Earlier this month, the U.S. Patent and Trademark Office announced that it would be implementing a COVID-19 Prioritized Examination Pilot Program, in which applicants that qualify for small or micro entity status will be allowed to request prioritized examination without paying the fees typically associated with such prioritized examination.  Under the new pilot program, the Office will try to reach final disposition of applications within six months, provided that applicants respond promptly to Office communications.  USPTO Director Andrei Iancu noted that the new pilot program was intended to help independent inventors and small businesses, adding that "[a]ccelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly."

Last week, the Office published a notice in the Federal Register (85 Fed. Reg. 28932), which provides additional details regarding the new pilot program.  In the notice, the Office indicates that the goal of the new pilot program is to provide final disposition within 12 months from the date an application has been granted prioritized status.  However, the Office believes that it can achieve final disposition in six months if applicants provide more timely responses to notices and actions from the Office.  Nevertheless, the notice points out that "[a]ny failure to meet the 12-month goal, or other issues related to this goal that arise, are neither petitionable nor appealable matters."  In addition to expedited examination, the new pilot program will also eliminate the requirement to pay the prioritized examination fee set forth in 37 C.F.R. § 1.17(c) ($1,000 for micro entities and $2,000 for small entities) or the processing fee set forth in 37 C.F.R. § 1.17(i)(1) ($35 for micro entities and $70 for small entities).

As discussed in the notice, the basis for the new pilot program is 37 C.F.R. § 1.183, which permits the Office, in an extraordinary situation, to suspend or waive sua sponte any requirement of its regulations that is not a requirement of the patent statutes.  And as the Office explains in the notice, it "considers the effects of the COVID–19 outbreak that began in approximately January 2020 to be an 'extraordinary situation' within the meaning of 37 CFR 1.183 for affected patent applicants and innovators."

While the new pilot program will be limited to small and micro entities in order "[t]o focus the USPTO's resources on those applicants that may be more resource constrained," the Office notes that it will periodically evaluate the new pilot program to determine whether its coverage should be expanded or narrowed.  In addition, to qualify for the new pilot program, the claims of an application must cover a product or process related to COVID–19, and such product or process must be subject to an applicable FDA approval for COVID–19 use.  The notice notes that such approvals may include, for example, 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).

Other requirements for participating in the new pilot program include making the request at the time of filing of a non-continuing original utility or plant nonprovisional application; at the time of filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 U.S.C. §§ 120, 121, or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or at the time of filing or after the filing of a Request for Continued Examination of a plant or utility application or a national stage of an international application.  The notice points out that any application that claims the benefit of the filing date of two or more prior filed nonprovisional U.S. applications or international applications designating the United States under 35 U.S.C. §§ 120, 121, or 365(c) will not be eligible for participation in the new pilot program.

Moreover, applicants seeking to participate in the new pilot program will be required to certify that at least one of the pending claims covers a product or process related to COVID–19 and that such product or process is subject to an applicable FDA approval for COVID–19 use, and to certify that the applicant qualifies for either small or micro entity status when the request is made.  The Office encourages applicants seeking to participate in the new pilot program to use Form PTO/SB/450, which includes the required certifications.  Requests to participate in the new pilot program must also include an Application Data Sheet.  As with other prioritized examination requests, under the new pilot program the application and request must be made via the Office's patent electronic filing systems (EFS-Web or Patent Center) if the application is a utility application, and qualifying applications cannot present more than four independent claims, more than 30 total claims, or any multiple dependent claims.

While the notice indicates that the Office will begin accepting requests under the new pilot program beginning on July 13, 2020, and will accept requests until the Office has accepted 500 requests, the Office issued a correction in a Patent Alert e-mail today that the Office actually started accepting requests under the new pilot program on May 14, 2020.  As with other USPTO pilot programs, the Office may extend the new pilot program (with or without modifications) or terminate it depending on the workload and resources needed to administer the program, feedback from the public, and the effectiveness of the program.  The notice also indicates that applications accepted into the First Action Interview (FAI) Pilot Program will not be eligible for the COVID-19 Prioritized Examination Pilot Program, and that applications accepted into the COVID-19 Prioritized Examination Pilot Program will not be eligible to participate in the FAI Pilot Program.

The Office will be accepting comments regarding the new pilot program, which can be sent by e-mail to Covid19PrioritizedExamPilot@uspto.gov.  Such comments must be received by July 13, 2020 to be considered.

Additional information regarding the new pilot program can be found at the Office's website.