The USPTO recently announced a pilot program to provide deferred fees to provisional patent applications useful for COVID-19 relief. The COVID-19 Provisional Patent Application Program started on September 17, 2020, and is currently scheduled to last for 12 months. Provisional applications within the program defer the fees usually due on filing a provisional patent application until a non-provisional patent application claiming priority back to the provisional is filed. The one-year deadline for a non-provisional application has not been extended for these applications, only the due date for filing fees. The deferred provisional application fees will be due at the time of filing a corresponding non-provisional application. The USPTO is making this program available with a goal of early disclosure to encourage the development of new products and processes to combat COVID-19. The USPTO encourages sharing the technical material of provisional patent applications within the program with collaborators or potential investors to advance COVID-19 innovation.
A feature of the program is the early public availability of the technical disclosure of the provisional patent application. Generally, provisional patent applications are not available for direct public inspection, although they can become available indirectly on publication of a non-provisional patent application claiming priority to the provisional. Provisional patent applications in the COVID-19 Provisional Patent Application Program, however, will be posted by the USPTO into a searchable public database. Applications in the program will be posted to the database directly after filing, even in the absence of filing a corresponding non-provisional application. Disclosures within the database can be considered as prior art by the USPTO. Even if no corresponding non-provisional application is filed, the provisional patent application will remain in the USPTO searchable database. The USPTO currently has no provision for the withdrawal of applications from the program or from the searchable public database.
Candidate applications for the pilot program must submit a specific cover sheet with a certification that the disclosure includes to a product or process related to COVID-19 and that the product or process is subject to an FDA approval for COVID-19 use. Examples of these approvals include an Investigational New Drug Application (NDA), 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). There is no requirement that the FDA approval process begins before the application is filed, only that the product or process in the disclosure that relates to COVID-19 use would be subject to a premarket regulatory review prior to commercial marketing or use.
The conditions of the COVID-19 Provisional Patent Application Program should be considered by potential applicants prior to filing applications within the program. Some applicants might consider the deferral of provisional patent application fees to be too little incentive to participate given the other conditions of the program. However, applicants with innovations that meet the program criteria and are interested in deferring provisional application costs until a later time could find the program helpful.
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