A hospital in eastern Ontario is launching a lawsuit against the owners of a patent of cardiac genes, in the hopes that the case will eventually make it easier for Canadian doctors to conduct important genetic testing.
The test case speaks directly to an issue affecting Canadian health-care services: Can human genes be patented?
The Children's Hospital of Eastern Ontario and the law firm Gilbert's LLP are launching the suit against the U.S. holders of a patent for genes related to the rare heart condition Long QT syndrome (LQTS).
LQTS is a heart rhythm disorder that can cause fast and chaotic heartbeats. These irregular heartbeats can cause palpitations, fainting and even death. The disorder arises from the mutation of several different human genes, which are detected through genetic testing.
CHEO said that because of the patent, whenever someone with one of the related heart problems needs a genetic test their samples must be sent to the U.S. at a cost of more than $4,000. The hospital must do this even though its own labs are capable of conducting the test.
The hospital said that the awarding of exclusive patents for genes may one day prevent Canadian doctors from offering accessible genetic testing to patients, especially as advances are made in the field of genetics and personalized medicine.
"Genetics is poised to make major advances that will allow us to more rapidly provide life-saving diagnoses and treatments; continued patenting of DNA will stop us from fully realizing that potential," Dr. Gail Graham, chief of the genetics program at CHEO, said in a statement released Monday.
U.S. and Europe decisions
The hospital notes that a similar case arose in the U.S. in 2013, when the U.S. Supreme Court was asked to rule on whether a company could patent the breast cancer gene BRCA 1. The court ultimately ruled that human genes can't be patented.
Justice Clarence Thomas delivered the Court’s opinion, writing that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”
You can read the full decision here (PDF).
The U.S. decision reversed decades of biological patents being awarded to firms, a phenomenon that started in the mid-1980s as scientists discovered new genes and genetic material.
The European Union took action on human gene patenting in 1998, when it issued its directive on the legal protection of biotechnological inventions.
“The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions,” the directive states.
But while the U.S. and Europe have developed gene patent policies outlining what types of genetic information can be patented, Canada still lacks such a policy, Gilbert's LLP said in a statement.
"As a result, Canada's health care system is particularly burdened by broad gene patents, causing a chilling effect on innovation, increased health system costs, and reduced access to genetic testing," the statement said.
The firm said that no company should have the exclusive rights on genetic information encoded in human DNA. Furthermore, it argues that patents should not prevent patients from getting the latest in medical testing and care.
"Patents filed in the 1990s on genetic information should not prevent access to the cutting-edge next-generation genetic tests developed years after the patents were filed," the statement said.
Gilbert's LLP said it is taking on the case free of charge, and lawyers for the firm will use testimony from genetics and biology experts to argue its case.
Hoping to set a precedent
Graham told CTV News that the hospital currently sends patients' samples to labs in the U.S. that are permitted to conduct the genetic testing for LQTS. This costs the health care system nearly twice as much as it would if labs at CHEO were permitted to do the testing.
Graham said she hopes that the case will set a precedent that will prevent companies and individuals from patenting new genes as they are discovered.
"Otherwise we'll increasingly be prevented from helping patients and families," she said.
"We just believe that nobody should be able to patent a gene because it's a naturally occurring substance. It's a little bit like patenting air or water in a sense."
CHEO's CEO Alex Munter said that while the hospital recognizes the important role patents play in the innovation process, no single person or firm should hold a monopoly on something that occurs naturally.
"We hope to obtain guidance from Canada's Federal Court that will allow all provinces to approve genetic tests conducted by Canadian healthcare providers. Our patients deserve nothing less," he said in a statement.
With files from CTV News' Medical Correspondent Avis Favaro and Senior Producer Elizabeth St. Philip
