USPTO Announces COVID Fast-Track Appeals Pilot Program
The USPTO recently announced a companion to the COVID-19 Prioritized Examination Pilot Program, the COVID Fast-Track Appeals Pilot Program. The goal is to expedite the processing of ex-parte appeals for applications related to COVID-19.
The USPTO has put a lot of effort into helping inventors and patent practitioners deal with the fallout of the COVID-19 pandemic. One of these efforts includes the COVID-19 Prioritized Examination Pilot Program for small and micro-entities.
Established in May 2020, the program waives application fees and shortens the consideration timeline for applications covering a product or process subject to FDA approval for COVID-19-related uses. In April 2021, the Office announced a companion to that pilot program, the COVID Fast-Track Appeals Pilot Program.
What does the program do?
Like the expedited prosecution pilot program, the COVID Fast-Track Appeals Pilot Program expedites the processing of ex-parte appeals for appellants whose applications claim a product or process that is subject to FDA approval for COVID-19-related uses. Applications eligible for consideration under the program include:
- Investigational New Drug (IND) applications
- Investigational Device Exemptions (IDE)
- New Drug Applications (NDA)
- Biologics License Applications (BLA)
- Premarket Approvals (PMA)
- Emergency Use Authorizations (EUA)
The appellant must file its appeal under 37 C.F.R. § 41.3 and identify the application and appeal by application number and appeal number to be considered for the program. The petition must certify that the application claims products or processes subject to FDA approval for COVID–19-related use. There is no petition fee.
How soon will the PTAB render a decision?
Appellants will receive a decision on approval within two business days of filing. Once approved, the PTAB aims to make a decision within six months from the date the appeal is entered into the pilot program. Appeals in the fast-track program will continue to receive expedited review through a rehearing, should the appellant request one.
Are there any limits on the program?
Unlike the COVID-19 Prioritized Examination Pilot Program, the fast-track appeals program is not limited to small and micro entities — entities of any size are eligible for participation. However, the program does impose several limitations. Most importantly, granted petitions are limited to 500 for the entire duration of the program. The number of slots available does not reset periodically as with other USPTO pilot programs. Certain types of “special” applications and proceedings are also excluded from the program, including:
- Reissue applications
- Reexamination proceedings
- Appeals made special due to the age or health of the applicant
- Appeals already expedited under the Fast-Track Appeals Pilot Program
Furthermore, applications examined under the COVID-19 Prioritized Examination Pilot Program are not automatically granted fast-track appeal status. Appellants in those cases must submit a petition for fast-track review on the same basis as everyone else.
When does it start?
The program officially began accepting applications on April 15, 2021, and there is no sunset date.
Appeals to the PTAB can be tricky and expensive, even for those that receive expedited review. And an appeal is not always the optimal path to allowance — in many cases, an examiner interview or RCE is more effective. Using an analytics tool like Juristat can help practitioners make informed decisions as to whether an appeal is the right move for their client’s application. Request a demo of Juristat today.