XXII ~ THE TECHNOLOGY
To this end, in 1997 Mr. Pandolfino met Dr. Mark Conkling, Director of the Biotechnology Programs at North Carolina State University. Dr. Conkling had recently cloned a key gene in the tobacco plant responsible for nicotine production. Dr. Conkling believed expression of this gene could be blocked to produce tobacco plants with virtually no nicotine. Mr. Pandolfino concurred and the result of their meeting was a successful 5-year research collaboration between 22nd Century and NCSU that resulted in a patented very low nicotine (VLN) tobacco variety (Xie et al. 2004). This became the first genetically modified (GM) tobacco variety deregulated by the Animal Plant & Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA).
In 1999, 22nd Century exclusively sublicensed this proprietary technology and VLN tobacco to Liggett Group, the fifth largest cigarette company in the United States, and shortly thereafter to other subsidiaries of Vector Group Ltd. (Wall Street Journal 2001). In 2003, Vector Tobacco Inc., an affiliate of Liggett Group, marketed in eight U.S. states Quest®, a novel cigarette brand containing 22nd Century’s proprietary tobacco, to gather data for the U.S. Food and Drug Administration (FDA) approval process of Quest® as a smoking cessation aid. Quest® also utilized Mr. Pandolfino’s product concept comprised of a series of cigarettes with the same “tar” yield but progressively reduced nicotine content for use in smoking cessation.
Also in 2003, the USDA, and in 2005, the Plant Breeders’ Rights Office of Canada granted NCSU plant variety protection (PVP) certificates for a VLN tobacco variety developed at NCSU from funding by 22nd Century. 22nd Century has exclusive rights to this VLN tobacco variety. Both the U.S. and Canadian PVP certificates expire in 2023. A PVP certificate is a useful piece of intellectual property since it legally prevents others from growing the protected tobacco variety, and in the case of tobacco, from importing or exporting the subject tobacco leaf.
