[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20343-20345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09600]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
[Docket No. PTO-P-2019-0007]
Patent Term Adjustment Procedures in View of the Federal Circuit
Decision in Supernus Pharm., Inc. v. Iancu
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice.
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SUMMARY: The United States Patent and Trademark Office (USPTO) is
modifying its patent term adjustment procedures in view of the decision
by the U.S. Court of Appeals for the Federal Circuit (Federal Circuit)
in Supernus Pharm., Inc. v. Iancu (Supernus). The USPTO makes the
patent term adjustment determinations indicated in patents by a
computer program that uses information recorded in its Patent
Application Locating and Monitoring (PALM) system. The event from which
the Federal Circuit measured the beginning of the patent term
adjustment reduction period in Supernus--a notice to the applicant from
a foreign patent authority--is not an event that is recorded in the
USPTO's PALM system. Thus, the USPTO will continue to make the patent
term adjustment determinations indicated in patents under the existing
regulations using information recorded in its PALM system. A patentee
who believes that the period of patent term adjustment reduction
exceeds the period of time during which the patentee failed to engage
in reasonable efforts to conclude prosecution of the application may
raise the issue in a timely request for reconsideration of the patent
term adjustment, providing any relevant information that is not
recorded in the USPTO's PALM system. The USPTO's decision on any timely
filed patentee request for reconsideration will apply the Federal
Circuit's decision in Supernus in view of the information presented by
the patentee.
DATES: The procedure set forth in this notice is effective on May 9,
2019.
FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Senior Legal Advisor,
Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patent Examination Policy, at 571-272-7757.
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 reasons: (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)) (``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)) (``B'' delays);
and (3) for delays due to a proceeding under 35 U.S.C. 135(a) (e.g.,
derivation, interference, secrecy order, or successful appellate review
(35 U.S.C. 154(b)(1)(C)) (``C'' delays). 35 U.S.C. 154(b)(2) places
limitations on the period of patent term adjustment granted under 35
U.S.C. 154(b)(1), one of which is that the period of patent term
adjustment under 35 U.S.C. 154(b)(1) shall be reduced by a period equal
to the period of time during which the applicant failed to engage in
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reasonable efforts to conclude prosecution (or processing or
examination) of the application (35 U.S.C. 154(b)(2)(C)(i)). 35 U.S.C.
154(b)(2) directs the USPTO to ``prescribe regulations establishing the
circumstances that constitute a failure of an applicant to engage in
reasonable efforts to conclude processing or examination of an
application.'' (35 U.S.C. 154(b)(2)(C)(iii)). The USPTO has prescribed
such regulations in 37 CFR 1.704. Further, 35 U.S.C. 154(b)(3)(A)
directs the USPTO to ``prescribe regulations establishing procedures
for the application for and determination of patent term adjustments.''
The USPTO has prescribed such regulations in 37 CFR 1.705.
On January 23, 2019, the Federal Circuit issued a decision in
Supernus pertaining to the patent term adjustment provisions of 35
U.S.C. 154(b), and specifically to a reduction of patent term
adjustment under 37 CFR 1.704(c)(8) resulting from the submission of an
information disclosure statement after the filing of a request for
continued examination under 37 CFR 1.114. See Supernus Pharm., Inc. v.
Iancu, 913 F.3d 1351 (Fed. Cir. 2019). Specifically, the applicant in
Supernus filed a supplemental information disclosure statement on
November 29, 2012, after the filing of a request for continued
examination on February 22, 2011. Id. at 1354-55. The supplemental
information disclosure statement of November 29, 2012 in Supernus
contained documents cited by the European Patent Office (EPO) in the
counterpart EPO patent (from an opposition filed in the EPO patent) in
a notice issued by the EPO on August 21, 2012. Id. The supplemental
information disclosure statement of November 29, 2012 also included the
opposition filed in the EPO patent and the EPO's notice of the
opposition. Id.
