Patent Term Extension

ICR 201908-0651-012

OMB: 0651-0020

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2019-09-24
Supporting Statement A
2016-10-27
Supplementary Document
2013-08-20
ICR Details
0651-0020 201908-0651-012
Historical Active 201610-0651-003
DOC/PTO
Patent Term Extension
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/29/2019
Retrieve Notice of Action (NOA) 10/04/2019
  Inventory as of this Action Requested Previously Approved
01/31/2020 01/31/2020 01/31/2020
1,340 0 1,340
6,187 0 6,187
369,455 0 351,504

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 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. 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 administers 35 U.S.C. 154 through 37 CFR 1.701-1.705. The public uses this information collection to file requests related to patent term extensions and 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.

US Code: 35 USC 154-156 Name of Law: null
  
None

Not associated with rulemaking

  81 FR 56608 08/22/2016
81 FR 74775 10/27/2016
No

  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 1,340 1,340 0 0 0 0
Annual Time Burden (Hours) 6,187 6,187 0 0 0 0
Annual Cost Burden (Dollars) 369,455 351,504 0 17,951 0 0
No
No

$31,022
No
    Yes
    Yes
No
No
No
Uncollected
Raul Tamayo 571 272-7728 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/04/2019


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