22nd Century Group, Inc. today announced that on June 9, 2014 the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance to the Company for technology that reduces nicotine in tobacco by suppressing expression of the NBB gene by itself and in combination with other nicotine biosynthesis genes.
There are various commercial applications of the NBB technology, including producing cigarettes with various nicotine levels, from very low to high. The Company expects to use very low nicotine cigarettes produced with the NBB technology for a modified risk application to be filed with the U.S. Food and Drug Administration. Many studies have been carried out with the Company’s proprietary very low nicotine cigarettes. A recently published independent clinical trial (Vogel et al. 2014), concluded, “Very low nicotine content (VLNC) cigarettes lead to a reduction in the number of cigarettes smoked, toxicant exposure, withdrawal symptoms and dependence.”
U.S. Patent Application Number 11/579,661, Reducing Levels of Nicotinic Alkaloids in Plants, and related International Patent Application PCT/IB2006/001741, cover methods for producing tobacco plants with decreased nicotine levels and tobacco plants and products produced therefrom. The patent will be granted by the USPTO shortly, and upon grant the USPTO will convey to the Company a Patent Term Adjustment, which is expected to extend the expiration date beyond February 28, 2026.
The NBB gene encodes a protein, “nicotine synthase,” that is involved in the final step of nicotine biosynthesis. Having eluded scientists for decades, this protein can be down-regulated or up-regulated to produce tobacco varieties with a wide range of nicotine levels. International Patent Application PCT/IB2006/004043 covers methods for producing tobacco plants with increased nicotine levels with the NBB technology and tobacco plants and products produced therefrom. Patent applications for the NBB technology have been filed by 22nd Century on a worldwide basis and patents are currently issued to 22nd Century in China, Japan, Taiwan, Mexico, Australia and South Africa. Patents will also soon be granted to 22nd Century for the NBB technology in the United Kingdom, Ireland, Germany, France, Italy, Spain, Poland, Switzerland and Turkey.
Dr. Takashi Hashimoto of the Nara Institute of Science and Technology (NAIST), a world-renowned plant molecular biologist, is an inventor of the NBB technology. 22nd Century funded research and development at NAIST from 2005 to 2009, and in 2010 NAIST assigned various patent families to 22nd Century, including the NBB patent families.
The Company’s vice president of research and development, Dr. Michael Moynihan stated, “The NBB gene technology is one of the keystones of 22nd Century’s intellectual property and represents our second-generation gene technology that has significant advantages over our earlier technology.” Specifically, the sole function of NBB is to produce nicotine and other nicotinic alkaloids. Enditem