TAKEAWAY: The USPTO has implemented a pilot program allowing applicants to fast-track ex parte appeals in applications relating to COVID-19 in order to receive a decision from the PTAB within an estimated six months.
The new pilot program is available to applicants seeking to overturn an adverse patentability decision through an ex parte appeal. Under the new pilot program, when an applicant’s appeal has been docketed at the USPTO Patent Trial and Appeal Board (PTAB), the applicant can file a petition to request fast-track review. The appeal must be for a COVID-19-related application — an application that claims a product or process that is subject to applicable FDA approval for COVID-19 use. No petition fee is required.
The PTAB aims to issue a decision within six months from the date the appeal is entered into the program. The average duration for an ex parte appeal is currently about 15 months.
To qualify for fast-track status under the new program, the USPTO has set the following requirements:
- the application is an original utility, design, or plant nonprovisional application that claims a product or process subject to FDA approval for COVID-19 use (e.g., Investigational New Drug (IND) application, Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval (PMA), or Emergency Use Authorization (EUA));
- the appeal is already pending before the PTAB (i.e., a notice of appeal was filed and a PTAB docketing notice issued); and
- a petition for the pilot program (Form PTO/SB/454) is submitted.
The PTAB will accept petitions until 500 appeals have been granted fast-track status during the duration of the program. Applicants can check the number of granted petitions on the USPTO website.
Please see the Federal Register Notice for additional information.