COVID fast-track appeals pilot program
To expedite the development of COVID-19 related therapeutics and products, the United States Patent and Trademark Office (USPTO) announced several fast-track programs in the past year. Previously, the USPTO announced the COVID-19 Prioritized Examination Pilot Program to expedite the patent examination for COVID-19-related applications. Now, the USPTO has implemented a Fast-Track Pilot Program for Appeals Related to COVID-19 to expedite certain COVID-19-related ex parte appeals before the Patent Trial and Appeal Board (PTAB or Board).
Under this program, the PTAB will try to issue final decisions within six months from the date the petition is granted, and the COVID-19-related ex parte appeal is entered into the pilot program.
Beginning April 15, 2021, the program will accept up to 500 petitions without a fee. To qualify for the appeal:
The application must be an original utility, design, or plant non-provisional application and must claim a product or process for COVID–19 use. Approvals may 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), or an Emergency Use Authorization (EUA).
The appeal for fast-track status must be an ex parte appeal for which a notice of appeal has been filed and a PTAB docketing notice has been issued by the USPTO (i.e., the appeal is pending before the PTAB).
The appellant must file a petition under 37 C.F.R. § 4
1.3, preferably via the USPTO’s electronic filing system, and must certify that claimed products or processes are subject to an applicable FDA approval for COVID–19 use.
The ex parte COVID-19 fast-track appeals will be conducted according to ordinary PTAB hearing procedures. Currently, hearings of appeals are being conducted by telephone only, until further notice.
Applicants should use Fast-Track COVID-19 Related Appeals Pilot Program Form PTO/SB/454 to request participation in the pilot. If you have any questions about participation in the COVID fast-track appeals pilot program, please feel free to contact a Leber IP attorney.
Further information on the pilot program is available by accessing the following web links.