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Australia's Genetic Technologies will sue over it's patents

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Postby rath » Tue Apr 21, 2009 11:34 pm

Genetic Technologies Owns & controls access to 95% of the DNA of every creature on earth. And they can charge license fees to anyone, anywhere in the world,


The Melbourne-based Genetic Technologies has consistently warned it would sue any company, research institution or university that infringed its patent over DNA.

So far Genetic Technologies has identafied over 5000 groups & companies in breach of its patants.


The Genius of Junk

Dr Malcolm Simons is an internationally recognised Australian immunologist.

He has spent 30 years of his life hunting for new and better ways to diagnose disease. Along the way he has gained a reputation as somewhat of an eccentric. He has been married – and divorced - five times. He has fathered three pairs of children. He's been bankrupt, a classical piano player, and played for Australia in international squash.

Genius of Junk is the story of how Malcolm Simons turned Junk into gold, enflaming one of the greatest controversies of our time - the control and ownership of our genetic material.

It is a story of triumph and tragedy. The triumph of a man flying in the face of conventional scientific thought, facing ridicule for his ideas and living to see those ideas vindicated. The tragedy of seeing his dreams come to fruition as he faces death. For he himself has cancer, Multiple Myeloma. A fatal and incurable cancer, formed in the very Junk DNA he spent 16 years exploring.

This is also a story of genius and character. Malcolm Simons had the genius to realise that the non-coding part of our DNA wasn’t in fact the junk DNA that many scientists had labelled it, but vital to the processes of life. And he has a character that fits the cliché of the eccentric scientist - brilliant at his work but hopeless with everyday life.

As he faces the greatest battle of all, Malcolm Simons takes us on a unique personal and scientific journey, to the heart of the things that matter to the very core of life - and death.


Background

Fifty years after Crick and Watson’s historic discovery of DNA, the scientific community has come a long way towards unravelling the mysteries of the key to life. The Human Genome Project has mapped our entire genetic code; we are genetically modifying plants and animals, finding genetic cures for diseases. There is no doubt that our investigation of what was called the coding region of DNA has revolutionized science and the world. But the coding part of DNA makes up less than 5% of our entire genome. Because the rest of our DNA didn’t seem to have any known function it was dubbed non-coding, or Junk DNA.

Malcolm Simons couldn’t believe that evolution would be so wasteful. In 1987, despite having no formal training in genetics, he had a moment of remarkable insight that convinced him that Junk DNA was serving a vital function; it provided markers that indicated susceptibility to disease. At a Workshop in the United States, he saw patterns emerge from the non-coding DNA. He realised that whatever was going on in non-coding DNA was not random. Malcolm Simons, "There was order in the 95%. If there was order there was likely to be function. Maybe this was a way to also contribute to understanding the function of genes and therefore their malfunction in disease and in so doing help diagnosis - make earlier diagnosis - help save lives." When he posed his radical theory that this junk might actually have a critical role in diagnosis, his peers announced, "Malcolm, you're off your friggin' head."

Undeterred, Malcolm set out to prove that this was no junk. The majority of geneticists were focused on coding DNA, the non-coding region was left field and probably irrelevant - but for Malcolm it became the main game. Fortunately one man believed in his genius - entrepreneur Mervyn Jacobson. In a real-life Odd Couple pairing (Mervyn is as organised and efficient as Malcolm is eccentric and chaotic) they formed Genetic Technologies in 1989. They believed that this non-coding DNA could prove valuable in diagnosing disease, perhaps in developing therapies, even cures.

There were others around the world exploring similar ideas, but Malcolm Simons took the crucial, unprecedented step - in the mid 1990s he patented the use of the so called Junk. It was an act of extraordinary and provocative foresight.

