On May 8, 2020, the United States Patent and Trademark Office (“PTO”) announced its new COVID-19 Prioritized Examination Pilot Program (“Pilot Program”) to provide prioritized examination of certain patent applications. To qualify, 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 Federal Drug Administration approval for COVID-19 use.

Under this Pilot Program, the PTO will grant qualified requests for prioritized examination without payment of certain fees associated with prioritized examination for applicants. To focus the PTO’s resources on those applicants that may be more resource constrained, the pilot is limited to applicants that qualify for either small or micro entity status.  The goal of prioritized examination is to provide a final disposition within an average of 12 months from the date the prioritized status has been granted. The PTO believes it can achieve final disposition in 6 months if applicants provide more timely responses to notices and actions from the PTO, as compared to those required by prioritized examination.

Typically, new patent applications are taken up for examination in the order of their U.S. filing dates. However, an application can be advanced out of turn for examination if the applicant files a grantable request for prioritized examination.[1] The Leahy-Smith America Invents Act provides for prioritized examination whereby an applicant may request prioritized examination upon payment of appropriate fees and compliance with certain requirements.[2] The PTO is also authorized to provide for prioritization of examination of applications for products, processes, or technologies that are important to the national economy or national competitiveness without requiring the prioritized examination fee. In an extraordinary situation, the PTO is permitted to suspend or waive sua sponte any requirement of its regulations that is not a requirement of the patent statutes.[3] The PTO considers the effects of the COVID-19 outbreak to be an “extraordinary situation” for affected patent applicants and innovators.

“Independent inventors and small businesses are often the difference makers when it comes to cutting-edge innovation and the growth of our economy,” said Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO. “They are also in most need of assistance as we fight this pandemic. Accelerating 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.”[4]

The Pilot Program will accept requests for prioritized examination beginning July 13, 2020 until such time as the PTO has accepted a total of 500 requests. The PTO may extend the 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 PTO will notify the public if the Pilot Program is extended or terminated.

Please see the Federal Registrar Notice for additional information outlining the conditions, eligibility requirements, and guidelines of the Pilot Program. 

[1] See 37 CFR 1.102(e).

[2] See MPEP 708.02(b).

[3] See 37 CFR 1.183 (In an extraordinary situation, when justice requires, any requirement of the regulations in this part which is not a requirement of the statutes may be suspended or waived by the Director or the Director’s designee, sua sponte, or on petition of the interested party, subject to such other requirements as may be imposed. Any petition under this section must be accompanied by the petition fee set forth in § 1.17(f).)

[4] United States Patent and Trademark Office. (May 8, 2020). “USPTO announces COVID-19 Prioritized Examination Pilot Program for small and micro entities” [Press release]. Accessed May 15, 2020, available at https://www.uspto.gov/about-us/news-updates/uspto-announces-covid-19-prioritized-examination-pilot-program-small-and.