(Promo video for Myriad)
WOMAN 1: Breast cancer runs in my family.

WOMAN 2: My mother...

WOMAN 3: My grandmother...

WOMAN 4: My dad's sisters...

ANDREW FOWLER, REPORTER: In the beginning there was Myriad, their biotech wizardry would save women's lives all around the world.

(Promo video for Myriad)

WOMAN 3: With effective medical options...

WOMAN 2: ...to be ready.

WOMAN 1: Be ready...

ALL WOMEN (in unison): ...be ready against cancer now.

(End of footage)

MARK SKOLNICK: I think the single greatest inventive thing I did was to create Myriad

ANDREW FOWLER: Others saw it differently, a medical mercenary price gouging the sick and vulnerable.

(To Dr Harry Ostrer): Do you think they're being greedy?

DR HARRY OSTER, NY UNIVERSITY MEDICAL CENTER: Yes.

ANDREW FOWLER: It was all to do with gene patents. It's big business and you're paying for it

DR GRAEME SUTHERS, ROYAL COLLEGE OF PATHOLOGISTS: In Australia we've had experience of ah, patent enforcement which has increased the cost of a test tenfold.

ANDREW FOWLER: Now the fight is on to break the back of the gene cartels.

LUIGI PALOMBI, PATENT LAWYER: One of the greatest frauds perpetrated on the public has been the idea that you can get a patent on an isolated gene.

ANDREW FOWLER: Tonight on Four Corners, Body Corporate, the high stakes battle over who owns your genes

Title: Body Corporate

Seven years ago Melbourne based businessman, Mervyn Jacobson, was a man on a mission. His company, Genetic Technologies had a swag of medical gene patents. Investors in Australia, and more importantly in America, were keen to do business.

(From Four Corners, 2003, 'Patently a problem')

MERVYN JACOBSON: The opportunities we have are very broad and they're very global, and they can't be fully valued just by a company listed on the Australian market alone.

ANDREW FOWLER: Venture capitalists paved the way for meetings at the top end of town.

The biotech industry is not for the faint-hearted. Many investment proposal have come unstuck. For Mervyn Jacobson there have been successes. Genetic Technologies was eventually listed on the prestigious Nasdaq stock exchange.

But now, the company is embroiled in a legal stoush over ownership of human genes. So just why has the dream soured?

(End of footage)

Times Square, New York, is as good a place as any to witness the whirlpool of human DNA.

In the melting pot of America, virtually every shape, size and colour you care to imagine is on display. Every person here tonight possesses at least 20,000 genes.

They determine everything about our make up, hair colour, eye colour, and more importantly our susceptibility to disease.

But what few probably realise is that drug and biotech companies own about 4000 or 20 per cent of those genes.

WOMAN ON NY STREET: Why?

ANDREW FOWLER: Because that's the law. For the past 20 years it has been perfectly legal to patent, to own the genes that occur naturally in your body. Well it was until recently.

Earlier this year a New York judge sitting here at the district court turned the law on its head. He ruled that no-one had the right to own someone else's genes. The decision stunned the big biotech and drug companies. Their multi-million dollar investments and even greater profits were now seriously under threat.

(Video produced by the American Civil Liberties Union, UCLU)

BARBARA BRENNER: How can it be that a company controls genes, how is that be possible?

(End of footage)

ANDREW FOWLER: In May last year, the American Civil Liberties Union, the ACLU, challenged the legality of gene patents. In particular the patent over a naturally forming mutant breast cancer gene.

MALE VOICEOVER (From UCLU video): Mothers and daughters are on the frontline in the fight against breast cancer. It's also a high tech battle. To win, scientists need the freedom to research genes and develop diagnostic testing, but one company, Myriad, decides who gets to test and research two genes associated with breast cancer.

SANDRA PARK, ACLU LAWYER: The Statue of Liberty is right over there. The court house where Judge Sweet issued his decision is in that direction.

ANDREW FOWLER: Sandra Park is one of the ACLU Lawyers that led the case against Myriad.

SANDRA PARK: Part of the problem here, is that the patents grant a monopoly on the information about all our genes. So it doesn't matter whether the gene that is taken is from your body or mine, Myriad Genetics, the patent holder, has the power to prevent anyone else from looking at those genes.

