The United States Patent and Trademark Office (USPTO) is implementing a COVID-19 Prioritized Examination Pilot Program for small and micro entities. The program is intended to help independent inventors and small businesses bring "important and possibly life-saving treatments to market more quickly." This pilot program began on May 14, 2020 and is initially being limited to 500 requests. However, the USPTO indicates it will evaluate the program to determine if it should be expanded or limited.

While the objective of this new pilot program is to complete examination within approximately 12 months, the USPTO notes they will endeavor to shorten this time to six months if applicants reply to notices by the USPTO within 30 days.

In order to qualify, an application must have a claim that covers a product or process that is subject to an applicable U.S. Food and Drug Administration (FDA) approval for COVID-19 use. Examples of such FDA approvals mentioned by the USPTO include 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), and an Emergency Use Authorization (EUA).

Some additional requirements of this COVID-19 Prioritized Examination pilot program include:

• The request must be made at the time the application is filed,
• The request is limited to applications with no more than one priority claim, or with or after filing a request for continued examination (RCE), and
• There is a limit to number of claims in the application to no more than four independent claims and 30 total claims.