Today, $20 million of investment later, that foresight is paying off literally. Researchers the world over are confirming that non-coding DNA holds critical clues to a vast range of diseases; breast cancer, HIV, Crohns disease, Alzheimer’s, heart disease, ovarian and skin cancer… the list is growing daily. A leading figure in world genetics, Prof. John Mattick, recently claimed that, "the failure to recognise the implications of the non-coding DNA will go down as the biggest mistake in the history of molecular biology". In the last year Genetic Technologies has signed a series of licensing deals allowing companies to use their Junk DNA patents. This is bringing in millions of dollars for the company and the profits look like they will continue to roll in. The junkyard it seems, is a goldfield.

And suddenly, the implications of the patents are staggering. Genetic Technologies controls access to 95% of DNA of every creature on earth. And they can charge license fees to anyone, anywhere in the world, working in the non-coding regions. The critics of DNA patenting are outraged. But for Malcolm Simons the vindication and controversy is somewhat meaningless. He resigned from Genetic Technologies in 2000. He no longer has any shares in the company he once co-owned, he’s broke and he’s grappling with the realities of final stage cancer.

TRANSCRIPT
Narration: DNA. Within its exquisite structure lie the clues to our destiny… how we are formed… how we will live… and how we may die. Yet vast tracts of DNA code were dismissed by science as meaningless ‘JUNK’.

But an Australian scientist saw order in this sea of chaos. He saw ways to use ‘Junk’ to diagnose disease and save lives. Controversially, he laid claim to the ‘Junk’, patenting the use of 95% percent of the DNA of all species on earth.

Yet just as his billion dollar vision is being realised Malcolm Simons's life hangs in the balance.

Ann Abrahmsen: Living with Malcolm was like living on the edge of a whirlwind…

Mervyn Jacobson: He doesn’t fit the normal mould. He is definitely not a grey man in a grey suit.

Dr Malcolm Simons: I see things in black and white. I’m correctly regarded, correctly described as a maverick, pigheaded, obstinate. My experience is that everything that I’ve been told is absolute… written in law and certain - just isn’t so. Under certain circumstances, light doesn’t even travel in straight lines

Narration: Malcolm Simons is an immunologist. He has spent 30 years of his life hunting for new and better ways to diagnose disease. Along the way he has gained a reputation as somewhat of an eccentric. He has been married - and divorced - 5 times. He has fathered 3 pairs of children. He's been bankrupt, a classical piano player, and an Australian squash champion.

After years of walking an unconventional path, today Malcolm’s professional and personal worlds are colliding. Malcolm the immunologist, has cancer. Multiple Myeloma – a disease of the immune system.

Today, he is undergoing a series of tests that will help him decide how best to proceed… His options are bone marrow transplant and heavy dose chemotherapy – or letting the disease take its course.

Dr Malcolm Simons: It’s a fatal disease, there’s no known cure. So it’s about how long you don’t die. My prognosis is that the disease will kill me unless I stay alive long enough for there to be better therapies, up to and including a cure.

Narration: The hope for such therapies - even cures - could well lie in the research that Malcolm himself pioneered research into the very core of life – DNA. For woven into these delicate strands are the genes that control everything from physique to intelligence, depression to longevity. These complex threads of information also contain the defects, the mutations, that can trigger disease.

Science of genetics is the quest to understand this code of life and death. Fifty years after Watson and Cricks’ historic discovery of the structure of DNA, scientists have mapped our entire genetic code. They discovered an extraordinary matrix of four molecules - represented by the letters A, T, C and G - repeated more than three billion times.

Within this matrix they explored the genes, the powerhouses of the genome… And within each gene they identified the specific sections, which they called the "coding regions" - packed with instructions for building proteins the building blocks of life.

Prof John Mattick: The primary output of the genome is to create protein. Proteins of course are the primary components of our system. They form the structural components of our hair and skin, our oxygen carrying molecules in our blood, the hormones – enzymes that digest our food and our energy metabolism. So they’re critically important

Narration: The “coding regions” became the major focus of genetic research… Even though they account for less than 5% of our entire DNA. All the rest - the other 95% - was assumed to be genetic gibberish with no known function. So they called it ‘non-coding’ or 'Junk' DNA.

