What is the COVID-19 Trademark Prioritized Examination Program?

In an effort to address the critical need to develop medical products and services that will aid in the elimination of the COVID-19 pandemic, the United States Patent and Trademark Office (the PTO) has implemented the COVID-19 Trademark Prioritized Examination Program (the Program), under which the examination of qualifying trademark applications can be expedited so that such products and services can move to market as soon as possible. The Program went into effect June 16, 2020, and there is no current end date.

How does a trademark application qualify for prioritized examination?

Trademark applications for marks that will be used in connection with one or more of the following qualifying COVID-19 medical goods or services are eligible for prioritized examination under the Program:

• Pharmaceutical products or medical devices such as diagnostic tests, ventilators, and personal protective equipment, including surgical masks, 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 (FDA); and

• Medical services or medical research services for the prevention, diagnosis, treatment of, or cure for COVID-19.

Will my trademark application still qualify for prioritized examination under the Program if it includes non-qualifying goods or services along with qualifying goods or services?

Yes, trademark applications may include additional related goods or services.

What does it mean that qualifying COVID-19 medical goods or services must be subject to approval by the FDA?

The FDA 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).

While the PTO uses the term “approval” in referring to the FDA regulatory status of the qualifying COVID-19 medical goods and services, it is clear that the Program includes more than only products with FDA approval. Most notably, products on the market pursuant to EUAs are not approved by the FDA. Rather, they have been “authorized” to be sold pursuant to an EUA for the duration on the COVID-19 State of Emergency. These products are not “approved” by the FDA. 

The PTO indicates that the above list is not exclusive. While not mentioned, presumably the non-exclusive nature of the list makes the Program available to COVID-19 medical devices subject to 510(k)s.

How do I seek FDA approval of my COVID-19 medical goods or services?

Information on INDs, IDEs, NDAs, BLAs, PMAs, and EUAs is available on the FDA’s website located at www.fda.gov.

How do I have my application examined under the COVID-19 Trademark Prioritized Examination Program?

Applicants who wish to have their trademark application examined under the Program should take the following steps:

What should I include in my Petition to the Director?

The Petition to the Director should include the following:

• The Serial Number of the subject application;

• A statement of facts that sets forth the applicant’s COVID-19 medical goods or services;

• An explanation of why the goods or services qualify for prioritized examination under the Program;

• The Code of Federal Regulations section under which the goods are regulated; and

• An affidavit or declaration under 37 C.F.R. § 2.20 to support the claims made in the petition.

Once my Petition to the Director is approved, how quickly can I expect my application to mature to registration?

Typically, trademark applications will be examined approximately four months after they are submitted. Under the Program, approved applications will be expedited by approximately two months. To ensure that approved applications are processed as quickly as possible, applicants should respond to any communication from the PTO Examining Attorney promptly. After examination, the application will still be published for opposition in the Trademark Official Gazette for the regular 30-day period.