Intellectual Property
In the early 1990s, as we were beginning to focus on the importance of interleukin cytokines, Dr. Gordon Duff in the United Kingdom identified the first SNPs in the Interleukin and tumor necrosis factor alpha (TNF) genes, and he and other investigators demonstrated that individuals with some of those variations produced higher levels of Interleukin and TNF proteins. In 1993, we initiated research collaborations with Dr. Duff, and in 1994, we initiated collaboration with the University of Sheffield to investigate and patent the clinical use of variations in the genes that control inflammation. Studies by us and others have now shown that individuals who have certain Interleukin gene variations or patterns of variations tend to have increased levels of interleukin proteins and also tend to have increased levels of other inflammatory or metabolic mediators that are produced downstream of the interleukin proteins.
Our intellectual property estate is focused on the discoveries that link variations in key inflammation and metabolic genes to various conditions or illnesses. We initially had concentrated our efforts on variations in the genes for the interleukin family of cytokines, because these compounds appear to be one of the strongest control points for the development and severity of inflammation. Our patent estate also covers genetic variations in the Perilipin family of proteins that are involved in fat storage and metabolism.
Our collaboration with investigators at the Tufts University Medical School has resulted in our in-licensing a number of patents related to the genes involved with perilipin proteins. We have in-licensed international rights to the use of these gene variations, or genotypes, that regulate one important mechanism involved in fat metabolism. Additional U.S. patents have been filed to cover the use of these genetic factors. When an individual consumes more calories than he or she burns, the excess energy is stored in fat cells as lipid droplets. One of the key chemicals that regulate the mobilization of fat from the lipid droplet to be burned as energy is called perilipin. Investigators at Tufts University Medical School and Tufts Human Nutrition and Research Center have identified variations in the perilipin genes that appear to regulate fat metabolism and body weight. Studies have been completed on several hundred individuals showing that women with one specific perilipin genotype weigh an average of 22 pounds more than women with another perilipin genotype. Seven clinical studies were published from 2004 through 2007 on the influence of perilipin genotypes on weight and related biological parameters. This research was conducted under the direction of Dr. Jose Ordovas, an international expert on the genetics of cardiovascular disease and on the interactions of genetics and nutrition. We have licensed rights to the use of these patents for weight management and to develop nutritional products to facilitate weight management in individuals who have certain perilipin gene variations. Our collaborators have completed research which indicates that the perilipin genetic variations could be used for the medical guidance of weight management. We plan to conduct additional research which may lead to the development of genetic tests for this use.
We currently own rights in twenty issued U.S. patents, which have expiration dates between 2015 and 2020, and have twenty-one additional U.S. patent applications pending, which are based on novel genes or novel associations between particular gene sequences and certain inflammatory diseases and disorders. Of the twenty issued U.S. patents, sixteen relate to genetic tests for periodontal disease, osteoporosis, asthma, coronary artery disease, sepsis and other diseases associated with interleukin inflammatory haplotypes. Our intellectual property and proprietary technology are subject to numerous risks, which we discuss in the section entitled ‘‘Risk Factors’’ of this report. Our commercial success may depend at least in part on our ability to obtain appropriate patent protection on our therapeutic and diagnostic products and methods.
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