The USPTO has recently announced extension of Patents 4 Patients, also called as the Cancer Immunotherapy Pilot Program, until June 30, 2020. This pilot program was started on June 29, 2016, to provide a fast-track examination for an application related to cancer immunotherapy. The PTO’s goal is to issue a final decision within a year of the entry of the program.
Qualifying applications are those including a claim directed to a method of treating cancer using immunotherapy. Applicant in such an application may file the petition to participate with no additional fees. The petition may be filed in applications at different stages of examination – i) in a pending application before a first Office Action, ii) at the time of filing a Request for Continued Examination (RCE), or iii) in a pending application which is not subject to final rejection and claims the treatment method included in an active Investigational New Drug (IND) application that has entered Phase II or III clinical trials in the U.S.
According to the report of October 9, 2018, total 255 petitions were filed since the pilot program started, out of which 208 were granted, and 20 were dismissed. Among the 208 applications that entered the program, 140 cases were closed (under final rejection, allowed, or abandoned) and 68 were pending as of the date of the report. 80 patents issued. On average it took 23 days for the PTO to issue a first action on the merits after the petition grant.