[Federal Register Volume 86, Number 71 (Thursday, April 15, 2021)]
[Notices]
[Pages 19877-19879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07704]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No. PTO-P-2021-0019]


Fast-Track Pilot Program for Appeals Related to COVID-19

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 
initiating the Fast-Track Pilot Program for Appeals Related to COVID-19 
to provide for the advancement of applications out of turn in ex parte 
appeals related to COVID-19 before the Patent Trial and Appeal Board 
(PTAB). An appellant who has filed an ex parte appeal of an application 
with claim(s) that cover a product or process related to COVID-19 (such 
product or process must be subject to an applicable U.S. Food and Drug 
Administration (FDA) approval for COVID-19 use) and received a notice 
that the appeal has been docketed may file a petition at no cost to 
expedite the review of his or her appeal without paying a petition fee. 
The Fast-Track Pilot Program for Appeals Related to COVID-19 sets a 
target of reaching a decision on an ex parte appeal within six months 
from the date the appeal is entered into the pilot program.

DATES: Applicability Date: Petitions for the pilot program can be filed 
starting on April 15, 2021. Duration: The Fast-Track Pilot Program for 
Appeals Related to COVID-19 is offered on a temporary basis, and 
petitions to request inclusion of an ex parte appeal in the pilot 
program will be accepted until 500 appeals have been accorded fast-
track status under the program. The USPTO may extend the Fast-Track 
Pilot Program for Appeals Related to COVID-19 (with or without 
modification) or may terminate it depending on the workload and 
resources needed to administer the program, feedback from the public, 
and the effectiveness of the program. If the pilot program is extended 
or terminated, the USPTO will notify the public.

FOR FURTHER INFORMATION CONTACT: Steven Bartlett, PTAB, by telephone at 
571-272-9797, or by email at [email protected].

SUPPLEMENTARY INFORMATION:

Background

    Appeals to the PTAB are normally taken up for decision in the order 
in which they are docketed. See USPTO Standard Operating Procedure 1 
(Sept. 20, 2018), available at www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/resources. Currently, the average 
appeal pendency is about 13 months. See PTAB Statistics, available at 
www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/statistics. However, a small number of appeals are advanced out 
of turn due to a special status. For example, reexamination 
proceedings, which are handled by the USPTO with ``special dispatch,'' 
and reissue applications are treated as special throughout their 
pendency, including during appeal. See Manual of Patent Examining 
Procedure (MPEP) 708.01. Applications that have been ``made special'' 
during examination through a petition based on the age or health of an 
applicant, or for other reasons listed in 37 CFR 1.102 (a)-(d), also 
maintain their special status through any appeal. See MPEP 1203(II). 
Furthermore, for the same reasons, an appellant may petition the PTAB 
to have an application on appeal made special. See id. Currently, about 
1.1% of appeals are given a special status through one of the above 
methods.
    Recently, the PTAB instituted the Fast-Track Appeals Pilot Program, 
in which the PTAB accepts petitions for advancing out of turn and 
according fast-track status to ex parte appeals that have already been 
docketed. 85 FR 39888 (July 2, 2020). This pilot program began on July 
2, 2020 and will continue for one year or until 500 appeals have been 
accorded fast-track status under the program. An appellant can seek 
fast-track status by submitting a petition to the Chief Administrative 
Patent Judge under 37 CFR 41.3 and paying the fee required under 37 CFR 
41.20(a), currently $420. The Fast-Track Appeals Pilot Program sets a 
target of reaching a decision on the ex parte appeal within six months 
from the date an appeal is entered into the pilot program. More 
information on the Fast-Track Appeals Pilot Program can be found at 
www.uspto.gov/patents/ptab/fast-track-appeals-pilot-program.
    In an extraordinary situation, 37 CFR 1.183 permits the USPTO to 
suspend or waive sua sponte any requirement of its regulations that is 
not a requirement of the patent statutes. The USPTO considers the 
effects of the COVID-19 pandemic that began in approximately January 
2020 to be an ``extraordinary situation'' within the meaning of 37 CFR 
1.183 for affected patent applicants and innovators. Consistent with 
the USPTO's determination under 37 CFR 1.183, the provisions of 35 
U.S.C. 2(b)(2)(G), and the COVID-19 Prioritized Examination Pilot 
Program, the USPTO has decided to implement the Fast-Track Pilot 
Program for Appeals Related to COVID-19, under which an appellant may 
have any ex parte appeal to the PTAB accorded fast-track status by 
filing a petition under 37 CFR 41.3, without payment of the petition 
fee under 37 CFR 41.20(a), for certain applications that claim products 
or processes that are subject to an applicable FDA approval for COVID-
19 use. Such approvals may include, but are not limited to, an 
Investigational New Drug (IND) application, an Investigational Device 
Exemption (IDE), a New Drug Application (NDA), a Biologics License 
Application (BLA), a Premarket Approval (PMA), or an Emergency Use 
Authorization (EUA). Information on INDs, IDEs, NDAs, BLAs, PMAs, and 
EUAs may be obtained at www.fda.gov.
    The Fast-Track Pilot Program for Appeals Related to COVID-19 will 
accept petitions for advancing out of turn and according fast-track 
status to ex parte appeals until 500 appeals have been accorded fast-
track status under the program. There is no time limit for receipt of 
these 500 COVID-19 related appeals. Additionally, the 500-appeal 
threshold for COVID-19 related appeals is distinct from the 500-appeal 
threshold used for the regular fast-track appeals pilot. The threshold 
of 500 granted petitions corresponds to approximately 8% of the total 
number of new appeals received in the average fiscal year and was 
chosen in accordance with maintaining the PTAB's overall decision 
pendency goals. Once the threshold of 500 granted petitions is met, the 
USPTO may extend the Fast-Track Pilot Program for Appeals Related to 
COVID-19 (with or without modification) or may discontinue it depending 
on the workload and resources needed to administer the program, 
feedback from the public, and the effectiveness of the program.