KEVIN NOONAN, PATENT ATTORNEY: Judges can decide a lot of things. A judge can decide the sky is pink, it doesn't make the sky pink.

ANDREW FOWLER: Kevin Noonan is dismissive of the New York court decision. A Chicago based Patent Attorney, he believes it will hurt both business and patients.

KEVIN NOONAN, PATENT ATTORNEY: I think we owe it to everyone else when we talk about this, to think about what are the consequences? You know, do we want a world in which you don't get the drugs quite as quickly, or if ever. Where you don't get the diagnostic tools as quickly, if ever? Um, just because we decided, well we're uncomfortable morally with ah, with patenting genes.

ANDREW FOWLER: The legal battle over the health and well being of Americans was, by all reports, a bruising one. Dr Harry Ostrer, head of the New York University Medical Center Human Genetics Program, helped bring the challenge against Myriad. According to him, Myriad played it hard.

DR HARRY OSTER, NY UNIVERSITY MEDICAL CENTER: You know our, our professional credentials, our motivations, were uh, questioned by some of their, their experts. It wasn't complimentary. Eh so the arguments were that we were dupes and also if you read the comments from some of their ah, experts, in fact they were quite unflattering about some of us.

ANDREW FOWLER: At Colombia University Medical Centre on Manhattan's Upper West side, Dr Wendy Chung joined Harry Ostrer and the civil liberties lawyers in the battle, but she was far from convinced they'd win.

DR WENDY CHUNG, COLUMBIA MEDICAL CENTER: They actually rang me up and they said 'can we have a meeting?' And we had a meeting literally ah, in my office here where we, I, I helped educate them about what the issues were and why this was important. At first I thought they were Don Quixote. You know again, I had, I had this idea that they would be chasing windmills and thought there's been many, you know, many years of precedent at this. Ah surely, ah this is going to be a futile exercise.

ANDREW FOWLER: For Dr Chung there was a lot riding on the result. She tests hundreds of women a month.

DR WENDY CHUNG: Ah it certainly is true that um, for individuals who carry mutations in these genes, the risk of, for instance breast cancer can be anywhere from 50 to some studies have estimated as high as 85 per cent lifetime risk of breast cancer. So certainly a very high lifetime risk of cancer of some sort associated with both these genes.

ANDREW FOWLER: But Myriad's enforcement of its gene patent means though she can carry out the tests for research purposes, Dr Chung can't legally share the results with the patients.

SANDRA PARK: When we first spoke with her, one thing that she mentioned to us was that she could do research, but people samples that she used for the research, if she ran the test in her lab, which she does all the time, she couldn't let those patients know what the test results were, otherwise she would be accused of infringing on the patent. And so it was a real ethical issue for her, that she's a doctor and a researcher, and she knows these test results, but can't pass on that information to her patients.

ANDREW FOWLER: How did you feel when you heard the words that the judge spoke, Judge Sweet, spoke about the case that you fought so hard for?

DR WENDY CHUNG: I have to say I was incredibly excited and when I heard the surprise result and it was a surprise to me, I said why didn't we do this many years earlier.

ANDREW FOWLER: But any celebration may be short lived, Myriad has appealed the court ruling. Given that the company currently earns more than $US4000 for each breast cancer test, it's easy to understand why Myriad may be prepared to take its argument all the way to the US Supreme Court.

(Audio from the documentary 'In the Family'): After Mary Claire-King's initial discovery, labs across the country, including hers, entered into a race to find the exact location of the BRCA 1 gene.

ANDREW FOWLER: It was the hard line taken by Myriad in enforcing its patent rights which so inflamed filmmaker Joanna Rudnick.

JOANNA RUDNICK, FILMMAKER: This is 'In the Family', a personal documentary I made about finding out at 27, I was positive to the BRCA 1 mutation.

ANDREW FOWLER: She knew about cancer. Her mother had developed it at 43. She feared she too could carry the gene.

JOANNA RUDNICK: I went to ah, get tested in New York City where I was living at the time. Got my blood drawn the same day, got counselling and then ah, a few weeks later, about a month later, I went in and she told me that I was positive and I saw that piece of paper that says positive for a deleterious mutation, ah, which is you know, take, takes the air right out of you.

