Intellectual Property and Access to Noninvasive Prenatal Genetic Testing
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 potentially 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 patient 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.
This research led to several peer reviewed publications , invited reviews and commentaries listed below. This also led to successful conference grants for a meeting in the US
1.Cook-Deegan R, Chandrasekharan S. Sequenom v. Ariosa - The Death of a Genetic Testing Patent. 2016 N Engl J Med. 375(25): 2418-2419
2. Meredith S, Kaposy C, Miller VJ, Allyse M, Chandrasekharan S, Michie M; Prenatal Testing PAG Coalition. Impact of the increased adoption of prenatal cfDNA screening on non-profit patient advocacy organizations in the United States. Prenatal Diagnosis. 2016 36(8): 714-9.
3. Minear MA, Lewis C, Pradhan S, Chandrasekharan S. Global perspectives on clinical adoption of NIPT. 2015 Prenatal Diagnosis 35(10): 959-67.
4.Li G, Chandrasekharan S, Allyse M. "The Top Priority Is a Healthy Baby": Narratives of Health, Disability, and Abortion in Online Pregnancy Forum Discussions in the US and China. 2016 J Genet Couns. Jun 9. [Epub ahead of print]
5. Minear MA, Alessi S, Allyse M, Michie M, Chandrasekharan S. Noninvasive Prenatal Genetic Testing: Current and Emerging Ethical, Legal, and Social Issues. 2015. Annu Rev Genomics Hum Genet 16:369- 98
6. Megan Allyse, Mollie Minear, Elisa Berson, Anthony Hung, Margaret Rote, Shilpa Sridhar and Subhashini Chandrasekharan Non-Invasive Prenatal Testing: A review of international implementation and challenges" accepted for publication in the journal. 2015 International Journal of Women's Health 7:113-26
7.Megan Allyse* and Subhashini Chandrasekharan* Commercial Provision of Non-Invasive Prenatal Testing for Sub-Chromosomal Abnormalities and Beyond: Too Much, Too Soon? 2015 Genetics in Medicine Mar 19. doi: 10.1038/gim.2015.23
8. Subhashini Chandrasekharan, Amy L McGuire, and Ignatia Van den Veyver. Do recent US Supreme Court rulings on patenting of genes and genetic diagnostics affect the practice of genetic screening and diagnosis in prenatal and reproductive care? 2014 Prenatal Diagnosis
9. Subhashini Chandrasekharan, Mollie Minear, and Megan Allyse. Noninvasive prenatal testing goes global 2014 Science Translational Medicine 6(231): 231fs15
10.Ashwin Agarwal, Lauren Sayres, Mildred Cho, Robert Cook-Deegan and Subhashini Chandrasekharan. Commercial Landscape of Noninvasive Prenatal Testing in the United States 2013 Prenatal Diagnosis Jun; 33(6): 521-3
Project Policy Impact Description
This research has identified the major barriers to appropriate implementation of cell free DNA screening as prioritizd by a panel of
Department & School
Duke Global Health Institute
- NIH-National Human Genome Research Institute
- University of North Carolina - Chapel Hill
- Oregon Health & Science University