The United States Patent and Trademark Office (USPTO) announced another new initiative relating to COVID-19 to help encourage innovation for products and processes related to COVID-19. Starting on May 8th, micro and small entity status applicants can apply for the "COVID-19 Prioritized Examination Pilot Program", which offers expedited examination of eligible applications without an additional fee. This program will provide assistance to small and micro entities such as small businesses, nonprofit organizations, and Universities looking to bring potentially life-saving COVID-19 innovations to market as quickly as possible.
The Program's goal is to reach final disposition of applications in the program within twelve months, and potentially as quickly as 6 months, from the date prioritized status is granted. This is a significant acceleration as it can take years before obtaining a granted application under the normal procedure. The absence of an additional fee is also a welcome offering. Normally for expedited examination, the USPTO charges $1,000 for micro entities and $2,000 for small entities.
Eligibility and How to Apply
An eligible application must have claim(s) to a product or process related to COVID-19 (ex. diagnosis or treatment) that is subject to an applicable FDA approval for COVID-19 use, and must meet the following requirements:
- The application must be a non-continuing original utility or plant nonprovisional application, or a request for continued examination (RCE) of such plant or utility application or of a national stage of an international application;
- Applicant must certify either small or micro entity status;
- The request must include an executed application data sheet; and
- The application must have no more than four independent claims, no multiple dependent claims, and no more than 30 total claims.
Examples of eligible FDA approvals include 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), and an Emergency Use Authorization (EUA).
Prosecution Timelines:
The time periods to reply to USPTO requests such as office actions will be the same as those for other prioritized examinations. If an applicant files a petition for an extension of time to a USPTO request, the application will lose its prioritized status.
Program Duration:
Currently, the Pilot Program will accept up to a maximum of 500 requests for prioritized examination. Depending on the Program's success, the USPTO may increase or decrease the number of applications it will accept.
Conclusion:
Hopefully patent offices in other jurisdictions will also implement programs to help expedite the patenting of COVID-19 innovations, especially if at a reduced cost to the innovator. Eligible inventors looking to take advantage of the USPTO Program should file quickly before the 500 spots fill up. A complete description of the new Program can be found on the USPTO website.
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