On September 16, 2020, the United States Patent and Trademark Office (USPTO) announced a new pilot program for COVID-19 related inventions. The new program allows for the deferral of filing fees for provisional patent applications directed to a product or process related to COVID-19, where the product or process requires Food and Drug Administration (FDA) approval for COVID-19 use. In exchange for the fee deferral, the applicant must allow the technical subject matter disclosed in their provisional application to be made publically available in a searchable database the USPTO’s website immediately upon filing. This new and interesting program is intended to facilitate innovation.
It is well-understood that the underlying policy of the patent system is to foster innovation by encouraging inventors to publically share their invention as a quid pro quo for receiving rights to exclude others from making, using, or selling their invention during the life of the patent. The publications of patents and patent applications contribute to a vital source of free-flowing technological information, thus promoting further innovation. The USPTO sets forth in the announcement that in the midst of the current pandemic, the flow of information is more important than ever in view of the urgent challenges presented by COVID-19.
As such, the pilot program is designed to expedite the flow of information related to COVID-19 technologies by expediting the availability of filed provisional applications. Typically, provisional applications are not made public until an applicant files a nonprovisional claiming priority to the provisional application. However, in the COVID-19 deferred-fee Provisional Patent Application Pilot Program, the provisional application will be immediately available on the USPTO website. The USPTO states such early availability of COVID-19 related provisional application allows the applicant to contribute to the public in the fight against COVID-19 while protecting their patent rights. This is because early public disclosure can facilitate collaboration and foster innovation to expedite the development of critically needed technologies to combat COVID-19.
For participating in the public disclosure required by the pilot program, the applicant can defer the provisional application filing fee until such a time as a nonprovisional patent application claiming the benefit of the provisional patent application is filed. If an applicant decides not to pursue a nonprovisional application claiming priority to the provisional patent application, the provisional patent application filing fee is indefinitely waived. Currently, the filing fee for a provisional patent application is $280 for applicants qualified as a large entity status, $140 for applicants qualified as a small entity status, and $70 for applicants qualified as a micro entity status.
The pilot program is limited to provisional patent applications and does not apply to non-provisional patent applications or international applications designating the United States.
To participate in the pilot program, an applicant must submit a Certification and Request for COVID-19 Provisional Patent Application Program along with the technical disclosure. The Certification and Request for COVID-19 Provisional Patent Application Program requires the applicant to certify that the provisional patent application relates to a COVID-19 process or product, wherein the process or product must be subject to FDA approval for use. Examples of such approvals 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). The subject matter requirement is broadly drafted to include any sort of FDA premarket regulatory review process. Further, an applicant need not have obtained FDA approval prior to requesting to participate in the deferred fee program.
In some situations, the public disclosure required when participating in the pilot program could have unwanted ramifications. Therefore, an applicant may want to consider consulting with a patent attorney in order to determine the implications of their participation in the pilot program.
The pilot program is scheduled to receive applications for 12 months starting on September 17, 2020. The USPTO may extend or terminate the pilot program based on the workload and resources needed to administer the program, feedback from the public, and its effectiveness. The USPTO may expand the program to other areas beyond COVID-19 depending on the feedback and public interest in order to facilitate rapid innovation in other areas.