ANDREW FOWLER: What does that mean?

JOANNA RUDNICK: It means that I have about, depending on who you ah, what statistics you trust, I have about an 87 per cent lifetime risk of developing breast cancer and up to ah, 60 per cent risk of developing ovarian cancer, ah, which as I said, my mum had at 43 and I'm ah, 36 now so it means that I'm in this very strange limbo of knowing my percentage for getting a disease, but still being healthy and trying to figure out what to do about it you know, and that's where we all are.

ANDREW FOWLER: The film took her on a remarkable journey. During its making, Rudnick sought a second opinion on her positive breast cancer test.

But such is the stranglehold of the Myriad patent, she had to leave the United States to get that second opinion.

JOANNA RUDNICK: I actually went to Canada and through the making of the film, I got my blood drawn and run in Canada and I got a second opinion. It was the same bloody result. [Laughs] I still had BRCA1 and still positive, but I was able to get a second opinion by leaving the country and going to a place where they are not upholding the Myriad patent.

(Referring to a scene from the film on her editing software) So here I visited Myriad genetics in Salt Lake City, Utah, to question the founder and chief scientific officer Mark Skolnick.

ANDREW FOWLER: Joanna Rudnick's visit was quite unique. Myriad guard their laboratory and media access as tightly as they guard their patents.

How difficult was it for you to get access to Myriad?

JOANNA RUDNICK: Ah, to get access to Myriad, my co producer on the film spent about a year corresponding with Myriad. Um, I would have to check that with her, but it was quite some time that she spent corresponding with them. This was before the ACLU um, challenge on Myriad, so I think that they um, ah, didn't realise that public opinion was turning in such a, a large way, in such a major way I guess I would say.

ANDREW FOWLER: According to Rudnick, Myriad who'd been aggressively advertising its cancer tests saw a marketing opportunity.

JOANNA RUDNICK: They realised that this would, ah, this is a crude way to say it, um, but potentially I think reach a number of the people and a number of the families that they were trying to reach.

(From 'In the Family')

JOANNA RUDNICK (Voiceover): Myriad genetics owns the patent on the BAC1 and 2 genes and they control all commercial testing in the US.

MARK SKOLNICK: We're now receiving about 350 samples a day.

ANDREW FOWLER (Voiceover): Rudnick even got a guided tour of Myriad by Mark Skolnick.

(Joanna Rudnick and Mark Skolnick are looking a huge stack of Fed Ex plastic bags that have just been delivered)

MARK SKOLNICK (Voiceover): Let's move on a little bit.

JOANNA RUDNICK: You see I think of these as all as people.

MARK SKOLNICK (Voiceover): Well these are people. These have the DNA that is a part of all of those people in these packages.

ANDREW FOWLER: Dr Skolnick is proud of his work and can see nothing wrong with owning the BRCA patent.

MARK SKOLNICK: People aren't upset about having patents for their Ipods or patents for their telephones or patents for their computers or patents for their cars. If it weren't for patents, modern society wouldn't exist.

ANDREW FOWLER: But then there's the point of just how much Myriad charges for its monopolistic services, courtesy of their patent.

JOANNA RUDNICK: And you said when this test came out that this is going to be a less expensive test. You said this test would one day be hundreds of dollars. So why is it still three thousand dollars, why is it increasing?

MARK SKOLNICK: That's a good question.

(End of footage)

JOANNA RUDNICK: When you look at the, what went into Myriad, um, and Myriad's there was a, a number of years of research, decades of research before Myriad got into the picture. And a lot of that research was done with government funding.

They wouldn't have gotten there without government dollars, so it is right I ask then for a company to come in, swoop in and take all that research that was funded by government dollars and then patent the gene and make money off of that?

Where is the payback back into research? Where is the, where is the payback back into those government dollars? I mean, I don't hear anyone talking about that part of the equation.

LUIGI PALOMBI, PATENT LAWYER: This is Chiron Corporation, it's now Novartis, but in 1982 it was Chiron, it was set up by three scientists from the University of California in San Francisco.

