New genetic testing deal could spur major research breakthroughs
Earlier this year, the Children’s Hospital of Eastern Ontario (CHEO) announced a deal with the holder of five patents over a genetic test for Long QT syndrome – a heart abnormality that too often leads to sudden death in young people.
In the settlement, Transgenomic, one of the leading US providers of genetic tests, agreed that all public sector hospitals and laboratories have a right to test for the genetic condition without cost and without paperwork. Although the deal related to one genetic condition, in practice, the CHEO agreement establishes a practical precedent that will stop any sensible gene patent holder from suing a hospital or public laboratory in Canada. Essentially, patents on genetic tests should soon be irrelevant to Canadian health care.
The CHEO agreement enables all Canadian public hospitals and laboratories to make use of the latest gene testing technology for all diseases as if the gene patents did not exist. The mechanism used to accomplish this is simple. The agreement provides the Canadian Intellectual Property Office with a precedent to apply under section 19 of the Patent Act to override any patent relevant to genetic testing should the patent holder refuse to sign a similar agreement as the one Transgenomic signed.
The solution that CHEO found not only opens the way for Canadians to access the best and most comprehensive genetic tests available, but represents a great opportunity for Canadian innovation in the field. Instead of shipping samples to private US laboratories, Canadian hospital laboratories can now perform diagnostic tests in house. The agreement therefore opens the door to the creation of a Canadian database of genetic variants that will massively accelerate biomedical research and development.
Here’s why. So far, data from genetic tests is fragmented into hundreds of different databases housed in different clinical laboratories, in large part because firms that hold gene patents do not publicly share the data from the genetic tests they perform. Further, researchers have been reluctant to share the data from the genetic tests they have performed out of fear of being sued. As public hospitals and laboratories perform more and more genetic tests, they will be free to upload their findings, and the interpretation of those findings, to a single, public database. This will be critical to developing the next generation of tests and treatments in the future.
This kind of big data is necessary to propel biomedical innovation. Deciding which genetic variants are associated with disease and which are not is complex. The more data we have, the better. A large body of evidence shows that most common diseases result from the interplay between multiple genes (hundreds even) and the environment.
While data on the genetic information could be available to researchers worldwide, Canadian researchers would additionally have access to anonymous health record data of patients who are tested. Thus, they could link diagnoses and other medical information with genetic information.
Canada has the opportunity to set the standards for these genetic databases so that they match the way we collect data in our public health care system. Canadian firms would then be in a position to develop software and health interventions that they can market internationally, putting us at the forefront of future innovation. Software might, for example, more accurately predict the likelihood that a person will develop a particular disease, how severe the disease will be and the treatment most suited to the person (the most effective intervention with the fewest side effects). Health interventions that could be developed could include not only better-targeted pharmaceuticals but better non-pharmacological therapies made possible through gains in our understanding of disease.
To make this happen, both federal and provincial governments need to come out strongly in stating that they expect gene patent holders to enter into agreements like the CHEO agreement regarding their respective gene patents. If firms do not, they should expect those governments to use section 19 of the Patent Act to force their hands. The federal government must also clarify the process for making applications under section 19 so that everything is transparent, fast and fair.
Researchers need to develop the databases necessary to share data, absent intellectual property rights, in a way that preserves privacy and is built on adequate informed consent. The federal research granting councils have established strict rules through which to protect individuals. The exercise of building these databases will, therefore, be nothing new to those in the bio-medical field where Big Data underlies so much research.
Canadian firms are well placed to seize the opportunity offered by access to large clinical databases. Because of our public health care system, these databases are easier to build here compared to down south. Canadian biotech and informatics firms ought to come out strongly in support of the CHEO agreement and pave the way for not only a thriving industry, but also new treatments – and with them, new hopes.
Richard Gold is associate dean of graduate studies at the McGill Faculty of Law and a James McGill professor at the McGill Faculty of Law and Faculty of Medicine. He is an internationally recognized expert on patent law and innovation policy.