Since the COVID-19 outbreak, the United States Patent and Trademark Office (USPTO) has implemented initiatives designed to expedite the grant of patents directed to COVID-19 treatment or to expedite the licensing/commercializing of patents/published patent applications directed to COVID-19 treatments. The key USPTO initiatives are summarized below.
I. COVID-19 Prioritized Examination Pilot Program for small and micro entities
On May 8, 2020, the USPTO announced a pilot program that waives the prioritized examination fee for COVID-19-related patent applications owned by small or micro entities, including universities, nonprofit organizations, individual inventors or a small-business concerns having fewer than 500 employees. Typically, a prioritized examination, which expedites prosecution of a patent application, costs $2,000 and $1,000 for small and micro entities, respectively.
Normally, the USPTO aims to complete examination within 12 months of the granting of a prioritized examination. For the pilot program, “the USPTO will endeavor to reduce pendency, from approval of the request for prioritized examination to final disposition, to six months if all replies occur within 30 days of a notice by the USPTO.” Thus, the pilot program aims to significantly speed up prosecution.
The pilot program is limited to 500 applications having claims that “cover a product or process that is subject to U.S. Food and Drug Administration (FDA) approval for use in the prevention and/or treatment of COVID-19.” Examples of such approvals include an investigational new drug application, a new drug application, a biologics licensing application, a premarket approval and an emergency use authorization.
The eligibility requirements for the pilot program are as follows:
- Request for prioritized examination under the pilot program has to be made (a) with the filing of a noncontinuing original utility or patent nonprovisional application; (b) with the filing of a new continuation application claiming priority to only one prior nonprovisional or international application; or (c) with or after the filing of a request for continued examination of such an application. While continuation applications claiming priority to two or more prior nonprovisional applications are not eligible, nonprovisional applications may claim priority to one or more provisional or foreign applications without losing eligibility.
- Applicant must certify that at least one of the claims covers a product or process that is subject to an applicable FDA approval for COVID-19 use.
- Applicant must certify small entity or micro entity status.
- Request must include an executed application data sheet.
- As with all requests for prioritized examination, the application cannot contain more than four independent claims, more than 30 claims or a multiple independent claim.
Use of USPTO form PTO/SB/450, titled “Certification and Request for COVID-19 Prioritized Examination Pilot Program under 37 CFR 1.102(e),” is encouraged. This form contains the necessary certifications (1 to 4) for participation in the pilot program. The First Action Interview Pilot Program cannot be used in conjunction with this pilot.
Upon the filing of a request for prioritized examination, the USPTO reviews the application for compliance with these requirements. If the application meets these criteria, it will be granted special status, and prioritized examination will proceed. However, if the claim count in the application goes above the threshold or if an extension of time is taken, the application is no longer under prioritized examination. Since the program aims to reduce pendency to six months if applicants promptly respond to USPTO action, this initiative should greatly expedite the patenting of COVID-19 treatments.
II. Patents 4 Partnership database to identify COVID-19-related patents/public applications for licensing
On May 4, the USPTO launched the Patents 4 Partnership database, which provides a listing of patents and published patent applications related to the COVID-19 pandemic that are indicated as available for licensing. The USPTO launched the database with hopes that it “may contribute toward this battle by helping to bring to the marketplace new products and technologies for the prevention, treatment, and diagnosis of COVID-19.” The initial listing in the database was generated based on COVID-19-related patents and published applications owned by the federal government or universities.
The database lists the patents and/or published patent application by title, publication/patent number, first named inventor, publication or issue date, and licensing status, and includes an option to view the abstract. The database is fully searchable for all the fields, including the abstract.
As of May 12, the database listed 182 patents and published patent applications, none of which is indicated as having been licensed. It is possible for patent owners and patent applicants to request addition of their patent rights to the database by filling out a form and emailing it to the USPTO. While the database is currently limited to COVID-19, the USPTO indicated that it may be expanded to include other patents or published patent applications.
These notices and other COVID-19-related notices are available on the USPTO website.