ANDREW FOWLER: Out here in California's biotech equivalent of Silicon Valley, there's no question where the money ends up. It's built some of the biggest names in biotechnology. Luigi Palombi, an Australia-based patent lawyer, gave us a guided tour of one of the largest.

LUIGI PALOMBI: It was one of the companies that was part of the genetic gold rush. They discovered the cause of what was nonA nonB Hepatitis. They patented that virus. They patented the entire genome of that virus and everything that you can do with that virus. Whether it's diagnostics or whether it's vaccines.

ANDREW FOWLER: Did it make them rich?

LUIGI PALOMBI: It made them extremely rich.

ANDREW FOWLER: Palombi has travelled in the opposite direction. He has abandoned the commercial world and is fighting for the other side.

LUIGI PALOMBI: San Francisco, the home of America's biotechnology industry and the place where the genetic land grab started.

ANDREW FOWLER: We caught up with Luigi Palombi on his way to an international conference in San Francisco. It's theme: the more open scientists are, the more the public benefits.

Everyone's was talking about the Myriad decision and the company's legal appeal.

PROF. ROCHELLE DREYFUSS: There are two problems. So one problem is the merits, will they uphold these patents, but also there is the question of whether the ACLU and the other named defendants actually have standing to bring the case.

ANDREW FOWLER: Professor Rochelle Dreyfuss, is an acknowledged expert advisor to successive US administrations. In fact, the room is filled with the best and brightest in patenting law and bio technology.

Palombi doesn't hold back.

LUIGI PALOMBI (at lectern): This is the crunch. Promoters of gene patents argue that genes are patentable when they are isolated and purified or removed from the body and placed in a form so that they can be replicated outside the human body. This argument seems absurd to me. It is like taking a hardback book, written by someone else, publishing it in a paperback and then claiming authorship because the binding is different.

ANDREW FOWLER: For many it's not just a matter of purely academic interest.

JAMES LOVE, ADVISOR: Well yeah, it's a little painful for me to be here in the audience and listen to this conversation about the patent on the BRCA test. Because I'm not here to talk about that issue at this conference, but just as a personal matter it's something that we're dealing with in our household right now.

ANDREW FOWLER: James Love is an advisor to UN agencies and national governments on intellectual property. He's at the conference to talk about market reform. Last year his wife's breast cancer was misdiagnosed.

JAMES LOVE: Right now she is almost certainly going to have both of her breasts removed, and if she had been properly diagnosed a year ago that would not have been the case. It would have been a much simpler, less invasive procedure and treatment.

ANDREW FOWLER: The Myriad test for the BRCA gene would have probably picked up her condition. But at $US4000, it was too expensive.

JAMES LOVE: I'm sure the reason why the access to the test is limited in the United States and other countries where the patents are enforced, is the price. It's entirely because of the patent protection on the test that the price is so high.

ANDREW FOWLER: Two years ago in Australia, the use of gene patents to enforce a company's legal rights, took a peculiar twist. It involved the controversial BRCA 1 and BRCA 2 breast cancer gene patents owned by Myriad.

At the centre of what would become a million dollar debacle, Genetic Technologies, the company that Mervyn Jacobson had been spruiking to New York investors five years earlier. Genetic Technologies holds the exclusive licence for Myriad's breast cancer gene patent in Australia.

ANDREW FOWLER: In 2008 the Melbourne based Peter MacCalum Cancer Centre and its then director, David Bowtell, found themselves caught in a patent war between Genetic Technologies and Myriad.

PROF. DAVID BOWTELL (showing Andrew through the Cancer Centre): So women from the ovarian study, their samples are being worked up here.

ANDREW FOWLER: Two years ago Bowtell was all set to enter into a research program with Myriad to investigate possible links between the BRCA1 and 2 genes and ovarian cancer.

PROF. DAVID BOWTELL: So what we've done is to generate cell lines from them and we're analysing the genetic changes that have occurred in the cell lines.

ANDREW FOWLER: David Bowtell and his team had drawn up a list of more than a thousand women to take part in the tests.

PROF. DAVID BOWTELL: We were interested in understanding the the risks that a woman carries one of these mutations if they have ovarian cancer. So we've been funded through a large grant from the United States and from Australia to test the Australian ovarian cancer study cohort.

