Ottawa hospital challenges patent on human genes (with video)

Saying no one should be able to patent human DNA, the Childrens Hospital of Eastern Ontario is asking the Federal Court to declare patents on genes linked to an inherited heart condition called Long QT Syndrome invalid.

The potential implications of the legal challenge, the first of its kind in Canada, are huge.

If the court agrees with the hospitals argument that the patents should never have been issued in the first place, there would be a ripple effect on other such patents and pending patents on human DNA. TheU.S. Supreme Court has already made a similar ruling invalidating patents on human DNA.

Our position is very straightforward, hospital CEO Alex Munter told a press conference held just after court documents were filed in Toronto on Monday. No one should be able to patent human DNA, it would be like patenting air or water. Doing so, he said, has a negative impact on the future of medicine, on patients access to their own genetic information and on the quality of care.

CHEO is taking on the first Canadian case because it is a major centre for genetics research and clinical applications. Patents on genetic materials, such as the ones that touch on Long QT Syndrome, Muntersaid, are a major obstacle to research and treatment of genetic diseases. The patents in question, five of them, are held by the University of Utah, Genzyme Genetics and Yale University.

Our genetics leadership really is at the leading edge in Canada of moving us toward that era of personalized medicine that everyone is talking about, Munter said. But patents on human DNA, he added, have been identified as an obstacle that will stand in the way of delivering on that promised future.

Long QT Syndrome affects an estimated one in 2,500 newborns. It can lead to life-threatening arrhythmias and is the cause of a significant number of sudden deaths in young adults, sometimes seen in deaths of young athletes playing sports. Sometimes symptoms such as fainting spells during exercise can help doctors diagnose and treat a patient, but in some cases, the first symptom of the syndrome is sudden death, said Dr. Gail Graham, who heads the hospitals department of genetics.

The syndrome is fully treatable with medications once diagnosed, but it can be tricky to diagnose using electrocardiogram alone, Graham said. Genetic testing along with ECG can come up with a conclusive diagnosis.

CHEO was set to become one of Ontarios testing centres for the syndrome but the province received a cease-and-desist order from the holder of the patents that are linked to the disease. Now, because of the patents surrounding the genes involved in the disease, testing must be done in the U.S. at a cost of about $4,500 to $4,800 a patient, said Graham, compared to between $1,500 and $2, 000 if it could be done here. Being able to test here, she said, would save the Ontario health system $200,000 a year. If genes continue to be patented, she said, the cost to the provincial health system will rise into the millions every year.

CHEO is in the final stages of verifying a new genetic test that wouldsimultaneously sequence all of the thousands of genes in an individual that been linked to human genetic diseases. It is something that couldnt even be imagined five years ago, said Graham, chief of the hospitals department of genetics. But such a test creates a potential nightmare scenario for patients with undetected Long QT syndrome, she said. If thetest done on a patient incidentally turned up the genetic mutations for Long QTsyndrome, she said, lab scientistswould be prevented by law from passing that information along to the physician treating the patient, meaning a potentially fatal condition would go untreated.

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Ottawa hospital challenges patent on human genes (with video)