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Legal dilemma over patenting human genes

Stephen Hitchcox discovered he had a potentially fatal genetic mutation one day when he was swimming and his heart started beating erratically. He lost consciousness and needed to be rescued and resuscitated.

The 57-year-old soon found out he has a genetic disorder called Long QT syndrome, and the episode involving his rapid heartbeat is typically one of the first symptoms that can be followed by sudden death.

"I was extremely lucky," he told CBC Canada. "And it was a complete surprise."

There is a test that can detect the genetic disorder, which is highly treatable with heart drugs such as beta-blocks and anti-arrhythmics, or medical devices such as pacemakers or defibrillators. However, the problem is that the test is patented by a U.S. company, which means doctors in Canada cannot access the test and help patients before they end up in life-threatening circumstances like Hitchcox.

With rapid advances in biotechnology, genetic testing for a range of health conditions is becoming more widely available. And while such data can help doctors and patients address many health concerns and plan for future health care, genomics has also opened the door to endless proprietary and ethical questions.

On Monday, the Children's Hospital of Eastern Ontario began the legal process with Canada's Federal Court to challenge University of Utah Research Foundation, Genzyme Genetics and Yale University, all of which hold patents on human genes that are analyzed to test for and diagnose Long QT syndrome. If the judge rules in favor of the Ontario hospital, the case will set a precedent and make gene patenting illegal in Canada.

"Genes are not inventions. They belong to all of us," Dr. Gail Graham, the head of the hospital's genetics department, said during a press conference.

Last year, the U.S Supreme Court ruled human genes cannot be patented in the United States. That case involved Myriad Genetics Inc., a medical diagnostic company that discovered the mutations to the BRCA1 and BRCA2 genes, which are related to an increased risk for certain types of breast and ovarian cancers. Because Myriad had patented the genes, the company also held a monopoly on the diagnostic test until the Supreme Court ruled otherwise.

But not every country is taking this stance. In Australia, a court upheld Myriad's right to patent the mutations in the BRCA 1 gene linked to cancer. The final ruling argued that isolating the DNA fragment of the mutation in a gene is an artificial process and not the gene itself.

Richard Gold, a lawyer and intellectual property expert at McGill University in Montreal, who is advising the Ontario hospital pro bono, told reporters that one of the licensees holding the patent for Long QT syndrome brought this to the hospital's attention with a letter. "And so we have a very concrete example of this patent holder trying to hold up Ontario labs and hospitals from being able to deliver this test," he said.

The U.S. lab that currently conducts the test charges $4,500 per patient, but the hospital said they could do the test for half the amount. According to Ontario's Health Ministry, allowing the hospital to process the test independently could save approximately $200,000 a year in health care costs.