Recent advances have led to the ability to activate the immune system against cancer cells. This approach, termed cancer immunotherapy, has shown success with melanoma, leukaemia, and lymphoma, and has great potential for treatment of a wider range of cancers. Another approach attacks multiple pathways fundamental in cancer development, using combinations of therapeutic agents to prevent resistance from occurring.
On 1st February 2016, the White House announced a $1 billion “Moonshot” initiative to eliminate cancer as we know it. The National Cancer Moonshot will work to accelerate cancer therapy research efforts, and break down barriers to progress by enhancing data access, and facilitating collaborations with researchers, doctors, patients, and patient advocates, and biotechnology and pharmaceutical companies. The initiative aims to bring about a decade’s worth of advances in five years, making more therapies available to more patients, while also improving the ability to prevent cancer and detect it at an early stage.
In support of the initiative, the United States Patent and Trademark Office (USPTO) has implemented a Cancer Immunotherapy Pilot Program to advance US patent applications relating to cancer immunotherapy out of turn for examination if the applicant files a grantable Petition to Make Special under the Pilot Program. The objective of the Pilot Program is to complete examination of the application within 12 months of special status being granted.
The Program began on 29th June 2016, and is currently set to run for 12 months. Thus, Petitions to Make Special must be filed before 29th June 2017 (although the Program may be extended by the USPTO).
The requirements for a Petition to Make Special include:
- The application must be a non-reissue, non-provisional utility application, or an international application that has entered the US national stage;
- The application must not contain more than 3 independent claims, more than 20 claims in total, or any multiple dependent claims (a preliminary amendment to meet this requirement may be made at the time the Petition is filed);
- The application must include at least one claim to a method of treating a cancer using immunotherapy;
- If the USPTO determines that the claims are directed to multiple inventions, the applicant must agree to make an election without traverse in a telephonic interview, and elect an invention directed to a method treating a cancer using immunotherapy;
- The application cannot previously have been granted special status under the Pilot Program or in any other program;
- The Petition must be filed at least one day prior to the date that notice of a first Office action (which may be an Office action containing only a restriction requirement) appears in the online Patent Application Information Retrieval (PAIR) system, or with a Request for Continued Examination (RCE). For applications in which the claimed cancer immunotherapy is the subject of an active Investigational New Drug (IND) application, a Petition to Make Special may be accepted any time prior to appeal or final rejection;
- If the application has not been published, the Petition must be accompanied by a request for early publication;
- The Petition must be filed electronically.
The USPTO’s Notice regarding the Pilot Program explains that the claim to a method of treating a cancer using immunotherapy must 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“. Examples of acceptable claims are stated to include those directed to:
- the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells;
- the co-administration of biological adjuvants (e.g., interleukins, cytokines, Bacillus Comette-Guerin, monophosphoryl lipid A, etc.) in combination with conventional therapies for treating cancer such as chemotherapy, radiation, or surgery;
- administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth;
- in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.
The USPTO will decide the Petition once the application has been docketed for examination.
The time periods set for reply in Office actions for an application granted special status will be the same as for normal applications. However, if an applicant files an extension of time, an RCE, or a Notice of Appeal, the special status of the application will be terminated. The special status will also be terminated by a final disposition, which includes the mailing of a final Office action, or a notice of allowance.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.