~Written by Jasmine La Juanie Hamilton, PhD (Contact: lajuaniehamilton@gmail.com)
Twitter: @jasminogen
Patenting of medicines and diagnostics has had huge implications and remains a hot topic in the global health space. But what happens when the medicine or material in question, is the human genome? Should anyone have exclusive rights to any part of the human genome and what are the consequences of such patents? Although the EU and the USA prohibit human gene patents, this question is sparking new discussions in Canada. According to a report published by the Globe and Mail on November 3rd 2014, the Children’s Hospital of Eastern Ontario (CHEO) is challenging the idea that patents on genetic material are valid, suggesting that such patents greatly hinder personalized medicine, patient diagnosis and care (1).
The patents in question are those associated with the genes that cause long QT syndrome (LQTS), the most common genetic arrhythmia syndrome (2). LQTS varies in severity and presentation and is characterized by fainting spells and sudden death due to defects in how the heart repolarizes (i.e. long QT) (2-3). Current patents on the genes hinder diagnosis of the disease, a critical aspect of disease management as undiagnosed LQTS may cause sudden death in patients, primarily at a young age.
This debate raises traditional questions about access to medicines but also adds additional layers. The definition of discovery and innovation, whether the purification or isolation of a material constitutes an invention, the ethics of patenting naturally occurring materials and whether all naturally occurring materials; genomes and derivatives of the genome are un-patentable, are very important considerations for policy making in the area. This debate also gives Canada a unique opportunity to push the boundaries on the definition of genetic discoveries in healthcare. For example, although patents on genes are prohibited in some countries, it is still possible to patent other types of genetic material like cDNA. If Canada decides that all genetic materials regardless of source are non-patentable, this case could be precedent setting (4).
It is undeniable that access to medicines and diagnosis is a critical component of maintaining public health. So what will the results of this case mean for the diagnosis of LQTS and similar disorders in Canada? More importantly, what is the impact on public health? I believe that there are several major advantages of ruling against the patenting of all human genetic material. First, a ruling which prohibits gene patenting will increase access to medicines and diagnostics for diseases, enabling a more efficient disease management. Moreover, it would assert Canada’s commitment to personalized medicine and research, the proactive and most effective approach to disease management. Furthermore, if the prohibition is extended toward all forms of human genetic material, it will effectively lead to a removal of all barriers to researching and treating genetic diseases. The long-term benefits for public health would be tremendous.
Although the possibility of diminished interest in genomic innovation by biotech should not be overlooked, such a ruling may also have a positive effect on the IP landscape as it may enable stakeholders to construct more useful methods of dialoguing, defining and rewarding genomic discovery in Canada and beyond.
References
- Globe and Mail: http://www.theglobeandmail.com/life/health-and-fitness/health/bad-patents-on-human-genes-hinder-health-care-hospital-urges-court/article21423222/
- Roden DM. Long-QT Syndrome, N Engl J Med 2008; 358:169-176
- Angrist M, Chandrasekharan S, Heaney C, Cook-Deegan R. Impact of Gene Patents and Licensing Practices on Access to Genetic Testing for Long QT Syndrome. Genetics in Medicine 2010; 12(4 Suppl): S111–S154.
- Sherkow JS and Greely HT. The Future of Gene Patents and the Implications for Medicine. JAMA internal medicine 2013; 173.17: 1569-1570.