"Bad patents" on human genes hinder health care, hospital tells court An Ottawa hospital is launching a court challenge to the validity of patents on genes, saying they are legally untenable and undermine patient care. No one should be able to patent human DNA. It's like trying to patent water or air," Alex Munter, CEO of the Children's Hospital of Eastern Ontario, said in an interview. The existence of these patents is a significant obstacle for our patients and their families and it can't be tolerated. Lawyers for the hospital - who are working pro bono - filed papers in the Federal Court of Canada on Monday morning challenging five patents related to the genetic sequencing and diagnostic testing for a heart condition called long QT syndrome. CHEO has made clear that the lawsuit is a test case. Mr. Munter stressed that the hospital is not challenging the principle that discoveries can be patented, because that legal protection is essential to innovation. But there are good patents and bad patents, and these are bad patents. It is a test case that the hospital hopes will result in parts of the Patent Act being struck down. That is what happened in a similar case last year in the United States, where genes can no longer be patented. The patents being challenged are held by the University of Utah and biotechnology company Transgenomic Inc. Dr. Gail Graham, chief of genetics at CHEO, said long QT syndrome 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. 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. Long QT syndrome 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 the disorder can be treated with medication and an implantable defibrillator. There are about 7,000 disease genes that are currently amenable to patenting under existing legislation in Canada and, if that patenting occurred, care of patients with genetic conditions would be costly and at times impossible, the hospital argues. Richard Gold, a professor in the faculties of law and medicine at McGill University who isn't directly involved in the case, said there two main arguments in the lawsuits: that the patents are invalid because thy were wrongly issued for non-patentable genes; that the patents no longer apply because the involve old technology that is no longer in use. Prof. Gold 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 United States. 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.