Dr Mervyn Jacobson: The word junk was applied and it stuck and people who came along thereafter saw that it was junk and took that as a message that there was no point looking in that area. So it became almost a convenience that instead of looking at 100% of a DNA you only need to worry about looking at 5%. But even that was daunting.

Prof John Mattick: What people should’ve done was take stock at that point. Instead they simply swept the observation under the intellectual carpet.

Narration: For decades this thinking dominated mainstream genetics. But Malcolm Simons couldn’t believe that evolution would be so wasteful. He believed that non-coding DNA must serve some sort of function.

Dr Malcolm Simons: Under Darwinistic notions you would think that junk would drop off under the theory of natural selection just like species drop off if they hit ecological niches which is incompatible with survival. If they can adapt to those niches, then those that can survive and those that can’t die. There’s the notion. If you apply that to the DNA sequence, then the coding region genes which survived have a function and by the way the non coding sequences have survived as well. So the proposition would have to be that if they’re there, they’ve got a function.

Narration: It was 1987 when Malcolm first glimpsed the potential of this ‘Junk’ DNA – it was a moment of insight that would change the course of his life. Malcolm was researching genes of the immune system called HLA; Human Leukocyte Antigens. He was attending a Workshop in the United States, where over 70 laboratories compiled genetic data from hundreds of individuals.

For a brief moment in history there was an extraordinary amount of information on both coding and non-coding regions. Malcolm was not a geneticist, but he sensed this data was important. Fearing this wealth of information might be buried, lost forever he felt driven to make sense of it.

Dr Malcolm Simons: This was likely to be the only time in the world’s history that this amount of data, which was providing potentially so much first time information about DNA genetics and HLA Region, was ever going to be seen.

Narration: So began many months of obsessive research. He flew back and forth across the States, nagged those with knowledge for assistance, learnt as much as he could as fast as he could.

Dr Malcolm Simons: I slept on the floor , I was there all the time taking up 10s to 100s of hours basically moving columns and rows and when you move columns and rows the jigsaw puzzle started to develop systematic blocks of information. At that stage I didn’t fully understand the significance of it.

Narration: Then came the moment of insight it dawned on him - there were patterns in amongst the chaos of code and they were being created in the non-coding region. In the so-called ‘Junk’.

Dr Malcolm Simons: Junk bespoke chaos – junk indicated or implied that whatever anybody found out there in the other 95% - when they got around to looking at it - it would be chaotic, that is the sequence variations would be random. So the significance of the observation was that could not possibly be the case… that notion could be rejected and if that notion could be rejected then the question is - what is it telling you?

Narration: Our understanding of coding DNA - a mere 5% of the genome - had already transformed medicine, allowing scientists to predict, diagnose, even cure disease. But what was the potential of the other 95%? Malcolm believed this so called ‘Junk’ provided markers that indicated if genetic abnormalities were present. It could provide an important, new way of diagnosing disease.

Dr Malcolm Simons: What I showed was that there was order in the 95%. If there was order there was likely to be function. Maybe this was a way to also contribute to understanding the function of genes and therefore their malfunction in disease and in so doing help diagnosis – make earlier diagnosis – help save lives.

Narration: Malcolm was defying decades of scientific dogma. But – as an ex-champion squash player – he was used to a bit of opposition.

Dr Malcolm Simons: When I showed the professional geneticists the data, which indicated to me that the 95% non-coding region wasn’t junk, and was ordered…The reaction was smiling disbelief at best – you’re off your friggin’ head and if you’re any good at squash – stick to your day job.

Narration: This thinking outside the square was the hallmark of Malcolm’s life in more ways than one.

