Ont. hospital reaches settlement over gene patents
Published Wednesday, March 9, 2016 12:15PM EST
Last Updated Wednesday, March 9, 2016 2:28PM EST
Gene patents will no longer stand in the way of diagnosing a life-threatening disease, after an Ontario hospital reached a settlement with a biotechnology company. The settlement is the first in the world that allows low-cost testing in the face of gene patenting, the hospital's lawyers say.
The Children's Hospital of Eastern Ontario announced on Wednesday that it had settled a legal dispute with Transgenomic, a biotech company that owns five gene patents related to a rare heart condition called Long QT syndrome (LQTS).
LQTS is a heart rhythm disorder that can cause fast and chaotic heartbeats. These irregular heartbeats can cause palpitations, fainting and even death. The disorder can run in families, and arises from the mutation of several different human genes, which are detected through genetic testing.
The hospital launched a legal challenge against Transgenomic in 2014, in the hopes that it would make it easier for Canadian doctors to conduct important genetic testing, including tests for LQTS, without running into legal roadblocks. Lawyers for CHEO argued that genes and other parts of the human genome should not be subject to patents.
According to the settlement, Transgenomic has agreed to provide CHEO and all other Canadian public sector hospitals and laboratories the right to test for LQTS on a not-for-profit basis. However, Transgenomic will still hold onto the patents.
CHEO's President and CEO Alex Munter said the settlement was a "tremendous win for families."
He noted that the agreement sets a "powerful precedent" for similar cases involving gene patents.
"This is a uniquely made-in-Canada solution to a thorny legal problem," he said Wednesday afternoon during a press conference. "It's going to save lives, improve care, cut costs, and increase access."
When CHEO initially launched the challenge, it said that whenever a patient with a related heart problem needed a genetic test, doctors were required to send their samples to the U.S. at a cost of more than $4,000. The hospital was required to do this, even though its own labs were capable of conducting the test at much less cost.
The hospital warned that the awarding of exclusive patents for genes could one day prevent Canadian doctors from offering genetic testing to patients, even as new advancements are made in the field of genetics and personalized medicine.
Nathaniel Lipkus, one of the lawyers representing CHEO, said that while the legal team had initially argued that patents shouldn't be issued for genes, the settlement allows doctors to provide genetic testing at a much lower cost.
He said the agreement "insulates the public health system from gene patents," while still remaining "fair." He added that while the lawyers wanted to go to court and make their case against gene patenting, the agreement is "as powerful" or "possibly more powerful" than any court decision they could have obtained.
In a statement issued on Wednesday, Richard Gold, a professor in law and medicine at McGill University, said similar agreements could be applied to new cases involving different patents.
"From now on, public hospitals and laboratories can ask patent holders to sign similar agreements allowing not-for-profit access," he said. "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 licence on the same terms."
Dr. Gail Graham, CHEO's chief of genetics, said the settlement was "great news" for the future of Canadian medicine.
"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," she said in a statement.