USPTO Announces New Program To Promote Publication Of COVID-19 Innovation

17 September 2020 Blog
Authors: Courtenay C. Brinckerhoff
Published To: PharmaPatents Coronavirus Resource Center:Back to Business

In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent applications related to COVID-19. Under this pilot program, applicants can defer paying the provisional application filing fee in exchange for agreeing that the subject matter of the application will be published in what the USPTO refers to as “a searchable collaboration database maintained on the USPTO’s website.”

The COVID-19 Provisional Patent Application Pilot Program

As explained in the September 17, 2020 Federal Register Notice, the gist of the COVID-19 Provisional Patent Application Pilot Program is to provide a mechanism for early disclosure of the subject matter of provisional applications targeting COVID-19. Thus, the substantive content of provisional applications filed under this program (i.e., the specification and any claims, drawings, and/or abstract) will be uploaded “into a searchable public collaborative database.” 

The Federal Register Notice does not state whether it will be expanding the new Patents 4 Partnerships IP marketplace platform discussed in this article or creating a new database for this program.

The “deferred fee” of the program is the provisional application filing fee, which can be deferred “until the filing of a corresponding nonprovisional application.” The current undiscounted provisional application filing fee is $280, increasing to $300 on October 2, 2020. As clarified in the Notice, participants who decide not to pursue a corresponding nonprovisional application never have to pay this fee. 

Eligible Patent Applications 

This new COVID-19 pilot program is open to new provisional applications filed with a completed form PTO/SB/452, which acts as a “Certification and Request” to participate in the program. The Federal Register Notice expressly states that the form “cannot be used to request that a provisional application that had previously received a filing date be included in the program; such a request will be denied.” To qualify for the program, the application must be filed electronically via the USPTO’s Patent Center filing system in DOCX format “to facilitate making the material text searchable.” To satisfy statutory requirements for provisional applications, the application also must be filed with a cover sheet or application data sheet (ADS).

Unlike the COVID-19 Prioritized Examination Pilot Program (C-19 PEPP) summarized in this article, this pilot program is open to large entity applications as well as applications that qualify for small or micro entity status. According to the Notice, the program will run for 12 months beginning on September 17, 2020. 

Eligible Subject Matter

The subject matter requirement for this pilot program is the same as that for the COVID-19 Prioritized Examination Pilot Program (C-19 PEPP). Thus, the provisional application must “concern[] a product or process related to COVID-19,” that is “subject to an applicable FDA approval for COVID-19 use,” such as based on 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). As explained in the Notice, an applicant need not have applied for FDA approval in order to participate in the program, but “the product or process disclosed in the application must require premarket regulatory review by the FDA prior to commercial marketing or use.”

Prior Art Consequences Of Participating In The Pilot Program 

The Federal Register Notice discusses some prior art effects of the publication, but applicants considering participating in this program should give careful thought to all possible prior art implications of participation. 

Importantly, the Notice states that the USPTO “does not consider adding the technical subject matter … to the … collaboration database under the program to constitute publication of the provisional application under 35 USC § 122(b).” As justification, the Notice emphasizes that “the database will not publish the cover sheet [or ADS], which is a requirement for a provisional application.” 

According to the Notice, publication in the collaboration database “cannot be used against the inventor’s own corresponding later-filed nonprovisional application in the United States, provided the later-filed application is filed within one year of the public disclosure.” This may stem from a straight-forward application of 35 USC § 102(b)(1). Indeed, the USPTO does not have authority to create new exceptions to the prior art statutes. 

The Notice does warn that “[s]pecial care should be taken where foreign patent protection is desired,” because “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.” 

Not addressed in the Notice, but certainly worthy of consideration, is the potential prior art effect of the publication on non-corresponding applications. Also, since the publication is not a publication of the application under § 122, the exceptions of 35 USC § 102(b)(2) do not apply.  Thus, the potential prior art effect of the publication on other applications owned by the same person but having different inventors also should be considered. 

The Notice also highlights that “[t]here is no provision for withdrawal from the program.” Thus, once the subject matter has been “made available to the public in the searchable collaboration database on the USPTO’s website, that public availability cannot be revoked.”

An Important Cost-Benefit Analysis

The USPTO states in the Notice that the pilot program is designed “to provide a cost-effective way for inventors to disclose their ideas to others quickly, but without losing their right to claim what is described and enabled by their disclosure.” As noted above, however, applicants considering participating in this program should give careful consideration to all possible prior art implications of participating. Many applicants may decide that the ability to defer or avoid paying the provisional application filing fee is not worth the possible unintended consequences of participating in this program. While, as stated in the Notice, “[e]arly public disclosure can facilitate collaborations, partnerships, or joint ventures,” publication too early can make it difficult to obtain the scope of patent protection that may be required to support investment in the development, FDA approval, and commercialization process.

Other Responses to COVID-19

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