Patents and non-invasive prenatal testing: Is there cause for concern?
Patents and non-invasive prenatal testing: Is there cause for concern?
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专利和无创产前检测：有理由担心吗？
DOI：
10.1093/scipol/scaa012
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发表时间：
2020
影响因子：
2.7
通讯作者：
Hawkins N
中科院分区：
文献类型：
--
作者：
Hawkins N
知识产权是将发现转化为个性化医疗临床应用的关键。本文探讨了知识产权，特别是专利，与基因组个性化医疗领域的相互作用，通过实证工作调查的作用，专利在开发和提供无创产前检测（NIPT）。单基因检测（SGT）和NIPT代表了两种不同类型的创新的例子，这些创新可能对个性化医疗很重要，并且在法律如何在实践中应用方面有所不同。一方面，在SGT，以前的研究表明，专利对英国公共部门开发基因检测的实践几乎没有影响，因为它们在很大程度上被忽视了。然而，相比之下，这项定性访谈研究发现，NIPT的法律和实践中的法律比SGT更加趋同。那些参与NIPT开发和交付的人更了解专利，并平衡更多参与或遵守专利法的成本和收益，与经营自由，诉讼和许可等因素有关，有利于合规。遵守可以采取不同的形式;许可就是遵守，如在没有专利许可的情况下禁止使用专利发明。本文探讨了NIPT中与专利法合规性相关的因素，并进一步考虑了对个性化医疗领域的影响。它认为，由于促进生物医学的开放性、可及性和可负担性的普遍手段是建立在现有的知识产权法律的结构基础上的，只有当知识产权法的这些现有法律的结构在相关领域得到承认和尊重时，这种解决方案才能有效并被采用。因此，只有在对实践中的法律运作有着细致入微的理解的情况下，才能采用这种解决办法。
Intellectual property rights are key to the translation of discoveries into clinical use in personalised medicine. This article explores the interaction of intellectual property rights, specifically patents, with the field of genomic personalised medicine, through empirical work investigating the role that patents play in the development and delivery of non-invasive prenatal testing (NIPT). Single gene testing (SGT) and NIPT represent examples of two different types of innovation likely to be important in personalised medicine, and which operate differently in terms of how the law is applied in practice. In SGT, on the one hand, previous studies demonstrate that patents have little impact on practice for those developing genetic tests in the public sector in the UK because they are largely ignored. In contrast, however, this qualitative interview study finds that law and law-in-practice in NIPT are much more convergent than found in SGT. Those involved in the development and delivery of NIPT are more aware of patents, and balance the costs and benefits of greater engagement or compliance with patent law, in relation to factors such as freedom to operate, litigation, and licensing, in favour of compliance. Compliance can take different forms; licensing is compliance, as is forbearance from using a patented invention in the absence of a patent licence. This article explores the factors relevant to patent law compliance in NIPT, and further considers the implications for the field of personalised medicine. It argues that, as the prevalent means to promote openness, access, and affordability in biomedicine are founded on the existing legal structures of intellectual property rights, such solutions will only be effective and adopted when these existing legal structures of intellectual property law are recognised and respected in the relevant field. It is therefore essential that such solutions only be deployed with a nuanced understanding of the operation of the law-in-practice.
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影响因子：
3
作者：
Chiu, Rossa W. K.;Lo, Y. M. Dennis
通讯作者：
Lo, Y. M. Dennis
影响因子：
9.3
作者：
Bianchi DW;Wilkins-Haug L
通讯作者：
Wilkins-Haug L
人类基因专利和基因检测
DOI：
--
发表时间：
2010
期刊：
影响因子：
--
作者：
klaguia
通讯作者：
klaguia
收获基因组和蛋白质组研究的好处：知识产权、创新和公共卫生
DOI：
--
发表时间：
2006
期刊：
影响因子：
--
作者：
S. Merrill;A. Mazza
通讯作者：
A. Mazza
知识产权 (IPR) 和遗传学 - 医疗保健领域知识产权影响和管理的研究
DOI：
--
发表时间：
2003
期刊：
影响因子：
--
作者：
W. Cornish;M. Adcock;M. Llewelyn
通讯作者：
M. Llewelyn