Ann Abrahmsen: Mal’s got an amazing free ranging brain that just loves everything, but the rest of us are not living there. It’s a wonderful place to visit. I used to love to romp with him to the fields of the fields of possibility. It was great fun, but you have to live somewhere else and he wasn’t concentrating on the people who were here or we weren’t in focus.

Narration: Anne is the most recent of Malcolm’s five ex-wives, and the mother of the youngest of his six children. He’s never been short of love, but success in his personal life has been as hard to achieve as success in his intellectual one.

Dr Malcolm Simons: In the past what some people call BC (before cancer) this person was of limitless energy – zoom mode and my mother used to describe it as like trying to catch hold of the tail end of a comet.

Dr Mervyn Jacobson: Malcolm is irrepressible, challenging and that’s how he is, you have to take the good with the bad. (smiles)

Narration: One man was prepared to take Malcolm on – entrepreneur Dr Mervyn Jacobson. In 1989 they set up a company, Genetic Technologies, to test Malcolm’s theory that junk wasn’t junk.

Dr Mervyn Jacobson: I was intrigued. I saw it had obviously commercial potential. It was going to be a hard grind – multi year process, very expensive, but if we were successful this would be truly revolutionary - I wanted to be part of it.

Narration: They set up a diagnostic laboratory … with what was then a novel strategy… Using non-coding DNA they believed they could invent new approaches to diagnostic testing.

Dr Mervyn Jacobson: Some people look in the coding - in other words they utilize 5% of what’s there – we utilize the 5% and the other 95%. Originally it was thought all those abnormalities had to be in the coding region. It’s now known that many of those abnormalities are in the non-coding region. So you have to look in both regions and in many cases, the coding region is intact – perfect – pristine and the only abnormality is in the non-coding region.

Narration: There were others around the world exploring similar ideas. But Malcolm took the crucial, unprecedented step - he turned ‘Junk’ into gold. In the mid 1990’s - in an extraordinary act of foresight - he successfully patented the use of non-coding DNA in every creature on earth. For the company it would prove a profitable – and provocative – step.

Dr Mervyn Jacobson: The patent process is more than 400 years old. It’s implemented by governments. It’s government law. They set the rules and it’s the government who issue the patents.

Dr Malcolm Simons: I so to speak captured the 95 percent that wasn’t coding. So that these inventions cover that 95 percent and according to those for whom patentable positions is not palatable, particularly the Europeans who have more difficulty accepting these processes than the North American’s, we have it for all DNA in all species.

Dr Mervyn Jacobson: We took the risk. We could have in fact failed. It could have been that Malcolm’s original ideas were wrong. It could have been they were right and non patentable. It could have been they were right and patentable, but someone else beat us to it.

Narration: Today, 13 years and almost 20 million dollars later, that risk is paying off – big time. Researchers the world over are confirming that non-coding DNA holds critical clues to a vast range of diseases. And suddenly, the implications of the patents are staggering - if you want to use non-coding DNA to test for diseases like breast cancer or AIDS, Genetic Technologies could demand a license fee.

It is bringing in millions of dollars for the company. Some suggest it's worth billions. The Junkyard, it seems, is a goldmine.

Dr Mervyn Jacobson: It’s not true that we own the non coding DNA. We don’t own any DNA. Everybody owns their own DNA – every human and every animal and every plant if you like. What we did is we applied human intelligence to a process that enabled scientists to do things they could not do before and that intelligent approach we developed is what’s patentable.

Narration: Over the past year Genetic Technologies has targeted international biotech and pharmaceutical companies, perceived to be infringing their patents. And now, universities and research labs may have to pay to use Junk DNA.

Dr Graeme Suthers: These patents essentially have a potential to freeze research at a particular point because they put the control of those genes out of the public domain and keep it private. It means then that the patent holder can control who does what research on their particular gene

Narration: Mervyn Jacobsen argues that patents encourage scientific research… without a financial incentive investors would stay away in droves.

