Human Genome and Patent

The first phase of the Human Genome Project came to an end by the summer of 2000. We have a fairly complete and accurate listing of all the genes in a typical human being. Apart from the tremendous impact that this knowledge will have on health care, it also represents a patent rush where both private and public institutions are trying to gain temporary control, through patents, over the use and reproduction of genetic information. This paper introduces the reader to issues involving the patent ability of genes, the tests used by patent offices to award patents. The ownership of the human genome--and the access to the tools and databases necessary to make sense out of the millions of bits of information that make up the estimated 100,000 human genes--constitutes one of the hottest debates in the public policy arena not just in the field of science but sociology, politics, law and ethics.     

人类基因组计划带来的伦理与法律问题

人类基因组计划是人类科学史上的一个里程碑。但是对于这一科学研究的迅速发展,人类社会还没有在心理上、伦理思考、法律建设上做好充分的准备,因而会受到巨大的冲击。因此,法律应该充分表现出自己的前瞻性,提前介入这一争端,对基因技术的使用加以规范和引导,使之按照符合人类伦理、道德的方向发展,避免出现一些危及整个人类的尊严、情感乃至生存的后果。     

The Human Genome as Common Heritage: Common Sense or Legal Nonsense?

This essay identifies two legal lineages underlying the common heritage concept, and applies each to the human genome. The essay notes some advantages and disadvantages of each approach, and argues that patenting of human genes would be allowable under either approach.     

The Human Genome Diversity Project: The Politics of Patents at the Intersection of Race, Religion, and Research Ethics

The patenting of human genetic materials provokes wide-ranging misgivings about the appropriate place and scope of intellectual property protections. The issues implicated range from anti-competitive practices in the market, the imposition of limits on biomedical research, increasing costs for health care, research ethics, potentials for racial discrimination, and various violations of human rights. Exploring controversies around the Human Genome Diversity Project, patents on genetic sequences, and patents on higher life forms such as the so-called "Harvard mouse," the authors find that North American patent policy has developed in the absence of necessary political debate. They link this de-politicization to the hegemony of neo-liberal principles most fully demonstrated by the incorporation of intellectual property under international trade negotiations. They point, however, to the recent emergence and increasing audibility of new social movements that seek to reposition issues of intellectual property in larger debates about human rights, distributional equalities, and social justice.     

基于Ion Torrent PGM~(TM)测序系统的人mtDNA全测序分析

目的应用Ion Torrent PGM~(TM)测序系统对人线粒体DNA(mitochondria DNA,mtDNA)全序列进行分析检测,研究不同组织间mt DNA序列差异情况。方法通过法医尸体检验采集6名无关个体的组织样本,包括胸腔血液、头发、肋软骨、指甲、骨骼肌和口腔上皮。使用4对引物对线粒体全序列进行扩增,应用Ion Shear~(TM)Plus Reagents试剂盒和Ion Plus Fragment Library试剂盒等构建文库,并在Ion Torrent PGM~(TM)测序系统上进行线粒体基因组全序列测序,并针对异质性位点和在HVⅠ区域突变位点,进行Sanger测序验证。结果所有样本的全基因组mtDNA都扩增成功,6名无关个体分属于6种不同的单倍型,同一个体不同组织之间mtDNA存在异质性差异。异质性位点和HVⅠ区域突变位点采用Sanger测序结果均得到验证。通过Kappa统计方法进行一致性检验后发现,相同个体不同组织的mtDNA序列检验结果仍具有较好的一致性。结论本研究所采用的人线粒体基因组全序列的测序检验方法,可以检测出同一个体不同组织间mtDNA的异质性差异,该差异具有较高的一致性,该结果对mtDNA在法庭科学中的应用具有指导作用。