Need an expedited decision on your ex parte appeals related to COVID-19?
The USPTO has implemented the COVID-19 Prioritized Examination Pilot Program to prioritize the examination of certain patent applications claiming a product or process subject to an applicable FDA approval for COVID–19 use.
As a companion to the COVID-19 prioritized examination, the USPTO has implemented the Fast-Track Pilot Program for Appeals Related to COVID-19, under which an appellant may have certain COVID-19-related ex parte appeals before the Patent Trial and Appeal Board (PTAB or Board) accorded fast-track status. Appellants simply file a petition to request fast-track review of their COVID-19-related ex parte appeal—i.e., an appeal of an application that claims a product or process that is subject to an applicable FDA approval for COVID–19 use. No petition fee is required.
The PTAB has set a target of issuing a decision within six months from the date the petition is granted and the COVID-19-related ex parte appeal is entered into the pilot program.
The Fast-Track Pilot Program for Appeals Related to COVID-19 is effective on April 15, 2021. This means an appellant may file a petition for inclusion of a COVID-19 related ex parte appeal in the pilot program starting on April 15, 2021.
Read the Federal Register Notice here
To qualify for fast-track status under this pilot, the following three conditions must be met:
- Application type: The application must be an original utility, design, or plant non-provisional application and must claim a product or process 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).
- Status of appeal: The appeal for fast-track status must be an ex parte appeal for which a notice of appeal has been filed and a PTAB docketing notice has been issued by the USPTO (i.e., the appeal is pending before the PTAB).
- Petition: The appellant must file a petition under 37 C.F.R. § 41.3, preferably via the USPTO’s electronic filing system identifying the application and appeal by application number and appeal number, respectively, for which fast-track review is sought. 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.
- Form: Petition—Fast-Track COVID-19 Related Appeals Pilot Program (Form PTO/SB/454)
Time to decision
The Board has set a target of issuing a decision on the merits of the appeal within six months from the date that a petition for fast-track review is granted. Appellants can expect a decision on their petition for fast-track status in approximately two business days.
Granted petition limits
The USPTO has limited the number of granted petitions to 500 for the duration of the Fast-Track Pilot Program for Appeals Related to COVID-19.
The table shows the status of the number of petitions received, the number of petitions granted, as well as open slots available.
|Granted petitions (Heard appeals)|
Available petition slots
Note: The petition denied was due to not being under PTAB jurisdiction
Hearings for COVID-19 related fast-track appeals
Hearings in ex parte appeals accorded COVID-19-related fast-track status will be conducted according to ordinary PTAB hearing procedures.
An appellant who does not wish to attend the hearing at the designated place, date, and time may waive the hearing. If the designated place is inconvenient, an appellant may request to attend the hearing by telephone. An appellant may not reschedule a hearing and remain in the pilot program.
Frequently asked questions