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

Selective Parenting - Patents and Morals

The line between what is 'good' and what is 'bad' is often a very fine one, especially when dealing with humans and human development. The question of when is a fetus a 'person' is one which treads an area often incredibly contentious to some, evoking strong feelings about the sanctity of human life or when a human actually is 'human'. From a lawyer's perspective morals are a thing we're meant to avoid and exclude in our considerations - or in other words; morals have no place in the law. This applies to intellectual property as well, with similar considerations having been discussed on this blog, but a recent turn of events have presented patents with yet another conundrum.

A patent which was recently awarded to 23andMe, a company which deals with genetic testing whose proclaimed mission is to be "...the world's trusted source of personal genetic information", deals with the potential to identify certain characteristics (specifically phenotypes) in sperm and the female egg (if picked from a pool of donated ones for example) and then selecting the ones which will have the higher likelihood of producing the desired characteristics in the subsequent baby. To put into more specific terms: "[t]he recipient is allowed to make a specification of one or more phenotypes of interest in the hypothetical offspring". Traits which can be selected include height, eye color, personality characteristics and potential disease risks.

Little Ethan had no idea he'd been "selected"

As can be seen from the basic description of the patent, this has caused quite the uproar, with people calling the potential selection of babies' traits "unethical" and "treacherous", and understandably so. But one has to pose the question, as so aptly pointed out in the title of this article, do morals play a part in patents? This question, as can be guessed, does not have a straightforward answer.

The US patent legislation does not have an explicit provision for the rejection of patents that contravene 'morals' of any kind, leaving the possibility open for patents such as this, which might skirt the realm of moral objection, to be granted. The European view of this is slightly different, as the European Patent Convention dictates that patents cannot be granted for inventions "...which would be contrary to "ordre public" or morality". This has been adopted in the UK under the Patents Act 1977. What this moral standard is is something that would have to be assessed in each separate instance, as the Convention does not define this in itself. In Australia and Canada there is no morality requirement, much like the US. Even so, in the US decision of Lowell v Lewis, the courts saw that under the requirement of 'utility' (used in both the US and Canada) patentable "...invention[s] should not be frivolous or injurious to the well-being, good policy, or sound morals of society". Whether the selection of babies' potential traits would fall under this remains an unanswered question.

Some 15 years ago a patent application was made for combining non-embryonic cells and human cells in the creation of a "humanoid chimera", which was subsequently rejected by the US Patent Office on the grounds that "...inventions directed to human/non-human chimera could, under certain circumstances, not be patentable because, among other things, they would fail to meet the public policy and morality aspects of the utility requirement". Following the USPTO's reasoning here the selection of human traits could be considered immoral; however it needs to be noted that the combination of human cells and non-embryonic cells is far from the selection of potential traits in a baby from human reproductive cells. Since the aforementioned "chimera" patent was filed and rejected, there has been no action on the American legislature to deal with this issue.

Bebop and Rocksteady don't really comprehend chimeras and patents

There is no definitive answer to questions such as whether patents like the one which was granted to 23andMe should be allowed, and they do present a conundrum for people and medical professionals. Being able to at least influence the health and traits of your future offspring could yield a generation of babies with a much lower risk of hereditary disease or other health related issues. On the other hand it could open the avenue for selection leading to the discrimination of certain 'undesired' traits. Keeping the latter point in mind, how much further would genetic selection go from a normal selection for a mate to reproduce with? After all, we all pick our mates based on physical traits (and other traits subconsciously), at least initially, which do influence the traits of the subsequent baby. If a person sees certain traits in another to be undesirable, they will simply not reproduce with them. In this humble writer's opinion the law would have to be very wary with the overt restriction of subject matters that pertain to morals. This is a concept so subjective that the judiciary would have a hard time deciding on issues which do not have a clear answer as to their morality - what is moral to me could very well be immoral to the person next to me.

As of today 23andMe have not done anything with their patent, but the door is still open for them to develop methods to utilize this patent. Much like the recent genetic patent cases, this will an issue that will have to be challenged if it is utilized, and only then will the judiciary be able to decide whether trait selection is patentable or not. Morals aside, a generation of super  kids sounds both intriguing and terrifying at the same time.

Source: BBC News

The US Supreme Court: Human DNA cannot be Patented

The long road of litigation has finally come to an end at the Supreme Court regarding the patentability of human genes. The Court was unanimous in its decision in the case (with Justice Scalia concurring in part but still agreeing with the decision), which came to a slightly surprising outcome, at least to this writer. The discussion on the possible outcome of the case based on the oral arguments a month or so ago on this blog can be found here.

The subject of patent desires

For those who haven't been fully introduced to the facts of the case, the Association of Molecular Pathology v Myriad Genetics dealt with patents relating to certain genomes; BRCA1 and BRCA2. These genes were patented by Myriad Genetics some 15 years ago, and they specifically relate to the identification of a potential heightened risk of getting breast or ovarian cancer for women. Analysis of the genes is used to identify potential mutations in those genes, causing the increased risk, and the only way to identify that potential mutation was controlled by Myriad. The Association of Molecular Pathology and others subsequently challenged the patentability of human genes.

The argument on the Association's part hinged on 35 USC § 101 which defines what subject matter can or cannot be patented. The Supreme Court's standing on what is excluded under section 101 was well stated in the case of Mayo Collaborative Services v Prometheus Labratories: "...laws of nature, natural phenomena, and abstract ideas". Whether the isolated genes could be seen as something that is not a natural phenomenon, they could be patented. A similar decision to the US Court of Appeals position prior to the Supreme Court have was handed down in Australia  (pending appeal to the Full Federal Court this Autumn), where the isolation of a human gene has been seen as a unnatural phenomenon, due to the isolation creating an artificial state of affairs. Myriad's contention to the appeal remained in that the locating and isolation of the gene (separating it from its natural state) from the human cell was enough to make that particular gene something which does not exist in nature by itself, attaining patentability.

The Supreme Court found against Myriad Genetics, and in a unanimous decision seems to have put this issue to bed with a firm stance. What was key in the Court's argument should be highlighted in itself to better appreciate why human genes, in this instance, couldn't be patented:

"It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them.  Nor did Myriad create or alter the genetic structure of DNA."

In locating and isolating the genes Myriad hadn't created anything new, or altered the existing genes in any way. The mere process of taking those genes out of the cell, although it did alter the physical space where the genes resided, didn't in itself change those genes enough for them to be patentable. Should Myriad have altered the genes some way in their structure for example, the genes could have potentially been a patentable subject matter. If simply looked at within the cell, after being located, the genes themselves would exist as exactly the same as the ones isolated from the cell. The Court did leave cDNA patentable, as it is an artificially created from RNA and therefor doesn't exist naturally.

So what does this mean in practice? Myriad Genetic's patents were both roughly 15 years old, with the patent term in the US being 20 years. With the patents being close to their terms' end, their financial value in them is probably very minimal. The appeal can largely be understood as one of principle, setting a precedent preventing future patenting of human genes by companies. As said, the decision doesn't outright prevent the patenting of genes, so should sufficient changes be made to the genes rendering them something that doesn't appear in nature, they potentially could be patented. Whether the decision will affect other jurisdictions such as Australia will remain to be seen, as US precedent is not binding on Australian courts. It would be incomprehensible that the case would not have any weight, so this writer will await the Australian decision with excitement.