USPTO Fast-Tracks Appeals For FDA Approved COVID-19 Patents

Rothwell, Figg, Ernst & Manbeck, P.C.

On April 15, 2021, the United States Patent and Trademark Office (“USPTO”) implemented the COVID-19 Prioritized Examination Pilot Program (“Pilot Program”) to fast-track ex parte appeals of products or processes subject to an applicable FDA approval for COVID-19 use.

Generally, appeals to the Patent Trial and Appeal Board (PTAB) are taken up for decision in the order they are docketed, with an average of 13 months from the time the PTAB receives the appeal to the date of the final decision.

For qualifying appeals, the PTAB has set a target of issuing a decision on the merits of the appeal within six months from the date that a petition for fast-track review is granted.  Appellants can expect a decision on their petition for fast-track status in approximately two business days.

To qualify for fast-track status under the Pilot Program, appellants must meet the following three conditions:

  1. The application must be an original utility, design, or plant non-provisional application claiming a product or process subject to an applicable FDA approval for COVID-19 use;
  2. The appeal 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); and
  3. The appellant must file a petition under 37 C.F.R. § 41.3 and certify that the application involved in the appeal claims products or processes that are subject to an applicable FDA approval for COVID-19 use.

The USPTO is offering the Pilot Program on a temporary basis and will accept petitions for fast-track review until 500 appeals have been accepted into the Pilot Program.

Hearings in ex parte appeals under the Pilot Program will be conducted according to ordinary PTAB hearing procedures.

Currently, the PTAB is conducting hearings by telephone only, until further notice.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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