USA- May 8, 2020

The United States Patent and Trademark Office (USPTO) today announced a new Prioritized Examination Pilot Program for qualified patent applications relating to COVID-19. This program is available without the usual prioritized-examination fees and the USPTO’s goal under the program is to reach final disposition of applications in the program within twelve months from the date prioritized status is granted. However, the USPTO notes that it may be able to reach final disposition in six months if applicants provide more timely responses to notices and actions from the USPTO. This pilot program is limited to a total of 500 accepted requests, but the USPTO may extend or terminate the pilot program at its discretion.

What do you need to do for your patent application to qualify for this program?

  • You must qualify for small or micro-entity status (as defined by 37 CFR § 1.27 and 35 U.S.C. § 123)
  • The claims of your application must cover a product or process that is related to COVID-19
  • The claims of your application must cover a product or process that is subject to FDA approval for use in the prevention and/or treatment of COVID-19
  • Act quickly before the limit of 500 applications is reached

The Food and Drug Administration maintains a publication, called the Orange Book, listing patents on drug products approved as safe and effective for public use. The point of the Orange Book is to make it easier for generic drug companies to identify the patent and FDA approval status of drugs they might want to manufacture.

Getting a drug patent listed in the Orange Book has enormous benefits for pharmaceutical companies because it triggers a 30 month legal delay to the introduction of competing versions.

This is being challenged as harmful to consumers and competitors alike. You can read more on the case, Jazz Pharms, Inc. v. Avadel CNS Pharms, LLC, here.