In a notice published in the Federal Register (85 Fed. Reg. 58038) on September 17th, the U.S. Patent and Trademark Office announced that it was implementing a deferred-fee provisional patent application pilot program in order to promote the expedited exchange of information about inventions designed to combat COVID–19. In the notice, the Office states that it recognizes that its charge to issue high-quality patents to inventors goes hand-in-hand with the dissemination of important technical information, and that the free-flow of such information is now more important than ever in view of the urgent challenges posed by COVID–19.
Applicants who participate in the pilot program will be allowed to defer payment of the provisional application filing fee (which is currently $280 for large entities) until the filing of a nonprovisional application claiming the benefit of the provisional application in exchange for permitting the Office to make the technical subject matter disclosed in the provisional application available to the public via a searchable collaboration database maintained on the Office's website. In order to qualify for participation in the pilot program, the subject matter disclosed in the provisional application must concern a product or process related to COVID–19, and such product or process must be subject to approval by the U.S. Food and Drug Administration (FDA) for COVID-19 use. According to the notice, a provisional application qualifies for participation in the pilot program if such FDA approval "has been obtained, is pending, or will be sought prior to marketing the subject matter for COVID–19." The notice indicates that 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), or an Emergency Use Authorization (EUA). The notice also indicates that the subject requirement for participation in the deferred-fee provisional patent application pilot program is the same as that for participation in the COVID–19 prioritized examination pilot program, which was announced in May (see "USPTO Announces COVID-19 Prioritized Examination Pilot Program").
The requirements to participate in the pilot program are as follows:
1. Applicants must submit a certification and request for participation in the program using form PTO/SB/452.
2. The submission must be in the English language.
3. The submission must include a provisional application cover sheet pursuant to 37 C.F.R. § 1.51(c)(1) (or an Application Data Sheet, which may serve as the provisional application cover sheet).
4. The submission (i.e., provisional application specification, including any drawings, claims, and/or abstract, provisional application cover sheet (or ADS), and form PTO/SB/452) must be filed electronically via the Office's Patent Center, and the specification must be filed in DOCX format to facilitate making the text searchable.
5. The submission must meet the requirements for a provisional application under 35 U.S.C. § 111(b)(1) and 37 C.F.R. § 1.53(c), except for the payment of the basic filing fee, which would be deferred under the pilot program.
The notice indicates that a submission that does not include a legible specification in DOCX format will be handled as a provisional application and not a pilot program submission. However, if a submission does not include a provisional application cover sheet or application size fee (if the latter is required), the Office will give Applicants an extendable two-month time period to submit the missing items.
The technical subject matter of provisional applications accepted to the pilot program will be uploaded by the Office into a searchable public collaborative database, and the submission will be processed as a provisional application. The notice states that the database will also publish the name of the inventor or the first named joint inventor, the provisional application filing date, and the date the submission was placed in the database, but will not publish the provisional application cover sheet.
The notice explains that while a provisional application filing fee is a statutory requirement under 35 U.S.C. § 111(b)(3), the Director is authorized under that same section to allow Applicants to pay that fee after the filing date of the application. However, the notice also explains that the basic filing fee under 37 C.F.R. § 1.16(d) must be paid by the Applicant in order to rely on the provisional application in a later-filed nonprovisional application. Participants in the pilot program will receive a reminder from the Office 10 months after the provisional application filing date indicating that the basic filing fee must be paid not later than 12 months after the provisional application filing date in order to claim the benefit of the filing date of the provisional application in a nonprovisional application.
In a section of the notice entitled "Prior Art Considerations," the Office states that "[a]n inventor's technical disclosure published in the collaboration database cannot be used against the inventor's own corresponding later-filed nonprovisional application in the United States, provided that the later-filed application is filed within one year of the public disclosure." However, the notice also states that:
Special care should be taken where foreign patent protection is desired. Many foreign jurisdictions treat an inventor's public disclosure made within one year of filing as prior art against the inventor's own application unless that earlier disclosure is the subject of a proper priority claim in that jurisdiction. For this reason, applicants should be aware of the prior art implications of their submissions.
Making a submission under the program will result in a public disclosure of the technical subject matter via the Office's searchable collaboration database. Thus, such a public disclosure may be citable as prior art under 35 U.S.C. 102(a)(1) as of the date it publishes. In addition, the complete provisional patent application submitted under the program may become prior art under 35 U.S.C. 102(a)(2) as of the filing date, but only if there has been a proper benefit claim under 35 U.S.C. 119(e) in a later-filed nonprovisional application or international application and the later-filed application has been published or deemed published under 35 U.S.C. 122(b) or has issued as a U.S. patent.
The notice also explains that "[t]here is no provision for withdrawal from the program," and that "[o]nce the technical subject matter of a program submission is made available to the public in the searchable collaboration database on the USPTO's website, that public availability cannot be revoked."
The Office began accepting certifications and requests for participation in the pilot program today and will accept requests for the next 12 months, at which time the program may be extended or terminated by the Office. The notice also indicates that depending on feedback and interest in the pilot program, the technological scope may be expanded beyond COVID–19 to other areas that are the focus of pioneering or rapid innovation. Provisional applications filed prior to September 17, 2020 are not eligible for participation in the pilot program.
The Office will accept public comments regarding the pilot program, but such comments must be received by November 16, 2020 to be considered by the Office. Comments should be sent by e-mail and addressed to Covid19ProvisionalApplication@uspto.gov.