USPTO Cancer Immunotherapy Pilot Program

Article  \  6 Jul 2016

On 29 June 2016, the United States Patent and Trademark Office (USPTO) announced the implementation of a pilot program to accelerate examination of patent applications having at least one claim to a method of treating a cancer with immunotherapy.[i] This follows in the wake of the White House announcing a $1 billion initiative to achieve ten years’ worth of cancer research in the next five years (the “National Cancer Moonshot”).[ii]


Applicants wishing to participate in the pilot program must file a petition for “special status” to be given to their application.  Reflecting the government’s commitment to the policy, there is no official fee associated with the request.  Applications which meet the criteria for the granting of special status will have examination advanced out of turn and completed within 12 months of special status being granted.

Criteria for Granting Special Status

“Special status” will be provided to standard or full utility patent applications which:

  • contain no more than three independent claims and no more than 20 claims in total;
  • include at least one claim to a method of treating a cancer using immunotherapy (to satisfy this requirement, the method must be directed to one 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”)[iii];
  • have not have been granted any other special status (e.g. under the PPH or prioritized examination); and
  • are not the subject to a nonpublication request.

Where the USPTO decides the claims are directed to multiple inventions, the applicant must agree to prosecute only those claims directed to a method of treating cancer using immunotherapy.

Petition Timing

Petitions for special status must be filed:

  • prior to the first Office Action issuing (including any restriction requirement); or
  • with a request for continued examination (RCE).

Duration of Program

The Cancer Immunotherapy Pilot Program will run for twelve months from 29 June 2016.  Therefore, petitions to make special under the program must be filed before 29 June 2017.  The program may be extended (with or without modifications).  It may also be terminated prior to 29 June 2017, depending on the workload of the USPTO in administering the program, public feedback and effectiveness of the program.


The allowance of a patent can validate the strength of a commercial project.  Obtaining earlier grant will provide the patentee, investors and competitors alike with increased certainty as to the scope of protection afforded.  It can also represent a significant factor in attracting further investment at an earlier stage of the project.  In addition, earlier grant provides for earlier enforceability against infringement.

If you are interested in utilising the pilot program or would like more information please contact Victoria Argyle and Shelley Rowland.

[i] https/ 81 FR 42328


[iii] Claims directed to diagnostic methods or methods of detection will not be considered as falling within the scope of a method of treating a cancer using immunotherapy.