USPTO Announces COVID-19 Prioritized Examination Pilot Program for Small and Micro Entities

The United States Patent and Trademark Office (USPTO) announced May 5, 2020 a special pilot program that will provide for accelerated examination of patent applications without payment of additional fees for prioritized examination. The pilot program applies to certain applications that claim products or processes that are subject to an applicable FDA approval for COVID-19 use and is limited to applicants that qualify for either small- or micro-entity filing status. Capacity of the pilot program is for the first 500 accepted requests.

According to the Federal Register Notice, applications that may be approved under this pilot program include applications that claim products or processes that are subject to an applicable FDA approval for COVID-19 use. Examples of corresponding FDA approvals 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). As further stated in the Notice, the USPTO’s goal of prioritized examination is to provide a final disposition within 12 months, on average, from the date the prioritized status has been granted. The USPTO further believes it can achieve final disposition of an application within six months if applicants respond in a timely manner to all notices or actions issued by the Office.

Note that the Office is still requiring a petition process for prioritized examination under this pilot program. In other words, it appears the Office will not sua sponte treat qualifying COVID-19-related applications as being prioritized. The request for prioritized examination must be filed at one of the following times: (1) the filing of a non-continuing original application; (2) the filing of an original application that claims priority to no more than one provisional application; or (3) the filing of a Request for Continued Examination (RCE) (though only one prioritization request can be filed per application by RCE).

For more information regarding the USPTO's special pilot program, please contact your local Quarles & Brady attorney or:

• James Aquilina: (202) 780-2637 / james.aquilina@quarles.com