July 26th, 2016

On June 29, 2016, the U.S. Patent and Trademark Office (USPTO) announced a new pilot program providing accelerated review for cancer treatment-related patents in the area of cancer immunotherapy. This “Patents 4 Patients” initiative is part of President Obama’s call for a “National Cancer Moonshot”.

The Cancer Immunotherapy Pilot Program aims to complete examination of patent applications pertaining to cancer immunotherapy within twelve months of the special status being granted. Qualifying patent applications will be advanced out of turn for examination even if they don’t meet the other current requirements for accelerated examination. No application fee is charged under the Pilot Program and it is expected to run until June 29, 2017.

For a patent application to be eligible for the Cancer Immunotherapy Pilot Program, it must satisfy the following requirements, namely it must:

  1. be a pending non-reissue, non-provisional utility application filed under 35 U.S.C. § 111(a), or an international application that has entered national stage in the United-States under 35 U.S.C. § 371;

  2. contain no more than three independent claims and no more than twenty total claims. Multiple dependent claims are not allowed;

  3. include at least one claim directed to a method of treating a cancer using immunotherapy. To satisfy this requirement, the claimed method must aim is improvement, treatment or prevention of cancer in a human subject and one of the steps of the method must be to assist or to boost the immune system in eradicating cancerous cells;

  4. in order to be granted special status under the Pilot Program, the application must be filed before the issuance of any Office Action, or with a request for continued examination (RCE). The application cannot have been granted special status previously. However, if the claimed cancer immunotherapy has entered phase II or phase III clinical trials, then the Petition may be filed at any time prior to a final rejection.

The Cancer Immunotherapy Pilot Program could be highly advantageous for anyone working in oncology who is seeking a quick and affordable patent grant. We encourage you to contact one of our experts at BCF LLP to discuss how the program can be used to expedite your patents and assist you in advancing your therapies to the clinic. For more details on the Pilot Program and the requirements, please click here to consult the USPTO’s notice.

If you have any questions regarding the impact of the Cancer Immunotherapy Pilot Program on your IP protection strategy, contact our patent specialists Andreanne Auger or Emma Saffman at BCF LLP.