In February The White House announced a national $1 billion initiative to achieve ten years’ worth of cancer research in the next five years to aid in the global fight against cancer.
Accordingly, effective immediately (June 29, 2016) the USPTO is implementing a Cancer Immunotherapy Pilot Program (CIPP) to advance patent applications pertaining to cancer immunotherapy out of turn for examination to provide for earlier review.
The objective of the Pilot Program is to complete examination of an application containing a claim(s) to a method of treating cancer using immunotherapy within twelve months of special status being granted.
The USPTO already has procedures for Accelerated Examination, but the new Cancer Immunotherapy Pilot Program can result in special status being granted without meeting all of the current requirements for accelerated examination. Under the Immunotherapy Program the normal fee for seeking special status is waived.
Under the Pilot Program the application must be limited to three independent claims, twenty total claims and must include at least one method claim for treating a cancer using immunotherapy, i.e., a method which invokes an immune response to destroy cancer cells. The petition must be filed at least one day before the first action on the merits in an application or with an RCE. If the immunotherapy is in phase II or Phase III clinical trials, the petition can be filed before an appeal or final action.
Until further notice, Petitions under the CIPP must be filed by June 29, 2017, but the USPTO may extend or terminate the program depending upon the Program’s perceived effectiveness. Hence, it is suggested that applications be prepared and filed promptly.