More turf wars over patents, not to mention the turning of a genetic "junkyard into a potential gold mine" - one that can only be exploited with the implicit threat of litigation against researchers.

We also see the constantly changing face of biological knowledge as DNA that was once understood to be redundant "junk" becomes transformed into something that "carries vital information," after which it's claimed by some, who would otherwise have to get a licence from the relevant patent holder, that that was always obvious anyway!

This is the dizzying and avaricious world within which genetic engineers manipulate genes in a way they claim is "specific, precise and predictable".
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GTG FOUNDER DEFENDS DNA PATENT CASE
August 13, 2003
Royal Society News
http://www.lifesciencenz.com/news-detail.asp?newsID=4492

Pioneer New Zealand geneticist Malcolm Simons says people criticising the controversial international patents for ways to use "junk" DNA are on the wrong track.

In the late 1980s, Dr Simons - then a New Zealand immunologist working in Melbourne - came up with the idea that "junk" or non-coding DNA sequences between genes might carry vital information.

In 1989 he co-founded a company initially named GeneType, with Dr Mervyn Jacobson, an Australian doctor turned scientist and entrepreneur, who was running a standard medical diagnostic laboratory at the time.

The company, now known as Genetic Technologies Ltd, listed on the Australian stock exchange three years ago as GTG to exploit a decade of discoveries and patents on processes developed for working with the "junk".

While international teams of researchers focused on "patenting" genes that were seen as potentially connected to lucrative future uses, Dr Simons and Dr Jacobson turned a junkyard into a potential gold mine.

They patented ways to use non-coding DNA, such as in screening tests to predict individuals' genetic risk of developing diseases like cancer and cardiovascular disease.

It has since turned out that only 5 percent of the human genome contains protein coding sequences - spaced out by large stretches of non-coding sequences.

Other researchers have belatedly come to realise that while commercial companies were spending billions of dollars to tie up intellectual property associated with "coding" DNA, the "junk" actually comprises a self-organising operating system that controls how, when and where the genes will work, and controls their interaction.

GTG is systematically approaching manufacturers of laboratory equipment, screening laboratories and biotechnology companies around the world - including as many as 20 in New Zealand - alerting them to the fact they are using patented processes, and proposing ways in which the use could be licensed.

New Zealand has been offered a "national" licence for use of its patented methods of testing junk DNA in human diagnostic testing at public institutions: for $10 million in a lump sum plus $350,000 a year.

But the company has run into criticism from doctors and researchers who have argued that the patents are far too broad, threaten to restrict academic research, and may make it too expensive for people to take potentially life-saving tests to identify their risks of cancer and other diseases.

In New Zealand, Genesis Research chief executive Jim Watson, president of national science academy the Royal Society, said it was a matter of considerable contention in the scientific community that something as basic as DNA sequences could be patented.

"Prior to their patents, non-coding DNA was already being used," he said. There was concern that GTG might try to sue companies and researchers it believed had infringed its patents, and it had been warning companies that it held unlimited insurance cover to pay for lawsuits.

Auckland University pathology professor Peter Browett has said the issue could have a serious impact on future genetic testing.

Prof Browett, spokesman on the issue for the New Zealand committee of the Royal College of Pathologists of Australasia, said geneticists had used markers to track genes and genetic diseases for decades, "hence the discovery is not novel. Our view is that the patent needs to be challenged."

But Dr Simons told Australian Biotechnology News it was necessary to separate the issues of the scope of a patent, and GTG's plans to charge for academic use of its patents, from the issues of "who is claiming to have discovered what", and critics' claims that his discoveries were neither novel, nor non-obvious, as required by international patent law.

The first patent applications had been made in 1989-1990, and the most significant patents were issued in 1993, 1997 and 1998.

During this period, patent offices in all jurisdictions had chosen to grant the patents, with some modifications.

"Most people would accept that by 1998, the US Patent Office knew what it was doing," he said. "We can assume it wasn't lacking in competence, and five more years have now elapsed, during which thousands of people have had their attention drawn to the issue by GTG."

With the exception of several claims that are still subject to litigation, the process had not uncovered any publication that could be considered "prior art" disqualifying the patent claim.

"I'm not aware of any need from GTG advisers to notify patent offices of any change, so after 10 years it's looking pretty solid, and people should direct their criticisms at the patent office, not at me," he said. Dr Simons said he wanted his peers to substantiate their case that the application of non-coding DNA to disease-risk prediction was "obvious".

"If they can't, then the patent office is correct, and it's thanks very much. I would like to be recognised for my foresight and inventiveness, or to be told I'm deluded," he said.

Dr Simons, 63, who is dying of bone marrow cancer, said the commercial exploitation of the patents he established for GTG had nothing to do with him.

"It's a commercial decision in which I've got no part."

He retired from GTG in 2000 and sold his stake in the company, but he has since then filed a patent in his own right, related to haploid chromosomes, containing half the full set of genes.

He said, if it was developed, access would be available for a nominal sum of $A1 ($NZ1.13). He has lost none of his interest in genetics, and argues that many of the current searches for complex disease genes are off-target.