USPTO Announces COVID-19 Prioritized Examination Pilot Program
To encourage and facilitate innovators to bring important and possibly life-saving treatments to market as quickly as possible, the United States Patent and Trademark Office (USPTO) has announced a new COVID-19 Prioritized Examination Pilot Program. Under this program, qualifying patent applications by small or micro entity status applicants will be granted prioritized examination without the fees ordinarily associated with prioritized examination. The goal of the program is to complete examination of a prioritized application within a (12) month period from the date prioritized status is granted. The USPTO believes this period can be further shortened to (6) months if applicant elects to reply to USPTO actions and notices within 30 days.
In order to qualify for this pilot program, a request for the prioritized examination (form found here) must be filed along with:
(i) an original non-provisional application;
(ii) a continuation application claiming the benefit of an earlier filing date of only one prior non-provisional application or one prior international application designating the United States; or
(iii) with or after the filing of a request for continued examination (RCE) of a non-provisional application.
In addition to the above, the applicant must certify (i) that it qualifies for either small or micro entity status (requirements found here), and (ii) that at least one of the pending claims covers a product or process related to COVID-19, where the claimed product or process is subject to FDA approval for COVID-19 use. The Federal Register notice provides examples of FDA approvals that satisfy this requirement, which include, but are not limited to, an Investigational New Drug (IND) application, a New Drug Application (NDS), a Biological License Application, an Investigational Device Exemption (IDE), a Premarket Approval (PMA), or an Emergency Use Authorization (EUA). Finally,the applicant must include an executed application data sheet, and the application and request must be filed using the USPTO’s patent electronic filing systems.
If the above requirements are met upon the filing of the request, the prioritized examination fee ($2,000 for small entity and $1,000 for micro entity) and processing fees ($75 for small entity and $35 for micro entity) are waived, and the applicant only pays the basic filing, search and examination fees. The regular requirements of prioritized examination do apply to these filings. Thus, the application must not, at any time, contain more than four (4) independent claims, thirty (30) total claims, or any multiple dependent claims.
Additionally, time periods for reply to USPTO Office Actions follow the shortened statutory periods, and any petition for extension of time to reply or a request for suspension of an action will terminate prioritized examination.
The USPTO will begin accepting requests for this pilot program on July 13, 2020 and will continue to do so until receipt of the 500 threquest. The USPTO may extend or terminate the pilot program depending on its resources and the effectiveness of the program.
Takeaway
The reduction in cost and expedited examination under this program provides an attractive filing incentive to many small companies, universities, nonprofit research groups, and individual inventors who are seeking to secure funding and/or partners to advance COVID-19 diagnostics and therapeutics to market quickly.