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 USPTOs 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