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The Impact of Patents on Translational Research - Non-Invasive Prenatal Diagnosis in Europe and US

专利对转化研究的影响——欧美无创产前诊断

基本信息

批准号：
ES/K009575/1
负责人：
Naomi Louise Hawkins
金额：
$ 22.53万
依托单位：
UNIVERSITY OF EXETER
依托单位国家：
英国
项目类别：
Research Grant
财政年份：
2014
资助国家：
英国
起止时间：
2014 至无数据
项目状态：
已结题

来源：
https://gtr.ukri.org/projects?ref=ES%2FK009575%2F1
关键词：
Impact Patents Translational Research Non

项目摘要

Patent law is the first area of law that comes into contact with new innovation, because patents are the main means by which the state incentivises innovation. In return for disclosure of an invention, the state grants a monopoly to the patent holder. Whilst patents may work as intended to provide that incentive to innovation, patents may also work against the public interest by reducing public access to technology, or by shaping the development of technology in inappropriate ways.The intersection of patent law with modern innovation such as genomics poses particular challenges, and the traditional principles of law are being strained almost to breaking point by patents claiming the very building blocks of life itself. Despite the publicly funded nature of this research, technologies in this area, and many genes themselves, are the subject of patent rights, and the patent owner has the potential to control the development of, and access to, the technology in question. At the same time, medicine is failing to accommodate patent rules, and there is divergence between law and practice.Through the Human Genome Project and continuing research, we now have the most detailed map to date of the information programmed in our DNA - the information that makes us who we are. DNA abnormalities can lead to many common conditions such as Down's Syndrome and Cystic Fibrosis, and we are currently able to diagnose these conditions in adults by genetic tests, or in unborn children by testing foetal tissue. Soon, we will be able to diagnose disorders, and decipher a baby's entire genetic make-up by the simple procedure of analysing a sample of blood from a pregnant woman; a process called Non-Invasive Prenatal Diagnosis (NIPD), which will revolutionise the clinical management of pregnancy worldwide. Understanding how patents in this field in Britain, Europe and the USA are enforced, and how companies, healthcare organisations and individuals interact with the system, is important to facilitate the development of, and public access to, NIPD. Perhaps more importantly, this research, and previous work of the PI investigating patents in single gene testing will be used as case studies to explore the wider issues surrounding the translation of innovations in genomic medicine into clinical practice. How patent law operates in practice has implications for delivery of technologies to the public, how companies and researchers innovate, how individuals decide to act, and how healthcare evolves in the face of emerging research that promises to change the face of medicine. The research will further make an important contribution to patent law scholarship, by an empirically informed conceptualisation of the role of patents in practice in frontier technologies.The applicant has extensive experience in the legal issues surrounding genomic medicine. She will employ and develop socio-legal research methods to develop a theory of the role that patents play in emerging fields of genomic medicine, and foster improved international awareness and discussion of the subject. She will interview the leading international players in the field, as well as investigating the relationships between them through social network analysis. The analysis will be used to tease out how an appreciation of patents shapes day-to-day practice and future direction in translational research in NIPD. This work is necessary to protect the interests of the public without impinging on innovation in the private sector. This project investigates an emerging and relatively young aspect of law which is set to become much more important as genomic medicine becomes a routine part of medical practice and as other frontier technologies challenge patent law in practice. Little legal work has been done in the area - this project will strengthen the applicant's position as a future leader in the field.

专利法是第一个接触到新创新的法律领域，因为专利是国家激励创新的主要手段。作为对发明披露的回报，国家将垄断授予专利持有人。虽然专利可能会像预期的那样激励创新，但专利也可能会减少公众获得技术的机会，或者以不适当的方式塑造技术的发展，从而违背公共利益。专利法与现代创新(如基因组学)的交叉构成了特别的挑战，传统的法律原则正因专利而几乎紧张到崩溃的边缘，专利本身就是生命的基石。尽管这项研究的性质是公共资助的，但这一领域的技术以及许多基因本身都是专利权的主体，专利所有者有可能控制相关技术的开发和获取。与此同时，医学无法适应专利规则，法律和实践之间存在分歧。通过人类基因组计划和持续的研究，我们现在拥有了DNA中编程信息的最详细地图--这些信息决定了我们是谁。DNA异常会导致许多常见的疾病，如唐氏综合症和囊性纤维化，我们目前能够通过基因测试在成年人身上诊断这些疾病，或者通过检测胎儿组织来诊断胎儿的这些疾病。很快，我们将能够诊断疾病，并通过分析孕妇血液样本的简单程序破译婴儿的整个基因构成；这一过程被称为非侵入性产前诊断(NIPD)，将彻底改变全球怀孕的临床管理。了解英国、欧洲和美国这一领域的专利是如何执行的，以及公司、医疗保健组织和个人如何与该系统互动，对于促进NIPD的发展和公众获得NIPD非常重要。也许更重要的是，这项研究以及PI在单基因测试中调查专利的先前工作将被用作案例研究，以探索围绕基因组医学创新转化为临床实践的更广泛的问题。专利法在实践中如何运作，对向公众提供技术、公司和研究人员如何创新、个人决定如何行动，以及面对有望改变医学面貌的新兴研究如何发展医疗保健都有影响。这项研究将通过对专利在前沿技术实践中的作用的经验性概念化，进一步为专利法学术做出重要贡献。申请人在围绕基因组医学的法律问题上拥有丰富的经验。她将采用和发展社会法律研究方法，以发展专利在新兴基因组医学领域所起作用的理论，并促进国际上对这一主题的更好认识和讨论。她将采访该领域的领先国际参与者，并通过社交网络分析调查他们之间的关系。这项分析将被用来梳理出对专利的欣赏如何影响NIPD翻译研究的日常实践和未来方向。为了在不影响私营部门创新的情况下保护公众利益，这项工作是必要的。这个项目研究了一个新兴和相对年轻的法律方面，随着基因组医学成为医疗实践的常规部分，以及其他前沿技术在实践中挑战专利法，这一方面将变得更加重要。在这一领域几乎没有法律工作--这个项目将加强申请人作为该领域未来领导者的地位。