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15 February 2013, 1.40pm EST

Historic ruling allows private firms to patent human genetic material

Private firms are allowed to hold a patent over cancer-causing gene mutations, according to an historic ruling in the Federal Court today that has wide-ranging implications for researchers and cancer patients. The case centred on a gene mutation called BRCA1, which puts women who have the mutation at…

The case centred on a gene mutation called BRCA1, which puts women who have the mutation at a higher risk of breast and ovarian cancer.

A US biotechnology company, Myriad Genetics, had given exclusive rights in Australia to a patent on BRCA1 to a firm called Genetic Technologies Limited.

The group Cancer Voices Australia and breast cancer survivor Yvonne D'Arcy had challenged the firm’s right to the patent in the Federal Court but lost the case today.

Federal Court Justice John Nicholas ruled today that the company may continue to hold the patent.

“We are extremely disappointed and it has far ranging impacts for people with cancer and researchers who want to be able to use these genes that have been patented,” said Sally Crossing AM, spokesperson for Cancer Voices Australia.

“The more we restrict use and allow ownership of human genes to particular commercial interests, the more difficult and costly it is to undertake research,” she said.

“The finding is in relation to one breast cancer gene mutation, BRCA1, but it could be applied to a patent over any human gene.”

Ms Crossing said the judge found that the fact BRCA1 is isolated by human intervention renders it a “manner of manufacture”.

“It’s an unexpected interpretation. It’s still a human gene,” she said.

Cancer Council CEO, Professor Ian Olver, said the case showed patent law should be changed “to protect the community from gene monopolies.”

“Discovering and isolating genetic materials is not inventive, yet the current law gives licence to biotechnology companies to claim ownership of naturally occurring substances,” Professor Olver said.

“The catalyst for this case was the attempt by Genetic Technologies in 2008 to monopolise tests for BRCA1 and BRCA2 genetic mutations, including demands that public hospitals cease providing the tests,“ he said.

“Following community outrage, the company withdrew its demands. But there was – and still is – nothing in the law to prevent such a demand being made in the future.”

Failing to change the law now to protect the community from gene monopolies could lead to “a handful of commercial interests owning the genetic materials essential to cancer detection and treatment,” Professor Olver said.

Professor Dianne Nicol, a law expert from the University of Tasmania who had followed the case said the judge “has given a broad reading of the ‘invention’ requirement in Australian law (referred to as manner of manufacture).”

“Using the language from a 1959 case, he says that what is required is an ‘artificially created state of affairs’ and that without human intervention an isolated DNA sequence does not exist outside the cell. This approach was clearly open to the judge to take based on prior cases,” she said.

“However, it does mean that this manner of manufacture requirement has very few teeth. It is difficult to think of the circumstances where an artificially created state of affairs would not exist whenever there is some form of human intervention.”

Dr Luigi Palombi, director of the Genetic Sequence Right Project at the Australian National University said he was disappointed by both the result and the reasoning used to arrive at it.

“In my view, it turns patent law on its head. The end result is that effectively now anything that’s artificial — and that can be just simply removing something from its natural environment — has the potential to be patented,” he said.

Dr Palombi said the case had far-reaching consequences.

“Effectively, everything in the human body can be considered patentable, the human body is now a commodity. It’s components are a commodity,” he said.

“It’s absurd because patents are about inventions and no one invented the genetic mutations that are linked to breast cancer. Myriad didn’t invent those genetic mutations.”

The ruling reasoned that merely pulling something out of its natural environment qualifies it to be a patent, said Dr Palombi.

“There is no sense of understanding of what patent law is about, there’s no sense of the policy implications, there’s no sense of the consequences of this ruling,” he said.

“I’m just appalled by the decision and I’m hoping now that the government, or that politicians within the parliament will try and address this.”

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19 Comments sorted by

Trevor Kerr

ISTP

Ian Olver is right. Will any other oncologist, or cancer institution, stand with him? There may be one or two, but most will be 'unavailable for comment'.
A great win for corporate medicine and mega-profits.

