To support the $1 billion National Cancer Moonshot initiative launched on February 1, 2016, the USPTO established Patents 4 Patients, also known as the Cancer Immunotherapy Pilot Program. This program provides a fast-track review for cancer immunotherapy-related patent applications without the need for applicant to pay a petition fee. Under this program, patent applications pertaining to cancer immunotherapy are advanced out of turn for examination, resulting in their accelerated review. Patents 4 Patients 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 view of the continued interest in the program and participation from various stakeholders from around the world― independent inventors, universities, research institutions, hospitals, medical centers, government agencies, and large and small companies―the USPTO has extended Patents 4 Patients until June 30, 2022. All pilot parameters remain the same as first implemented on June 29, 2016.
- 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 the USPTO patent electronic filing system (EFS-Web).
- Open to:
- any application that has not received a first Office action,
- any application where the petition is filed with a Request for Continued Examination (RCE), 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 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 our 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 a new application, do not choose “Accelerated Exam” or “Track One”
Announcements and reports
For questions about EFS-Web or the PAIR system, please contact the Patent Electronic Business Center at 866-217-9197.
For questions regarding a specific cancer immunotherapy petition, please contact one of the following:
For questions regarding the Cancer Immunotherapy Pilot Program Federal Register Notice, please contact the Office of Patent Legal Administration at 571-272-7704 or e-mail PatentPractice@uspto.gov.
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