ANDREW FOWLER: While Myriad's own patent enforcement practices might be questionable, there's no doubt they offer world class testing facilities. Facilities the Peter MaCallum, Centre wanted to use.

However Myriad had already issued a licence for all tests in Australia to Jacobson's Genetic technologies. That put the tests for ovarian cancer on shaky ground.

PROF. DAVID BOWTELL: The problem was that it the work was just about to get started and Myriad realised that they had licensed the testing of those genes to ah, Genetic Technologies. So we went to Genetic Technologies to talk to them about whether we would be able to go forward with the study with Myriad, but unfortunately they took a pretty hard-nosed position on that and and essentially blocked us from working with Myriad.

ANDREW FOWLER: Did you speak with them and ask them to change their minds?

PROF. DAVID BOWTELL: Yes, we did speak with them. It was a pretty tough discussion and their position was firm. They ah, they didn't resile from it and so we weren't able to do the study with Myriad.

ANDREW FOWLER: Genetic Technologies not only blocked any research deal with Myriad, they demanded a fee from Peter Mac that was unacceptable. The ovarian cancer tests were put on hold.

(To Prof. David Bowtell): So did the Genetic Technologies decision slow down that process, so that the women who may have been at risk weren't tested?

PROF. DAVID BOWTELL: Yes, it slowed it down by at least two years.

ANDREW FOWLER: What effect would that have or did that have on the people who, who weren't tested?

PROF. DAVID BOWTELL: Well, we don't we don't know, but it it means that we're now testing them. We're now finding those mutations. We're now feeding that information back. People are now acting on it, but it's happened two years later. Whether anyone has developed ovarian cancer in that two years time that might have not, ah, who's to say? We'll never know the answer to that, but, but besides...

ANDREW FOWLER: It was possible. It is possible.

PROF. DAVID BOWTELL: It, it's possible but we don't know.

ANDREW FOWLER: And the delay came with a huge price tag.

PROF. DAVID BOWTELL: It's certainly cost us more money, yes.

ANDREW FOWLER: How much?

PROF. DAVID BOWTELL: Ah, I don't know the exact figure but probably about another million dollars, I would say.

ANDREW FOWLER: So a million dollars extra because of the two year delay?

PROF. DAVID BOWTELL: Yes, and because of the the need to actually do the testing here and because it would have been very cheap to have done it in Myriad in the beginning.

ANDREW FOWLER: For David Bowtell removing the restrictions on research imposed by gene patents is a high priority.

PROF. DAVID BOWTELL: In the future when we want to measure someone's risk of developing cancer, we'll probably want to measure tens or even maybe even hundreds of genes. If they were all owned by different people it'd be an absolute nightmare to do that. So it's extremely important that we have freedom to be able to do the testing of those genes as a group, because people in the end are not so much worried about whether they carry this gene or that gene, they want to know what is there risk of developing bowel cancer or breast cancer.

ANDREW FOWLER: At Clovelly beach in Sydney's eastern suburbs, mother nature has kindly turned on a glorious day. For the extended Simmonds clan it's a lovely backdrop for a family get together. It might not look like it, but they too are deeply affected by the machinations of gene patenting.

The ties that bind this particular family are unique, and potentially lethal. Many of them suffer from Long QT Syndrome, known as LQT.

EVELYN PETTIT: I've got a sister with, she lost a son at 23, and no reason why she lost it and her other son's got the LQT, and his two children have got it. And also lost a sister at 34 I think she was and she left two young children to be reared and there was no reason why she passed away.

ANDREW FOWLER: Long QT in its most devastating form causes the heart to beat too quickly. Having a defibrillator implant is almost mandatory to ensure survival.

TRISH RAMSAY: My eldest daughter got the fibrillator in, Dr McGuire, because she had couple of, two little young children, he virtually said she'd best to have it in and she's had two children since. So it doesn't stop you having children.

ANDREW FOWLER: There is of course a current LQT gene patent, owned by an American biotech company. Dr Chris Semsarian is an LQT specialist.

