The United States Patent and Trademark Office (USPTO) considers the outbreak of COVID-19 to be an extraordinary situation, and pursuant to 35 U.S.C. § 2(b)(2)(G) and 37 C.F.R. § 1.183, implemented a pilot program for prioritized examination of COVID-19 related inventions (“COVID-19 pilot program”). The COVID-19 pilot program provides prioritized examination for certain patent applications that claim a product or process that is subject to Food and Drug Administration (FDA) approval for COVID-19 use.
The COVID-19 pilot program provides Track-1 type prioritized examination without payment of the prioritized examination fees. The pilot program waives the fees normally associated with prioritized examination. The fees waived include (a) the prioritized examination fee of $1,000 for a micro entity, or $2,000 for a small entity; and (b) the processing fee of $35 for a micro entity, or $70 for a small entity.
The USPTO started accepting requests for participation in the COVID-19 pilot program on May 14, 2020. The COVID-19 pilot program will last until the USPTO has accepted a total of 500 requests, unless the pilot program is extended.
The USPTO will grant a request for participation in the COVID-19 pilot program if the following conditions are satisfied:
- The Applicant must qualify for micro or small entity status at the time the request for participation in the COVID-19 pilot program is filed.
- The patent application must be a utility or plant non-provisional application that contains only one priority claim under 35 U.S.C. § 120, 121, or 365(c).
- The non-provisional patent application must include at least one claim directed to a product or process subject to FDA approval for COVID-19 use (e.g., 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 non-provisional patent application must be accompanied by an executed application data sheet.
- The non-provisional application is filed via the USPTO’s electronic patent filing systems (EFS-Web or Patent Center).
- The non-provisional application is presented with no more than four independent claims and 30 total claims, and no multiple dependent claims.
- The basic filing fee, search fee, and examination fee must accompany the non-provisional application upon filing.
The typical goal under the Track-1 type prioritized examination is to provide a final disposition within 12 months, on average, from the date the prioritized status has been granted. However, the USPTO believes, under the COVID-19 pilot program, it can “achieve final disposition in six months if applicants provide more timely responses to notices and actions.”
Michael Best’s attorneys are ready to assist if you are interested in utilizing the COVID-19 pilot program for your existing or yet-to-be-filed COVID-19 related patent application(s). We can also provide guidance on whether your invention is subject to FDA approval for COVID-19 use in order to qualify for the COVID-19 pilot program.