| Allowance, Patent Term Adjustment or Extension |
Referenced Items (260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273) |
(266) DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No.: PTO-P-2010-0006]
Interim Procedure for Patentees to Request a
Recalculation of the Patent Term Adjustment to
Comply with the Federal Circuit Decision in
Wyeth v. Kappos Regarding the Overlapping Delay
Provision of 35 U.S.C. 154(b)(2)(A)
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice.
SUMMARY: The United States Patent and Trademark Office (USPTO) is
modifying the computer program it uses to calculate patent term
adjustments in light of Wyeth v. Kappos, No. 2009-1120 (Fed. Cir., Jan.
7, 2010). The USPTO expects to complete this software modification by
March 2, 2010. In the meantime, the USPTO is providing patentees with
the ability to request a recalculation of their patent term adjustment
without a fee as an alternative to the petition and fee required by 37
CFR 1.705(d). In order to qualify, a form requesting a recalculation of
the patent term adjustment must be submitted no later than 180 days
after the patent has issued and the patent must be issued prior to
March 2, 2010. In addition, this procedure is only available for
alleged errors that are specifically identified in Wyeth. The USPTO is
deciding pending petitions under 37 CFR 1.705 in accordance with the
Wyeth decision. This notice also provides information concerning the
Patent Application Information Retrieval (PAIR) screen that displays
the patent term adjustment calculation.
DATES: Effective Date: The procedure set forth in this notice is
effective on February 1, 2010.
Applicability Date: The procedure set forth in this notice is
applicable only to patents issued prior to March 2, 2010, in which a
request for recalculation of patent term adjustment in view of Wyeth is
filed within 180 days of the day the patent was granted.
FOR FURTHER INFORMATION CONTACT: The Office of Patent Legal
Administration by telephone at (571) 272-7702, or by mail addressed to:
Mail Stop Comments-Patents, Commissioner for Patents, P.O. Box 1450,
Alexandria, VA 22313-1450.
SUPPLEMENTARY INFORMATION: Under 35 U.S.C. 154(b)(1), an applicant is
entitled (subject to certain conditions and limitations) to patent term
adjustment for the following reason: (1) If the USPTO fails to take
certain actions during the examination and issue process within
specified time frames (35 U.S.C. 154(b)(1)(A)), which are known as the
"A" delays; (2) if the USPTO fails to issue a patent within three
years of the actual filing date of the application (35 U.S.C.
154(b)(1)(B)), which are known as the "B" delays; and (3) for delays
due to interference, secrecy order, or successful appellate review (35
U.S.C. 154(b)(1)(C)), which are known as the "C" delays. 35 U.S.C.
154(b)(2)(A) provides that "[t]o the extent that periods of delay
attributable to grounds specified in [35 U.S.C. 154(b)(1)] overlap, the
period of any adjustment granted under this subsection shall not exceed
the actual number of days the issuance of the patent was delayed.'' The
USPTO interpreted this provision as covering situations in which a
delay by the USPTO contributes to multiple bases for adjustment (the
"pre-Wyeth" interpretation of 35 U.S.C. 154(b)(2)(A)). See
Explanation of 37 CFR 1.703(f) and of the United States Patent and
Trademark Office Interpretation of 35 U.S.C. 154(b)(2)(A), 69 FR 34283
(June 21, 2004). The United States Court of Appeals for the Federal
Circuit, however, recently held in Wyeth that the USPTO's
interpretation of 35 U.S.C. 154(b)(2)(A) was too strict, and that
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periods of delay overlap under 35 U.S.C. 154(b)(2)(A) only if the
periods which measure the amount of adjustment under 35 U.S.C.
154(b)(1) occur on the same calendar day.
The USPTO makes patent term adjustment determinations by a computer
program that uses the information recorded in the USPTO's Patent
Application Locating and Monitoring (PALM) system, except when an
applicant requests reconsideration pursuant to 37 CFR 1.705. See
Changes to Implement Patent Term Adjustment Under Twenty-Year Patent
Term, 65 FR 56365, 56370, 56380-81 (Sept. 18, 2000) (final rule). The
USPTO is in the process of revising the computer program it uses to
calculate patent term adjustment to calculate overlapping delays
consistent with the Federal Circuit's interpretation of 35 U.S.C.
154(b)(2)(A) in Wyeth. The USPTO expects the revisions to the patent
term adjustment computer program to be in place for use on the patents
issuing on March 2, 2010.
