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

专利法是与创新接触的第一个法律领域，因为专利是国家激励创新的主要手段。作为公开发明的回报，国家给予专利权人垄断权。虽然专利可能如预期的那样为创新提供激励，但专利也可能通过减少公众对技术的获取或以不适当的方式塑造技术的发展而违背公共利益。专利法与现代创新（如基因组学）的交叉带来了特殊的挑战，而传统的法律原则正因专利声称拥有生命本身的基本组成部分而受到几乎崩溃的压力。尽管这项研究的本质是公共资助的，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发展和使用。与此同时，医药未能适应专利规则，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，我们现在拥有了迄今为止最详细的DNA信息图谱——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检测在成人中诊断这些疾病，或者通过检测胎儿组织在未出生的儿童中诊断这些疾病。不久，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来破译婴儿的整个基因构成；这一过程被称为无创产前诊断（NIPD），它将彻底改变全球妊娠的临床管理。了解英国、欧洲和美国这一领域的专利是如何实施的，以及公司、医疗机构和个人如何与该系统互动，对于促进NIPD的发展和公众访问非常重要。也许更重要的是，这项研究以及PI之前调查单基因检测专利的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问题。专利法在实践中的运作方式影响着向公众提供技术、公司和研究人员如何创新、个人如何决定采取行动，以及面对有望改变医学面貌的新兴研究，医疗保健如何发展。通过对前沿技术实践中专利作用的经验化，该研究将进一步对专利法学术做出重要贡献。申请人在基因组医学相关法律问题方面具有丰富的经验。她将运用和发展社会法律研究方法，发展专利在基因组医学新兴领域中所起作用的理论，并促进对该主题的国际认识和讨论。她将采访该领域的主要国际参与者，并通过社会网络分析调查他们之间的关系。该分析将用于梳理对专利的欣赏如何影响NIPD转化研究的日常实践和未来方向。这项工作是必要的，以保护公众的利益，而不影响私营部门的创新。这个项目研究了法律的一个新兴的和相对年轻的方面，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，它将变得更加重要。该领域的法律工作很少，这个项目将加强申请人作为该领域未来领导者的地位。

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.