To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination of patent applications directed to methods of treating cancer using immunotherapy. It will be interesting to see how many applicants take advantage of this program, and whether the program is effective to expedite grant of cancer immunotherapy patents.
The National Cancer Moonshot Initiative
The National Cancer Moonshot initiative is a $1 Billion initiative lead by Vice President Biden to end cancer by doubling the rate of progress toward a cure, aiming to compress ten years’ of cancer research into a five year period. The Vice President has highlighted immunotherapy approaches, since immunotherapy “has shown success with melanoma, leukemia, and lymphoma, and is ripe for further exploration in a wider range of cancers.” According to the White House announcement, “the National Cancer Moonshot will work to accelerate these research efforts and break down barriers to progress by enhancing data access, and facilitating collaborations with researchers, doctors, philanthropies, patients, and patient advocates, and biotechnology and pharmaceutical companies.”
The USPTO Cancer Immunotherapy Pilot Program
The USPTO announced the Cancer Immunotherapy Pilot Program in a Federal Register Notice published June 29, 2016. The program provides a mechanism for earlier review of patent applications by placing applications admitted to the program on the examiner’s “special new” docket until a first Office Action on the merits is issued. Once a response to a first Office Action has been filed, the application will be placed on the examiner’s regular “amended” docket, but the USPTO will provide incentives for examiners to review the response promptly. The USPTO’s overall objective is to complete examination of an application (i.e., issue a final Office Action or Notice of Allowance) within twelve months from the time the application is accepted into the program.
The Federal Register Notice explains the subject matter requirements for participation in the program: An eligible 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 cancerous cells.” The Federal Register Notice indicates that eligible claims could include “administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells.” According to the Federal Register Notice, claims drawn to combination therapies of biological adjuvants and conventional therapies for treating cancer, vaccines that activate the immune system to prevent or destroy the growth of cancer cells, and in vivo, ex vivo, and adoptive immunotherapies also will be considered.
In addition to the subject matter requirement, the following formal requirements must be met:
- The application must be a non-reissue, non-provisional, utility application filed under 35 U.S.C. 111(a) or an international application that has entered the national stage under 35 U.S.C. § 371.
- The application must contain no more than three independent claims and twenty total claims, and have no multiple dependent claims. (The applicant can/must file a Preliminary Amendment to bring an application into compliance with this requirement.)
- The application must include at least one claim directed to a method of treating a cancer using immunotherapy (as defined in the Federal Register Notice and summarized above).
An applicant must apply for the program by filing a petition to make special that meets the following requirements:
- The petition must include a statement indicating that special status is sought because the application includes a claim that meets the eligibility requirements set forth above.
- The petition must include a statement that, should the USPTO find that the invention is directed to multiple inventions, the applicant agrees to make an election without traverse in a telephonic interview to elect an invention that is directed to a method of treating a cancer using immunotherapy.
- The petition must state that the application has not previously been granted special status in this or any other USPTO program.
The petition must be filed either (1) at least one day before the first Office Action is issued (as indicated in the USPTO’s Patent Application Information Retrieval (PAIR) system) or (2) with a proper request for continued examination (RCE). However, these timing requirements do not apply if the claimed cancer immunotherapy method is the subject of an active Investigational New Drug (IND) application filed by the applicant or their agent that has entered phase II or III clinical trials, in which case a petition can be filed after the first Office Action but before a final Office Action or Notice of Appeal.
The program also requires that a request for early publication be filed with the petition to make special. If the applicant has requested nonpublication, the applicant must rescind the nonpublication request.
The program will run until June 29, 2017, unless it is extended or terminated earlier.
Impact On Patent Prosecution
Being accepted into the Cancer Immunotherapy Pilot Program has several implications for patent prosecution. First, the First Action Interview Pilot program is not available, although regular interview practice is available. Additionally, responses “must be limited to responding to rejections, objections, and requirements made by the examiner.” Any amendment that would take the application out of compliance with the above requirements will be treated as not fully responsive, and the examiner may–at his or her discretion–give the applicant an opportunity to file a fully responsive reply.
Termination Of “Special” Status Impact On Patent Prosecution
As with many USPTO expedited examination programs, fling an extension of time will terminate the application’s special status. Also, the program is considered to have run its course once a final Office Action has been mailed or a Notice of Appeal has been filed. If an appeal is pursued, “the application will be treated in accordance with the normal appeal procedure.” Also, an application will not retain its special status after an RCE has been filed.
Moonshot Or Pie In The Sky?
It is good to see the USPTO supporting the National Cancer Moonshot, but it is not clear that this program is addressing a problem faced by cancer immunotherapy applications. Currently, the average time from filing a patent application to receiving a first Office Action is about 16 months. Rather than seeing that time period as an impediment, applicants in this field may see it as an opportunity to obtain additional experimental data to confirm their most promising embodiments and strengthen their applications. Similarly, once a first Office Action is issued, an applicant may require an extension of time to marshal experimental data or other evidence to address any enablement or obviousness rejections. Given these factors, it will be interesting to see whether this program is effective to expedite grant of patents to cancer immunotherapies.