The US Patent and Trademark Office (USPTO) on May 8 announced a new COVID-19 Prioritized Examination Pilot Program (Pilot Program), under which eligible small and micro entities will receive prioritized examination without payment of the additional fees for prioritized examination. As such, eligible small and micro entities will save $2,000 and $1,000, respectively, when making a request for prioritized examination under the new Pilot Program.
The applicant may qualify as a “small entity” if the applicant is an (a) individual inventor, (b) a nonprofit organization, or (c) a business whose number of employees, including its full-time, part-time, and temporary employees and those of its US and foreign affiliates, does not exceed 500 persons. Additionally, the applicant must not have assigned, granted, conveyed, or licensed, and must not be under an obligation under contract or law to assign, grant, convey, or license, any rights to any entity that is not one of (a), (b), or (c) above.
The applicant may qualify as a “micro entity” if the applicant met the requirement for small entity status as well as specific other limitations associated with the number of applications filed, licenses assigned, and gross income.
Under ordinary circumstances, the goal of prioritized examination is to provide a final decision of patentability within 12 months, on average, from the date that prioritized status has been granted. According to the Federal Register Notice, however, the USPTO believes it can achieve final decisions in six months in the Pilot Program when applicants provide timely responses to notices and actions from the USPTO. This is a significant acceleration of typical patent application pendency which averages about 30 months.
The program is available for new noncontinuing original applications (i.e., not reissue applications), applications that claim priority to no more than one nonprovisional US application or international application designating the United States, and upon the filing of a first request for continued examination with a Pilot Program acceleration request. Claiming priority to a first filed non-US application under 35 USC 119 will not cause a nonprovisional application to be ineligible under the Pilot Program. Other limitations exist, however, and certain criteria must be met to qualify for the Pilot Program. For example, the applicant must certify that the patent claims in the application cover a product or process related to COVID-19 and that is subject to FDA approval. While the Federal Register Notice lists Investigation New Drug applications, Investigational Device Exemptions, New Drug Applications, Biologics License Applications, Premarket Approvals, and Emergency Use Automations, the program is not limited to these approvals. Other restrictions of traditional petitions to accelerate examination also apply such as restrictions on the type and number of claims and on timing to respond to USPTO actions.
The Pilot Program is expected to continue until the USPTO has accepted 500 such requests.
The USPTO encourages the use of form PTO/SB/450, titled “Certification and Request for COVID-19 Prioritized Examination Pilot Program under 37 CFR l.102(e),” to make the request and provide one certification for prioritized examination under the Pilot Program.
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If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the author Kenneth J. Davis (Philadelphia), or any of the following lawyers:
Chicago
Christopher J. Betti
Boston
Stephen L. Altieri, Ph.D.
Mark L. Hayman, Ph.D.
Orange County
M. Todd Hales
Nathan S. Smith
Philadelphia
Eric Kraeutler
Louis W. Beardell, Jr.
Kenneth J. Davis
San Francisco
Christina A. MacDougall, Ph.D.
Jeffry S. Mann, Ph.D.
Silicon Valley
Dion M. Bregman
Andrew J. Gray IV
Washington, DC
Jeffrey G. Killian, Ph.D.
Janice H. Logan, Ph.D.
Robert Smyth, Ph.D.