USPTO Extends Cancer Immunotherapy Pilot ProgramJuly 18, 2022

The United States Patent and Trademark Office recently issued a notice extending the Cancer Immunotherapy Pilot Program (AKA “Patents 4 Patients”) until September 30, 2022. The program was first implemented in 2016 as part of the $1 billion National Cancer Moonshot initiative and allows for fast-track review of cancer immunotherapy-related patent applications without the need for a petition fee. Eligible patent applications are advanced out of turn for examination and typically receive a final decision in one year or less from the time the application is filed.

To be eligible for the program, patent applications must contain at least one claim directed to a method of treating cancer using immunotherapy and applicants must fill out and submit a grantable petition form on or before September 30, 2022. The program is open to applications that have not yet received a first Office Action, any application where the petition is filed with a Request for Continued Examination, or 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 III of FDA clinical trials.

The USPTO reports that, to date, over 835 petitions requesting participation in the pilot program have been filed and over 615 patents have been granted under the program. In view of the continued interest in the program, as well as the recent reignition of the National Cancer Moonshot initiative, the USPTO is considering further extensions beyond September 30, 2022, as well as potential expansions to the scope of the program.

More information and full program statistics are available on the USPTO’s website.

Melissa Mitchell is an intellectual property attorney in the MVS Biotechnology and Chemical Practice Group. To learn more, visit our MVS website, or contact Melissa directly via email.