Brisbane grandmother Yvonne D'Arcy celebrates High Court victory in battle over BRCA-1 cancer gene patent
Updated about 3 hours ago
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A two-time cancer-surviving grandmother from Brisbane has won her "David and Goliath" battle against a US biotech firm that wanted to patent the BRCA-1 cancer gene.
Myriad Genetics had argued it held the patent over the BRCA-1 and BRCA-2 genes which, if present, dramatically increase a woman's chance of developing breast and ovarian cancer.
But Yvonne D'Arcy, 69, argued the genes existed in nature, so were discovered rather than invented.
The company succeeded twice in the Federal Court, but the High Court overturned those decisions as it ruled unanimously in Ms D'Arcy's favour.
Ms D'Arcy said the High Court challenge had been a "David and Goliath" battle, and said the ruling would make testing for the BRCA-1 gene more accessible.
"I'm only a little person, but it's not the size of the dog in the fight, it's the size of the fight in the dog," she said.
"For all those people who do have the genetic footprint for breast cancer or any cancer basically, it's a win for them because now they're forewarned," she said, speaking from Brisbane.
"The testing will be a lot cheaper and it will be more available ... rather than using only Myriad's agents at a price that nobody really can afford.
"I'm just hoping that other countries will see sense and follow us and the Americans."
Does identification equal invention?
The main legal issue was whether the identification of the gene by Myriad Genetics could be recognised legally as an invention.
At the heart of the case was the concern that ownership of the gene patent could stifle the research and development of treatments for genetic diseases.
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The court found that while the discovery of the gene was a product of human action, to consider it an invention would stretch the law too far.
The ruling is in line with the US Supreme Court ruling that genes are not inventions, but discoveries.
Myriad Genetics had argued that patents ensured innovation could be commercialised for everyone's benefit.
Before the Australian case, in 2013 the United States Supreme Court also ruled against the patent.
Specifically the US Court ruled that naturally occurring DNA was a product of nature and not patentable.
But the court did recognise synthetic DNA created in a laboratory, known as cDNA, was not a product of nature and could be patented.
Myriad Genetics' lawyers said the law in the US did not reflect the law in Australia and the legal test in the US differed, asking only if the material "is a product of nature".
Invention claimed not within concept of 'manufacture'
In Australia, what is known in legal terminology as "the manufacture test" applies.
This arose from a case in 1959, when the court ruled in favour of patenting a new type of weed killer that did not harm crops, but was made from already known compounds.
Myriad Genetics said the patent applies to a product, an isolated nucleic acid, that is chemically, structurally and functionally different to naturally occurring DNA.
More information on human gene patenting:
- The BRCA-1 and BRCA-2 genes were isolated and sequenced by researchers at Utah University in Salt Lake City in 1994
- Myriad Genetics was assigned the patents on the isolated sequences and the cDNA variants
- At the time of the US Supreme Court ruling there were concerns about future investment in medical research when patents could be at risk. But there were also claims the ruling could free up research in the area.
- In Australia there have already been calls for the Federal Government to legislate against gene patents.
Myriad said under Australian law the emphasis was on the differences in the structure and function of the genetic material, and not the similarities, as it would be in the US.
The company believed the US ruling supported the Australian patent, as the material in use was isolated from the gene, creating a "non-naturally occurring molecule".
But on Wednesday the High Court ruled that the invention claimed did not fall within the concept of "manufacture".
In a summary of the case, the court found: "While the invention claimed might be, in a formal sense, a product of human action, it was the existence of the information stored in the relevant sequences that was an essential element of the invention as claimed."
But some in the industry questioned the significance of the ruling, saying future patents would not target the same sort of material.
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"Innovation in relation to gene sequences has moved on from claiming those sequences perse, to more in relation to how they can be used," Patent Attorney Grant Shoebridge said.
"Patents in the future or patents which are being drafted now, which relate to gene sequences, will predominantly have claims directed to how those sequences are used.
"This decision does not affect those claims."
Mr Shoebridge said there was also "no evidence to suggest that gene patents stifle research".
"There was a Senate inquiry in relation to that - no evidence whatsoever," he said.
