29 June 2016, the US Patent Office announced a Pilot Program for Cancer Immunotherapy aimed at accelerating prosecution and grant of cancer immunotherapy patent applications.
In more detail, as part of the “Moonshot” initiative which is aimed at eliminating cancer and which was announced by President Obama in his 2016 State of the Union address, the US Patent Office has unveiled a Pilot Scheme which provides a fast-track review for cancer immunotherapy-related patent applications without having to pay a petition fee.
Under the scheme (so-called “Patents 4 Patients”), US patent applications directed to cancer immunotherapy undergo accelerated prosecution, with the aim of issuing final decisions within a year after the application is received by the US Patent Office.
The Scheme is open to any patent application containing at least one claim relating to a method of treating cancer using immunotherapy and which meets one of the following requirements:
* The application has not received a first Office Action;
* The petition is filed with a request for continued examination (RCE); or
* The application is not under final rejection and the claimed immunotherapy is subject of an active Investigational New Drug (IND) application that has entered Phase II or Phase III (FDA) clinical trials.
A petition must be filed and as noted above, no fee is due.
The term “cancer immunotherapy” covers a number of different approaches including monoclonal antibodies such as authorised therapies nivolumab and ipilimumab, non-specific immunotherapies e.g. interferons, CAR-T technology and oncolytic virus therapy.
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