On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This program is in support of the “National Cancer Moonshot,” which is a $1 billion dollar White House initiative to achieve ten years' worth of cancer research over the next five years to aid in the global fight against cancer. The objective of the program, referred to as the “Cancer Immunotherapy Pilot Program,” or “Patents 4 Patients,” is to complete examination of patent applications meeting the requirements of the program within twelve months or less.
Patent applications typically are examined by the USPTO in the order of their U.S. filing date. The examination process, from the filing date to a final disposition of either allowance or abandonment, can take on average about three years. The USPTO currently offers accelerated or prioritized examination programs to expedite the examination process, but these programs require the applicant to provide extensive examination support documents or pay hefty fees, e.g., up to $4,000.
Applications eligible under the Cancer Immunotherapy Pilot Program will not be subject to these requirements. Instead, the USPTO will accelerate examination of patent applications containing at least one claim to a method of treating a cancer using immunotherapy if the applicant files a grantable petition to make special under the program. Such special status can be afforded to either a new application or a pending application. Further, in contrast to current USPTO programs, no fee is required to file a petition for accelerated examination under the Cancer Immunotherapy Pilot Program.
Briefly, immunotherapy can be used to treat cancer by either stimulating a patient’s own immune system to attack cancer cells or providing manmade therapeutic agents designed to do so. Approximately 900 cancer immunotherapy related applications are received annually by the USPTO. A goal of the Cancer Immunotherapy Pilot Program is to move innovative new immunotherapy treatments from conception through the patent process more quickly. The program is open to any applicant, including early stage biotech companies, universities, and large pharma, as well as entities who might have cancer immunotherapy treatments already in FDA-approved clinical trials.
Also, as part of the USPTO’s Patent 4 Patient initiative, the USPTO will take steps to leverage patent data and identify research and development trends in cancer immunology, virology, and combination therapies via a variety of visualization tools for analyzing patent filings in these fields. Such data can be combined with economic trends to enable the federal government, as well as the medical, research, and data communities, to make more precise funding and policy decisions related to potentially commercially-viable cancer treatments.
By short-circuiting the time required to obtain a patent, the USPTO’s Cancer Immunotherapy Pilot Program should boost an applicant’s prospects for commercializing cancer immunotherapy treatments. Entities having patent applications in the field of cancer immunotherapy should consider taking advantage of this program.