Actress Angelina Jolie drew attention to the BRCA-1 gene in 2013 when she revealed she had a double mastectomy after she learned she carried the gene, which has killed several women in her family.
Topics: genetics, science-and-technology, courts-and-trials, law-crime-and-justice, canberra-2600, act, australia, united-states
First posted yesterday at 7:30pm
COMMENTS
Comments on this story are closed.
24 comments
Score: 2
saline
8:23 PM on 07/10/2015
This decision should be known henceforth as the Darcy Ruling.
Score: 3
saline
8:18 PM on 07/10/2015
Everyone who has a wife, mother, Daughters and granddaughters should celebrate the decision.
I guess that makes all of us, really.
We are pleased, our niece can use any help she can get, and she will be fine. No company or person should have a patent on naturally occurring biological material. Ridiculous.
I guess that makes all of us, really.
We are pleased, our niece can use any help she can get, and she will be fine. No company or person should have a patent on naturally occurring biological material. Ridiculous.
Score: 3
empiricist
6:39 PM on 07/10/2015
Hmm, journos with little training or understanding of science reporting on scientific concepts, very often get the science part glaringly wrong.
Almost everyone will *HAVE* the BRCA 1 & 2 genes as they are an essential part of DNA repair, stability and cell cycle machinery.
It is "mutations" in these genes that cause improper functioning and increase the risk of breast and ovarian cancers.
Unfortunately for some families these "genetic mistakes" are passed on through generations (e.g. Angelina Jolie).
SMH and Guardian reporters were able to get this important scientific nuance right, why not the ABC?
Kudos to Ms D'Arcy and her lawyers for pursuing this in the public interest, it has already been two years since the US courts saw fit to redress granting of an inappropriate patent that has not been allowed for any other genes since (particularly since the Human Genome Project made all of our DNA sequence essentially public domain).
Almost everyone will *HAVE* the BRCA 1 & 2 genes as they are an essential part of DNA repair, stability and cell cycle machinery.
It is "mutations" in these genes that cause improper functioning and increase the risk of breast and ovarian cancers.
Unfortunately for some families these "genetic mistakes" are passed on through generations (e.g. Angelina Jolie).
SMH and Guardian reporters were able to get this important scientific nuance right, why not the ABC?
Kudos to Ms D'Arcy and her lawyers for pursuing this in the public interest, it has already been two years since the US courts saw fit to redress granting of an inappropriate patent that has not been allowed for any other genes since (particularly since the Human Genome Project made all of our DNA sequence essentially public domain).
Score: 3
shocked again
6:22 PM on 07/10/2015
What a legend! When the law and common sense are in agreement, we get a win for all of society.
Score: 5
erewego
6:13 PM on 07/10/2015
Good on you Yvonne, thanks.
Score: 3
surrey
5:52 PM on 07/10/2015
Thank you to this woman from up here in Canada! It's wonderful to see people stand up to these giant companies and win.
Score: 2
malavae
5:39 PM on 07/10/2015
I never could fathom the logic of allowing a patent on a naturally-occuring anything that's simply 'discovered'. I do however, understand allowing a patent on the processes developed by the company to identify the something.
But as that's not the point at issue here - bravo Madam D'Arcy.
I'm looking forward to all the court cases that can now use this case as precendence and free up more patent-locked genes.
But as that's not the point at issue here - bravo Madam D'Arcy.
I'm looking forward to all the court cases that can now use this case as precendence and free up more patent-locked genes.
Score: 2
the usual suspect
5:14 PM on 07/10/2015
"Myriad Genetics had argued that patents ensured innovation could be commercialised for everyone's benefit". Who buys that garbage?
Anyhow, to get over the manufacture hurdle one must map the genome, recreate the genes themselves, study manufactured genes, make discoveries and voila!
Anyhow, to get over the manufacture hurdle one must map the genome, recreate the genes themselves, study manufactured genes, make discoveries and voila!
Score: 0
gabrianga
4:41 PM on 07/10/2015
Well done Yvonne D'Arcy.
Not so well done fearlessfred who ignores the victory and comments with the usual Left Wing garbage.
