On June 29, 2016, U.S. Vice President Joe Biden and the USPTO announced the “Patents 4 Patients” initiative as part of President Obama’s call for a “Cancer Moonshot” at the White House Cancer Moonshot Summit. As part of the Patents 4 Patients initiative, a free “Cancer Immunotherapy Pilot Program” was unveiled to accelerate examination for cancer immunotherapy-related patent applications. The USPTO aims to cut in half the time it takes to review patent applications in cancer therapy (aiming to have final decisions made in 12 or fewer months). This “fast track” will be open to any applicant, foreign or domestic, including early stage bio-tech companies, universities, and large pharmaceutical firms, as well as entities who may have products already in FDA approved clinical trials, which will also be able to opt in to the acceleration program, even if they have a patent application already filed with the USPTO.
The pilot program includes the following eligibility requirements. (1) The application must contain at least one claim to a method of treating cancer using immunotherapy. (2) The application is limited to three independent claims and 20 total claims. (3) If the Examiner deems a Restriction Requirement necessary, Applicant must make a telephone election without traverse to the immunotherapy claims. (4) The First Action Interview Pilot Program is not available.
(5) If a petition for extension of time is filed, then the application will no longer be in the pilot program. (6) The 12-month goal will be considered satisfied at time of mailing a notice of allowance or final Office Action, or at the time of filing of a Notice of Appeal or RCE.
The Federal Register announcement for the Cancer Immunotherapy Pilot Program can be found here: https://www.gpo.gov/fdsys/pkg/FR-2016-06-29/pdf/2016-15533.pdf
Additional information on the Patents 4 Patients initiative and Cancer Moonshot Summit can be found here: http://www.uspto.gov/about-us/national-cancer-moonshot