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 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 USPTOÂs 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.
All burden changes for this collection are due to administrative adjustments. The decreases in total annual responses and burden hours are due to revised annual response estimates, which were partially offset by an increase in the time estimates for two of the petitions included in this collection, the Petition for Reconsideration of Patent Term Adjustment Determination and the Petition for Reinstatement of Reduced Patent Term Adjustment. The decrease in annual cost burden for this collection is primarily due to overall decreases in the estimated responses for items that have associated fees and a decrease in the estimated number of items being submitted by mail and incurring postage costs, which were partially offset by an increase in the estimated number of items submitted electronically and incurring recordkeeping costs.
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.
Form PTO/SB/131 Request for Recalculation of Patent Term Adjustment in View of Wyeth
0651-0020-emergencyclearancememo-Jan2010.pdf
Application to Extend Patent Term under 35 U.S.C. 156