Details

OMB Control No: 0651-0020	ICR Reference No: 201001-0651-002
Status: Historical Active	Previous ICR Reference No: 200709-0651-002
Agency/Subagency: DOC/PTO	Agency Tracking No: E2010-01
Title: Patent Term Extension
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 01/27/2010
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/28/2010
	Date Received in OIRA: 01/25/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2010	6 Months From Approved	02/28/2011
Responses	38,859	0	26,859
Time Burden (Hours)	32,945	0	30,905
Cost Burden (Dollars)	5,989,522	0	5,988,050

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Abstract: The Federal Food, Drug and Cosmetic Act of 35 U.S.C. 156 permits the 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 an extension. Under 35 U.S.C. 154 the USPTO may also in some cases adjust the term of an original patent due to certain delays in the prosecution of the application. The information in this collection is used by the USPTO to consider whether an application 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.

Emergency Justfication: The United States Patent and Trademark Office (USPTO) requests emergency review of an information collection request associated with 0651-0020 Patent Term Extension. A recent Federal Circuit Court decision has impacted the information collection activities. The USPTO is implementing a new procedure for patentees to seek a revised patent term adjustment in a patent if the patentee’s sole basis for requesting recalculation of the patent term adjustment in the patent is the USPTO’s pre-Wyeth interpretation of 35 U.S.C. 154(b)(2)(A).

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Authorizing Statute(s): US Code: 35 USC 154-156 Name of Law: Federal Food, Drug and Cosmetic Act
  

Citations for New Statutory Requirements: US Code: 35 USC 154(b) Name of Law: null

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 35222	06/27/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 53233	09/18/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
Request for Recalculation of Patent Term Adjustment in View of Wyeth	PTO/SB/131	Request for Recalculation of Patent Term Adjustment in View of Wyeth
Subsequent Application for Interim Extension under 37 CFR 1.790
Response to Request to Identify Holder of Regulatory Approval
Petition to Accord a Filing Date to an Application under 37 CFR 1.740 for Extension of a Patent Term
Request for Interim Extension under 35 U.S.C. 156(e)(2)
Declaration to Withdraw an Application to Extend Patent Term
Petition for Reconsideration of Patent Term Adjustment Determination
Initial Application for Interim Extension under 35 U.S.C. 156(d)(5)
Petition to Review Final Eligibility Decision under 37 CFR 1.750
Application to Extend Patent Term under 35 U.S.C. 156
Response to Requirement to Elect
Petition for Reinstatement of Reduced Patent Term Adjustment

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	38,859	26,859	12,000	0	0	0
Annual Time Burden (Hours)	32,945	30,905	2,040	0	0	0
Annual Cost Burden (Dollars)	5,989,522	5,988,050	1,470	0	2	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: As a result of a recent Federal Circuit Court decision, the USPTO is implementing a new procedure for patentees to seek a revised patent term adjustment in a patent if the patentee’s sole basis for requesting recalculation of the patent term adjustment in the patent is the USPTO’s pre-Wyeth interpretation of 35 U.S.C. § 154(b)(2)(A). The new procedure permits eligible patentees to request a recalculation of their patent term adjustment in lieu of the petition and fee required by 37 CFR 1.705(d). The USPTO is proposing to add a new form for patentees to request recalculation of their patent term adjustments in light of Wyeth: Request for Recalculation of Patent Term Adjustment in View of Wyeth, Form PTO/SB/131. The addition of this form will add 12,000 responses, 2,040 burden hours, and $1,470 in annual cost burden to this collection as a program change. An administrative adjustment of $2 has also been made to account for a rounding difference in previously reported postage costs for this collection.

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Annual Cost to Federal Government: $509,369

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/25/2010

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