While Big Pharma is well-poised to incur the expense of patent filing, including the additional expense of paying for accelerated examination of their applications, smaller concerns may not be in a position to do so. To help small businesses and solo inventors in this regard, the United States Patent Office has announced a program that would fast-track the examination of certain patent applications related to the pandemic. While the typical turn-around time for an Examiner to provide an initial review of a new application is about two years after filing, payment of an extra fee to accelerate examination is also an option. Small businesses and startup companies, however, typically can’t take advantage of this program due to the substantial increased initial cost. To remove this impediment, the new program enables business with less than 500 employees to request accelerated examination of certain COVID-19-related applications with no additional upfront payment. If an application qualifies for the program, the Patent Office promises to fully examine it within a year of being granted prioritized status.
The program is further limited to therapeutics, vaccines and diagnostic tests that are subject to FDA approval for COVID-19 related uses. FDA approvals include, for example, Investigational New Drug (IND) applications, Investigational Device Exemptions (IDE), New Drug Applications (NDA), Biologics License Applications (BLA), Pre-market Approvals (PMA), and Emergency Use Authorizations (EUA).
As of Thursday, August 20th, there have been 274 applicants with 146 requests having been granted. The program is limited to the first 500 approved applicants.