In July 2016, the USPTO launched the Cancer Immunotherapy Pilot Program to provide a fast-track review for cancer immunotherapy-related patent applications without the need for applicants to pay a petition fee.  Under this program, patent applications pertaining to cancer immunotherapy are advanced out of turn for examination, resulting in accelerated review.

The program aims to cut the time it takes to review patent applications pertaining to cancer immunotherapy in half by issuing final decisions in one year or less after they are received.  In order to request consideration for the program:

  • Applications must contain one or more claims to a method of treating a cancer using immunotherapy.
  • Applicants must file a grantable petition under this initiative using our patent electronic filing system (EFS-Web).
  • Open to:
  1. any application that has not received a first Office action,
  2. any application where the petition is filed with a Request for Continued Examination (RCE), or
  3. any application not under final rejection where the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application that has entered Phase II or Phase III (FDA) clinical trials.
  • No additional fee is required to participate in the program.

How to file

  • Fill out Petition Form: PTO/SB/443
  • Save form and upload via the USPTO patent electronic filing system, EFS-Web
  • Select document description, “Petition for Cancer Immunotherapy Pilot” (found under the “Petition Category”) on the EFS-Web screen to ensure processing)
  • If the application is a new application, do not choose “Accelerated Exam” or “Track One”