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Thursday, July 30, 2020 1:40:37 AM
A normal patent would normally fall under a NDA (Non-Disclosure Agreement) and are published after 18 months.
SBFM has filed for a priority patent under the new covid-19 pilot, and this is being fast tracked. Both the FDA & USPTO are working together with priority and fast tracking to market new drugs and expedite the patenting process. This is stated in their own press releases.
SBFM has filed either an IND, IDE, or NDA (New Drug Application), BLA, PMA, or EUA patent. This changes the time frame significantly with the USPTO!
In this case, NDA does not mean Non-Discloser Agreement, it means New Drug Application. The terms are confusing. Here are the fast track/priority patent process according to USPTO:
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)
In short, SBFM is not subject to the typical time frame because their patent is covid-19 related. The PR on 6/3/2020 stated they filed a priority patent and submitted it on 5/22.
This means the submitted patent application will be marked for priority and fast tracked. It meets one of the above requirements (IND, NDA (New drug Application), BLA, PMA, or EULA, but SBFM has not stated which. It would be nice to get clarification on that, but the processing time is still the same (prioritized).
Information is all found here:
https://www.uspto.gov/initiatives/covid-19-prioritized-examination-pilot
https://www.uspto.gov/sites/default/files/documents/TM-COVID-19-Prioritized-Examination.pdf
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