From The Field

June 9, 2020

On May 8, 2020, the USPTO announced that it will initiate a COVID-19 Prioritized Examination Pilot Program, under which it will accept 500 qualifying patent applications for prioritized examinations and exempt them from the normal prioritized examination fees.  Prioritized examination puts an application on a fast track rather than waiting for examination to begin in the normal queue, which may take years.

On May 18, 2020, the USPTO rolled out the details regarding this program.  The program will begin accepting requests on July 13, 2020, and it will continue until such time as the USPTO has accepted a total of 500 requests.  For now, the program only accepts applications from qualifying small entities or micro entities, which are typically resource-constrained small firms, individual inventors, or universities.

To qualify for this pilot program, the applicant must certify that at least one of the pending claims covers a product or process related to COVID-19, and that such product or process is subject to an applicable FDA approval for COVID-19 use.  Such approvals may include, but are not limited to, an 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).  Except for the prioritized examination fee payment, other normal requirements for any prioritized examination requests also must be satisfied to qualify for participation in the pilot program.

Once the PTO grants a prioritized examination request, the application will proceed under prioritized examination (also known as “Track 1”).  The requirements for maintaining the application on the fast track are the same as for fee-based prioritized examinations.  For example, the prioritized examination will be terminated if an applicant files a petition for an extension of time to respond to an office action.  The case would then be removed from the examiner’s special docket and placed on the examiner’s regular docket.

The goal of the prioritized examination is to reach a final disposition within 12 months from the filing date of the application.  The final disposition may be, among other things, a notice of allowance, a Final Office Action, a Request for Continued Examination (RCE), or a filing of a Notice of Appeal.  Just as with fee-based prioritized examinations, if the applicant files an RCE or an Appeal, the application will not retain its special status.  The applicant can make a second request for prioritized examination with or after filing an RCE.  But, after this second request, no further such requests can be granted in the same application..

An applicant may abandon the application that has been granted special status under the COVID-19 Pilot Program in favor of a continuing application.  However, a continuing application will not automatically be given prioritized examination status based on the request filed in the parent application.

Additional details regarding this pilot program are available at https://www.federalregister.gov/documents/2020/05/14/2020-10372/covid-19-prioritized-examination-pilot-program

Author: Ray Huang