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Intellectual Property and Access to Noninvasive Prenatal Genetic Testing

知识产权和无创产前基因检测的获取

基本信息

批准号：
8841802
负责人：
Subhashini Chandrasekharan
金额：
$ 39.09万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-05-07 至 2017-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8841802
关键词：
Address Adoption Affect Aneuploidy Base Sequence Bioethics Bioethics Consultants Biomedical Technology Businesses Clinical Clinical Trials Complex Data Decision Making Development Diagnostic Diagnostic Procedure Down Syndrome Educational workshop Ethics Fostering Genes Genetic Genetic screening method Genomics Goals Guidelines Health Health Insurance Reimbursement Health Policy Healthcare Hereditary Disease Industry Intellectual Property Interview Investments Justice Laboratories Laws Legal Legal patent Licensing Light Litigation Maps Medicine Methods Modeling Neonatal Outcome Outcome Study Outcomes Research Paper Patients Policies Policy Analysis Policy Developments Pregnancy Principles of law and justice Property Rights Provider Public Health Qualifying Qualitative Research Quality Control Regulation Relative (related person)Research Research Methodology Research Personnel Resources Secure Shadowing (Histology)Structure Technology Testing Translations Uncertainty Universities base cell free fetal DNA clinical practice commercialization cost cost effectiveness experience fetal medicine genetic analysis health economics improved innovation multidisciplinary policy implication prenatal prenatal testing public health relevance reproductive research and development screening theories

项目摘要

DESCRIPTION (provided by applicant): The purpose of this study is to provide empirical data on effects of intellectual property (IP) and commercialization on clinical translation of noninvasive prenatal genetic testing (NIPT) and identify potential barriers to clinical adoption and patient access. Advances in technologies for genetic analysis of cell-free fetal DNA could make NIPT routine. Early clinical trials indicate that sequencing-based NIPT tests for chromosomal aneuploidies are more accurate than currently used noninvasive screening tests. A commercial NIPT test for Down Syndrome recently became available and tests for common genetic conditions are in prospect. It is still too early to know the clinical utility and cost effectiveness of these tests. Nevertheless, NIPT could significantly change the paradigm of prenatal testing and screening and potentialy even lower costs. Intellectual property (IP) and commercialization promise to be important components in the emerging debate about when and how such technologies should enter clinical practice. IP could induce commercial investment in R&D, in regulatory approval, and in securing third-party payment. But exclusive IP rights could also hamper innovation, increase transaction costs for test developers and providers, and decrease patient access, especially if monopolies emerge. Indeed patents on foundational NIPT technologies have been exclusively licensed to companies, raising such concerns. The commercial landscape is quickly evolving and companies are already involved in patent litigation. The disposition of these patents could determine who can offer the tests and the business models that will prevail, which in turn can impact clinical adoption and patient access. The IP landscape for NIPT appears complex and is unclear. Few if any data are also available on stakeholders' views about effects of IP vs non-IP factors on clinical adoption, and patient access to NIPT.. This study will address these gaps with the following specific aims: 1) map IP relevant to NIPT and assess potential IP effects on development of new NIPT genetic tests; 2) identify and rank IP versus non-IP barriers to clinical adoption and patient access based on stakeholders' views; and 3) identify ethical and policy implications of potential barriers to patiet access. A multidisciplinary team of researchers with expertise in genetics, IP law, health policy, bioethics, health economics, maternal and fetal medicine and health law will use established qualitative research methods combined with legal, ethical, and policy analysis. One outcome of this study will be a careful empirical analysis of whether and how IP can affect patient access to NIPT genetic testing. This analysis will be enabled by a publicly available IP and commercialization landscape for NIPT technologies that we will create. Another expected outcome is a forecast of barriers to clinical adoption and patient access ranked by stakeholders. A workshop at the conclusion of the study will include stakeholder representatives groups and experts from relevant domains to identify approaches and policy priorities for reducing barriers to clinical translation and promoting patient access to NIPT.

描述（由申请人提供）：本研究的目的是提供关于知识产权（IP）和商业化对无创产前基因检测（NIPT）临床转化影响的经验数据，并识别临床采用和患者获取的潜在障碍。无细胞胎儿DNA遗传分析技术的进步可以使NIPT常规化。早期临床试验表明，基于测序的染色体非整倍性NIPT检测比目前使用的非侵入性筛查检测更准确。一个商业NIPT测试唐氏综合症最近成为可用和测试常见的遗传条件是在前景。现在要知道这些测试的临床效用和成本效益还为时过早。然而，NIPT可以显着改变产前检测和筛查的模式，甚至可能降低成本。知识产权（IP）和商业化有望成为关于此类技术何时以及如何进入临床实践的新辩论的重要组成部分。知识产权可以在研发、监管审批和确保第三方支付方面吸引商业投资。但专有知识产权也可能阻碍创新，增加测试开发者和提供者的交易成本，并减少患者的使用，特别是在出现垄断的情况下。事实上，基础NIPT技术的专利已经被独家授权给公司，引起了这种担忧。商业格局正在迅速发展，公司已经卷入专利诉讼。这些专利的处置可以决定谁可以提供测试和将占主导地位的商业模式，这反过来又会影响临床采用和患者访问。NIPT的知识产权格局似乎很复杂，也不清楚。关于利益相关者对IP与非IP因素对临床采用和患者获得NIPT的影响的看法，几乎没有任何数据可用。本研究将通过以下具体目标来解决这些差距：1）绘制与NIPT相关的知识产权，并评估知识产权对新型NIPT基因检测开发的潜在影响; 2）根据利益相关者的观点，识别和排名临床采用和患者获取的知识产权与非知识产权障碍;和3）识别患者获取的潜在障碍的伦理和政策影响。一个多学科的研究人员团队，在遗传学，知识产权法，卫生政策，生物伦理学，卫生经济学，孕产妇和胎儿医学和卫生法的专业知识将使用既定的定性研究方法结合法律的，伦理和政策分析。这项研究的结果之一将是对IP是否以及如何影响患者接受NIPT基因检测进行仔细的实证分析。这种分析将通过我们将创建的NIPT技术的公开可用的IP和商业化景观来实现。另一个预期结果是预测利益相关者对临床采用和患者访问的障碍。研究结束时的研讨会将包括利益相关者代表、团体和相关领域的专家，以确定减少临床翻译障碍和促进患者获得NIPT的方法和政策重点。