Not so well done fearlessfred who ignores the victory and comments with the usual Left Wing garbage.
Score: 5
wombatmobile
4:15 PM on 07/10/2015
Yvonne D'Arcy deserves the highest recognition for her selfless battle to win back the rights of ordinary Australians to be screened for cancer without paying a gratuitous tax to an American corporation. Her persistence is a rare quality that makes our society stronger.
Score: 2
ronfel
2:42 PM on 07/10/2015
Thank you, Yvonne, for your immense courage and persistance. It must have taken a massive personal toll on you. As a family repeatedly afflicted by this terrible disease in it's every shape and form, you have our grateful appreciation. God grant you peace and rest after this huge fight. You are awesome!!! A thousand thankyou's for your contribution to the world of medicine.
Score: 6
danielmatthews
2:33 PM on 07/10/2015
Yvonne D'Arcy is the sort of person who should be awarded the title of "Australian of the Year", rather than the celebrities and sports people that we frequently see winning.
Score: 1
bobrox
2:00 PM on 07/10/2015
Well done to Yvonne D'Arcy and the high court. American greed knows no bounds. Before any politician thinks about changing the law, if a discovery is patentable then the decendents of Cook and Dampier are owed a LOT of money by white australia.
If the same politicians believe in god then no human can claim rights to a gene.
Also if discovery is patenable then I claim a patent over the two dollar coin, because I've found a few of them.
Yet again we have a case of Yankee go home, and stay there.
If the same politicians believe in god then no human can claim rights to a gene.
Also if discovery is patenable then I claim a patent over the two dollar coin, because I've found a few of them.
Yet again we have a case of Yankee go home, and stay there.
Score: 2
cruising
1:55 PM on 07/10/2015
Finally a win for common sense. If it's not 'manufactured', it has to be naturally occurring, regardless of who isolated the gene first, particularly when it naturally occurs right across the globe. This is not about manufacturing a treatment, this is purely isolation & identification of a naturally occurring faulty gene. How can you claim 'intellectual property' relating to a genetic defect? If you want to take it to extremes, if a company's gene is responsible for premature deaths, then surely they are also liable for damages? But no, their defence would be it's 'naturally occurring'. End of claim.
Score: 3
hillier
1:27 PM on 07/10/2015
Congratulations Yvonne D'Arcy and all that helped - have so much respect for your belief and tenacity to continue to fight for this - loved your quote 'not the dog fight its the fight in the dog' - this has been a fight for people's health not big business profit - really proud of you!
Score: 8
gendervie
1:27 PM on 07/10/2015
Yvonne D'Arcy, thank you!
I feel confident to add, on behalf of Australian women, thank you!
...
Corporate greed is a blight on all humanity.
I feel confident to add, on behalf of Australian women, thank you!
...
Corporate greed is a blight on all humanity.
Score: 3
steve berry
1:10 PM on 07/10/2015
Great news, but the question is whether the TPP agreement would allow Myriad Genetics to sue Australia due to this ruling affecting their "investment". This question needs to be thoroughly answered before the TPP is ratified in Parliament, as no doubt a company like that wouldn't hesitate to litigate against us if they had an avenue to do so. I sincerely hope Australia wouldn't give away our rights to make these decisions simply for the sake of selling more butter and sugar.
Score: 2
photon
1:08 PM on 07/10/2015
Patents on naturally occurring genes, brought to you by the people with stupid gun laws.
Score: 9
mcn31l
12:58 PM on 07/10/2015
This is the only result that it should have been. The alternative would be like every single person alive having to pay the relatives of Sir Isaac Newton because they 'use' gravity.
Of course the flipside of a ruling for Myriad is then every single breast cancer patient suing them because they 'made' the gene... (as I have just noticed mijami has pointed out)
Of course the flipside of a ruling for Myriad is then every single breast cancer patient suing them because they 'made' the gene... (as I have just noticed mijami has pointed out)
Score: 10
dog tags
12:42 PM on 07/10/2015
Hooray, a win for common sense.
The biggest concern here is how did the two previous courts get it so wrong?
The biggest concern here is how did the two previous courts get it so wrong?
Comments on this story are closed.
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