After offering to expedite review of trademark applications for COVID-19 products and services, the USPTO has now launched a prioritized examination pilot program for certain patent applications “that claim products or processes that are subject to an applicable FDA approval for COVID-19 use.”

After identifying the COVID-19 outbreak as an “extraordinary situation,” USPTO Director Andrei Iancu implemented the pilot program with the goal of providing final disposition of qualifying patent applications within one year. The program will accept up to 500 qualifying patent applications without requiring payment of certain fees that are typically associated with the prioritized examination if certain conditions are met.

According to the USPTO website, to qualify, applicants must meet the following conditions:

• Subject to FDA COVID-19 approval: The application must claim a product or a process that is subject to applicable FDA approval for COVID-19 use. FDA 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).
• Small or micro-entity: The Applicant must qualify for either small or micro-entity status, at the time the request for prioritized examination under the pilot program is made. Small and micro-entities include nonprofit organizations and certain small businesses. For more details on small and micro-entity status, see this post.
• Priority claim and application status: The application claims priority to no more than one earlier US non-provisional or PCT application. Applications that are currently under a request for continued examination (RCE) are also eligible to apply for prioritized examination under this program; however, such a request must be filed before the mailing of the first USPTO Office Action after the filing of the RCE.

Examination and grant
According to the Federal Register notice announcing the pilot program, the objective of the pilot program is to complete, on average, the examination of an application within 12 months of the date of the decision granting the petition to expedite review. The notice further stated that the USPTO would “endeavor to reduce” the application time frame to six months if all replies occur within 30 days of a notice by the USPTO after the request for prioritized examination has been approved.

Total number of applications
The USPTO currently capped the total number of requests under this pilot program at 500. However, according to the USPTO, the pilot program may be extended (with or without modifications) or terminated earlier depending on the workload and resources needed to administer the program, feedback from the public, and the effectiveness of the program. The USPTO’s “Track 1” Prioritized Patent Examination program started with a similar pilot status, and has since become a routine option available to all qualifying applicants.

Status
The pilot program is effective as of May 14, 2020. As of June 18, the USPTO had received 122 applications to the program, 35 of which were granted, leaving 465 spots available.

Fee waiver
The USPTO is waiving the following fees that are normally associated with the request for prioritized examination under the pilot program:

• the prioritized examination fee of $1,000 for a micro-entity, or $2,000 for a small entity as set forth in 37 CFR 1.17(c); and
• the processing fee of $35 for a micro-entity, or $70 for a small entity as set forth in 37 CFR 1.17(i).