The
Children's Hospital of Eastern Ontario (CHEO) filed a statement of claim on November 3, 2014, asking the
Federal Court of Canada to invalidate claims to human genomic DNA and methods of diagnosis using this DNA and, alternatively, to declare uses of such DNA and diagnostic methods noninfringing. The Canadian patents at issue,
CA 2,240,737,
2,336,236,
2,337,491,
2,369,812, and
2,416,545, are all related to the diagnosis of a genetic condition called
Long QT Syndrome. This
excerpt from the statement of claim presents the main medical/legal issue:
6. Long QT syndrome ("Long QT") is an inherited cardiac disorder affecting about 1 in 3000 to 1 in 5000 people, in which the heart takes too long to recharge after each beat. Patients with Long QT may experience seizures, cardiac arrest or sudden death.
7. Symptoms of Long QT can present at any time from infancy to middle age. Sudden death is the first sign of the disease in 10 to 15 percent of affected individuals.
8. Treatment is available to prevent fainting, cardiac arrest and sudden death. Therefore diagnosis of Long QT is extremely important.
9. Long QT is known to be associated with mutations in 13 humans genes, five of which are the subject of unexpired Canadian patents. These five genes are KCNQ1, KCNH2, KCNE1, KCNE2, and SCN5A (the "Patented Long QT Genes").
10. The Patented Long QT Genes encode for human proteins involved in cardiac ion channel function. Certain mutations in these genes can disrupt the normal function of cardiac ion channels, resulting in the symptoms of Long QT.
11. Presently, no laboratory in Ontario has obtained approval from the Ontario Government to conduct on-site genetic screening for Long QT. The Long QT Patents are currently preventing such testing from being approved and conducted for the benefit of Ontario patients.
On June 13, 2013, the United States Supreme Court rendered genomic human DNA patent-ineligible subject matter in its AMP v. Myriad decision. Canadian courts, including, ultimately, the
Supreme Court of Canada, are likely to arrive at the same result. As I have
previously discussed at LEXVIVO, and published as
The Unpatentable Human Being, people cannot be patented. This principle applies as strongly in Canada as elsewhere.
