In addition to the COVID-19 Priority Examination Pilot Program and patent-related relief provided by the CARES Act of 2020, the US Patent and Trademark Office (“USPTO”) recently announced a similar fast-track patent filing appeals pilot program, a process or product that requires COVID-19 FDA approval for use. In general, under 35 USC § 134, after two rejections of an applicant’s claims, the applicant has the right to appeal the examiner’s decision to a jury of administrative patent judges on the Patent Trial and Appeal Board (“PTAB”). However, one downside to the appeal process may be the average period of 13 months to appeal to a decision.
The program will override up to 500 of these requests and aims to reach a decision by PTAB within six months of the objection being included in the pilot program. There is no time limit for receiving these 500 COVID-19-related complaints. Similar to the Fast Track Exam Pilot Program, however, this Fast Track Exam pilot program also has several requirements that applications for admission to the program must meet. In particular the application:
- Must be a non-provisional application of an original utility, design, or plant operation
- Must not already be included in another pilot program for rapid appointment procedures, e.g. B. Appeal procedures specifically conducted based on the age or state of health of an applicant
- Must file a signed petition per 37 CFR § 41.3 without paying the $ 420 petition fee per 37 CFR 41.20 (a).
- Must certify (e.g. via Form PTO / SB / 454) that the application contains claims that would require applicable FDA approval for the use of COVID-19, e.g. a New Drug Application (NDA), a Biologics License Application (BLA), a Premarket Approval (PMA) or an Emergency Use Authorization (EUA)
An application to participate in this pilot program for rapid complaints can be made at any time between (1) the date on which the PTAB publishes a notice that the complaint has been submitted to the PTAB and (2) the date on which the complainant withdraws the complaint, a final decision will be made by the PTAB under 37 CFR 41.50, or the responsibility of the PTAB ends under 37 CFR 41.35. The USPTO evaluates each petition in the order it is received, but does not take more than a month to evaluate each petition.
Although effective vaccines are starting to have a positive impact on responding to the pandemic, the USPTO continues to provide facilities and incentives to innovate at this critical moment.