New USPTO Pilot Program to Expedite Grant of Small Entity COVID-19 Patents

11 May 2020 Blog
Authors: Navid Fanaeian Courtenay C. Brinckerhoff Stephen B. Maebius
Published To: Coronavirus Resource Center: Back to Business PharmaPatents

In an effort to help independent inventors and small businesses bring “important and possibly life-saving treatments” to market more quickly, the United States Patent and Trademark Office (USPTO) is implementing the COVID-19 Prioritized Examination Pilot Program (“C-19 PEPP”). This new pilot program will expedite examination of certain non-provisional patent applications related to COVID-19. Under the C-19 PEPP, the prioritized examination fee and processing fee will be waived, saving small entities over $2000. According to the USPTO’s press release, applications accorded special status under this program could be granted within six months, if the applicants respond promptly to USPTO communications.

To qualify, an application must cover a product or process that is subject to an applicable FDA approval for COVID-19 use. Examples of such FDA approvals given by the USPTO include 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), and an Emergency Use Authorization (EUA). 

At least initially, the C-19 PEPP will be available only to applicants that qualify for small or micro entity status, and initially will be limited to 500 applications. The USPTO will periodically evaluate the scope of the C-19 PEPP and determine if it should be expanded or limited.

Requests for expedited examination under the C-19 PEPP must be made at the time the non-provisional application is filed, or with or after filing a request for continued examination (RCE). A request may be made in a newly filed continuation application, but applications that claim priority to two or more non-provisional applications are not eligible to participate. The USPTO plans to release a form that will contain the necessary certifications for qualification, and encourages use of the form to facilitate and expedite processing of requests to participate in this new program.

This program presents a unique opportunity for sole inventors, university researchers, and small businesses to significantly shorten the patenting process from a few years to a few months for qualifying applications. In turn, the potential opportunity to obtain a patent in substantially less time at lower cost may help bring important new technologies to market and be attractive to potential investors.

The C-19 PEPP is one of several initiatives the USPTO has rolled out in response to the COVID-19 pandemic. Other initiatives include the ability of those personally affected by the COVID-19 pandemic to defer certain patent and trademark deadlines until June 1, 2020, and the creation of the Patents 4 Progress web-based marketplace for COVID-19-related intellectual property. Clients wanting to take advantage of one or more of these initiatives should contact their Foley relationship partner or the Foley attorneys listed below. You can stay up to date on these and other topics impacting your intellectual property in the life sciences space by subscribing to Foley’s Pharma Patents blog.

Foley has created a multi-disciplinary and multi-jurisdictional team, which has prepared a wealth of topical client resources and is prepared to help our clients meet the legal and business challenges that the coronavirus outbreak is creating for stakeholders across a range of industries. Click here for Foley’s Coronavirus Resource Center to stay apprised of relevant developments, insights and resources to support your business during this challenging time. To receive this content directly in your inbox, click here and submit the form. 

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