As a companion to the COVID-19 Prioritized Examination Pilot Program and patent-related relief provided by the 2020 CARES Act, the United States Patent and Trademark Office (“USPTO”) recently announced a similar Fast-Track Appeals Pilot Program for patent applications claiming a process or product requiring FDA approval for COVID–19 use. In general, under 35 U.S.C. § 134, once an Applicant’s claims have been twice rejected, the Applicant has a right to appeal the Examiner’s decision to a panel of administrative patent judges on the Patent Trial and Appeal Board (“PTAB”). However, one drawback to the appeals process can be the average appeal pendency of 13 months to receive a decision.
The program will advance up to 500 of these applications out of turn and aims to provide a decision from the PTAB within six months from the appeal entering the pilot program. There is no time limit for receipt of these 500 COVID-19 related appeals. However, similar to the fast-track examination pilot program, this fast-track appeals pilot program also has several requirements that applications must satisfy for acceptance into the program. Specifically, the application:
- Must be an original utility, design, or plant non-provisional application
- Must not already be accepted into another fast-track appeals pilot program, such as appeals made special due to the age or health of an applicant
- Must file a signed petition under 37 C.F.R. § 41.3 without paying the $420 petition fee under 37 CFR 41.20(a)
- Must certify (via Form PTO/SB/454, for example) that the application includes claims which would require an applicable FDA approval for COVID–19 use, such as 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)
A petition to enter this fast-track appeals pilot program 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. The USPTO will evaluate each petition in the order they are received, but will require no more than one month to evaluate each petition.
Although effective vaccines have begun to have a positive impact on responding to the pandemic, the USPTO continues to provide relief and incentives for inventors and applicants innovating during this critical moment.