USPTO Announces COVID-19 Prioritized Examination Pilot Program | Practical Law

USPTO Announces COVID-19 Prioritized Examination Pilot Program | Practical Law

The US Patent and Trademark Office (USPTO) is instituting a prioritized examination pilot program that does not require payment of certain prioritized examination fees, for certain COVID-19 related patent applications covering a product or process subject to US Food and Drug Administration (FDA) approval where the applicant is a small or micro entity.

USPTO Announces COVID-19 Prioritized Examination Pilot Program

Practical Law Legal Update w-025-4113 (Approx. 4 pages)

USPTO Announces COVID-19 Prioritized Examination Pilot Program

by Practical Law Intellectual Property & Technology
Law stated as of 08 May 2020 • USA (National/Federal)
The US Patent and Trademark Office (USPTO) is instituting a prioritized examination pilot program that does not require payment of certain prioritized examination fees, for certain COVID-19 related patent applications covering a product or process subject to US Food and Drug Administration (FDA) approval where the applicant is a small or micro entity.
On May 8, 2020, the USPTO issued a notice that it is implementing a prioritized examination pilot program, which would not require certain prioritized examination fees for certain patent applications, where both:
  • The claims cover products or processes subject to US Food and Drug Administration (FDA) approval for COVID-19 use.
  • The applicant is either a small or micro entity.
Under the pilot program:
  • The USPTO will aim to complete examination:
    • within 12 months; or
    • within 6 months if the applicant files all replies within 30 days after a UPSTO notice.
  • The applicant need not pay the prioritized examination:
  • The applicant must still pay:
To qualify for the program, the applicant must:
  • Submit a request, preferably on form PTO/SB/450, which will be available on the USPTO forms webpage, along with:
    • a non-continuing original utility or plant nonprovisional application;
    • an original utility or plant nonprovisional application claiming a domestic benefit under 35 U.S.C. §§ 120, 121, or 365(c) of one prior nonprovisional application or one prior Patent Cooperation Treaty (PCT) application designating the US; or
    • a request for continued examination of such plant or utility application or of a national stage of a PCT application, or thereafter.
  • Certify that:
    • at least one claim covers a product or process related to COVID-19 that is subject to FDA approval for COVID-19 use; and
    • the applicant qualifies for small or micro entity status.
  • Include an executed application data sheet under 37 C.F.R. § 1.53(f)(3)(i).
The applicant must still meet the prioritized examination requirements of 37 C.F.R. § 1.102(e), other than payment of the request and processing fees.
This pilot program is not available for a patent application that either:
  • Claims the domestic benefit of two or more prior nonprovisional US patent applications or PCT applications designating the US under 35 U.S.C. §§ 120, 121, or 365(c).
  • Is accepted into the First Action Interview pilot program
The USPTO will accept up to 500 requests for the pilot program, although it may extend or terminate the program based on, among other things, the program's effectiveness. Comments, which will be made available to the public, must be received 60 days from the notification's publication in the Federal Register and should be emailed to [email protected].