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 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.
The changes to estimated annual
responses and burden hours are due to administrative adjustments
from updated annual response estimates and program changes from the
removal of one item from this collection: the Request for
Recalculation of Patent Term Adjustment in View of Wyeth
(PTO/SB/131). The net decrease in annual (non-hour) costs is
primarily due to program changes from the removal of associated
fees that have been moved into collection 0651-0072, the removal of
recordkeeping costs that are not required, and a net decrease in
postage from the removal of the Request for Recalculation of Patent
Term Adjustment in View of Wyeth (PTO/SB/131) from 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-USPTO-InfoQuality-Guidelines-01_07_2013.pdf
Application to Extend Patent Term Under 35 U.S.C. 156