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Epigenetic Patents: A Stressful Environment for an Emerging Science*
Biotechnology Law Report ( IF 0.2 ) Pub Date : 2013-10-01 , DOI: 10.1089/blr.2013.9868
William Noonan , Adria Decker Dismuke , Mitchell S Turker

Genetic science has been a cornerstone of medical research for more than half a century. Since the discovery of the structure of DNA by Watson and Crick in 1953, the central dogma of molecular biology has been that there is a “residue-by-residue transfer of sequential information” from DNA to proteins,1 and this sequential information was understood to code for the expression of proteins that affected most aspects of health. The detection of DNA mutations associated with disease was regularly reported throughout the last decades of the 20th Century. Genetic research reached a critical point in 2003, when the Human Genome Project was completed and the sequence of the 3 billion nucleotides in the complete human genome was published. It had been expected that this information would solve many of the mysteries of medical science and suggest therapies for previously untreatable diseases. However, before the Project was complete, it became evident that the genomic sequence information would provide only a partial explanation of the causes and cures of disease. A more extensive understanding of genetic medicine would require an inquiry into the “epigenome” and the effect of the history of the cellular environment on gene expression. The biologically deterministic paradigm of the central dogma has now yielded to a more subtle understanding that gene function can be affected by environmental factors. Such factors can modify genes in somatic cells and lead to disease, or potentially modify genes in germ cells to pass harmful modifications to subsequent generations.2 Epigenetic research has suggested that environmental conditions can cause chemical modifications (such as the addition or removal of methyl groups) to DNA or histones to alter the health of humans and their offspring—even in a transgenerational manner—apart from changing the nucleic acid sequences of their genes. An early published example of this phenomenon was a Swedish study that showed an abundant food supply for a grandfather before his pre-pubertal growth spurt increased the likelihood that his grandson would die of a diabetes-related disorder.3 A father's poor food supply and a mother's ample food supply were associated with a lower risk of cardiovascular death in their subsequently born children.4 Differences in early post-natal life have also been found to result in lasting, transgenerational changes in behavior, mediated in part by changes in epigenetic histone marks and DNA methylation states.5 For example, early parental care-giving in rodents causes epigenetic changes that can alter an offspring's life-long response to stress, an effect that can be passed from one generation to the next, perhaps by affecting the parental care behavior of subsequent generations.6 One of the best-documented examples in humans of a transmissible epigenetic effect was the use of the estrogenic agent diethylstilbestrol (DES) to prevent miscarriages in pregnant women, which led to the development of a rare form of vaginal cancer in their prenatally exposed daughters.7 The growing knowledge of epigenetic science and the relation between this science and human health has led to an increasing number of patents that could aid in the discovery and treatment of the root causes of many common diseases. As these patents proliferate, however, a shifting legal landscape could reduce intellectual property rights in various aspects of epigenetic science, thus reducing commercialization of this new technology. This article examines epigenetic science and resultant patents, how these patents are changing over time as basic scientific discoveries lead to new treatments, and how future epigenetic patents might fare in the light of recent court decisions limiting the patent eligibility of biomedical technologies. A stressful prenatal and perinatal environment can alter the lifetime health of a human, and a harsh legal environment can have similar effects on the commercial development of new technologies.

中文翻译:

表观遗传专利:新兴科学的压力环境*

半个多世纪以来,遗传科学一直是医学研究的基石。自 1953 年 Watson 和 Crick 发现 DNA 结构以来,分子生物学的中心法则一直是从 DNA 到蛋白质的“顺序信息的“逐个残基转移”,1 这种顺序信息被理解编码影响健康的大多数方面的蛋白质的表达。在 20 世纪的最后几十年中,定期报道与疾病相关的 DNA 突变的检测。基因研究在 2003 年达到一个临界点,当时人类基因组计划完成,人类完整基因组中 30 亿个核苷酸的序列被公布。人们曾预计,这些信息将解开医学科学的许多谜团,并为以前无法​​治愈的疾病提出治疗建议。然而,在项目完成之前,很明显基因组序列信息只能部分解释疾病的原因和治疗方法。对基因医学的更广泛理解需要对“表观基因组”和细胞环境历史对基因表达的影响进行调查。中心法则的生物学决定论范式现在已经让我们对基因功能受环境因素的影响有了更微妙的理解。这些因素可以修改体细胞中的基因并导致疾病,或者可能修改生殖细胞中的基因,从而将有害的修改传递给后代。2 表观遗传研究表明,环境条件会导致 DNA 或组蛋白发生化学修饰(例如添加或去除甲基),从而改变人类及其后代的健康——即使是以跨代的方式——除了改变核酸序列他们的基因。这种现象的一个早期发表的例子是瑞典的一项研究,该研究表明,在祖父青春期前的生长突增之前,他的食物供应充足,这增加了他孙子死于糖尿病相关疾病的可能性。 3 父亲的食物供应不足和母亲充足的食物供应与随后出生的孩子发生心血管死亡的风险较低有关。 4 产后早期生活的差异也被发现会导致行为的持久、跨代变化,7 表观遗传学知识的不断增长以及该科学与人类健康之间的关系导致越来越多的专利可以帮助发现和治疗许多常见疾病的根本原因。然而,随着这些专利的激增,不断变化的法律格局可能会减少表观遗传科学各个方面的知识产权,从而减少这项新技术的商业化。本文探讨了表观遗传科学和由此产生的专利,随着基础科学发现导致新的治疗方法,这些专利如何随着时间的推移而发生变化,以及鉴于最近法院决定限制生物医学技术的专利资格,未来的表观遗传专利可能会如何发展。压力大的产前和围产期环境会改变人类一生的健康,
更新日期:2013-10-01
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