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USPTO Prioritized Examination and the COVID-19 Relief Program

Author: William Yarbrough

Contributing Editor: Blaire Farine

In May of 2020, the United States Patent and Trademark Office launched the COVID-19 Prioritized Patent Examination Pilot Program, as well as the COVID-19 Prioritized Trademark Examination Program, to address the unique patent office related needs of USPTO patent examiners and applicants and to provide for examination within a ‘set goal’ of completing, on average, examination within 12 months of mailing of a decision granting special status. These programs expedite and give special recognition to those applications that relate to COVID-19 medical products and services. These applications receive prioritized examination (i.e., are taken out of turn) and waived or deferred fees related to prioritized examination.

Directed to medical treatments, diagnostic technology, and vaccines, a patent application must qualify for this accelerated treatment where a product or process is subject to FDA approved COVID-19 use (including 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)) and where at least one pending claim covers said product or process related to COVID-19. And, while the USPTO has historically allowed expedited examination (a) for a fee and (b) under special circumstances (e.g., applicant’s age or the applications ability to enhance the quality of the environment, conservation of energy sources or contributions to counterterrorism) under 37 CFR 1.102(e), the law also permits allowances for extraordinary situations, under 37 CFR 1.183, permitting the USPTO to suspend certain requirements in “extraordinary situations” and to initiate a pilot program in response to these situations. And we can all agree that COVID-19 is just such an “extraordinary situation”.

Yet, the current pilot program is not without limits, wherein at least one patent application claim must be (1) for an applicable FDA approvable COVID-19 use in (2) an original (non-continuing) application, (3) those applications claiming benefit of exactly one earlier filing date (in a previous application), or with a (4) request for continued examination (RCE) in a (5) utility or plant patent for those applicants qualifying for a (6) micro entity or small entity status.

Another difference in the COVID-19 includes allowance for four (4) independent claims and thirty (30) total claims (versus three independent claims and 20 total claims) and, opposite of normal prosecution but in keeping with all other expedited prosecution, request for extensions in time to reply to an outstanding response will result in that applications being removed from prioritized examination. And expanding beyond the above set claim limits or amending with the addition of any multiple dependent claims, will result in termination of the special status.

The expedited patent program began accepting applications on July 13 of 2020 (up to the acceptance of 500 recipients), where, to date, the USPTO has seen 251 patent requests for prioritized patent applications and has granted or allowed 33 of these patents. Too, the prioritized trademark program, enacted in June of 2020, has granted petitions in 129 COVID-19 related trademarks.

Given the urgency and success of the pilot program, the USPTO additionally announced in September the COVID-19 deferred-fee provisional patent application pilot program where payments of provisional application filing fees could be deferred. The impetus of the program was to remove even preliminary hindrances that applicants face in paying the application fees for their COVID-19 related provisional patent applications and allow them to equally contribute to the fight against the COVID-19 pandemic. These fees are deferred until the filing of the corresponding non-provisional patent application. Interestingly, one differentiating caveat, from traditional provisional patents, is that the subject matter of the provisional patent must be disclosed to the public on the USPTO’s website giving others the opportunity to contribute and use provided technical information in the fight against COVID-19 – which is a departure from the non-publication of a provisional application, generally. Finally, identical to non-provisional applications, the subject matter of the patent must concern a product or process that is COVID-19 related and must require FDA approval for use.

To date, these applications have made up more than half of all expedited patent applications. Additionally, almost half of this year’s trademark petitions that were granted were for PPE, devices used to detect COVID-19, treatments, and medical goods.

For an applicant or applicants to claim a COVID-19 prioritized examination, applicants are requested utilize form PTO/SB/450, titled “Certification and Request for COVID-19 Prioritized Examination Pilot Program under 37 CFR 1.102(e),” to make the request for prioritized examination under the pilot program whereby applicants must certify that at least one of the pending claims covers a product or process related to COVID-19, that such product or process is subject to an applicable FDA approval for COVID-19 use where the request must include a certification that the applicant qualifies for either small entity (37 CFR 1.27) or micro entity (37 CFR 1.29) status when the request is made.

Navigating the USPTO is extremely difficult, and anyone interested in applying for a trademark or patent should contact Attorney William Yarbrough at wyarbrough@kmd.law. Nothing in this article is intended to be considered legal advice. Please do not hesitate to reach out to Kearney, McWilliams & Davis, PLLC with any questions,