PROF. CHRIS SEMSARIAN, ROYAL PRINCE ALFRED HOSPITAL: The initial evaluations of the families we do here in Sydney. Um, we then extract the DNA from blood sample, and then we send that DNA to an overseas testing laboratory ah, to look for those particular gene faults in the Long QT genes.

ANDREW FOWLER: There is a system here, there is a testing laboratory that could do that work here. Why don't you send it here?

PROF. CHRIS SEMSARIAN: Yes, there is an excellent laboratory in in Melbourne that does testing in Long QT Syndrome. But in this age of limited funding and funding available for genetic testing, what we have to do is really go for the cheapest option, yet the most efficient as well. And so at this stage in time, the overseas laboratories really do the testing at half the cost, ah, with a very efficient turnaround of a few weeks.

ANDREW FOWLER: So how long does it take for the laboratory in Melbourne to carry out the tests? And how much do they charge you for it?

PROF. CHRIS SEMSARIAN: Yeah, routinely the testing takes about six months and the costs are around $3000 to $4000, as opposed to testing overseas which takes a few weeks, four to six weeks, at a cost of around $1800.

ANDREW FOWLER: Do you know why that is?

PROF. CHRIS SEMSARIAN: Ah, my understanding is probably twofold. Ah, the first um, um, explanation is ah, that there is a higher throughput of samples in the overseas laboratory. So the higher throughput in the overseas laboratory no doubt brings down the costs. Ah, I also understand that there is a patent on these Long QT genes, and so there is a royalty that needs to be paid with each test for that particular test to be conducted.

TRISH RAMSAY: I don't think they should have to pay the patent to go into more research for it at all. I think it should be available to whoever wants it.

ANDREW FOWLER: Like most five year olds, Liam Bentley loves his food.

LIAM BENTLEY: I want a sausage.

PAUL BENTLEY, FATHER: A sausage this time in the morning?

CHERYL BENTLEY, MOTHER: Here how about a golden coin.

LIAM: Coin.

CHERYL: Coin chocolate.

ANDREW FOWLER: For Liam the treats of life have been few and far between. He was born with autism. A tough deal for Liam and his parents, Cheryl and Paul Bentley.

Unfortunately it gets worse. When Liam was just six months old, his mother found him having a seizure.

CHERYL BENTLEY: Well initially um, that was just one of his arms that was jerking um, and it's like I'm going to call the children's hospital and then ah, the second, about 30 seconds later Paul was downstairs with him and his second arm was, his other arm was doing it as well and I'm like 'Forget that I'm calling triple 0'. So I called the ambulance straight away. Um, while I was doing that he then went into a full body seizure. Um, so yeah, I was freaking out.

ANDREW FOWLER: Eventually Liam was tested for Dravet's Syndrome, a rare kind of epilepsy caused by genetic malfunction.

CHERYL BENTLEY: Liam was actually in ICU at the time in the hospital and we went and spoke with his neurologist the next day when he came to visit us, and we asked him 'Do you think he has this Dravet Syndrome?' And he said 'Yes I do, but we need to do tests to find out.' So I was like 'okay', I said 'Well how do we go about doing this test, what's involved?' He said 'Oh it's quite expensive.' I said 'how expensive? Can we pay for it and just get it done? I just want it done.'

ANDREW FOWLER: The test should have been straight forward. After all Australian scientists discovered the gene, linked it to epilepsy and developed a diagnostic test.

Hardly surprisingly the Bentleys hadn't bargained on dealing with another crisis in Liam's healthcare, the side effects of gene patenting.

Australian researchers had sold the gene patent to a South Australian biotech company and the rights to the test ended up with non other than Genetic Technologies, who in turn charge $2000 for each and every test.

PROF JOHN CHRISTODOULOU, WESTMEAD HOSPITAL: I'm sure they've they charge what they feel is a fair and reasonable rate, but at the end of the day they're a company, they're out to make a profit and so they will charge what they think is appropriate for that test.

ANDREW FOWLER: Westmead hospital finds it cheaper to have the tests carried out on the other side of the world in the UK. At about $700, it's a third the price they'd pay here in Australia.

PROF JOHN CHRISTODOULOU: By sending the samples to the UK, we can actually get the test done more cheaply than it would cost to have done here.