[[Page 19878]]

Requirements for Entry Into the Pilot Program

    The PTAB will accord fast-track status to a pending ex parte appeal 
under the following conditions:
    (1) The application must be an original utility, design, or plant 
nonprovisional application. The Fast-Track Pilot Program for Appeals 
Related to COVID-19 is not available for applications or proceedings 
that are already treated as special during appeal, such as reissue 
applications, reexamination proceedings, appeals made special due to 
the age or health of an applicant, or appeals subject to any other 
pilot program that advances an appeal out of turn, including the Fast-
Track Appeals Pilot Program. See MPEP 708.01 for a complete list of 
cases that are treated as special.
    (2) Petition Requirements.
    A petition under 37 CFR 41.3 must be filed in the application 
involved in the ex parte appeal for which fast-track status is sought 
and must identify that application and appeal by application number and 
appeal number, respectively. See MPEP 502.05. The petition may be 
submitted via: (1) The USPTO patent electronic filing systems (EFS-Web 
or Patent Center), (2) the U.S. Postal Service by Priority Mail Express 
under 37 CFR 1.10 or with a certificate of mailing under 37 CFR 1.8, or 
(3) hand-delivery to the USPTO Customer Service Window (MPEP 501). 
Electronic submission of a petition is preferred for faster petition 
processing. In addition, the appeal for which fast-track status is 
sought must be an appeal for which a notice of appeal has been filed 
under 37 CFR 41.31 and an appeal docketing notice has been mailed by 
the PTAB.
    The petition must certify that the application involved in the 
appeal claims products or processes that are subject to an applicable 
FDA approval for COVID-19 use. Such approvals may include, but are not 
limited to, an IND application, an IDE, an NDA, a BLA, a PMA, or an 
EUA. Information on INDs, IDEs, NDAs, BLAs, PMAs, and EUAs may be 
obtained at www.fda.gov.
    The USPTO has created a form-fillable Portable Document Format 
(PDF), ``Petition--Fast-Track Pilot Program for Appeals Related to 
COVID-19'' (Form PTO/SB/454), that is recommended for filing a petition 
under 37 CFR 41.3 for the Fast-Track Pilot Program for Appeals Related 
to COVID-19. Form PTO/SB/454 is available on the USPTO's website 
(www.uspto.gov/patent/patents-forms). Form PTO/SB/454 contains all 
necessary certifications for participation in the program. Form PTO/SB/
454 does not collect ``information'' within the meaning of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). See 5 CFR 
1320.3(h). Therefore, this notice does not involve information 
collection requirements that are subject to review by the Office of 
Management and Budget. It is recommended, but not required, that 
appellants use Form PTO/SB/454 when petitioning for entry into the 
Fast-Track Pilot Program for Appeals Related to COVID-19. Any petition 
filed by any means other than Form PTO/SB/454 must still contain the 
required information.
    (3) Signature Requirements.
    The petition under 37 CFR 41.3 must be signed by an applicant who 
is prosecuting the applicant's own case under 37 CFR 1.31 (except that 
a juristic entity must be represented by a registered practitioner even 
if the juristic entity is the applicant), a registered practitioner who 
has a power of attorney under 37 CFR 1.32, or a registered practitioner 
who has the authority to act under 37 CFR 1.34, in order for the 
application involved in the appeal to be accorded fast-track status.
    (4) Fee.
    The petition fee ordinarily required under 37 CFR 41.20(a) will be 
waived pursuant to 37 CFR 1.183.
    (5) Limit on Number of Ex Parte Appeals Accorded Fast-Track Status.
    The number of granted petitions in the Fast-Track Pilot Program for 
Appeals Related to COVID-19 is limited to a total of 500 granted 
petitions.
    The threshold of 500 granted petitions has been chosen to allow for 
robust participation in the Fast-Track Pilot Program for Appeals 
Related to COVID-19 without compromising the PTAB's ability to deliver 
on other appeal pendency goals. The limit of 500 granted petitions 
corresponds to approximately 8% of the total number of new appeals 
received in the average fiscal year. The USPTO may modify or terminate 
the pilot program depending on the workload and resources needed to 
administer the program, feedback from the public, and the effectiveness 
of the program.

