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

Goliath triumphs over David - US Supreme Court upholds Monsanto's rights on their seeds

In true David vs Goliath fashion, Monsanto, a multinational biotechnology company, took on a farmer over the use of their patented soybean seed some 5 years ago. The legal saga has come further than anyone expected, reaching as far as the steps of the US Supreme Court late last year. The Court released its decision only some days ago, yielding an interesting, albeit not surprising result.

The case of Bowman v Monsanto Co concerned Mr. Bowman, having purchased and used Monsanto's gene manipulated seeds from a certified vendor, much like many of his peers. The seeds themselves were altered to be pesticide resistant, giving farmers the ability to plant their crops and protect them from the bug scourge that wreaks havoc amidst fields all over the world (scenario slightly exaggerated here). One caveat in the purchase of Monsanto's seed is that they can only be used for one planting cycle; that is that any seeds from the harvested crop cannot be used to plant another cycle and the farmer has to buy yet another batch, thus preventing the self-growing of plantable seeds by farmers, retaining Monsanto's monopoly over that particular seed. Mr. Bowman had fully complied with all terms set by the company in his operations, but wished to lower his costs and bought his seed from a grain elevator, ones meant for consumption and not planting. Some of these seeds contained the alteration patented by Monsanto, which Mr. Bowman used to then plant his subsequent crops once he has killed off the plants which weren't resistant to the pesticides. Once Monsanto discovered Mr. Bowman's actions, the company proceeded to sue him for patent infringement.

Terrifying - from a farmer's perspective

In their decision the Court was unanimous, showing a clear stance as to where the law stands today. In his argument Mr. Bowman relied on the doctrine of patent exhaustion. This effectively means that once a patented item has been legally sold, the person who's bought that particular item can sell or dispose of it as they wish, much like with any item they legally purchase. Once the patented item has been legally sold, the patent rights in that particular item end, or are exhausted, preventing the patent holder from controlling it post-purchase. Because the doctrine relates to a "particular article" the person who's bought the item has no right to make copies of that item - in this case creating new plantable seeds. There is no exhaustion if new copies are made, resulting in Mr. Bowman infringing Monsanto's patent. Having bought the seeds from a grain elevator didn't help his cause either, making his claim over exhaustion all the more dubious. As stated the appeal was unanimously dismissed.

You have to accept that the Supreme Court was perfectly right in their decision, and the unanimity further highlights this. As Justice Kagan stated in the Court's decision, should the exception have been accepted "...patents on seeds would retain little value." Clearly this would decimate any patents related to seeds, and once planted and used over and over, possibly even resold to other farmers, the patents would be completely worthless. The decision was one of common sense.

Source: GEN