In an effort to foster innovation, the U.S. Patent and Trademark Office (USPTO) recently announced a new COVID-19 Prioritized Examination Pilot Program. To qualify, the claim(s) of an application must cover a product or process related to COVID-19, and the product or process must be subject to an applicable FDA approval for COVID-19 use. The pilot is limited to applicants that qualify for either small or micro entity status, including small businesses and individual inventors.

Patents that are fast-tracked through the program could reach a final decision in as fast as six months. In addition, qualifying applicants will not need to pay the USPTO’s typical prioritized examination fees.

“Independent inventors and small businesses are often the difference-makers when it comes to cutting-edge innovation and the growth of our economy,” Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO said in a press statement. “They are also in most need of assistance as we fight this pandemic. Accelerating examination of COVID-19-related patent applications, without additional fees, will permit such innovators to bring important and possibly life-saving treatments to market more quickly.”

Prioritized Examination

Typically, the USPTO examines new patent applications in the order of their U.S. filing dates. However, the agency has several programs under which eligible patent applications can be advanced out of turn.

The new COVID-19 Prioritized Examination Pilot Program will provide prioritized examination without payment of the additional fees for prioritized examination for certain applications that claim products or processes that are subject to an applicable FDA approval for COVID-19 use. According to the USPTO, such approvals may include, but are not limited to, 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 goal of prioritized examination is to provide a final disposition within 12 months, on average, from the date the prioritized status has been granted. However, the USPTO believes it can achieve final disposition in six months if applicants provide more timely responses to notices and actions from the USPTO.

Eligibility Requirements As set forth in the USPTO’s Federal Register Notice, patent applicants seeking to take advantage of the pilot program must satisfy several eligibility requirements. The request for prioritized examination under the pilot program must be made:

  • With the filing of a non-continuing original utility or plant nonprovisional application;
  • With the filing of an original utility or plant nonprovisional application claiming the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c) of one prior nonprovisional application or one prior international application designating the United States; or
  • With or after the filing of a request for continued examination (RCE) of such plant or utility application or of a national stage of an international application. Consistent with 37 CFR l.102(e)(2), only a single request for prioritized examination filed with or after filing an RCE may be granted in an application.

The pilot program is reserved for the above nonprovisional applications. Accordingly, any application that claims the benefit of the filing date of two or more prior-filed nonprovisional U.S. applications or international applications designating the United States under 35 U.S.C. 120, 121, or 365(c) is not eligible for participation under the pilot program.

Act Fast: The Pilot Program Limits the Number of Requests

The COVID-19 Prioritized Examination Pilot Program will accept requests for prioritized examination until the USPTO has accepted a total of 500 requests. According to the USPTO, it may extend the pilot program (with or without modifications) or terminate it depending on the “workload and resources needed to administer the program, feedback from the public, and the effectiveness of the program.”

If you have questions, please contact us

If you have any questions or if you would like to discuss the matter further, please contact me, Libby Varghese, or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.