ANDREW FOWLER: Did you ever think that you would maybe do the test yourself here?

PROF JOHN CHRISTODOULOU: We were prepared to consider that, but when it became apparent that there was patent on this and we would have to look at the prospect of buying a licence to be able to do this, we had a a moral objection to that and so we chose not to go down that path at this stage.

ANDREW FOWLER: As the Westmead doctors struggled through the medical minefield that Genetic Technologies' licence had created, the Bentleys had to sit and wait.

CHERYL BENTLEY: It was about a three month wait um, from when we discussed it initially so it was the September and then in the December that's when we got asked to take him cause it just took our doctor that long to get the funding to organise for the testing to be done.

ANDREW FOWLER: So three months?

CHERYL BENTLEY: Three months.

ANDREW FOWLER: To get to get the testing done?

CHERYL BENTLEY: Yes.

ANDREW FOWLER: And then how long to get the results?

CHERYL BENTLEY: It took about another five to six months to get the actual results from when the tests were done.

ANDREW FOWLER: Dr Christodulou says Westmead had explored other possibilities with Genetic Technologies, GTG, to break the impasse over Dravet's Syndrome testing.

(To Prof. John Christodoulou): Have you ever um, dealt with GTG and, and asked them if you could do ah, testing without paying them a licence fee?

PROF JOHN CHRISTOLOULOU, WESTMEAD HOSPITAL: We're in the public hospital domain. We've asked our, ah, Department of Health to make inquiries about that and they've made a number of inquiries, but as I understand it, um, have not received any communication back.

ANDREW FOWLER: That must cause you a certain amount of heartache?

PROF JOHN CHRISTOLOULOU: Heartache, frustration, particularly for the families because you know the families um, aren't interested in the politics behind what's going on, they just want the answer for their child so that the best treatment can be put in place for them.

CHERYL BENTLEY: I think if the test could have been done here in Australia or even if the hospital itself, the children's hospital had um, the access to do it within the hospital itself, I think that would have been so beneficial, because Liam could have been tested a lot earlier than what he actually was.

DR LUIGI PALOMBI, AUSTRALIAN NATIONAL UNIVERSITY: It's just ludicrous that these scientists who could actually do the testing in-house, I mean they don't actually have to buy the test from Genetic Technologies. Ah, the, the technology is already there. he know-how in actually making ah, a diagnostic test already exists. It's not rocket science.

ANDREW FOWLER: The muddle of gene patent laws which made children like Liam Bentley's life such a misery, has been under the microscope of an Australian Senate inquiry since early last year.

One of the key expert witnesses, Luigi Palombi.

(Footage from the Senate Enquiry into Gene Patents, 14/09/2009)

DR LUIGI PALOMBI: Under Australia law the isolated gene and the protein that is identical or substantially identical to that which exists in nature, in accordance with all scientific evidence, is that it is not an invention. That it is part of the discovery process.

SENATOR HEFFERNAN: Do you think that given the overwhelming evidence from the clinically driven, vocationally guided, and humanely inspired side of this debate, which is lining up against from what I can see, against a bunch of lawyers, bankers and people who are financially driven, do you think it's time for the Commonwealth to step up to the plate and fund a test case and let's just sort this out in the courts.

DR LUIGI PALOMBI: Ah, Senator, we definitely need to have this issue resolved. We are going to probably need a court decision to make it clear as to whether or not these patents are valid.

(ABC News, 8 June 2010)

REPORTER: Yvonne Darcy was first diagnosed with breast cancer in 1998, then again 10 years later. She's part of a landmark Australian case which will test whether the patent awarded to a US biotech company for the breast cancer gene is legal.

(End of footage)

ANDREW FOWLER: In the end it hasn't been the Commonwealth which has taken the first step to bring a test case, but representatives of breast cancer victims and a team of lawyers.

REBECCA GILSENAN, LAWYER: It's completely groundbreaking in the sense that it's the first time an Australian court has been asked to rule on the validity of granting patents over human genetic material.

ANDREW FOWLER: They want a once and for all decision on the legality or otherwise of Australian gene patents.

YVONNE DARCY: To me it is morally wrong to privatise human parts of the body.

