In an e-mail News Brief distributed last week, the U.S. Patent and Trademark Office reported on the participation to date in its COVID-19 Prioritized Examination Pilot Program.  The pilot program, which was implemented last May, allows applicants that qualify for small or micro entity status to request prioritized examination without paying the fees typically associated with such prioritized examination (see "USPTO Announces COVID-19 Prioritized Examination Pilot Program").  In announcing the pilot program, the Office noted that it would endeavor to reach final disposition of applications within six months, provided that applicants respond promptly to Office communications.

In addition to providing expedited examination for qualifying applications, the pilot program also eliminates the requirement to pay the prioritized examination fee set forth in 37 C.F.R. § 1.17(c) ($1,050 for micro entities and $2,100 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).  In addition to the requirement that applicants qualify for small or micro entity status, the claims of a participating 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.  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).  When the pilot program was announced, the Office noted that it would accept up to 500 requests.

Other requirements for participating in the 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.  However, 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) is not eligible for participation in the pilot program.  In addition, requests to participate in the pilot program must include an Application Data Sheet, be made via the Office's patent electronic filing systems (EFS-Web or Patent Center), and qualifying applications cannot present more than four independent claims, more than 30 total claims, or any multiple dependent claims.

In its e-mail last week, the Office noted that 251 patent requests for prioritized examination under the pilot program have been granted to date, resulting in the allowance or issuance of 33 applications or patents.  The Office also noted that more than half of the patent applications granted prioritized examination are directed to medical treatments, vaccines, and diagnostic technology, with the remainder being directed directed to ventilators, personal protective equipment (PPE), and other technology related to COVID-19.  In commenting on the pilot program, USPTO Director Andrei Iancu stated that "[o]ver the past two centuries, solutions to some of the nation's greatest problems have passed through the halls of the USPTO, and it's very likely that some of the solutions to America's current pandemic have already been examined by this agency."