On Sept. 17, the United Patent and Trademark Office (USPTO) issued a notice implementing a deferred-fee provisional application pilot program for COVID-19-related technologies. The pilot is designed “[t]o disseminate information designed to combat COVID-19 on a more expedited basis while still securing rights for inventors.”
I. Fundamentals of the Pilot Program
Participation is limited to provisional applications concerning a product or process relating to COVID-19. “The product or process must be subject to an applicable FDA approval for COVID-19 use.” According to the USPTO, “[t]he requirement is broadly drafted to include any sort of FDA premarket regulatory review procedure.”
A. Requirements for Participation
To participate in the pilot program, the provisional application filing must include:
(1) A Certification and Request for COVID-19 Provisional Application Program (PTO/SB/452) form.
(2) A provisional application cover sheet, as required by 37 C.F.R. § 1.51(c)(1).
(3) A specification in DOCX format.
The USPTO mandates the filing of an electronic specification. “A submission that fails to include legible copy in DOCX will not be treated as a program submission, even if it is accompanied by form PTO/SB/452.”
B. Effect of Participation
When a provisional application is filed under the pilot program, the USPTO “will upload the technical disclosure and the form into a searchable public collaborative database and process the cover sheet as a filing of a provisional application.” The collaborative database will include the technical subject matter disclosed, the name of the first inventor, the filing date and the date the submission was placed in the database. The collaborative database will not include the application datasheet. As indicted on PTO/SB/452, “inclusion in the public database is a publication of the description and this form.”
When one participates in the pilot program, payment of the provisional application fees is deferred until the filing of a nonprovisional application. However, for the applicant to have a valid priority claim, the fees must be paid no later than 12 months after the provisional application filing date.
The pilot program lasts for a period of 12 months, beginning on Sept. 17, 2020. It may be extended or terminated early “depending on the workload and resources needed to administer it, feedback from the public, and its effectiveness.”
II. Strategic Considerations
Since the technical disclosure will be published in a database that includes contact information, the pilot program seems to be designed for companies that are seeking potential collaborators and/or funding in their quest to treat COVID-19. For such applicants, the pilot program might be an easy tool to advertise technology that may be available for licensing.
Furthermore, as indicated in a previous blog post, the USPTO has a COVID-19 prioritized examination pilot program for small and micro entities, which is limited to 500 applications. Thus, it may be possible to rely on the USPTO’s COVID-19 deferred-fee provisional application pilot to identify licensing/development partners and then expedite prosecution of an application (as long as small- or micro-entity status is preserved).
As the USPTO pointed out in the notice, participation in the pilot program raises prior art considerations. While an inventor’s technical disclosure published in the collaboration database cannot be used against the same inventor, the same may not be true in foreign jurisdictions. Also, if there is a later-filed nonprovisional application, the complete provisional application may become prior art under 35 U.S.C. § 102(a)(1). Furthermore, while the USPTO does not consider adding the technical subject matter to be a publication under 35 U.S.C. § 122(b), it is uncertain how courts will treat the subject matter. Accordingly, when considering whether to participate in the pilot program, applicants need to be mindful that such participation may result in a prior art publication. Thus, it may be necessary to file a complete provisional application with claims, which can be converted into a non-provisional filing without further revision.
For applications filed under the pilot program before the Oct. 2, 2020 fee increases, applicants will have to pay higher fees if the deferred fees are paid at a later date. As the USPTO’s form PTO/SB/452 indicates, “Applicant recognizes that the filing fee due in the future may be more than the current fee due and that by deferring payment of the filing fee, there may be an increase in the total fee due.” Therefore, participation in the program may actually increase the total fees paid.