Sam Abraham is adjunct professor, Department of Pathology at the University of British Columbia and Department of Molecular Biology & Biochemistry, Simon Fraser University; David Castle is professor, School of Public Administration, University of Victoria; and E. Richard Gold is professor, Faculties of Law and Medicine, McGill University
Canadian prosperity depends on our ability to innovate. When it comes to unlocking the power and mysteries of genomic medicine, our competitors in the United States now have free reign – but Canadian innovators continue to be shackled.
The Children's Hospital of Eastern Ontario (CHEO) launched a test case against human gene patents on Monday. The primary objective of the case is to ensure that CHEO patients – children with a potentially lethal yet often otherwise undetectable disease – receive the health care they need. A parallel objective of the case is to address long-standing problems with gene patents that hamper rather than enable innovators.
Patents enable innovative firms to bring a new health product or service to market and reward that effort with 20 years of reduced competition. Leaving aside generic criticisms of patents, not all patents are created equally or have the same effects on innovation. Patents over natural gene sequences and over basic genetic tests not only lessen patient access to health care but prevent innovators from developing the next generation of tests needed to better predict the onset of disease.
At the heart of CHEO's fight are several genes linked to a heart condition called Long QT. Patients with this condition have an abnormal heart rhythm. While this condition can often be predicted through routine tests, a substantial proportion will be missed unless a genetic test is conducted on a patient's blood sample. If detected, the condition can easily be treated and the patient can live a normal life. If not found, the patient may die without warning, often at a very young age.
CHEO focuses attention on the needs of its patients. Patents restrict CHEO from deploying cutting-edge genetic tests because Canadian patents require that tests must sent, at considerable cost, for analysis to authorized firms in the United States. Paradoxically, while courts in the U.S. have held these types of patents invalid in that country, no similar ruling exists in Canada; hence the need for a test case.
Reduced access to diagnostics obviously affects patients, but also has implications for innovators. Most gene patents focus on a single gene's effect within a disease, and don't take into account other genes and complexities involved in the development of the disease. Universities, hospitals and private companies are developing sophisticated genetic tests that diagnose multiple diseases and involve multiple genes. In Canada, these innovators live in fear of being sued by owners of single patents. This chilling effect leads to fewer tests being developed and offered.
Patents have been awarded on the basis of the discovery of a single gene, but the problem is that the innovative aspect of genetic testing is not the discovery but the interpretation of errors – mutations – in those genes and the analysis of their interaction with other genes. That is, gene testing today involves innovation in data interpretation, competition between ways of analyzing the data and constant questioning and review of results.
The current patent system restricts access to data, allowing the few rather than the many to both analyse and review the results. Firms holding gene patents are motivated to keep data to themselves and, worse, do not share their insights into the impact of particular errors on disease development. Unlocking those patents will enable the new generation of firms that compete not on the basis of exclusive rights, but on the accuracy of their methods of analysis, their service to patients and doctors and the reliability and reproducibility of their results. Patents on these methods, rather than on the genes themselves, will spur innovation as competing groups will try to outdo each other, provided that they all have access to the same basic data.
Canadian prosperity increasingly depends on our ability to innovate and compete. Pro-innovation strategies must recognize both the importance of patents and their limits. In many cases gene patents stand in the way of the next generation of innovation. While our competitors in the United States now have free reign, our innovators continue to be shackled. It is time to unlock those patent chains and provide Canadian innovators with the same opportunities to innovate and compete granted to their U.S. counterparts.