37 CFR 1.704(c)(8), the regulatory provision at issue in Supernus,
provides as a circumstance that constitutes a failure of the applicant
to engage in reasonable efforts to conclude prosecution (processing or
examination) of an application: ``Submission of a supplemental reply or
other paper, other than a supplemental reply or other paper expressly
requested by the examiner, after a reply has been filed, in which case
the period of adjustment set forth in Sec. 1.703 shall be reduced by
the number of days, if any, beginning on the day after the date the
initial reply was filed and ending on the date that the supplemental
reply or other such paper was filed.'' Id. The Federal Circuit in
Supernus noted that it previously held 37 CFR 1.704(c)(8) to be `` `a
reasonable interpretation of the [patent term adjustment] statute'
insofar as it includes `not only applicant conduct or behavior that
results in actual delay, but also those having the potential to result
in delay irrespective of whether such delay actually occurred.' '' 913
F.3d at 1356 (quoting Gilead Scis., Inc. v. Lee, 778 F.3d 1341, 1349-50
(Fed. Cir. 2015)). And also that 37 CFR 1.704(c)(8) ``encompasses the
filing of a supplemental [information disclosure statement] in the
calculated delay period.'' Id. The Federal Circuit, however, held that
the period of reduction provided for in 37 CFR 1.704(c)(8) as applied
in Supernus exceeded the period of time during which Supernus failed to
engage in reasonable efforts to conclude prosecution of the application
because there were no identifiable efforts that Supernus could have
undertaken to conclude prosecution of its application during the period
between the filing of the request for continued examination (on
February 22, 2011) and the EPO's notice of the opposition (on August
21, 2012). Id. at 1360. Specifically, the Federal Circuit held that as
35 U.S.C. 154(b)(2)(C)(i) provides that patent term adjustment ``shall
be reduced by a period equal to the period of time during which the
applicant failed to engage in reasonable efforts to conclude
prosecution of the application,'' the USPTO cannot count as applicant
delay under 35 U.S.C. 154(b)(2)(C) ``a period of time during which
there is no identifiable effort in which the applicant could have
engaged to conclude prosecution.'' Supernus, 913 F.3d at 1359.\1\ Thus,
the Federal Circuit restricted the patent term adjustment reduction
under 37 CFR 1.704(c)(8) due to the filing of the supplemental
information disclosure statement on November 29, 2012 to 100 days,
corresponding to the period between the notice issued by the EPO on
August 21, 2012 and the filing of the supplemental information
disclosure statement on November 29, 2012. Id. at 1360.
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\1\ The patent term adjustment reduction at issue in Supernus
can be avoided by the prompt submission of the information
disclosure statement. Specifically, 37 CFR 1.704(d) provides a
``safe harbor'' in that a paper containing only an information
disclosure statement in compliance with 37 CFR 1.97 and 1.98 will
not be considered a failure to engage in reasonable efforts to
conclude prosecution (processing or examination) of the application
under 37 CFR 1.704(c)(6), (c)(8), (c)(9), or (c)(10) if the
information disclosure statement is accompanied by one of the
statements set forth in 37 CFR 1.704(d)(1)(i) or (d)(1)(ii). See
Interim Procedure for Requesting Recalculation of the Patent Term
Adjustment With Respect to Information Disclosure Statements
Accompanied by a Safe Harbor Statement, 83 FR 55102 (Nov. 2, 2018).
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The final rule to implement the patent term adjustment provisions
of the Leahy-Smith America Invents Act Technical Corrections Act
contains a comprehensive discussion of the USPTO's procedures for
patent term adjustment determinations and requests for reconsideration
of the patent term adjustment determinations. See Revisions to
Implement the Patent Term Adjustment Provisions of the Leahy-Smith
America Invents Act Technical Corrections Act, 79 FR 27755, 27757-58
(May 15, 2014). The USPTO makes the patent term adjustment
determinations indicated in patents by a computer program that uses
information recorded in its PALM system relating to the communications
exchanged between applicants and the Office during the patent
application process. Id. at 27757. The patent term adjustment
determination to be indicated in a patent is calculated at the time of
the mailing of the Issue Notification and is provided with the Issue
Notification and printed on the front page of the patent. The event
from which the Federal Circuit measured the beginning of the patent
term adjustment reduction in Supernus (the EPO's notice to Supernus of
the opposition on August 21, 2012) is an event external to the USPTO
and is thus not an event that is recorded in the USPTO's PALM system.
