Patents related to isolated DNA corresponding to a gene, as well as methods claiming the diagnostic use of such DNA sequences are often referred to as "Gene Patents". Gene Patents have recently been controversial and garnered significant publicity in the United States where patents relating to breast cancer susceptibility genes BRCA1 and BRCA2, have been contested. In June 2013, the United States Supreme Court invalidated claims to isolated BRCA1/BRCA2 DNA that did not differ from the naturally occurring gene holding “that genes and the information they encode are not patent eligible….[s]imply because they have been isolated from the surrounding genetic material”.1 See previous post for further details. The bounds and impact of the holding are currently unclear. Although method claims using the isolated DNA were not invalidated by the Supreme Court, the U.S. patent office has struggled on how to implement the decision in light of other jurisprudence resulting in considerable uncertainty and debate in the diagnostics industry and beyond.
On November 3, 2014, the Gene Patent’s controversy officially came to Canada when the Children's Hospital of Eastern Ontario ("Children’s Hospital") commenced a patent proceeding against defendants University of Utah Research Foundation, Genzyme Genetics and Yale University ("the Defendants") attempting to obtain a declaration of non-infringement and/or invalidation of a series of patents which claim isolated nucleic acids and methods of assessing a risk for an inherited cardiac disorder, long QT syndrome.
According to the statement of claim, the patents in question ("Long QT Patents")2 are directed to 5 of 13 genes known to be associated with the disorder ("Patented Long QT Genes"). The statement of claim indicates that no laboratory in Ontario has obtained approval from the Ontario Government to conduct on site genetic screening for Long QT and alleges that the Long QT Patents are preventing such testing from being approved. It adds that Ontario hospitals and physicians that wish to screen patients for Long QT syndrome must obtain Ontario government funding to purchase testing services from genetic testing laboratories outside of Canada. The Children’s Hospital wishes to incorporate testing of the Long QT associated genes, including the Patented Long QT Genes, and alleges that their proposed tests ("Proposed Tests") will not infringe the Long QT Patents.
In addition, and what can be considered the crux of the controversy, the Children’s Hospital alleges that the isolated nucleic acid claims, testing method claims and hybridization probe claims, as defined in their statement of claim, are invalid and void.3
In the alternative, they allege that their Proposed Tests constitute public, non-commercial uses of the subject matter claimed by the Long QT Patents and hence the Proposed Tests are eligible for authorization to be used without seeking licenses from the Defendants.
Australia has also recently dealt with challenges to the BRCA Gene Patents. Unlike the United States where some types of claims to isolated DNA where patentability rested simply on isolation, Australia has taken a different direction and has confirmed that isolated DNA is indeed patentable, concluding that an isolated gene sequence is different to the gene as it exists in nature, with specific reference to the functional differences that arise as a result of isolation.4
Should this case progress to trial, time will tell what direction the Canadian courts will take. If so, no matter what decision is reached, it is likely to have far reaching impacts on the diagnostic industry. If you are seeking to protect inventions relating to diagnostics or isolated DNA, the professional advice of a patent agent or patent lawyer is recommended.