COVID-19 Prioritized Examination Pilot Program. Episode 121

(The podcast episode first aired in 2020, but it no longer in effect (as of at least 2025).)

Why This Topic Now

I’ve hesitated to talk about COVID in both my newsletter and this podcast because it seems like every article you read and every news story is about COVID. I wanted to give you all a break from hearing something COVID-related. But I decided it was important to let you know about a special program at the USPTO for COVID-related patent applications.

Background on Accelerated Examination

Previously, I talked about ways to accelerate your application being reviewed—such as being over 65, having cancer or HIV, having an inventor in poor health, paying extra fees, or using the Patent Prosecution Highway. I went into all those options in a previous episode.

What Is the COVID-19 Prioritized Program?

This new program only allows 500 applications where your patent application can be taken out of turn and put at the front of the line—if your invention is COVID-19 related. As of April 6, 2021, 345 of those slots have been granted, so there are only 155 remaining. You’ll want to move quickly if you think you qualify.

What Counts as COVID-19 Related?

Now, what does “COVID-19 related” actually mean? For example, what if you have a new type of hand sanitizer? You might argue it’s COVID-19 related, but I doubt that will be sufficient.

Here are the basic rules: your application must have one or more claims directed to a product or process related to COVID-19, and that product or process must be subject to applicable FDA approval for COVID-19 use.

That means your claimed invention may need to fall under one of the following FDA classifications:

• Investigational New Drug Application (IND)

• Investigational Device Exemption (IDE)

• New Drug Application (NDA)

• Biologics License Application (BLA)

• Premarket Approval (PMA)

• Emergency Use Authorization (EUA)

Who Can Apply

You must be a small entity or micro entity—so large companies are not eligible. You also have to submit a specific request using Form PTO/SB/450.

The application must be a new, non-continuing application, or one that claims priority to a provisional application. If you don’t know what those terms mean, I have episodes covering both continuation and provisional applications.

How to Apply

The form is very simple—it asks for your name, the title of your invention, a checkbox, and your signature. When you submit online, you’ll be submitting your application and choosing the “New Application – Track One Prioritized Examination” option. Do not choose “Accelerated Exam.”

Then, when you upload the COVID-19 form, select the document description as “COVID-19 Prioritized Examination Request.” There is no fee for this request.

Limitations of the Program

You can still get an application examined quickly through the usual methods like paying for prioritized examination or other acceleration options, but this COVID-related route is just one additional way.

However, I think this will be hard to qualify for in most cases because of the FDA approval requirement. For example, I helped someone file an application for a particular kind of glove that prevents contamination. While it was somewhat COVID-related, it didn’t qualify because it wasn’t subject to FDA approval for COVID-specific use.

The Benefit

If your request is granted, the goal of the program is to have your patent application allowed within 6 months of filing, which is much faster than the standard 1.5 to 2 years it might normally take.

I’m Adam Diament, and until next time, keep on inventing.