Patentees should note that the patent term adjustment provisions of
35 U.S.C. 154(b) are complex, there are numerous types of
communications that are exchanged between applicants and the USPTO
during the patent application process, the PALM system was not
originally designed for the purpose of calculating patent term
adjustment as provided in 35 U.S.C. 154(b), and one or more of the time
frames specified in of 35 U.S.C. 154(b)(1)(A) and (B) are not met
presently in a high percentage of the patents. In addition, revisions
to the patent term adjustment computer program necessary to calculate
overlapping delays consistent with the Federal Circuit's interpretation
of 35 U.S.C. 154(b)(2)(A) in Wyeth significantly increases the
complexity of the patent term adjustment computer program. Thus, for
patents issuing on or after March 2, 2010, a patentee who believes that
the patent term adjustment calculation for his or her patent is not
correct must file a request for reconsideration under 37 CFR 1.705(d)
that complies with the requirements of 37 CFR 1.705(b)(1) and (b)(2)
within two months of the date the patent issued. The USPTO is modifying
and will continue to modify the patent term adjustment computer program
as it becomes aware of situations in the patent term adjustment
computer program where it is not correctly calculating the applicable
patent term adjustment.
Requests for Reconsideration of the Patent Term Adjustment
indicated in the Patent: 37 CFR 1.705(d) provides, in part, that any
request for reconsideration of the patent term adjustment indicated in
the patent must be filed within two months of the date the patent
issued and must comply with the requirements of 37 CFR 1.705(b)(1) and
(b)(2). 35 U.S.C. 154(b)(4) provides that an applicant dissatisfied
with a determination made by the Director under 35 U.S.C. 154(b)(3)
shall have remedy by a civil action against the Director filed in the
United States District Court for the District of Columbia within 180
days after the grant of the patent.
The USPTO is providing an optional procedure under which patentees
seeking a revised patent term adjustment in a patent issued prior to
March 2, 2010, may request that the USPTO recalculate the patent term
adjustment without a request for reconsideration under 37 CFR 1.705(d)
(or fee), provided that the patentee's sole basis for requesting
reconsideration of the patent term adjustment in the patent is the
USPTO's pre-Wyeth interpretation of 35 U.S.C. 154(b)(2)(A) and such a
request is filed within 180 days of the day the patent was granted. The
USPTO is providing a Request for Recalculation of Patent Term Adjustment in
View of Wyeth form (PTO/SB/131) for use in making such a request. The
Request for Recalculation of Patent Term Adjustment in View of Wyeth form
(PTO/SB/131) is available on the USPTO Web site at
http://www.uspto.gov/forms/index.jsp. This procedure and Request for
Recalculation of Patent Term Adjustment in View of Wyeth form (PTO/SB/131)
are applicable only for patents that issue prior to March 2, 2010. The
USPTO will deny as untimely any request for recalculation of patent term
adjustment indicated on a patent that is not filed within 180 days of the
day the patent was granted. Patentees are reminded that this is an optional
procedure, and that any patentee who wishes to preserve his or her right to
review in the United States District Court for the District of Columbia of
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the USPTO's patent term adjustment determination must ensure that he or she
also takes the steps required under 35 U.S.C. 154(b)(3) and (b)(4) and
37 CFR 1.705 in a timely manner.
The fee specified in 37 CFR 1.18(e) is required for a request for
reconsideration under 37 CFR 1.705 (37 CFR 1.705(b)(1)), and the USPTO
may only refund fees paid by mistake or in excess of that required (35
U.S.C. 42(d)). Therefore, the procedure set forth in this notice is not
a basis for requesting a refund of the fee specified in 37 CFR 1.18(e)
for any request for reconsideration under 37 CFR 1.705, including any
previously filed request that was solely based on the USPTO's pre-Wyeth
interpretation of 35 U.S.C. 154(b)(2)(A).
The procedure set forth in this notice and the Request for
Recalculation of Patent Term Adjustment in View of Wyeth form (PTO/SB/
131) may not be used to request a reconsideration of the patent term
adjustment indicated in the notice of allowance in an application that
has not yet issued as a patent. If the application issues as a patent
prior to March 2, 2010, the optional procedure set forth in this notice
and the Request for Recalculation of Patent Term Adjustment in View of
Wyeth form (PTO/SB/131) may be used to request recalculation of the
patent term adjustment provided on the patent. It is expected that for
applications issuing as patents on or after March 2, 2010, the patent
term adjustment calculation will be consistent with the Federal
Circuit's interpretation of 35 U.S.C. 154(b)(2)(A) in Wyeth.
