Although the Supreme Court of the United States limited their availability in Association for Molecular Pathology v. Myriad Genetics, gene patents remain important around the world. We examine the situation in Canada, where gene patents continue to exist, in light of recent litigation relating to familial long QT syndrome (LQTS).
We conducted in-depth semistructured interviews with 25 stakeholders across five Canadian provinces and supplemented this with a case analysis of the litigation.
The majority of LQTS testing was carried out outside Canada. Rising costs prompted several provinces to attempt to repatriate testing. However, LQTS gene patents stymied efforts, particularly in provinces where testing was more centralized, increasing costs and lowering innovation. It was in this context that a hospital launched a test case against the LQTS patents, resulting in a novel agreement to free Canadian hospitals from the effects of patents.
Our analysis reveals a rapidly evolving genetic test provision landscape under pressure from gene patents, strained budgets and poor collaboration. The litigation resulted in a blueprint for free public use of gene patents throughout Canada's health-care system, but it will only have value if governments are proactive in its use.
access; equity; gene patents; intellectual property; long QT syndrome
- The fate and future of patents on human genes and genetic diagnostic methods. Nat Rev Genet 2012;13:441–448. , , .
- 2013 12-398:569 U.S. 133 S.Ct. 2107.
- 2015 S28/2015.
- Myriad’s impact on gene patents. Nat Biotechnol 2016;34:1119–1123. , , et al,
- Are the gene-patent storm clouds dissipating? A global snapshot. Nat Biotechnol 2015;33:347–352. , , .
- Using thematic analysis in psychology. Qual Res Psychol 2006;3:77–101. , .
- http://paceomics.org/index.php/outputs/tools-and-resources/. Accessed August 25, 2016. , Intellectual asset management in personalized medicine innovation: guide to a bibliography of literature on public policy implications 2016.
- Global News. The genetic test you couldn't get in Canada, until now http://globalnews.ca/news/2567172/the-genetic-test-you-couldnt-get-in-canada-until-now/ Accessed August 25, 2016.
- http://www.cheo.on.ca/en/gene-patents. Accessed September 8, 2016.
- http://business.financialpost.com/legal-post/canadian-patent-settlement-sets-model-for-not-for-profit-gene-testing. . Canadian patent settlement sets model for not-for-profit gene testing.
- The significance of saturation. Qualitative Health Research 1995;2:147–149. .
- Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349–357. , , .
- http://www.qsrinternational.com/nvivo-product. Accessed September 19, 2016.
- Using numbers in qualitative research. 2010;16:475–482. .
- Familion genetic testing for cardiovascular disorders. The FAMILION LQTS Test – The FIRST Comprehensive Genetic Test for LQTS http://www.transgenomic.com/wp-content/uploads/602373.pdf. Accessed September 8, 2016.
- https://www.genedx.com/test-catalog/disorders/long-qt-syndrome-lqts/35212/. Accessed 8 September 2016. , Syndrome (LQTS).
- Impact of gene patents and licensing practices on access to genetic testing for long QT syndrome. Genet Med 2010;12:S111–S154. , , et al,
- Technology assessment and resource allocation for predictive genetic testing: a study of the perspectives of Canadian genetic health care providers. BMC Med Ethics 2009;10:6. , , et al,
- , , et al, A project to expand the capacity of genetic testing labs in Ontario, Canada. 2010 ACMG Annual Clinical Genetics Meeting, Albuquerque, NM.
- http://www.health.gov.on.ca/en/common/ministry/publications/reports/lab_services/labservices.pdf. , , . Laboratory services expert panel final review.
- Expert Panel on Quality Management. Project to establish a quality management program for repatriated genetic testing: report of the expert panel 2010. Meeting abstract from the 2010 annual American College of Medical Genetics (ACMG) meeting. Available at: http://acmg.omnibooksonline.com/2010/data/papers/309.pdf (accessed April 2017).
- The impact of human gene patents on genetic testing in the United Kingdom. GenetMed 2011;13:320–324. .
- Myriad genetics: in the eye of the policy storm. GenetMed 2010;12:S39–S70. , .
- https://www.sussex.ac.uk/webteam/gateway/file.php?name=sc30-wp3.pdf&site=25 (accessed April 2017). , , et al, The role of patents in the development and clinical use of genetic tests. Final Report. Deliverable D3b. Case studies on the role of IP in the development and clinical use of genetic tests for Factor V Leiden, TPMT and HPV in the USA and EU.
- AMP v. Myriad: a surgical strike on Blockbuster business models. Sci Transl Med 2013;5:192ed9. , , .
- A centralized approach to out-of-province genetic testing leads to cost savings: the Alberta experience. Clin Genet 2013;84:373–377. , , et al,
- An assessment of Canadian systems for triaging referred out genetic testing. ClinGenet 2015;88:90–94. , .
- Myriad stands alone. Nat Biotechnol 2014;32:620. , .
- CCMG statement on gene patents. ClinGenet 2012;82:405–407. , , et al,
- Canadian Open Genetics Repository (COGR): a unified clinical genomics database as a community resource for standardising and sharing genetic interpretations. J Med Genet 2015;52:438–445. , , et al,
- The next controversy in genetic testing: clinical data as trade secrets? Eur J Hum Genet 2013;21:585–588. , , et al,
- Genetic testing for long-QT syndrome: distinguishing pathogenic mutations from benign variants. Circulation 2009;120:1752–1760. , , et al,
- GENOMICS. A federated ecosystem for sharing genomic, clinical data 2016;352:1278–1280. .
- DATA SHARING. Montreal institute going 'open' to accelerate science. Science 2016;351:329. .
- An assessment of Canadian systems for triaging referred out genetic testing. Clin Genet 2015;88:90–94. , , .