4 months ago report
Ben H

logged in via email @gmail.com

Failing a sensible legislative response, would the published drafts of the humane genome serve as prior art to prevent any future patenting of existing human genetic sequences?

4 months ago report
1. Ben H
  
  logged in via email @gmail.com
  
  In reply to Ben H
  
  'humane genome' should read 'human genome'. An edit your own posts feature would be really handy.
  
  4 months ago report
Robert McDougall

Small Business Owner

So does this mean that a cancer patient who has this gene would be legally liable to pay royalties to the patent holder?

4 months ago report
Haydon Dennison

Student

Hopefully the case is taken to the High Court and the verdict altered, because to somehow claim that removing a naturally occurring gene from its natural environment is proportional to 'invention' isn't simply a "broad" interpretation, it's an insanely idiotic one. As those quoted in the article make clear, this has the potential to lead to very, very dire consequences. Already, Genetic Technologies have tried to block public hospitals from providing tests - how much further do medical corporations have to go with this before it becomes clear to those in power that a change is required?

4 months ago report
Sean Lamb

Science Denier

There are no rewards for incompetence.
Next generation sequencing has effectively swept away the justification for patent protection on individual sequences - since taken to its logical conclusion the judge's decision means that complete genomes would have to be carefully annotated to remove all sections of the genome that someone claims a patent over.
But it will take a long time before lawyers will be able to understand this and in meantime will keep going over same last century's legal arguments and will keep losing cases.
When complete genome sequences become affordable then these patents will collapse into irrelevance overnight, in the meantime we get enjoy to the spectacle of legal and judicial incompetence.

4 months ago report
John Holmes

Agronomist - semi retired consultant

If applied in a very restrictive sense, and a patent holder blocks access for others to work on, or detect a critical gene / genome or part there of, and there are significant loss of life, when do such issues of manslaughter, genocide etc come into play? Shades of the previous problems of effective access to AIDS drugs where first world prices made unaffordable in the 3 ed world.

From above - "... Using the language from a 1959 case, he says that what is required is an ‘artificially created…
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If applied in a very restrictive sense, and a patent holder blocks access for others to work on, or detect a critical gene / genome or part there of, and there are significant loss of life, when do such issues of manslaughter, genocide etc come into play? Shades of the previous problems of effective access to AIDS drugs where first world prices made unaffordable in the 3 ed world.

From above - "... Using the language from a 1959 case, he says that what is required is an ‘artificially created state of affairs’ and that without human intervention an isolated DNA sequence does not exist outside the cell. ..."

I wonder if I could under this reasoning, patent a lamb roast? It has been extracted from its natural environment. However to claim to be the originators of such a novel process would be difficult. Ancient/medieval cook books may represent prior publications and knowledge.

This issue reminds me of some of the convolutions of patents and copyright during the early days of microprocessor development. Each company achieved the same outcome using different designs.

Yet this ruling attempts of cut off access to the outcome independently through preventing the development of alternative methods of identifying the gene and by implication would it also prevent any other group from attempting to block the effects of this gene in causing cancer using say a DNA probe.
What happens when some one patents critical gene(s) that produce factors which allows the up take of oxygen in humans and then attempts to charge a royalty for breathing for all humans?

If this gene can be found from tissue samples taken from humans prior to the granting of the patent, surely this would indicate that the process for which the patent is apparently granted, did not create the gene.

Patent the process of working with the gene, not the gene especially if it is a naturally occurring molecule which may not be exactly the same in every individual. Does the patent stand if as little as 1 base pair is different?

4 months ago report
Riddley Walker

.

That is one really bad decision from the Federal Court. Maybe we need some new judges who are on top of the issues.

4 months ago report
Luke Weston

Physicist / electronic engineer

Is it right for a naturally occurring gene, or a natural protein encoded by a particular gene, or any living thing say a plant species, naturally evolved in the wild without human intervention to be patentable? I would say not.

