The United States Patent and Trademark Office (“USPTO”) recently announced the “Cancer Immunotherapy Pilot Program,” (“CIPP”) which will provide FREE accelerated examination for cancer immunotherapy patent applications. i The goal of the program is to complete examination of an application within 12 months of qualifying for the program. ii
To qualify for the program, the application must be a non-provisional, non-reissue utility application with at least one claim directed to a method of ameliorating, treating, or preventing malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells.iii The claims are limited to twenty claims with no more than three independent claims. The request must be filed before the issuance of any Office Action (including those with just a restriction requirement) or with a request for continued examination. The program is slated to end on June 29, 2017; however, it may be extended or added as a permanent program as we have seen happen with other pilot programs.iv
One practical benefit of using this program is the potential increase in patent term extension (“PTE”).v PTE extends the term of a patent beyond the 20 year limit to compensate patent owners for lost patent term due to pre-market approval requirements before a regulatory agency.vi PTE only applies to the time from when a patent issues to when regulatory approval is granted. Thus, the earlier your patent issues, the more potential PTE.
Another practical benefit of using this program is the increased value that an issued patent brings to a potential investor. Issued patents are a commodity that can be licensed, enforced, traded, or contributed to a patent pool. Pending patent applications are not. Having an issued patent within one year as opposed to the standard three to five years may make all the difference in the success of a start-up company.
If you would like more information on the Cancer Immunotherapy Pilot Program or patent term extension, please contact Kathryn Hull or Susan Meyer of the Intellectual Property Practice Group at Gordon Rees Scully Mansukhani.
[i] See Federal Register notice on 6/29/2016 (https://www.federalregister.gov/articles/2016/06/29/2016-15533/cancer-immunotherapy-pilot-program#page-42328)
[ii] Examination is complete upon the issuance of a final Office Action or Notice of Allowance
[iii] For example, this can include the administration of cells, antibodies, proteins, or nucleic acids that invoke an active (or achieve a passive) immune response to destroy cancerous cells. The Pilot Program also will consider claims drawn to 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. Claims to administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth are included. The Pilot Program also will consider in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.
[iv] Pilot programs that have been extended or made permanent include the After Final Consideration program, the Patent Prosecution Highway program, the Quick Path Information Disclosure Statement program, and the First Action Interview program.
[v] 35 U.S.C. § 156
[vi] Agencies include the Food and Drug Administration and the U.S. Department of Agriculture