One of the country's premiere pediatric hospitals is challenging the notion that human genes can be patented by filing a lawsuit that, if successful, could lead to a rewriting of patent law and sharply advance the advent of personalized medicine.
The Children's Hospital of Eastern Ontario argues in court filings that restricting access to genetic information by researchers and clinicians undermines patient care and is morally and legally untenable.
"No one should be able to patent human DNA. It's like trying to patent water or air," said Alex Munter, chief executive officer of CHEO. He noted that Canada is one of the only jurisdictions in the Western world that still allows gene patenting.
This poses a significant obstacle to diagnosing and caring for children with a genetic condition and that "can't be tolerated," he said. Conversely, striking down the law, will "open the door to an era of personalized medicine," where treatments are tailored to specific genetic characteristics.
Mr. Munter said CHEO is taking on the case because it is a leader in genetic research, particularly in the field of rare diseases, but many institutions will benefit if it is successful.
Lawyers for the hospital – who are working pro bono – filed papers in the Federal Court of Canada on Monday challenging five patents related to genes associated with a heart condition called long QT syndrome.
It is a test case that the hospital hopes will result in parts of the Patent Act being struck down. There are about 7,000 disease genes that are amenable to patenting under existing legislation in Canada.
"This is the first Canadian court case to ask the question: 'Are human genes patentable?'" said Nathaniel Lipkus of the law firm Gilbert's LLP.
Last year, the U.S. Supreme Court ruled that genes can no longer be patented. Biotech companies want to patent genes so they can profit from testing of those genes. When patents are struck down – as in the U.S. – a company can still market tests but cannot do so exclusively, so the price drops significantly.
The patents being challenged by CHEO are held by the University of Utah but were filed in Canada.
Mr. Lipkus said there are two principal legal arguments: that the patents are invalid because genes can't be patented and that the patents no longer apply because they involve old technology that is no longer in use.
Dr. Gail Graham, chief of genetics at CHEO, said the hospital believes "patents are important for protecting inventions, but genes are not inventions." She said researchers at the hospital have not and will not patent any genes they discover.
Long QT syndrome (LQTS) is a heart rhythm problem caused by a genetic abnormality that affects about one in 7,000 children. Sufferers can experience fainting, seizures or even sudden death but it can be treated with medication and an implantable defibrillator.
LQTS is diagnosed with a combination of electrocardiography and a genetic blood test.
There are two patented blood tests that, together, cost about $4,800. The genetics lab at CHEO can do similar testing for about $1,500 but it is forbidden from doing so because there is a patent on the gene. Ontario alone spent $24-million last year on genetic tests sent out-of-country; most of those costs are related to patent issues.
Even if the genetic defect that points to long QT syndrome is discovered incidentally – for example, when the lab does a panel that features information on larger parts of the genome – that information cannot be communicated to patients, again because of the patent.
"We simply cannot accept a situation where a patent prevents us from diagnosing and treating a sick child," Dr. Graham said.
Richard Gold, a professor in the faculties of law and medicine at McGill University, said patents on genes are fairly common, but not applied in a consistent or coherent fashion.
For example, the Ontario government created its own test for the so-called breast cancer genes BRCA1 and BRCA2 and the patent holder took no action. (Those patents were struck down a decade later in the U.S.) But, in the case of the long QT gene, the patent holder has been quite aggressive.
"Hopefully, this case will bring clarity to a whole set of stakeholders, including patients, researchers, clinicians and companies," Prof. Gold said.