An Ottawa hospital is asking the Federal Court to decide whether companies can patent naturally occurring genes.
Here are five things you should know about the gene patent case:
1. At issue in the case is a gene associated with Long QT, a genetic heart condition.
The University of Utah holds Canadian patents on the gene and threatened to sue the Children’s Hospital of Eastern Ontario, which was developing a process to replace the $4,500 proprietary test it currently uses to diagnose the disease.
The CHEO is now asking the Federal Court to revoke those patents.
2. Courts in the U.S. have already concluded that genes cannot be patented if they occur naturally.
In 1980, the U.S. Supreme Court decided that living organisms created by humans could be patented.
The court concluded that General Electric biologist Ananda Chakrabarty could patent a type of bacteria he had designed to clean up oil spills, because it was “a product of human ingenuity.”
The ruling excluded any organism that occurs naturally. Last year, the U.S. Supreme Court made a similar ruling in a case against Myriad Genetics, which two genes associated with breast and ovarian cancer — BRCA1 and BRCA2.
Myriad Genetics argued that because the company had removed the genes from the human body, the isolated genes became its intellectual property.
That argument “defies common sense,” the court ruled.
“Under this rationale, a kidney ‘isolated’ from the body would be patentable, gold ‘isolated’ from a stream would be patentable, and leaves ‘isolated’ from trees,” the court wrote.
3. Like with any other invention, the right to patent a manufactured organism is meant to provide an incentive for often costly research.
But with BRCA1 and BRCA2 patented, Myriad could block anyone from doing further work on the genes, which created a “chilling effect on research,” the court wrote.
4. How will this impact you?
In the Myriad case, the company had not tried to block research on the gene. But it had prevented others from doing genetic testing on BRCA1 and BRCA2.
That protection of the company’s patent had “serious and urgent consequences for patients,” the Supreme Court wrote.
In Canada, the CHEO is considering a process that can be used test for 5,000 genetic conditions, but thinks it may have to exclude some of those conditions if they are related to patented genes.
5. Will the discussion impact all genes, or just genes found in humans?
In the lawsuit filed Monday, the CHEO repeats the arguments made in the Myriad and Chakrabarty cases — that “naturally occurring phenomena and discoveries thereof” cannot be patented. If the court accepts that argument, it could apply to all naturally occurring genes.
Isolating the genes requires only “trivial effort,” and removing them from the body does not make them into a new compound that could be patented, the CHEO argues.