On June 29, 2016, the United States Patent and Trademark Office (USPTO) implemented a pilot program for expediting examination of patent applications relating to cancer immunotherapy. This pilot program was designed in support of the White House’s National Cancer Moonshot initiative to accelerate immunotherapy cancer research over the next five years.
Also coined as “Patents 4 Patients”, the objective of the pilot program is to advance a US patent application directed to cancer immunotherapy out of turn for examination, if the applicant files a Petition to Make Special under the Pilot Program. Once accepted into the program, the goal is to complete examination of the application within 12 months of special status being granted.
The USPTO announcement highlights that the eligibility of a patent application should be in the field of oncology and must have “at least one claim encompassing a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancer cells”. The USPTO goes on to provide the following examples as acceptable claims:
- administration of cells, antibodies, proteins or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancer cells;
- co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies of treating cancer such as chemotherapy, radiation or surgery;
- administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth; and
- in vivo, ex vivo and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.
Moreover, for the patent application to qualify into the pilot program, several requirements have to be met and are detailed as follows:
- The patent application must be a non-reissue, non-provisional utility application, or an international application that has entered the US national stage;
- The patent application must not contain more than (a) three independent claims, (b) more than 20 claims in total or (c) any multiply dependent claims;
- The patent application must include at least one claim to a method of treating cancer using immunotherapy;
- If the USPTO determines that the claims are directed to multiple inventions, the applicant must make an election without traverse in a telephonic interview, and elect an invention directed to a method of treating a cancer using immunotherapy;
- The patent application cannot previously have been granted special status under the Pilot Program or any other program;
- The Petition must be filed at least one day prior to (a) the date the notice of a first Office Action appears in PAIR, or (b) with a Request for Continued Examination (RCE). For applications in which the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application, a Petition to Make Special may be accepted any time prior to appeal or final rejection; and
- If the application has not been published, the Petition must be accompanied by a request for early publication.
The program is set to run for a period of 12 months until June 29, 2017, unless the petition is cancelled or terminated earlier.