DR GRAEME SUTHERS, ROYAL COLLEGE OF PATHOLOGISTS: In the healthcare community, the great majority of people remain appalled and puzzled that genes have ever been patented, and very concerned about the current and potential impact of these patents in doing what we want to do, which is to help people. Healthcare is about helping people. It is not just about making a buck and so there is ah, key interest in having this issue resolved and sorted.

ANDREW FOWLER: But Professor John Shine, Executive Director of Sydney's Garvan Institute believes if patents are ruled out the future of gene research will be put at risk.

(To Prof. John Shine): One of the people we've spoken to is a patent lawyer, his name is Luigi Palombi. He says that people have been gouged by the patent system and that he says it verges on fraud.

PROF JOHN SHINE: Well, that's his view. I mean I totally disagree with that. I mean clearly it's complex, but at the end of the day you have to recognise that it requires literally often hundreds of millions of dollars to take a, a, a real research invention, especially in the human health area, through to a new drug to treat cancer or heart disease or osteoporosis, and that sort of resource and that sort of expertise is only going to come from industry. And they are only going to invest that amount of money, because it's a very risky business, they have to put up hundreds of millions of dollars for something which has perhaps a few percent chance of success, and they won't do it unless they feel at the end of the day, if they are successful, that they will have a good income stream. It's simply you know, it's simply the marketplace.

DR GRAEME SUTHERS: Before we had gene patents, there was very vigorous medical research going on, as there has been over the last ah, 60 or so years, with tremendous advances in the ah, quality and complexity of the services that could be delivered and that was done without needing to have a lot of investment protected by gene patents to, to help that roll forward. So I'm not persuaded that in fact, the, the gene patents have been necessary for the development of genetic research.

Um, there is now very clear evidence that these patents actually compromise the quality of research, the amount of research, the training of researchers and so on. So it's ah, it's not all a good thing to have a lot of money pumping in there and there maybe some benefit in having perhaps less money, better targeted in a freer environment.

ANDREW FOWLER: But it seems science itself may offer a solution .

(To Prof. Sean Grimmond): So what do we have here?

PROF. SEAN GRIMMOND: So what we're looking at here is a snapshot of DNA sequence, here we are looking at 400 million reeds being performed, so 400 million fragments in one time.

ANDREW FOWLER: At the University of Queensland, Professor Sean Grimmond is using a system which can map a gene sequence in seconds.

They could patent the genes they're sequencing, but instead they've decided to place them in the public domain, making them impossible to patent and to profit from. It's redefining the gene research industry.

(To Prof. Sean Grimmond): Is it right to say that the way that um, people patented genes in the past is really out of date now, that there's a new model?

PROF. SEAN GRIMMOND: Yeah, I think, I think that's true for a number of reasons. One is that um, where once upon a time to find a gene that might be associated with a disease and there was a monumental task. It could take you years, decades to, to, to get to that point.

That is something that we have the potential now to do much, much quicker, in a much quicker fashion and we can do it in, in thousands of fold cheaper than what you may have done previously.

ANDREW FOWLER: For the scientific community it's a significant development.

DAVID BOTWELL: It's suddenly at an inflection point that I haven't seen before in my career in science. The technology is incredibly powerful now and, and our knowledge about how these things work is growing very rapidly, so it's just extremely important that we can innovate in this space and develop things that are going to help people.

ANDREW FOWLER: Genetic Technologies, the Australian licensees of Myriad's patents declined to speak to Four Corners.

(From 'In the Family')

JOANNA RUDNICK: So the most controversial patent would be the composition?

MARK SKOLNICK: There's no controversial patent.

(End of footage)

ANDREW FOWLER: Three weeks ago, lawyers acting on behalf of Myriad offered to surrender ownership of its Australian breast cancer patent. In a letter obtained by Four Corners, the company stated:

"Myriad wishes to gift Australian Patent No 686004 (the Patent) to the people of Australia."

Myriad's critics argue it's a cynical ploy to kill of any legal challenge in Australia which could bolster the New York court decision.

Significantly the company pointed out:

"Myriad's offer does not constitute an admission that the Patent is invalid."

In the twists and turns of the genes war, the battle is far from over.

[END OF TRANSCRIPT]