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Pilot program offers prioritized examination for some COVID-19 related patent applications
In an effort to expedite novel COVID-19 related products and processes to the market, while concurrently facilitating seeking patent protection, the U.S. Patent and Trademark Office (USPTO) implemented a pilot program to provide prioritized examination without payment of additional fees for certain applications that claim products or processes that are subject to an applicable FDA approval for COVID-19 use. The USPTO outlined that such approvals may include, but are not limited to:
- 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),
- or an Emergency Use Authorization (EUA).
Information on INDs, IDEs, NDAs, BLAs, PMAs, and EUAs may be obtained at www.fda.gov.
Given the limited bandwidth of the USPTO and likely influx of applications under the pilot program, the pilot is limited to applicants that qualify for small or micro entity status. This is potentially huge for universities and other institutions of higher education that are balancing the public interest of getting the product to the market as quickly as possible while preserving any patent rights. The USPTO indicated it will periodically evaluate the pilot program to determine whether and to what extent its coverage should be expanded or limited.
The pilot program is reserved for the above non-provisional applications. This indicates the program is intended for mature technologies that are close to market-ready. The USPTO notes that any application that claims the benefit of the filing date of two or more prior filed non-provisional U.S. applications or international applications designating the United States under 35 U.S.C. 120, 121, or 365(c) is not eligible for participation under the pilot program, but the applicant may request prioritized examination under 37 CFR 1.102(e). Claiming the benefit under 35 U.S.C. 119(e) of one or more prior provisional applications or claiming a right of foreign priority under 35 U.S.C. 119(a)-(d) or (f) to one or more foreign applications will not cause a non-provisional application to be ineligible for the pilot program.
Participation in the pilot program requires the following:
- The request for prioritized examination under the pilot program must be made.
- The applicant must certify that at least one of the pending claims covers a product or process related to COVID-19 and that such product or process is subject to an applicable FDA approval for COVID-19 use. Form PTO/SB/450 contains this certification.
- 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. Form PTO/SB/450 contains this certification.
- The request must include an executed application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i).
For more information on the pilot program, please click here.