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 United States Department of
Agriculture (USDA). 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 5 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.
US Code:
35
USC 154-156 Name of Law: Drug Price Competition and Patent Term
Restoration Act of 1984
The USPTO estimates that this
information collection will receive 720 fewer annual responses over
the 3-year period covered by this renewal request. This adjustment
also causes the number of burden hours for this activity to
decrease 2,085 hours. Despite minor increases due to the rise in
postage rates, the overall decrease in non-hourly costs is due to
the decreased number of responses.
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.
0651-0020-Supporting Statement-2020 final.docx
Information Quality Guidelines _ USPTO 2020.html
Application to Extend Patent Term Under 35 U.S.C. 156