Acceleration for cancer-related patent applications

In 2016 the Obama administration initiated the “National Cancer Moonshot” project to drive forwards cancer research. In support of this project the USPTO implemented a pilot program to accelerate examination of patent applications relating to cancer immunotherapy.

Applications qualifying for the pilot program are examined out of turn, with the aim of completing examination within 12 months; clearly a significant acceleration. Unlike some of the USPTO acceleration programs this one does not require the applicant to make any assertions about the validity of the claims over the prior art, nor pay any fees. To qualify for the program an applicant must make a request early in examination, and the application must meet certain formality requirements as well as having at least one claim in the right technical field.

The technical field is defined as 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 cancerous cells." Some examples of allowable claims are "the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells," "the co-administration of biological adjuvants (eg interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for 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," or "in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines".

The pilot program has now been extended to 30 June 2020, giving applicants further opportunities to benefit. The USPTO has reported that more than 300 petitions for entry to the program have been filed, and over 100 patents have been granted.