But is the patenting of a gene itself what is actually happening here? Clarification is needed.

Is it right for a plant breed (or a bacterium, or any living thing, or something like a particular protein or gene) that has been engineered and crafted through human labour…
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Is it right for a naturally occurring gene, or a natural protein encoded by a particular gene, or any living thing say a plant species, naturally evolved in the wild without human intervention to be patentable? I would say not.

But is the patenting of a gene itself what is actually happening here? Clarification is needed.

Is it right for a plant breed (or a bacterium, or any living thing, or something like a particular protein or gene) that has been engineered and crafted through human labour (whether that's recombinant biotechnology, or that's just mutation breeding or artificial selection or whatever) to be patentable or otherwise protectable under intellectual property law of some kind?

I would say yes... and the law says yes. Intellectual property laws like the Plant Breeders' Rights Act have been around for a long time to protect intellectual property that has been crafted through human labour including in biological systems. That's been going on, and we've had the IP law in place to protect breeders, long before the relatively recent advent of recombinant DNA technologies.

What about an invention of a technological application of a living thing? (or a natural protein or gene, as evolved in nature) Should that technology be patentable? We would say yes, even if the living thing itself shouldn't be patentable.

For example, the production of acetone and butanol from Clostridium acetobutylicum is a technology that should be considered patentable, but that's not the same thing as saying C. acetobutylicum is itself an invention which is a patentable thing.

The technological application of the thermally-stable DNA polymerase from Thermus aquaticus for PCR is a technology, an invention, which is patentable, but T. aquaticus is not itself an invention and is not patentable. The same is true for example for Aequorea victoria, the jellyfish famous for its green fluorescent protein which finds applications in molecular biology - you would expect that the protein itself is not patentable but its technological applications should be.

If you have something like, say, a human gene which you study and characterize and you find that this gene has some specific relationship with breast cancer of a certain type, for example, and you use that knowledge of that natural gene as the basis of a technology which applies knowledge of a gene such as BRCA1 (which, by the way, is a human caretaker gene that produces a protein called breast cancer type 1 susceptibility protein which is involved with DNA repair systems) - a screening or diagnostic test based around looking at that gene, for example - then it's the same sort of situation.

Methods to diagnose the likelihood of a patient with mutations in BRCA1 and BRCA2 getting cancer were covered by patents owned or controlled by Myriad Genetics, but that is a clearly distinctly different thing from patenting the gene itself.

4 months ago report
Anthony Peterson

logged in via Twitter

The gene patent debate is clouded with misinformation. Research exemptions in our new Act allow for anyone to conduct research on patented inventions, free from fear of litigation. It's only when you wish to commercialise your research you must either wait for the original patent to lapse or negotiate a license. If the original patent owner doesn't want to play fair, there are legal avenues for compulsory licensing which have rarely been pursued (again, possibly due to ignorance).

There is no…
Read more

The gene patent debate is clouded with misinformation. Research exemptions in our new Act allow for anyone to conduct research on patented inventions, free from fear of litigation. It's only when you wish to commercialise your research you must either wait for the original patent to lapse or negotiate a license. If the original patent owner doesn't want to play fair, there are legal avenues for compulsory licensing which have rarely been pursued (again, possibly due to ignorance).

There is no such thing as a free lunch. Would these costly but lifesaving technologies exist without the patent incentive? It's difficult to say. They certainly wouldn't exist without publicly funded research, but that's only part of the equation. Perhaps the best comparison we can make is where state owned economies have existed alongside free markets. Where would the citizens of North Korea live if they had the choice?

Finally, in the overall scheme of things a twenty year patent is relatively short. Once it expires, the technology enters the public domain. Only a tiny minority of patents last the full twenty years, because innovation is risky and most patents aren't worthy the modest cost of renewal fees.

