Editor’s note: The recently launched #CancerMoonshot coupled with a new patent office initiative will likely benefit the Triangle. says Ward and Smith, P.A. Attorney Dr. Jeff Childers. He expects a boost will come for cancer immunotherapy patent applications. WRAL TechWire asked Childers, a PhD, to explain his thoughts.

RALEIGH, N.C. – 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. Thus, no fee is required to file a petition for accelerated examination under the new initiative. 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 new and pending non-provisional utility patent applications, including international patent applications entering the U.S. national stage.

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. To be eligible for the Cancer Immunotherapy Pilot Program, patent applications should be in the field of oncology and “must contain 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.”

Examples of claims eligible for expedited examination under the program 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 USPTO 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.” Further, claims directed “to administering any vaccine that works by activating the immune system to prevent or destroy cancer cell growth” are included in the program. The program also will consider “in vivo, ex vivo, and adoptive immunotherapies, including those using autologous and/or heterologous cells or immortalized cell lines.”

Also, as part of the 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.

A goal of the Cancer Immunotherapy Pilot Program is to move innovative 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 those who have cancer immunotherapies already in FDA-approved clinical trials. This program should be particularly attractive to start-ups and universities as the initial costs of obtaining a patent should be lower and the applicant has the possibility of having an issued patent in hand much sooner than normal, which should aid in obtaining financing and more attractive licensing opportunities.

The USPTO plans to run this program for 12 months. Thus, a petition for accelerated examination under the Cancer Immunotherapy Pilot Program must be filed before June 29, 2017, unless the USPTO opts to extend the program.

By short-circuiting the time required to obtain a patent, the Cancer Immunotherapy Pilot Program should boost an applicant’s prospects for commercializing cancer immunotherapy treatments. This program will likely positively impact the Triangle, as our area is known for biopharma research. To wit: in May of this year, the Genetic Engineering and Biotechnology News ranked the Research Triangle as the #8 Biopharma Cluster in the country. The Triangle also is home to two of the nation’s 40 Comprehensive Cancer Centers – Duke Cancer Institute and UNC Lineberger Comprehensive Cancer Center. Further, the Research Triangle Regional Partnership’s 2016 State of the Region report shows the number one and two industry clusters for the Triangle by investment are Pharmaceuticals at $2.2 Billion and Advanced Medical Care at $240 Million. Both clusters stand to be impacted by the Cancer Immunotherapy Pilot Program.

Entities having patent applications in the field of cancer immunotherapy, many of which have a presence in the Research Triangle, should consider taking advantage of this program.

About the author

Dr. Jeffrey Childers leads the Firm’s Life Sciences Practice Group and is a patent attorney whose practice includes preparing, filing, and prosecuting domestic and foreign patent applications in the pharmaceutical, chemical, and molecular diagnostic arts, material sciences, medical device field, and other related areas; preparing patentability, freedom-to-operate, and infringement/non‑infringement opinions; providing guidance and counseling on the intellectual property aspects of licensing and business transactions; and providing strategic advice and management of patent portfolios. His background also includes significant experience with corporate and university technology, including serving as patent counsel with the Johns Hopkins Technology Transfer Office.

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