Genes Lost - Myriad Genetics Loses in the Australian High Court

The Myriad Genetics saga has been going on for several years now in the Land Down Under, and this writer has been waiting for the Australian High Court decision with bated breath. After a ruling in both the Federal Court and the Full Federal Court (more on which can be found here) in favor of Myriad Genetics, the cause seemed all but lost to the appellant, Yvonne D'Arcy. She was awarded the right to appeal to the High Court of Australia, who handed their judgment down only last month.

Although the case has been discussed on this blog before, some exposition is needed for those who might not be wholly familiar with the matter. The case of D'Arcy v Myriad Genetics dealt with the protein BRCA1; one that is quite relevant as a marker for a potential heightened risk for breast and ovarian cancer should it possess a mutation within it. Myriad Genetics acquired a patent for the sequence's isolation and subsequent analysis (Australian patent no. 686004), which was challenged by Yvonne D'Arcy, a cancer patient herself, in 2013.

What the High Court had to consider was whether the patent can be defined as a 'manner of manufacture' under the Statute of Monopolies 1623; a requirement for patentability under the Australian Patents Act 1990.

Genes are not that important

In a lengthy, multi-opinion decision, the High Court unanimously decided that the disputed claims of the patent were not a 'manner of manufacture', and thus were not patentable. Discussing the science and precedent, the majority still focused on the substance of the patent in in-depth detail. What Myriad Genetics argued, and the preceding judges agreed with, was that the isolation of the genetic sequence, and its analysis, created an artificial state of affairs, changing what is in simplistic terms a natural phenomenon into a man-made substance falling under the definition of a 'manner of manufacture'. The majority disagreed, and saw that "...the information stored in the sequence of nucleotides coding for the mutated or polymorphic BRCA1 polypeptide is the same information as that contained in the DNA of the person from which the nucleic acid was isolated. It is the existence of that information which is an essential element of the invention as claimed. The product is the medium in which that information resides". In the majority's view the isolation of the genetic content retains the very same information as occurs naturally within that person, adding or 'making' nothing new. Myriad Genetics' claims honed on the information within the genetic sequence, and not the chemical changes made to it when isolating, falling foul of a 'manner of manufacture' as a result, attempting to claim what already exists through nature (echoing, and accepting, the position by the US Supreme Court, more on which can be found here).

Ultimately what befell Myriad Genetics' case was the language used in the patent's claims, as stated by the majority: "Although it may be said in a formal sense that the invention as claimed, referring to isolated nucleic acids, embodies a product created by human action, that is not sufficient to support its characterisation as a manner of manufacture. The substance of the invention as claimed and the considerations flowing from its substance militate against that characterisation". As such the High Court allowed the appeal by Ms. D'Arcy.

The complexity and uncertainty around the case is evidenced by the length and multitude of opinions, and even though the decision was unanimous in allowing the appeal, the opinions reflect different approaches in arriving in the same answer. To this writer the focus seems to be very language specific, and had Myriad Genetics differentiated their claims through more specific, composition-heavy language, they could have been successful. Nevertheless, the case was more of a point of principle, as the patent expired only a few months ago, but it does set a precedent for the genetics industry in Australia. The Australian government has given guidance on proper practice in relation to genetic materials and patents, which looks gloomy for the industry, but the consultation does allow for comments and thoughts going forward.

Source: ABC Online 

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.

Can human genes be patented? The US Supreme Court starts its deliberation

Patents relating to medicine or medical treatments often don't come without controversy. Should we allow the patenting of essential medicines or treatments, which if provided cheap enough could save countless lives, or ease the suffering of many? What about the monetary interests of parties who've sunk millions into research and development, should we prevent them from recouping that investment? One of the more interesting, and possibly more important decisions in patents was put forth to the US Supreme Court on the 15th of April, when oral arguments for the case were heard.

Not the genes you were thinking of

The case of Association of Molecular Pathology v Myriad Genetics put forward the question of whether human genes could be patented, more specifically, genes relating to the increased risk of both ovarian and breast cancer in women in mutated. Myriad Genetics sought to patent the genes after their discovery, which was subsequently contested. 

This presents an incredible dilemma where monetary interests clash with what is intrinsically a part of you; your own genes. Should the investment of billions of dollars go to waste, or should companies be allowed to patent something which is present in humans without any outside interference? Also would the patentability of genes hinder future cures or therapies related to those genes to prevent ovarian or breast cancer? At the end of the day the act of balancing interests is a tough one. If billions of dollars spent on research and development can be made useless due to gene patents being unpatentable, companies will have less incentive to go about this research, or might even cause serious financial harm to them. On the other side is companies having monopoly rights to something arguably occurring naturally; your genes. Should any legal entity have the exclusive rights to parts of the human genome? There are two ways of looking at this question: as a lawyer, I can say it is very possible that companies could patent genes, but as a human being, I’d want that type of information to be accessible to anyone, not under the supervision of a company.


Experts have stated that such patents have "...faded in importance" and that the law suit "...will be much more ideological than it will be practical". This is probably because there is very little use for an isolated gene or its analysis. The average consumer will never need the genes in question analyzed, and the few researchers that will use them probably will come few and far between. In addition the patents in question will expire in a few years, effectively rendering the nullification of the patents through litigation nothing but a matter of principle for the Association of Molecular Pathology. Precedent will surely prevent the future patenting of human genes, should the Supreme Court decide so, but the real monetary interests of companies lie in medicines, not genetics.

(Source)

What the court has to decide is whether an isolated gene would be patentable as an isolated item, being sufficiently different from the genes found in your individual cells, or that they are purely a product of nature. The New York Times indicated that a fifth of the 20,000 genes found in the human body are patented, clearly showing that this has been an accepted practice for a while in the US. The US Government presented the courts with a statement expressing their opinion that human genes should not be patentable, showing support for the idea that they are indeed a natural occurrence, or the very least a subject matter that should not be covered under patents.

Indeed this case will present the Justices an interesting subject matter to tackle, and I for one will be waiting for their judgment with excitement. What seems to be the more probable outcome is the allowance of the patents, as decisions in both the UK and Australia (subject to further appeal) have been decided to favor the patenting of genes. What the US Supreme Court decides will undoubtedly influence later decisions in other jurisdictions, giving the case still the clout it deserves.