4 months ago report
1. Sean Lamb
  
  Science Denier
  
  In reply to Anthony Peterson
  
  " Would these costly but lifesaving technologies exist without the patent incentive? It's difficult to say."
  
  No, it is immensely easy to say. The original research was done on either public or charitable money. The grants would have been awarded on the basis of scientific merit, not on the basis of potential commercialization - in any case the profits here are largely disappearing into private pockets. Incidentally - speaking of misinformation and its prevalence - do you have a vested interest…
  Read more
  
  " Would these costly but lifesaving technologies exist without the patent incentive? It's difficult to say."
  
  No, it is immensely easy to say. The original research was done on either public or charitable money. The grants would have been awarded on the basis of scientific merit, not on the basis of potential commercialization - in any case the profits here are largely disappearing into private pockets. Incidentally - speaking of misinformation and its prevalence - do you have a vested interest in patent law?
  http://lawyerlist.com.au/729-Anthony-Peterson--Co.aspx
  
  There is absolutely no doubt that there would be a BRCA test without patent protection. None whatsoever.
  Incidently the company Genetic Technologies is a real biotech parasite. They claim to hold a patent on microsatellites, a generic but somewhat dated method of detecting gene-disease links. No one serious believes their patent is justified but no one can be bothered going to the expense of fighting it in court. So they have developed a business of going around to organizations that are tracking disease genes and accuse them of violating their patent and name an enormous sum in compensation. The institution obviously objects, so then Genetic Technologies says, well we understand, you are engaged in research for the public good, perhaps we can reach a compromise and then propose a figure pitched at level which they calculate would not make it worth going to court to fight over. The institution takes legal advice, figures it would be cheaper to pay than fund a court case - and risk losing and paying a higher amount. Thank you very much says Genetic Technologies - can we make that settlement confidential please - and then move on to the next institution.
  
  They are parasites and leeches, sucking public moneys through a form of legal blackmail and contribute absolutely nothing. They are truly the ugly face of the biotech industry.
  
  4 months ago report
2. Sean Lamb
  
  Science Denier
  
  In reply to Sean Lamb
  
  I should add that Genetic Technologies is the Australian company that holds the rights from Myriad. Myriad might be a real parasite as well, but I am not aware of them engaging the unique brand of legal standover tactics of GT. And agree or disagree with Myriad - at least their patent is comparatively limited in scope, they don't pretend to own the rights to every single pair of repeating nucleotides in the universe.
  
  4 months ago report
3. Trevor Kerr
  
  ISTP
  
  In reply to Anthony Peterson
  
  "The gene patent debate is clouded with ..." NO information for the consumer as to the costs for individual healthcare. That is, there is NO information for the consumer as to the costs of ANY episode of treatment for anything as complex as cancer care. It's likely that a woman with breast cancer will have very little personal costs for complete care in the public sector, but if she elects to "go private" with her sickness insurance she will get whacked at every turn for out-of-pocket expenses…
  Read more
  
  "The gene patent debate is clouded with ..." NO information for the consumer as to the costs for individual healthcare. That is, there is NO information for the consumer as to the costs of ANY episode of treatment for anything as complex as cancer care. It's likely that a woman with breast cancer will have very little personal costs for complete care in the public sector, but if she elects to "go private" with her sickness insurance she will get whacked at every turn for out-of-pocket expenses.
  We, as voters, cannot be expected to make decisions on the charges laid to government for pharmaceuticals. We are in the dark. That's good for the Minister with a career trajectory in politics or after politics with a consultancy. The Minister stands pretty, making deals with, say, CSL for the HPV vaccine. Why, goodness gracious, says Pharma, these lifesaving innovations cost a billion bucks each to get on the shelf. So, isn't it reasonable that we get to make a fair profit? The $1bn for R&D pops up regularly, so it must be correct, right? Well, yes, of course, because the data to arrive at the mythical figure are provided by Pharma, and it's not as though they are commercial secrets. Look, here's an "independent" surveyor who has been paid to "verify" the claims.
  The Minister, her Department, and the white-coated shills who tout for Pharma will continue to grind out tax-payers dollars, until the electorate has access to actual costs.
  
