With an eye toward supporting the fast-moving research and development process of COVID-19 treatments, the U.S. Patent and Trademark Office (USPTO) has announced two new programs aimed at expediting review of certain mark and patent applications. Under each program, applicants must demonstrate that the product or process is directly correlated to COVID-19.
Effective June 16, 2020, the trademark program allows applicants to file a Petition to the Director to expedite review of COVID-19-related marks, which accelerates review of trademark and service mark applications by two months.
Typically, a Petition to the Director requests that the USPTO, instead of reviewing the application in the order in which applications are received, expedite the initial examination of an application based on valid cause. The petition is accompanied by (1) a required fee, (2) an explanation why the applicant requests the special action, and (3) a statement of facts, supported by an affidavit or declaration, demonstrating why the special action is justified.
In the newly-implemented program, the USPTO will accept petitions to advance examinations of applications for marks that identify COVID-19 medical products and services falling within two categories. The categories are:
- Pharmaceutical products or medical devices such as diagnostic tests, ventilators, and personal protective equipment, including surgical marks, face shields, gowns, and gloves, that prevent, diagnose, treat, or cure COVID-19 and are subject to approval by the United States Food and Drug Administration; and
- Medical services or medical research services for the prevention, diagnosis, treatment of, or cure for COVID-19.
The FDA approvals include Investigational New Drug (IND) applications, Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License Application (BLA), Premarket Approval (PMA), or Emergency Use Authorization (EUA).
Applicants must file the application and then file the petition with the application’s serial number via the Trademark Electronic Application System. Applications must include a standard statement of facts, specifically noting the type(s) of medical goods or services covered and explaining why the application should receive a prioritized examination. Under this program, the USPTO is waiving the standard fee for Petitions to the Director. If the USPTO grants the petition, the application proceeds to an examining attorney for review. Approved applications will continue to be published for opposition in the Trademark Official Gazette, with a 30-day period for the public to file oppositions or extensions. It is important to note that while this new program accelerates initial review of applications, it does not change the standard steps required to acquire a federal trademark.
Effective on May 14, 2020, the pilot patent program expedites examination of qualifying patent applications with the goal of providing final disposition of the applications in less than one year after becoming prioritized. The program accepts up to 500 patent applications without any fees for requesting prioritized examination. Applications for the patent program are limited to applicants who can certify to being a small or micro entity. The program also offers a separate pilot program request form in which applicants certify to their status and claims.
To qualify for the program, applications:
- Must contain at least one claim to a COVID-19-related product or process that is subject to FDA approval for COVID-19 use, which includes an IND application, IDE, NDA, BLA, PMA, and EUA, similar to the trademark program;
- Are limited to four independent claims and thirty total claims;
- May not claim the “benefit of the filing date of two or more previously filed non-provisional U.S. applications or international applications designating the United States”; and
- Must fall in one of three categories of applications listed in the program information, including non-continuing, non-provisional utility or plant patent applications.
The USPTO also suggests that the time frame for receiving final disposition may accelerate even further if the applicants promptly respond to office actions sooner than required. Participation in the pilot program terminates when the USPTO mails a notice of allowance or a final office action, or if the applicant files a Notice of Appeal or an extension of time. To participate in the pilot program until final disposition, applicants must file their applications before the 500 application quota is filled and promptly respond to any office actions without any extensions of time or disqualifying changes to the application.
The USPTO intends both programs to help innovators protect their intellectual property rights in the current fast-paced environment, with particular focus on getting medical products to market faster. While both programs allow for expedited review and possible determination, the timelines are by no means guaranteed. Additionally, the programs do not skip any required examination steps, eliminate any fees for the base application, or guarantee approval by the USPTO.
It is important to discuss your interest in pursuing a patent application with legal counsel, particularly if you believe that the new pilot program may suit your needs. If you would like to file a trademark or patent application under the programs, please consult with legal counsel to confirm if your product, service or invention qualifies for the programs.
Information about COVID-19 and its impact on local, state and federal levels is changing rapidly. This article may not reflect updates to news, executive orders, legislation and regulations made after its publication date. Visit our COVID-19 resource page to find the most current information.