On June 29, 2016, the U.S. Patent and Trademark Office (USPTO) launched a pilot program to provide expedited review of patent applications directed to cancer immunotherapy. Under the new program, a patent application having at least one claim to a method of treating cancer using immunotherapy can be “made special” and advanced out of turn for examination, simply by filing a grantable petition. The program is intended to support the White House’s $1 billion initiative to achieve ten years worth of cancer research in the next five years.
Unlike the USPTO’s accelerated examination and Prioritized Examination (Track I) programs, no fees are required to participate in the Cancer Immunotherapy Pilot Program.
To be eligible for the program, a patent application must include at least one claim directed to a method of treating cancer using immunotherapy. According to the USPTO, the claim should encompass “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.” For example, eligible methods may involve administration of an agent that actively or passively activates an immune response to destroy cancer cells. It appears that other methods of treating cancer that do not involve the immune system, such as methods using small molecule chemotherapeutics, will not be eligible. However, claims to methods of using chemotherapeutic agents or other traditional therapies, such as radiation or surgery in combination with immunotherapeutic methods, should be eligible. The USPTO indicates that it will consider claims to administering vaccines that activate the immune system to prevent or destroy cancer cell growth, along with in vivo, ex vivo, and adoptive immunotherapies.
Non-provisional U.S. utility patent applications and international applications entering the U.S. national stage are eligible for the pilot program, while re-issue applications are not eligible. Applications can include no more than three independent claims and 20 total claims, and at least one claim must be directed to a method of treating cancer using immunotherapy, as described above. The application cannot have previously been granted special status. Applicants must expressly agree to make a verbal election without traverse to any restriction requirement and must elect an invention directed to a method of treating cancer using immunotherapy. Petitions must be electronically filed before a notice of a first office action appears in the Patent Application Information Retrieval (PAIR) system.
For applications already undergoing examination, a petition can be filed along with a request for continued examination. However, if the application meets other eligibility requirements and if the claimed cancer immunotherapy is the subject of an active Investigational new drug application filed by the patent applicant (or a licensee or assignee) with the Food and Drug Administration, and if the drug has entered phase II or phase III clinical trials, a petition may be filed any time prior to an appeal or a final rejection.
If an application has not yet been published, the applicant can file a petition but must also file a request for early publication. Any request for nonpublication must be rescinded.
The USPTO’s goal is to complete examination of applications within 12 months of special status being granted, although in addition to a notice of allowance, the USPTO will consider examination to be completed upon the mailing of a final office action, or the filing of a request for continued examination or a notice of appeal. During prosecution of the application under the pilot program, the First Action Interview Pilot Program will be unavailable. Furthermore, requests for extensions of time will terminate the special status granted to an application under this program. Other amendments that will effectively terminate the special status include adding claims such that there are more than three independent claims or twenty total claims, adding a multiple dependent claim, or canceling all claims directed to methods of treating cancer using immunotherapy.
The USPTO will run the pilot program for 12 months, although it may extend the program or terminate the program early depending on workload, administrative resources, public feedback, and the program’s effectiveness. Absent extensions or early termination, the deadline for filing petitions under the pilot program will be June 29, 2017.
Further details regarding the pilot program can be found at https://www.federalregister.gov/articles/2016/06/29/2016-15533/cancer-immunotherapy-pilot-program.