The U.S. Patent and Trademark Office (USPTO) today announced a webpage to help small and micro businesses apply for streamlined consideration for products that require FDA approval for COVID-19 use.
The COVID-19 Prioritized Examination Pilot Program, announced May 8, will allow up to 500 qualifying patent applications to be accepted for priority examination and be exempted from priority examination fees. The USPTO will try to reach a final decision on each application within six months if applicants respond promptly its communications, according to the patent office.
FDA programs covered by the pilot program include 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).
Here are links to the program’s webpage and to its official notice and to the new webpage. Note that the program’s effective date is May 14, 2020, not July 13, as was erroneously reported in the Federal register.