In addition, the USPTO expects that the situation in Supernus should
arise infrequently. An extended delay between the filing of a request
for continued examination and the subsequent Office action (932 days in
Supernus) should be a rare occurrence now, as the average time between
the filing of a request for continued examination and the subsequent
Office action is currently only 79 days. Thus, the USPTO's patent term
adjustment determinations indicated in patents as provided for in 37
CFR 1.705(a) will continue to be based upon the beginning and ending
dates of events recorded in the USPTO's PALM system as specified in 37
CFR 1.703 and 1.704 (including 37 CFR 1.704(c)(8)).
A patentee dissatisfied with the patent term adjustment indicated
on the patent may file a request for reconsideration under 37 CFR
1.705(b). A patentee who believes that the period of reduction provided
for in 37 CFR 1.704(c)(8) (or any of 37 CFR 1.704(c)) exceeds the
period of time during which the patentee failed to engage in reasonable
efforts to conclude prosecution of the application because there is no
identifiable effort the patentee could have undertaken to conclude
prosecution of the underlying
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application \2\ may raise the issue in a timely request for
reconsideration of the patent term adjustment under 37 CFR 1.705(b).
The request for reconsideration must provide any relevant information,
including factual support, which is not recorded in the USPTO's PALM
system to show that there was no identifiable effort the patentee could
have undertaken to conclude prosecution of the underlying application
during a portion of the period provided for in 37 CFR 1.704(c)(8) (or
any of the periods set forth in 37 CFR 1.704(c)). For example, in a
situation analogous to Supernus, the request for reconsideration must
include the facts concerning how and when each of the documents
contained in the information disclosure statement at issue were first
cited by the USPTO or a foreign patent authority in a related or
counterpart application. See 37 CFR 1.705(b)(2)((iv) (stating that a
request for reconsideration must be accompanied by a statement of the
facts involved, specifying ``[a]ny circumstances during the prosecution
of the application resulting in the patent that constitute a failure to
engage in reasonable efforts to conclude processing or examination of
such application as set forth in [37 CFR] 1.704''). The USPTO's
decision on any timely filed patentee request for reconsideration will
apply the Federal Circuit's decision in Supernus in view of the
information presented by the patentee.
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\2\ An argument presenting a justification for a failure to
engage in reasonable efforts to conclude prosecution is distinct
from an argument that there is no identifiable effort a patentee
could have undertaken to conclude prosecution. 35 U.S.C.
154(b)(3)(C) provides for reinstatement of ``all or part of the
cumulative period of time of an adjustment under [35 U.S.C.
154(b)(2)(C)(ii)] if the applicant, prior to the issuance of the
patent, makes a showing that, in spite of all due care, the
applicant was unable to respond within the 3-month period'' and is
distinct from an argument that there is no identifiable effort a
patentee could have undertaken to conclude prosecution. Any request
for reinstatement of ``all or part of the cumulative period of time
of an adjustment under [35 U.S.C. 154(b)(2)(C)(ii)]'' on the basis
of ``a showing that, in spite of all due care, the applicant was
unable to respond within the 3-month period'' must comply with the
requirements of 35 U.S.C. 154(b)(3)(C) and 37 CFR 1.705(c).
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While the USPTO has adopted ad hoc procedures for seeking
reconsideration of the patent term adjustment determination in the past
when there have been changes to the interpretation of the provisions of
35 U.S.C. 154(b) as a result of court decisions, these ad hoc
procedures were adopted because former 35 U.S.C. 154(b)(4) provided a
time period for seeking judicial review that was not related to the
filing of a request for reconsideration of the USPTO's patent term
adjustment determination or the date of the USPTO's decision on any
request for reconsideration of the USPTO's patent term adjustment
determination. See 79 FR at 27759. As 37 CFR 1.705 now provides that
its two-month time period may be extended under the provisions of 37
CFR 1.136(a) (permitting an applicant to request reconsideration of the
patent term adjustment indicated on the patent as late as seven months
after the date the patent was granted), the USPTO is not adopting an ad
hoc procedure for requesting a patent term adjustment recalculation
specifically directed to the Federal Circuit decision in Supernus. Id.
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
(44 U.S.C. 3501 et seq.). The collection of information involved in
this notice is covered by OMB control number 0651-0020.
Dated: May 3, 2019.
Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2019-09600 Filed 5-8-19; 8:45 am]
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