  4 months ago report
Andrew Rodda

logged in via Facebook

There seems to be a lot of very loose wording in media reports - I was concerned enough to actually go and read the judgement (it's freely available online, and not as difficult to read as I expected), and it made me feel a lot better. The gene itself is not patentable, nor is the sequence information for the mutations and this is expressly noted in several places. The only thing that seems to be patentable is isolating the gene *and* then using it as a test for breast cancer susceptibility. Both…
Read more

There seems to be a lot of very loose wording in media reports - I was concerned enough to actually go and read the judgement (it's freely available online, and not as difficult to read as I expected), and it made me feel a lot better. The gene itself is not patentable, nor is the sequence information for the mutations and this is expressly noted in several places. The only thing that seems to be patentable is isolating the gene *and* then using it as a test for breast cancer susceptibility. Both Professor Olver and Dr Palombi seemed to have missed the point of the judgement - correct me if I'm wrong please, I'm a PhD student in a bio-related field, not a lawyer. But the company developed a test that no-one else developed, and applied for a patent on the test.

Whether charging so much for it is a nice thing to do is another matter.

Also, the judgement notes new laws brought in last year that allow a "research exception" to the patent, which was news to me. So (it seems to me) research into these mutations should be able to continue unhindered.

What I'd like clarification on, if anyone can give it to me: how does this judgement fit in with whole genome sequencing services like 23andme? Is there anything to stop me from getting myself sequenced (if I was female anyway), scanning through "my code" and looking for the mutations myself? They're listed in the patent which is also freely available.

4 months ago report
1. Sean Lamb
  
  Science Denier
  
  In reply to Andrew Rodda
  
  "correct me if I'm wrong please"
  
  With pleasure. The company didn't develop the test, they simply applied for a patent over the BRCA 1 gene. The knowledge which the patent benefits from was partially developed at the University of Utah - on public money - but also elsewhere. For example the Breast Cancer Linkage Consortium and a group in Surrey England and another group at the University of California Berkeley. Had Utah not isolated the gene first and instead the Surrey group, then it is unlikely…
  Read more
  
  "correct me if I'm wrong please"
  
  With pleasure. The company didn't develop the test, they simply applied for a patent over the BRCA 1 gene. The knowledge which the patent benefits from was partially developed at the University of Utah - on public money - but also elsewhere. For example the Breast Cancer Linkage Consortium and a group in Surrey England and another group at the University of California Berkeley. Had Utah not isolated the gene first and instead the Surrey group, then it is unlikely they would have patented it - with the tools of the time the isolation, once the locus had been identified (not by the Utah group) while time consuming, was not conceptually difficult.
  One academic from Utah then founded Myriad Genetics with others and took out a patent. However, at this point not much was known about the gene. The patent became far more valuable because after it was taken out many more research groups - using public money - poured research effort into it and added more knowledge and hence value to the patent. But what makes the patent is just that - the knowledge that the research community gives it by doing more and more sophisticated association studies.
  
  The legal fiction that DNA is not patentable inside the cell is just a desperate hunt for a pretext. Some genetic tests, like FISH, do in fact test DNA quite literally inside the cell. Doubtless if a large amount of money was at stake the good judge and barristers assisting would have found a legal reasoning to demonstrate that DNA inside a cell was in fact perfectly patentable.
  
  When you isolate DNA, you don't isolate a particular gene, you isolate the whole kit caboodle. There is no technique known to man that could extract BRCA1 DNA outside a cell by itself. The techniques of isolating DNA are generic (and their patents have doubtlessly expired) there are many different ways of testing for sequence variants in DNA - many of them developed after the BRCA1 patent. The BRCA1 patent could not possibly cover MALDI-TOF method of genotyping because it had not yet been invented. Yet Myriad will certainly be preventing anyone using MALDI-TOF to genotype BRCA1 because - whatever the judge may pretend - the patent covers the gene and its mutations and not a method.
  
