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有关知识产权（IP）和商业化对非侵入性产前基因检测（NIPT）临床翻译影响的经验数据，并确定临床采用和患者使用的潜在障碍。无细胞胎儿DNA的遗传分析技术的进步可能会导致常规。早期的临床试验表明，基于测序的NIPT测试对染色体非整倍性的测试比当前使用的非侵入性筛查试验更准确。最近可用于唐氏综合症的商业NIPT测试，并有针对常见遗传条件的测试。知道这些测试的临床效用和成本效益还为时过早。然而，NIPT可以显着改变产前测试和筛查的范式，甚至更低的成本范围。知识产权（IP）和商业化有望成为有关何时以及如何进入临床实践的新兴辩论中的重要组成部分。 IP可以在研发，监管机构批准和确保第三方付款方面引起商业投资。但是，独家IP权利也可能会妨碍创新，增加测试开发人员和提供商的交易成本，并减少患者的访问权限，尤其是在出现垄断时。实际上，基础NIPT技术的专利已仅获得了公司的许可，引起了此类担忧。商业格局正在迅速发展，公司已经参与了专利诉讼。这些专利的处置可以确定谁可以提供盛行的测试和业务模式，这反过来又会影响临床采用和患者的使用。 NIPT的IP景观显得复杂，尚不清楚。很少有关于利益相关者对IP与非IP因素对临床采用以及患者访问NIPT的影响的看法的数据。本研究将以以下具体目的解决这些差距：1）与NIPT相关的MAP IP并评估潜在的IP对新NIPT基因检测的开发的影响； 2）根据利益相关者的观点确定并对临床采用和患者访问权限的IP与非IP障碍进行排名； 3）确定潜在的Patiet通道障碍的道德和政策含义。具有遗传学，知识产权法，健康政策，生物伦理学，卫生经济学，孕产妇和胎儿医学和卫生法专业知识的研究人员的多学科团队将使用既定的定性研究方法，结合法律，道德和政策分析。这项研究的一个结果将是仔细的经验分析，即IP是否以及如何影响患者接受NIPT基因检测。该分析将通过我们将创建的NIPT技术的公开IP和商业化领域来实现。另一个预期的结果是对利益相关者对临床采用和患者访问的障碍的预测。研究结束时的研讨会将包括来自相关领域的利益相关者代表团体和专家，以确定减少临床翻译障碍并促进患者进入NIPT的方法和政策优先级。