CHEO and Transgenomic reach agreement on Long QT patents that sets pathway for next generation of patient care
Ottawa, ON–This is a great day for DNA. It is also a great day for Canadian patients and their families.
CHEO, a children’s hospital in the Ottawa region 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. The 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 managed to find a solution to the issue without the expense and delay of a prolonged court case.
Additionally, 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.
The settlement opens the way for 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,” adds 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 per cent 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.