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本文引用的文献

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Legal uncertainty in the area of genetic diagnostic testing.遗传诊断检测领域的法律不确定性。
Nat Biotechnol. 2009 Oct;27(10):903-9. doi: 10.1038/nbt1009-903.
2
The phantom menace of gene patents.基因专利的潜在威胁。
Nature. 2009 Mar 26;458(7237):407-8. doi: 10.1038/458407a.
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Gene patents and genetic testing in the United States.美国的基因专利与基因检测
Nat Biotechnol. 2007 Sep;25(9):989-90. doi: 10.1038/nbt0907-989.
4
Patents and translational research in genomics.基因组学领域的专利与转化研究。
Nat Biotechnol. 2007 Jul;25(7):739-41. doi: 10.1038/nbt0707-739.
5
How can genetic tests be evaluated for clinical use? Experience of the UK Genetic Testing Network.基因检测如何进行临床应用评估?英国基因检测网络的经验。
Eur J Hum Genet. 2007 Sep;15(9):917-21. doi: 10.1038/sj.ejhg.5201867. Epub 2007 May 30.
6
DNA patenting: the end of an era?DNA专利:一个时代的终结?
Nat Biotechnol. 2007 Feb;25(2):185-7. doi: 10.1038/nbt0207-185.
7
Evidence and anecdotes: an analysis of human gene patenting controversies.证据与轶事:人类基因专利争议分析
Nat Biotechnol. 2006 Sep;24(9):1091-4. doi: 10.1038/nbt0906-1091.
8
Patent pools and diagnostic testing.专利池与诊断测试。
Trends Biotechnol. 2006 Mar;24(3):115-20. doi: 10.1016/j.tibtech.2006.01.002. Epub 2006 Jan 27.
9
Human dignity: a guide to policy making in the biotechnology era?人类尊严:生物技术时代的政策制定指南?
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10
Intellectual property. Enhanced: intellectual property landscape of the human genome.知识产权。强化:人类基因组的知识产权格局。
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人类基因专利对英国基因检测的影响。

The impact of human gene patents on genetic testing in the United Kingdom.

机构信息

School of Law, University of Exeter, Rennes Drive, Exeter, United Kingdom.

出版信息

Genet Med. 2011 Apr;13(4):320-4. doi: 10.1097/GIM.0b013e3181fc50bc.

DOI:10.1097/GIM.0b013e3181fc50bc
PMID:21150786
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3319650/
Abstract

PURPOSE

This article reports the results of an empirical study examining the impact of human gene patents on the development and delivery of genetic tests in the public sector in the United Kingdom.

METHODS

Semi-structured qualitative interviews.

RESULTS

The study found that, despite the potential for gene patents to have significant negative consequences for genetic testing, in fact, human gene patents have little or no impact on practice for those developing genetic tests in the public sector in the United Kingdom. This is not because patents are managed optimally; rather, gene patents are essentially ignored. This article reports the factors that motivate this behavior.

CONCLUSIONS

At least insofar as there seems to be no apparent problem of lack of patient access, there is no significant public health problem. However, there is divergence between the legal and the practical situation. Complacency about the lack of impact of patents on access to diagnostics is risky, and concerns about patents should be addressed proactively, rather than reactively.

摘要

目的

本文报告了一项实证研究的结果,该研究考察了人类基因专利对英国公共部门基因检测开发和提供的影响。

方法

半结构化定性访谈。

结果

研究发现,尽管基因专利可能对基因检测产生重大负面影响,但实际上,对于在英国公共部门开发基因检测的人员而言,人类基因专利对其实践几乎没有影响。这并不是因为专利管理得很理想;相反,基因专利基本上被忽视了。本文报告了促使这种行为的因素。

结论

至少在似乎不存在明显的患者准入缺乏问题的情况下,就不存在重大的公共卫生问题。然而,法律和实际情况之间存在分歧。对专利对诊断获取的影响缺乏关注的自满态度是有风险的,应该积极主动地处理对专利的担忧,而不是被动应对。