  "Whether charging so much for it is a nice thing to do is another matter."
  
  Yes well, that is what happens when you allow monopoly pricing on research funded by public moneys. People don't really have an incentive to be nice.
  
  4 months ago report
2. Andrew Rodda
  
  logged in via Facebook
  
  In reply to Sean Lamb
  
  Most of what you say is pretty much irrelevant to the case Sean - the only things under examination was whether isolating the gene is a "method of manufacture" - i.e. did it create something that otherwise wouldn't exist (which is roughly how it's interpreted in law) that was useful, or find a new use for something that already existed. Also note, the judge awarded costs against CVA - basically saying that the law was pretty clear already. If you want to argue a different case, go for it. Either…
  Read more
  
  Most of what you say is pretty much irrelevant to the case Sean - the only things under examination was whether isolating the gene is a "method of manufacture" - i.e. did it create something that otherwise wouldn't exist (which is roughly how it's interpreted in law) that was useful, or find a new use for something that already existed. Also note, the judge awarded costs against CVA - basically saying that the law was pretty clear already. If you want to argue a different case, go for it. Either that, or explain to our representatives in parliament why they didn't see fit to change the law last year when they debated doing exactly that - for me, I think I'm happy with it the way it is.
  
  In other notes:
  - If someone wants to take out a patent on something that's not valuable, I'm not going to stop them. Patents aren't cheap. So clearly the Utah team saw the value of the work before all the other work was done. In any case, if researchers work on processes and governments fund research into patented work, because it's for the greater good, that's great. But I don't think they can complain about then not being able to use their work.
  - I routinely purify bits of DNA outside a cell. I even get to pick which bits I want to isolate, using the polymerase chain reaction. I assume you know this.
  - You assume Myriad will be preventing anyone from genotyping with later generation sequencing techniques. I would content that if this was the case, they would already be doing it, and hence I suspect that they can't. But some confirmation would be nice. Anyone?
  
  4 months ago report
Michael Gioiello

High school music teacher/ freelance Opera singer

Well, who could have guessed it!!

As usual, big, rich corporate interests have triumphed over the little people. These guys can afford to pay for big shot lawyers and barristers, in effect, influencing public policy to their own advantage, and to our detrement.

I thought that's why we had politicians, so that these things would not take place.

Business as usual.

4 months ago report
wilma western

logged in via email @bigpond.com

Why quote only the lobbyists against patenting of cell technologies?

Recent Senate hearing wasn't convinced by these groups , and universities were solidly on the other side , (in favour of patenting the technologies)

The big issue is reasonably-priced access to tests - which can be deal with by different means.

4 months ago report
John Harland

bicycle technician

This would appear to be wonderful news. Surely it means that any sufferer from that mutation should be able to sue the patent holder for damages caused.

The gene was isolated by human intervention, therefore is a kind of manufacture?!

That is the old colonial argument again. We sailed our ships here to "discover" this land, therefore it belongs to us.

Galileo discovered the moons of Jupiter through the telescope he devised. DId that make him their owner?

All discoveries are made through human intervention. Especially scientific discovery where we deliberately manipulate the conditions, through our experimental design, to isolate the specific phenomena we are studying.

The central argument of the judgement is such a philosphical obscenity that it does suggest we should be looking more closely at the integrity of our judicial systems and the possibilities of any improper associations or influence.

4 months ago report

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Historic ruling allows private firms to patent human genetic material

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19 Comments sorted by

Trevor Kerr

Ben H

Ben H

Robert McDougall

Haydon Dennison

Sean Lamb

John Holmes

Riddley Walker

Luke Weston

Anthony Peterson

Sean Lamb

Sean Lamb

Trevor Kerr

Andrew Rodda

Sean Lamb

Andrew Rodda

Michael Gioiello

wilma western

John Harland

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