Handling of Petitions in the Fast-Track Pilot Program for Appeals 
Related to COVID-19

    Petitions for entry into the Fast-Track Pilot Program for Appeals 
Related to COVID-19 will be decided in the order they are received. 
Petitions meeting the requirements listed above for entry into the 
pilot program will be granted, and the petitioner will be notified by a 
decision granting the petition to accord fast-track status. Petitions 
not meeting the requirements listed above for entry into the pilot 
program will be denied, and the petitioner will be notified of a 
decision denying the petition. A petitioner may reapply if a first 
petition is denied. Any second petition filed by a petitioner for the 
same application and same appeal covered by a first, failed petition 
will not be accorded the filing date of the first petition for purposes 
of determining whether the second petition fell within the threshold of 
500 granted petitions.
    The PTAB will communicate the number of granted petitions for fast-
track appeal via the PTAB web page, www.uspto.gov/PTABCOVIDFastTrack, 
and appellants should take this information into account when deciding 
whether to file a petition. The PTAB may also exercise discretion to 
grant a small number of petitions in excess of the threshold of 500 
granted petitions.

Conduct of Fast-Track Pilot Program for Appeals Related to COVID-19

(1) Time to Decision

    The goal for rendering a decision on the petition to accord fast-
track status to an ex parte appeal is no later than one month from the 
filing date of the petition. The goal for rendering a decision on the 
ex parte appeal is no later than six months from the date an appeal is 
entered into the program, which occurs when a petition to accord fast-
track status to the appeal is granted.

(2) When a Petition May Be Filed

    A petition may be filed anytime between (1) the date when the PTAB 
issues a notice that the appeal has been docketed to the PTAB, and (2) 
the date at which the appellant withdraws the appeal, a final decision 
is rendered by the PTAB under 37 CFR 41.50, or PTAB jurisdiction ends 
under 37 CFR 41.35. Petitions for fast-track status may be filed for ex 
parte appeals regardless of whether the appeal is newly docketed or was 
docketed previously. If the petition complies with the formal 
requirements (i.e., signature, identification of application, 
certification that the application claims a product or process subject 
to an applicable FDA approval for COVID-19 use), the appeal will be 
given fast-track status in accordance with current procedures, 
including the overall program threshold described above.

