Canadian legal challenge to human gene patents

6 November 2014

A Canadian hospital is questioning the validity of US gene patents that are currently enforced to prevent some genetic tests being performed in Canada rather than the US, on the basis that they are morally objectionable and refer to outdated technology.

The Children’s Hospital of Eastern Ontario (CHEO) in Ottawa has begun legal proceedings in the Canadian Federal Court challenging human gene patenting. Their case is focused on tests for genetic mutations associated with long QT syndrome; the hospital is presently not able to test for these mutations because a US company has patented the test and the genes.

After the Ontario Ministry of Health gave permission for the hospital to begin using its own tests for long QT syndrome, the American patent holders (including the University of Utah Research Foundation, Genzyme Corporation and Yale University) sent the ministry a letter asserting their exclusive right to diagnose the condition.

Dr Gail Graham, head of the genetics department at CHEO, said that the US patent holder’s laboratories charge around about US $4,500 per test, which could be done locally for around half the cost, as well as providing results much faster. She added: "Our doctors and scientists simply cannot accept the prospect of child dying or potentially being orphaned because a patent prevented us from diagnosing and treating a serious life-threatening condition".

Last year the US Supreme Court ruled that elements of key BRCA1/2 gene patents were invalid on the basis that they represented products of nature, but this ruling did not affect the status of patents in Canada. The Full Federal Court of Australia ruled that gene patents were valid earlier this year. This new case is the first of its kind in Canada, and could well become an important test case that reaches the Supreme Court of Canada with potentially broad implications for genetic testing in the country.

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