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Ground-breaking settlement changes landscape for genetic medicine in Canada

OTTAWA - March 9th was is a great day for DNA. It is also a great day for Canadian patients and their families.

CHEO, the children's hospital of Canada's capital region, announces that gene patents will no longer stand in the way of diagnosing a life threatening disease. It has reached a deal that defines a pathway for all public Canadian hospitals and labs to conduct genetic testing without legal roadblocks from gene patents.

Specifically, CHEO has reached a settlement of its legal challenge with Transgenomic, the owner of five gene patents related to the potentially deadly Long QT syndrome. Transgenomic has agreed to provide CHEO and all other Canadian public sector hospitals and laboratories the right to test Canadians for Long QT syndrome on a not-for-profit basis.

This agreement resolves the immediate issue with Long QT testing – and it also provides a way of addressing the issue of gene patents more broadly in Canadian health care.

"This is a tremendous win for families," says Alex Munter, CHEO's President and CEO. "As these tests can now be performed in Canada, families across the country will have better, quicker access to the answers and the care they need. This agreement sets a precedent and will save lives."

While CHEO and Transgenomic were originally going to look to the courts for a resolution on this important health care issue, they were both committed to finding a solution to the issue without the expense and delay of a prolonged court case.

Transgenomic has agreed to allow access to its Long QT patents for the entire public sector.

"This agreement will act as a model for public access to future gene patents, so that Canadian hospitals are empowered to provide access to cutting-edge genetic tests. We are very proud of this result," says Nathaniel Lipkus, a lawyer at Osler, Hoskin & Harcourt LLP. He and Sana Halwani, a lawyer at Gilbert's LLP, represented CHEO as pro bono counsel in this case.

It is now up to the federal and provincial governments to make use of this pathway to ensure that Canadians receive not only current genetic tests, but the next generation of tests.

"This agreement gives the public health sector the tools it will need to deal with gene patents in the future. From now on, public hospitals and laboratories can ask patent holders to sign similar agreements allowing not-for-profit access," said Richard Gold, a Professor in Law and Medicine at McGill University who advised CHEO on policy aspects of the case. "If the patent holder doesn't agree, the province can step in and ask the patent office to give it, on behalf of those hospitals and laboratories, a compulsory license on the same terms."

"This settlement is great news for the future of Canadian medicine," says Dr. Gail Graham, CHEO's Chief of Genetics. "Freer access to testing will allow geneticists, as well as other physicians and researchers to realize the full potential of genomic medicine, which promises to unlock many medical mysteries, and tailor medical decisions and treatments to a patient's specific genetic profile."

Since hospitals and labs will no longer need to send blood samples to licensed private labs in the United States for testing, patients will get their results faster and start treatment more quickly. Hospitals will also save money, as it is about 50 percent cheaper to perform these tests in the Canadian public sector.

Launched in 2014, the goal of CHEO's Federal Court challenge was to change the law so that broad gene patents would not prevent medically necessary genetic tests. Gene patents covering a single gene or genetic mutation should not stand in the way of genetic tests that comprehensively sequence much or all of a patient's DNA.

No hospital dollars have gone towards this legal challenge. CHEO thanks its legal representatives – Nathaniel Lipkus and Sana Halwani -- who provided their services pro bono, as did several leading experts, including Professor Richard Gold of McGill University's Faculty of Law. Mr. Gold and his team are funded through PACEOMICS, a project supported by Genome Canada, Genome Alberta, Genome Quebec and the Canadian Institutes for Health Research. In addition, CHEO's physicians and scientists donated their time because they felt so strongly that the legal challenge was just.

CHEO, the pediatric hospital in Canada's capital region, helps over 500,000 kids each year in Ontario, Quebec and Nunavut. CHEO is affiliated with the University of Ottawa and is home to globally recognized clinicians and researchers tackling cancer with viruses, mental illness, genetic discoveries, obesity and much more.

Ground-breaking settlement changes landscape for genetic medicine in Canada

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