(3) Hearings

    Inclusion in the Fast-Track Pilot Program for Appeals Related to 
COVID-19 may be requested for ex parte appeals in which the appellant 
seeks an oral hearing before the PTAB (heard appeals), as well as those 
appeals for

[[Page 19879]]

which no oral hearing is requested (on-brief appeals). Hearings in ex 
parte appeals accorded fast-track status under the pilot program will 
be conducted according to the ordinary PTAB hearing procedures. 
Appellants seeking an oral hearing should submit with the request for 
oral hearing any preferences as to the time, date, or location of the 
hearing. The PTAB will make its best efforts to schedule a hearing in 
accordance with such preferences, consistent with the goals of the 
pilot program. If the PTAB is unable to accommodate an appellant's 
preferences, the PTAB will schedule the hearing in an available hearing 
room at any office, including a regional office, and at a time and date 
best suited to meeting the goals of the pilot program. If no such 
hearing room is available, the PTAB will schedule a hearing to be 
conducted by videoconference or telephone.
    Because an appellant seeks a faster decision and hearing room 
availability is limited, an appellant in an ex parte appeal accorded 
fast-track status may not seek to relocate (to a different office) the 
hearing after receiving a Notice of Hearing. An appellant who does not 
wish to attend the hearing at the designated location may, however, 
request to attend the hearing by videoconference or telephone, in 
accordance with current PTAB hearing procedures. An appellant may also 
waive the hearing and continue under the Fast-Track Pilot Program for 
Appeals Related to COVID-19 for consideration and decision on the 
briefs.
    An appellant may not reschedule the date or time of a hearing and 
remain in the Fast-Track Pilot Program for Appeals Related to COVID-19. 
If an appellant in an ex parte appeal accorded fast-track status must 
reschedule the date or time of a hearing and is not willing to waive 
the oral hearing, then the appellant may opt out of the Fast-Track 
Pilot Program for Appeals Related to COVID-19, thereby regaining the 
ability to reschedule or relocate the hearing as per ordinary PTAB 
hearing procedures.

(4) Termination of Fast-Track Status Under the Fast-Track Pilot Program 
for Appeals Related to COVID-19

    Fast-track status will be maintained in an ex parte appeal from the 
date at which the petition for inclusion in the Fast-Track Pilot 
Program for Appeals Related to COVID-19 is granted until the PTAB's 
jurisdiction ends under 37 CFR 41.35(b). Activities subsequent to an 
appellant's withdrawal from the pilot program or the PTAB's decision, 
including any reopened prosecution, will not be treated as subject to 
fast-track status, nor will filing a petition for inclusion in the 
Fast-Track Pilot Program for Appeals Related to COVID-19 cause an 
application to be accorded fast-track status outside the jurisdiction 
of the PTAB. Additionally, any request by an appellant that causes a 
delay in the conduct of the appeal, such as for an extension of time 
under 37 CFR 1.136(b), or for additional briefing, will be cause for 
the removal of fast-track status.

Status of the Pilot Program

    The Fast-Track Pilot Program for Appeals Related to COVID-19 is 
being adopted on a temporary basis until 500 appeals have been accorded 
fast-track status under the program. The USPTO may extend the Fast-
Track Pilot Program for Appeals Related to COVID-19 (with or without 
modification) or may discontinue the pilot program depending on the 
workload and resources needed to administer the program, feedback from 
the public, and the effectiveness of the program.
    The USPTO will notify the public when the threshold of 500 granted 
petitions for the Fast-Track Pilot Program for Appeals Related to 
COVID-19 is about to be reached, and with any further relevant 
information, on the PTAB web page at www.uspto.gov/PTABCOVIDFastTrack.

Andrew Hirshfeld,
Commissioner for Patents, Performing the Functions and Duties of the 
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2021-07704 Filed 4-14-21; 8:45 am]
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