USPTO Offers Small Businesses a Pathway to Obtain Patents on Certain COVID-19 Related Inventions Within Six Months Without Additional Fees
On May 8, 2020, the United States Patent and Trademark Office (USPTO) published a Federal Register Notice that provided a pilot program that allows for small businesses to obtain prioritized examination on patent applications for certain COVID-19 related inventions without any additional fees over a standard priority application. The USPTO considers the outbreak of COVID-19 to be an “extraordinary situation” within the meaning of 37 CFR § 1.183, and has decided to implement this pilot program to allow affected patent applicants and innovators a pathway to quickly and efficiently obtain patents on their inventions.
In order to receive benefit of the pilot program, the applicant must qualify as a small or micro entity status under USPTO rules. In short, for most small entities, this means the applicant must have fewer than 500 employees.
Further, in order to qualify, the invention must:
- cover a product or process related to COVID-19; and
- be subject to an applicable FDA approval for COVID-19 use.
While a standard priority application would usually take on average about two years or more to process through final disposition, the typical prioritized examination application receives final disposition in just twelve months. Further, per the Notice, the USPTO believes it can achieve final disposition of COVID-19 related inventions under the pilot program in as little as six months, so long as the applicants provide timely responses to notices and actions from the USPTO.
The Notice also identifies some of the products and processes subject to FDA approval that would fit into the pilot program. Notably, they include Investigational New Drug (IND) applications, 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).
Finally, to give an idea on cost savings to small businesses for utilizing the program, the standard Track I Prioritized Examination fees can typically add up to over two-thousand and seventy dollars ($2,070) to the filing fees of such an application. This can represent a significant savings to small businesses, especially in these trying times. Given the cost savings, and the quick pathway to obtaining a patent, this should be an exciting option for small businesses looking to keep costs low, while enjoying a significant decrease in the processing time of their patent applications.
The USPTO has set an initial limit of 500 requests for the pilot program, but it retains the ability to alter that number at any time. Still, clients should assume time is of the essence with respect to these filings.
There are other considerations to take into account as to whether a specific invention qualifies for this pilot program, so speaking to counsel before making any decision is a necessary consideration.