In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications related to cancer immunotherapy and is set to launch in July 2016. According to the USPTO, this initiative:
- aims to cut the time it takes to review patent applications in cancer therapy in half (final decisions in 12 months or less);
- is open to any applicant, including early stage bio-tech companies, universities, and large pharmaceutical firms;
- is open to entities who may have products already in FDA-approved clinical trials, allowing them to opt in, even if they have a patent application already filed; and
- moves new treatments from conception through regulatory approval swiftly to reach patients faster.[1]
For a non-provisional U.S. application or international application entering the U.S. national stage to qualify for fast track review under this program, the application “must contain 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 cancerous cells.” Claims drawn to co-administration of biological adjuvants in combination with conventional therapies, administration of vaccines that activate the immune system to prevent or destroy cancer cell growth, and other immunotherapies will also be considered. The application also must not contain more than three independent claims, more than 20 total claims, or any multiple dependent claims.
The petition to make special under this Pilot Program must also include the following statements:
- the Applicant agrees that the application will not have more than three independent claims, more than 20 total claims, or any multiple dependent claims while the application is in special status under the Pilot Program;
- the special status is sought because the application contains a claim to a method of treating cancer using immunotherapy that meets the eligibility requirements;
- the Applicant will agree to make an election without traverse in a telephonic interview and elect an invention directed to a method of treating a cancer using immunotherapy that meets the eligibility requirements; and
- the application was not previously granted special status.
The petition to make special can generally be filed at least one day prior to the date of notice of a first Office Action or with a Request for Continued Examination. For applications with a pending Office Action, a response to the Office Action must be filed with the petition.
Additionally, if the claimed cancer immunotherapy is also the subject of an active Investigational New Drug (IND) application filed by the Applicant or their agent (e.g., a licensee or assignee of the Applicant) at the U.S. Food and Drug Administration (FDA) that has entered phase II or phase III clinical trials, the petition may be filed any time prior to an appeal or a final rejection.
For unpublished applications, the petition to make special must also include a request for early publication. For applications where nonpublication requests were previously submitted, the Applicant also must file a rescission of the nonpublication request no later than the filing date of the petition.
While the USPTO may extend or terminate the Cancer Immunotherapy Pilot Program, the program is currently expected to run until June 29, 2017, and thus petitions must be filed prior to this date.
Additional information on the Pilot Program can be found in the Federal Register: https://www.gpo.gov/fdsys/pkg/FR-2016-06-29/pdf/2016-15533.pdf
Please contact us with any questions and if you would like to discuss taking advantage of this new Pilot Program for your pending applications.