Dr Mervyn Jacobson: And patents have a very limited lifespan and then it’s gone. It’s a brief moment in time when you’re allowed to commercialise your invention and then it’s gone. It reverts to public ownership. Of course the invention is there forever for the benefit of mankind,

Prof John Mattick: Now that Genetic Technologies has started to attempt to enforce the patent – aggressively - across a range of organizations, I think that people are starting to realize the impact – potential impact of this and in a sense are starting to band together to try to find the resources that would be necessary to challenge the patent in court.

Narration: With billions of dollars potentially at stake, the battle over who can - and who cannot – have access to the non-coding regions is intensifying. Some scientists like Prof John Mattick, have a vested interest. He’s researching the actual function of non-coding DNA, taking Malcolm’s conviction that junk isn’t junk to new levels.

John Maddick: The failure to recognize the implications of the non-coding DNA will go down I think as the biggest mistake in the history of molecular biology.

Narration: John believes that far from being ‘Junk’ the non-coding regions form an intricate, multilayered, operating system co-ordinating the function of all the components of the genome. The non-coding regions may in fact DRIVE the coding regions telling them what proteins to create. The importance indeed the ‘genius’ of so-called ‘junk’ may be its ability to organise and arrange the very building blocks of life.

Prof John Mattick: I think the future of molecular biology is going to be non-coding DNA. In the next 5-10 years I predict that we will have to find what all the components do – first approximation and then of course the much bigger question is how you put it together. How do you build a human? How do you build a tree? Why are you and I different from each other but the same components? So the main game is going to be non-coding DNA – not because it’s non-coding but because it actually is coding. It’s coding for the information that puts you and me together.

Narration: Sixteen years after Malcolm’s original insight, ‘junk’ DNA is now revolutionizing our understanding of genetics.
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Postby rath » Tue Apr 21, 2009 11:38 pm

November 18, 2003


Investors piled into Genetic Technologies yesterday after the biotech company announced that two US groups it was suing for patent infringement had settled out of court.

The Melbourne-based Genetic Technologies has consistently warned it would sue any company, research institution or university that infringed its patent over the so-called junk DNA.

In the past, scientists concentrated on a tiny 1.5 per cent slice of the human genome, dismissing the remaining 98.5 per cent DNA system as useless.

But since early sequences of the human genome were released in 2000, scientists around the world realised the non-coded sections of DNA played a role in switching particular genes on and off and so were crucial in finding cures for gene-related diseases.




Genetic Technologies founder and executive said his team pounced on the unwanted DNA and successfully bought the patent covering the non-coded DNA of every living creature, including humans.

Speaking from his home in Colorado, Dr Jacobson said Genetic Technologies had settled its court case with Nuvelo and Covance, though details of the settlement were confidential.

The outstanding lawsuit is with US biotech giant Applera Corporation, and Dr Jacobson said he was determined to go all the way to a final judgement to protect the company's patents.

He said a win against Applera, which has annual sales of more than $US2 billion ($A2.8 billion), could be a warning to any other company considering an infringement of the patents.

Dr Jacobson said Genetic Technologies had sold more than a dozen licences to institutions to enable them to use its patent to conduct research on non-coded DNA.
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Postby rath » Tue Apr 21, 2009 11:45 pm

Genetic Technologies celebrates win over Applera in patent battle

12/12/2005

An elated Dr Mervyn Jacobson, CEO of Genetic Technologies (ASX:GTG, NASDAQ:GENE), flew back to Melbourne from San Francisco this morning after slaying his company's most reluctant dragon, giant US rival Applera.

After an exhausting mediation session lasting from 9am on December 8 to 3am on December 9, Applera's lawyers agreed to pay an undisclosed fee to license GTG's patented 'junk DNA' gene-testing technology, one of the broadest patents ever issued in the recombinant DNA technology field, and the only US patent on the use of non-coding DNA markers for gene testing.

