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.
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 patenteeÂs sole basis for requesting recalculation of the patent term adjustment in the patent is the USPTOÂs pre-Wyeth interpretation of 35 U.S.C. 154(b)(2)(A).
US Code:
35 USC 154-156
Name of Law: Federal Food, Drug and Cosmetic Act
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 patenteeÂs sole basis for requesting recalculation of the patent term adjustment in the patent is the USPTOÂs 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.
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