| Allowance, Patent Term Adjustment or Extension |
Referenced Items (296, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310, 311, 312) |
(296) 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.
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 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
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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.
\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).
The final rule to implement the patent term adjustment provisions of the
Leahy-Smith America Invents Act Technical Corrections Act contains a
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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
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.
\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
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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).
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.
May 3, 2019 ANDREI IANCU
Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office
[1463 OG 126]