The commercial terms of the settlement remain confidential, but according an announcement to GTG shareholders today, GTG and Applera have executed several binding agreements, including a final settlement agreement, a licence agreement, and a supply agreement, before Judge Joseph Spero, of the US District Court of Northern California.

The two parties will also move to dismiss all claims and counterclaims in their legal action before Judge Phillis Hamilton, in the same jurisdiction.

Lone holdout

GTG originally sued Applera, and two other US gene testing companies, Novelo and Covance, in March 2003, for refusing to take licences and pay royalties on its patented technologies. Novelo and Covance both submitted and took licences in November 2004, leaving Applera -- the largest gene-testing company in the US -- as the lone holdout.

The first sign of a negotiated settlement came on October 13 this year, when the parties executed a confidential term sheet and agreed to further negotiations before Judge Spero.

Applera and GTG were originally to have reached a negotiated settlement on November 9, but after three extensions, finally settled on December 9.

Jacobson today described the mediation process as "quite strenuous".

"But standing back and looking at it from 38,000 feet, it's a very significant result," he said. "Since GTG launched its licensing program three years ago, we've had people challenging our right to charge licence fees, or telling us to go to hell and sue us.

"It's been constant -- even when we were pursuing licences, there has always been some company or group challenging us, so we've been continually distracted with ongoing legal battles. But this is the end of the seventh and final battle.

"Today, with the Applera matter settled, nobody in the world is challenging our patents. For a little Australian company to file a lawsuit against Applera, and have the resources to see it through, and bear the associated legal costs for three years, is obviously very significant."

Turning point

Jacobson said the research community and commercial gene-testing companies around the world had been watching the case, and would see it as a turning point.

"Lots of people have hidden behind Applera, believed that time was on their side, if Applera could continue to obstruct us, and invalidate our patents -- or simply wait us out," he said. "Now that Applera has come to an agreement with us, they have nowhere to hide."

Jacobson warned that companies that had delayed taking a licence from GTG were now exposed. "The nature of the settlement may justify us repricing," he said. "Our own view on what the patents are worth may need to be reexamined.

"I am now setting my sights on hundreds of targets who, in our view, already owe substantial amounts for past activities, and will owe us more for future activities."

Win for Australian biotech

Jacobson characterised the win as "a great victory for Australia's biotechnology industry too."

"In human terms, this is a case of the little guy taking on a giant and prevailing," he said. "So we have to assume that the little guy had something of great value -- that's now clearly established.

Genetic Technologies said, we've not sued anybody within Australia."
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Postby rath » Thu Nov 01, 2012 7:56 am

NEW YORK (GenomeWeb News) – Genetic Technologies has filed four separate lawsuits claiming infringement of a patent covering its non-coding DNA technology.

Its case against Genesis Genetics Institute was filed in US District Court, Eastern District of Michigan, Southern Division on Sept. 13. In separate cases, it also sued Reprogenetics and Medical Diagnostic Laboratories in the US District Court for the District of New Jersey on Sept. 26, and it sued IVF Institute in the US District Court for the District of Eastern Virginia.

Court documents for the IVF lawsuit were not yet available online, but in the other three cases GTG is alleging infringement of US Patent No. 5,612,179 titled "Intron sequence analysis method for detection of adjacent and remote locus alleles as haplotypes," which was assigned by an entity called Genetype AG to GTG. The patent was originally assigned by the technology's inventor Malcolm Simons.

The patent is at the center of a series of lawsuits that Melbourne, Australia-based GTG has directed at numerous companies including Agilent Technologies; Bristol-Myers Squibb; Hologic; Navigenics; Pfizer; and 454 Life Sciences, as well as Beckman Coulter and Gen-Probe, now part of Hologic. Some of the earlier litigation has been settled, and since it filed its lawsuit against Beckman Coulter, now a Danaher company, in early 2010 it has secured more than $15 million in licensing revenues, GTG said.

In August, GTG sued Reproductive Genetics Institute claiming the Chicago-based firm infringes the '179 of it's patent.
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