The USPTO is deciding any currently pending request for
reconsideration of the patent term adjustment indicated in the patent
under 37 CFR 1.705(d) that was filed within two months of the date the
patent issued consistent with the Federal Circuit's interpretation of
35 U.S.C. 154(b)(2)(A) in Wyeth. Patentees who received a decision on a
request for reconsideration of the patent term adjustment indicated in
the patent under 37 CFR 1.705(d) under the USPTO's pre-Wyeth
interpretation of 35 U.S.C. 154(b)(2)(A) may file a request for
reconsideration of that decision if such a request for reconsideration
is filed within two months of the date of the decision on a request for
reconsideration (37 CFR 1.181(f)). If the patentee's sole basis for
requesting reconsideration of the decision is the USPTO's pre-Wyeth
interpretation of 35 U.S.C. 154(b)(2)(A), the request for
reconsideration need only state that reconsideration is being requested
in view of the Federal Circuit's decision in Wyeth (the Request for
Recalculation of Patent Term Adjustment in View of Wyeth form (PTO/SB/
131) may also be used for this purpose).
Patentees seeking a revised patent term adjustment in a patent
issued on or after March 2, 2010, must file a request for
reconsideration under 37 CFR 1.705(d) that complies with the
requirements of 37 CFR 1.705(b)(1) and (b)(2) within two months of the
date the patent issued.
To the extent that the procedures adopted under the authority of 35
U.S.C. 2(b)(2) and 154(b)(3) require that any request for
reconsideration of the patent term adjustment indicated in the patent
must be filed within two months of the date the patent issued and
include the information required by 37 CFR 1.705(b)(2) and the fee
required by 37 CFR 1.18(e), these requirements are hereby sua sponte
waived for patents that meet all of the following criteria: (1) The
patent must be issued prior to March 2, 2010; (2) the patentee's sole
basis for requesting reconsideration of the patent term adjustment in
the patent is the USPTO's pre-Wyeth interpretation of 35 U.S.C.
154(b)(2)(A); and (3) the Request for Recalculation of the Patent Term
Adjustment in View of Wyeth form (PTO/SB/131) is filed within 180 days
of the day the patent was granted. See 37 CFR 1.183. This waiver does
not apply to patents issued on or after March 2, 2010, to requests that
the USPTO recalculate the patent term adjustment for alleged errors
other than that identified in Wyeth, or to any request for
reconsideration of the patent term adjustment indicated in the patent
filed later than 180 days after the patent was granted.
Paperwork Reduction Act: This notice involves information
collection requirements which are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
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(44 U.S.C. 3501 et seq.). The collection of information involved in
this notice is covered by OMB control number 0651-0020.
Patent Term Adjustment Information Displayed in PAIR: The USPTO
provides a patent term adjustment calculation screen that is viewable
through PAIR. The patent term adjustment screen has been displaying the
following information at the right hand column: (1) USPTO delay days
(the number of days of "A" and "C" delay); (2) Three Year Delay
days (the number of days of "B" delay); (3) Applicant Delay days (the
number of days by which the USPTO delay days will be reduced); and (4)
the Total Patent Term Adjustment. Patentees who use the PAIR patent
term adjustment calculation screen should note that it does not display
the periods of delay which overlap and thus is not adequate for
calculating the patent term under the Federal Circuit's interpretation
of 35 U.S.C. 154(b)(2)(A) in Wyeth. The USPTO plans to revise this
screen to show: (1) the number of days of "A" delay; (2) the number
of days of "B" delay; (3) the number of days of "C" delay; (4) the
number of days of "A" delay that overlap with a day of "B" delay
plus the number of days of "A" delay that overlap with a day of "C"
delay (the provisions of 35 U.S.C. 154(b)(1)(B)(ii) prevent a "B"
delay period and "C" delay period from overlapping); (5) the number
of days of non-overlapping USPTO delay; (6) the number of days of
applicant delay; and (7) the total patent term adjustment. The revised
PAIR patent term adjustment screen, however, will not be ready by March
2, 2010. The USPTO expects the revised PAIR patent term adjustment
screen to be ready by July of 2010.
Nothing in this notice shall be construed as a waiver of the
requirement of 35 U.S.C. 154(b)(4) that any civil action by an
applicant dissatisfied with a determination made by the Director under
35 U.S.C. 154(b)(3) be filed in the United States District Court for
the District of Columbia within 180 days after the grant of the patent.
January 26, 2010 DAVID J. KAPPOS
Under Secretary of Commerce for
Intellectual Property and
Director of the United States Patent
and Trademark Office
[1351 OG 204]