On May 8, the United States Patent and Trademark Office (USPTO) announced a new COVID-19 Prioritized Examination Pilot Program (CPEPP). This pilot program grants prioritized examination to applicants qualifying for small or micro entity status and waives payment of certain fees otherwise associated with prioritized examinations. To qualify for this program, the claims of the pending application must be directed to a product or process related to COVID-19, such as its treatment and/or prevention, and the technology must also be subject to FDA approval.

The goal of the program is to provide a final disposition regarding patentability of the application’s claims within 12 months. Final dispositions under CPEPP include the following:

• Mailing of a notice of allowance
• Mailing of a Final Office action
• Filing of a request for continued examination (RCE)
• Abandonment of the application
• Filing of a Notice of Appeal

An applicant may further expedite the time to final disposition, for example to 6 months, by replying to Office Actions and Notices within 30 days of a notice from the USPTO.

Duration

The CPEPP will accept a total of 500 requests for prioritized examination. The number of accepted requests may be increased or terminated based on agency resources and the public will be notified.

Fees

The examination fee and processing fee normally associated with prioritized examinations will be waived under the CPEPP. Any remaining fees will still require payment.

Requirements

1. The CPEPP request must be made:

• With the filing of a non-continuing original nonprovisional application
• With the filing of a continuation application, a divisional application, a continuation-in-part application, or a U.S. national stage entry application from a PCT application
• With or after the filing of a request for continued examination

2. The applicant must certify that at least one pending claim in the CPEPP application covers a product or process related to treatment and/or prevention of COVID-19 and subject to FDA approval, such as:

• Investigational New Drug (IND) application
• Investigational Device Exemption (IDE)
• New Drug Application (NDA)
• Biologics License Application (BLA)
• Premarket Approval (PMA)
• Emergency Use Authorization (EUA)

3. The request must include a certification that the applicant qualifies for either small entity or micro entity status when the CPEPP request is made.

4. The CPEPP request must include an executed application data sheet.

5. The USPTO encourages the use of form PTO/SB/450, titled “Certification and Request for COVID-19 Prioritized Examination Pilot Program” to make the request for prioritized examination under the CPEPP pilot. A copy of the form is available here:

https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012

Additional information including the processing of the request under the pilot program and replying to Office Actions can be found in the Agency Notice.

Comments should be sent by email address to Covid19PrioritizedExamPilot@uspto.gov