01 December, 2014

Genetic Patents Saga Continues - Next Stop, Canada

After the Myriad Genetics saga has been experienced on both sides of the world, in the US and Australia (both discussed on this very blog quite extensively: US here and here; Australia here), the fight seemed to be over and the decision, at least for now, settled. With the Australian case having been appealed to the High Court of Australia, most IP practitioners and academics awaited the conclusion of the patent's road in Australia, a new challenge in the field of genetic patents has begun in the colder of the North American powerhouses; Canada. The Myriad Genetics patents have not been challenged in Canada, although the Provinces themselves have rejected them and refuse to enforce the patents, and this case would be an important stepping stone in completely answering the question of the patentability of genetic material, at least in North America.

The challenge is being mounted by Children's Hospital of Eastern Ontario (more commonly known as CHEO), however taking the fight to (finally) someone else but Myriad Genetics. The question relates to patents covering the testing and/or assessment of Long QT Syndrome, which, as explained by the Mayo Clinic: "...is a heart rhythm disorder that can potentially cause fast, chaotic heartbeats. These rapid heartbeats may trigger a sudden fainting spell or seizure. In some cases, your heart may beat erratically for so long that it can cause sudden death". One does not catch Long QT, as it is a genetic disorder, which requires identification prior to treatment. CHEO were prevented from conducting their own genetic analyses on-site, as the University of Utah holds the patents for the testing of this genetic disorder, much akin to the Myriad Genetic Patent (Canadian patents 2240737, 2336236, 2337491, 2369812 and 2416545 respectively). Due to the mandatory outside testing at the University of Utah, CHEO's costs to diagnose this disorder are nearly double when compared to internal testing, resulting in increased costs and potentially even diagnosis times; again, very similar to the problems with the Myriad Genetics case.

The Canadian Patent Act reflects the US legislation quite heavily in relation to patentable subject matter. Under section 2 of the Canadian Patents Act an 'invention' is defined as "...any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter". A nearly identical definition is set out in 35 USC section 101 in the United States. The relevance of this is very important, as the Supreme Court's rejection of genetic patents in the US will undoubtedly influence the Canadian courts going forward.

Even genes have it tough under today's beauty standards (Source: Dan Collins)
Under the Canadian Patents Act section 27 both scientific methods and abstract theorems are not patentable, although an application of such can potentially be patented. One has to note the omission of an express exclusion of naturally occurring subject matter, which is included in many other jurisdictions. The argument raised by CHEO therefore hangs on whether a naturally occurring phenomena can be patented under section 2, if it is deemed to be a sufficiently marked departure from the naturally occurring thing itself. One has to wonder why the Canadian legislature has left this exclusion out of the law, as it is very much the standard all over the common law.

As for potentially applicable case law the pickings are quite slim. The case of Harvard College v Canada (Commissioner of Patents), the Canadian Supreme Court saw that, even though section 2 is very broad in its wording, it does not include "....anything under the sun that is made by man", and can be therefore limited in its scope. The Harvard case effectively dismissed the patentability of 'higher lifeforms', which has been argued to encompass plants as well as animals, such as the genetically modified mice in question in the case itself, it still remains a useful examination of some of the wording the Federal Court will face. Whether one can include genes in the term 'higher lifeforms' remains to be seen, and in this writer's opinion, it will be a tough argument to press, but a possible one due to the complexity and higher level of function which genes serve in the human body. In Monsanto Canada Inc. v Schmeiser the Supreme Court looked at patents relating to genetically modified crops. The case largely focused on infringement, rather than the patentability of genetically modified crops, but as the Supreme Court did briefly bring the fact to light, it still might be used as a starting point to defend the patentability of other genes; even human genes.

This writer for one will await the emergence of this case in the courts, and wonders if the decision will be different to that of the US Supreme Court. Arguably the Canadian courts should hold that patents are not eligible for patent protection; however, as recently seen in the Full Federal Court of Australia as mentioned above, things are not always as straightforward as you might think. Yet, due to the sheer similarities of the Canadian and US law, and the significant influence of its North American brethren in the South, one can imagine things going CHEO's way on this one. As the case was filed in the very early parts of November a judgment will be a long ways away, but this will be one to look forward to in 2015.

Source: Ars Technica

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