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UPDATE: Canadian Pediatric Hospital Challenges Gene Patenting for Long QT Syndrome

This article has been updated with the name of the US laboratory that sent Ontario's Ministry of Health a cease and desist letter.

NEW YORK (GenomeWeb) – The Children's Hospital of Eastern Ontario is challenging the legality of US gene patents in Canada.

In a complaint filed today with Canada's Federal Court, CHEO is challenging the validity of five patents held by the University of Utah Research Foundation, Genzyme Genetics, and Yale University on genes underlying tests for Long QT syndrome, a cardiac disorder that can be fatal.

In a statement, CHEO Genetics Chief Gail Graham said that while genetic advances are poised to significantly impact healthcare, patents on genes are hindering the life sciences community from realizing that potential.

According to a report by CBC News, one of the US labs holding licenses to the patents for Long QT syndrome testing sent a cease and desist letter to Ontario's Ministry of Health after it awarded CHEO a grant to develop a test that would include genetic markers associated with the condition and that would be a cheaper alternative to the $4,500 test from US labs. GenomeWeb Daily News confirmed with CHEO that the US lab that sent the letter to the ministry was PGx Health (now a part of Transgenomic).

After that letter, the ministry scuttled plans to develop a locally developed Long QT test, which according to some legal experts provides evidence that gene patents have had a stifling effect on Canadian hospitals and labs.

This is the first lawsuit in Canada questioning the legality of patenting genes. Courts in other countries, meanwhile, have tackled the same question and come up with varying answers.

In the US, for example, the Supreme Court has drawn a line between patenting isolated gene sequences and complementary DNA (cDNA). In Association for Molecular Pathology et al. v Myriad Genetics , the court last year ruled against the patent claims held by Myriad and University of Utah on isolated BRCA1 and BRCA2 gene segments, reasoning that these DNA fragments, although removed from the body, are too similar to the DNA sequences in our bodies to be patent eligible. In the same ruling, the US court upheld the patent eligibility of claims on complementary DNA, which don't occur in nature and are created in a lab for use as diagnostic probes.

In contrast, the Federal Court of Australia in September upheld an earlier judgment that Myriad could patent mutations in the BRCA1 gene linked to an increased risk of hereditary breast and ovarian cancer. The Australian court reasoned that the process of isolating a DNA fragment makes it an artificially created, economically useful product, which in turn renders it deserving of patent protection.

In filing the suit against the University of Utah, CHEO wants this same issue to be taken up by Canada's Federal Court. "As a research hospital, we recognize that patents are an important part of the innovation process," CHEO CEO Alex Munter said in a statement. "No one should have a monopoly on something that occurs naturally. Patenting a gene is like patenting the water we drink and the air we breathe."

CHEO, affiliated with the University of Ottawa, is a regional pediatric hospital in Canada that treats more than 500,000 children each year. The hospital is being represented by Gilbert's LLP in the federal patent litigation. Meanwhile, lawyers Nathaniel Lipkus and Sana Halwani, as well as McGill University law professor Richard Gold, are providing their services pro bono.

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