Can genes be patented? An Ottawa hospital filed a legal claim Monday that will bring that thorny question to Canada.
The U.S. Supreme Court ruled in 2013 that it isn’t possible to patent naturally occurring genes because they are products of nature, throwing out patents held by the company Myriad Genetics on the BRCA1 and BRCA2 genes. Carriers of the genes have an increased risk of breast and ovarian cancer, and testing for it became cheaper and more widely available within hours of the U.S. ruling.
But the issue has not been considered by Canadian courts. Monday’s legal case, brought by the Children’s Hospital of Eastern Ontario (CHEO), deals with five patents held in Canada by the University of Utah on genes and tests for an inherited cardiac condition called Long QT syndrome.
The disorder can cause fainting, seizures and sudden death. Patients who are identified before they show symptoms can be treated with drugs and, in some cases, medical implants.
“Long QT is just one of thousands and thousands of genetic conditions. So (the case) is specifically about long QT, but really it’s a much broader issue about the future of medicine and delivering on the potential of recent technology,” said Alex Munter, president and CEO of the hospital.
Yet proponents of gene patents have long argued that invalidating them will stifle medical innovation, since patents are meant to act as an incentive to create new and better technologies.
CHEO filed the suit Monday morning in Federal Court; the University of Utah has not yet had a chance to respond.
Currently, if an Ontario doctor suspects that their patient has Long QT syndrome, the diagnosis includes sending a blood sample to a lab in the U.S.
The two-tier test currently costs approximately $4,500 (U.S.) per person, CHEO estimates, whereas researchers at the hospital believe they could administer the same process in-house for about half the cost.
“The collective impact (of this case) could easily be in the orders of millions of dollars for the healthcare system,” said Gail Graham, a clinical geneticist at the hospital.
Graham said that part of the impetus for prompting the court battle was a contract the hospital won from Ontario’s Ministry of Health to develop a cheaper way to test for inherited cardiac disorders.
Graham says that the Ministry of Health, realizing how much money it was spending on out-of-province tests, issued a request for proposals to develop an in-province process. CHEO applied and won.
But Long QT syndrome was then excluded from the test because the Ministry of Health received a warning letter from the Long QT patent-holders, said Graham.
CHEO is also validating a commercially available test that can diagnose 5,000 genetic conditions simultaneously, but believes gene patenting hinders the use of it.
“I could conceivably be sitting across the table from a patient who has Long QT syndrome and not be able to tell them that they have that condition, even though it’s detectable on the test, because of these patents,” said Graham.
It is not known how many gene patents exist in Canada, but experts estimate they number in the thousands.
American and European courts have dealt with the issue of gene patenting, but Canadian courts are “behind the times,” said Richard Gold, a law professor at McGill who is involved with the case.
“There is nothing in Canadian law to tell us whether these things are patentable or not. It should bring clarity to all the actors involved” – patients, researchers, healthcare providers, governments, and companies who hold the patents.