The United States Patent and Trademark Office (USPTO) announced a Prioritized Examination Pilot Program for COVID-19-related patent applications. To qualify, an applicant must be a small entity or micro-entity and the application must contain at least one claim covering products or process that are subject to U.S. Food and Drug Administration (FDA) approval for uses related to COVID-19.
This pilot program is generally similar to the USPTO’s Track One Prioritized Examination, but offers some additional advantages. First, prioritized examination fees are waived (a total of $2,070 for small entities, $1,035 for micro-entities). Second, the application may receive final disposition (such as a Notice of Allowance or a Final Office Action) within as little as six months.
To qualify, the applicant must be a small entity (37 CFR 1.27; typically a small business with 500 employees or less or a nonprofit) or a micro-entity (37 CFR 1.29; typically individual inventors with income below a threshold). Large entity applicants can still consider Track One Prioritized Examination, which requires a payment of a fee but does not require the claimed invention to be subject to FDA approval.
Under the pilot program, the USPTO will aim to complete examination and make a final disposition within 12 months of the grant of the request (possibly within 6 months, if the applicant responds within 30 days to USPTO notices). The USPTO will accept 500 requests, but the limit may be extended. The request must be filed with the filing of a utility or plant non-provisional application or with or after filing of a request for continued examination (RCE). The pilot program also includes requirements similar to the Track One program. See USPTO COVID-19 Pilot Program Website and the Federal Register Notice for details. Interested applicants should contact patent counsel regarding benefits and requirements of the pilot program.
Should you have any questions about U.S. and foreign patent prosecution strategy, and FDA-related regulatory matters, our U.S. and foreign offices are operating remotely and are ready to provide assistance. Morrison & Foerster’s COVID-19 Resource Center also provides updated multidisciplinary guidance to help you face these evolving issues.