[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

[[Page 20344]]

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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