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Why are gene patents so controversial?

Labor backbencher Melissa Parke is set to introduce a private member’s bill into federal parliament to ban patents on genetic material. The government recently passed new legislation, the Raising the Bar Act, which allows researchers access to patented genes.

But Parke and Liberal Senator Bill Heffernan (a fellow avid supporter of abandoning gene patents) believe there is an omission in the legislation, which they aim to rectify. Four thousand human genes have already been patented and the two politicians want to ban all patents on human genes.

Crikey spoke to Dr Matthew Rimmer, an Australian Research Council Future Fellow and intellectual property law expert at the Australian National University to find out why gene patenting is so divisive …

What is gene patenting and why is it so controversial?

Some companies have been patenting individual human genes, claiming the rights to those genes under intellectual property law. This means that those companies can theoretically establish a monopoly on new medical treatments or procedures which may be of benefit to a large section of the community. This has the potential to make innovative medical treatments unaffordable by the people who need them, say critics.

Rimmer says there is a backlash against the push to patents by civil society groups and dissenting politicians and that even the courts have become divided over the issue.

The classic controversy revolves around laws of nature and abstract ideas which are outside patentable subject matter,” Rimmer told Crikey. “The debate has previously revolved around certain genes relating to breast cancer and ovarian cancer, which has caused controversy in the EU, US and Australia. The really complex question is in determining what is a product of nature and what is a scientific invention. It is hard to draw lines of distinction.”

Parke appeared on Lateline on Monday arguing that genetic information belongs to everyone, not just corporations. ”Well I think the fundamental issue is that genes … contain fundamental information about the human body that should be freely available to people everywhere. It should not be locked up in the hands of private corporations,” said the MP.

What efforts have been made before to prohibit gene patents?

Rimmer says the current debate gives him a ”feeling of déjà vu”. ”We’ve had a rolling, inconclusive debate which has been taking place since the 1970s since Genentech started filing patents,” he told Crikey.

Various efforts have been made in Australia in the 1990s and the 2000s to prohibit gene patents. In the 1990s the Australian Democrats led the push and it has been taken up by Liberal Senator Bill Heffernan more recently. The Heffernan bill [2010] was unsuccessful because it was too broad, with ambiguous and unclear definitions,” he explained.

The Liberal Senator is again involved, helping to draw up the bill with Parke and arguing for it in his own party.

As we have seen in the past, the broader the bill is, the less likely it is to get up,” said Rimmer. “If Melissa Parke can draft a prohibition bill which has the clarity required it might get through, although there would need to be broader consensus amongst the major political parties to get up such a prohibition.”

In 2010 a New York federal court ruled that patents on two genes that produce breast cancer are invalid, although in 2011 a US appeals court determined that companies can patent genes. A similar case is currently before the Federal Court of Australia, challenging gene patents relating to breast and ovarian cancer, which the US company Myriad Genetics holds.

Did the Raising the Bar Act do enough to protect research on patented genes?

The Raising the Bar bill did contain some reforms that could be applied to gene patents — such as raising patent criteria, such as the standard of utility, and introducing a defence of experimental use,” said Rimmer.

However, the Raising the Bar bill did not address patentable subject matter. The Raising the Bar bill needed proper committee debate in Parliament. It was railroaded through. It would’ve been worthwhile to review that further, especially in regard to developments in the US. The bill was rushed through without proper scrutiny,” he argues. Rimmer added: “Melissa Parke and I differ on options. She is very focused on prohibition. She takes a human rights perspective, that patent law should respect human rights, especially the right to health and the right to freedom of research.”

What does the new bill need to incorporate?

It needs to take a broader view of intellectual property and biotechnology, says Rimmer. ”The topic of access to essential medicines has been overlooked,” he said. “I find it peculiar that there’s been such inertia in the federal Parliament around these issues. Some medications are important for HIV aids, malaria, tuberculosis and other infectious diseases. It’s important to introduce a patent reform in line with Doha [the 2001 Doha Declaration], but given the cuts to foreign aid in the recent federal budget it looks unlikely.

We need to take on the full gamut of new technologies, being developments in IT, biotechnology, stem cell technology, nanotechnology and synthetic biology,” Rimmer told Crikey.  There is a need to consider the impact of biotechnology on agriculture, health and medicine, energy and climate change.”

5
  • 1
    JamesH
    Posted Wednesday, 16 May 2012 at 3:01 pm | Permalink

    In 2010 a New York federal court ruled that patents on two genes that produce breast cancer”. What?

  • 2
    Crikey Intern
    Posted Wednesday, 16 May 2012 at 3:12 pm | Permalink

    Oops. Thanks for that, JamesH. A typo slipped through. Rectified.

  • 3
    michael r james
    Posted Wednesday, 16 May 2012 at 3:12 pm | Permalink

    The really complex question is in determining what is a product of nature and what is a scientific invention. It is hard to draw lines of distinction”

    No, it is not really complex or difficult. Genes and their DNA sequence are a simple discovery.
    I don’t know why Matthew Rimmer has a problem understanding this — except of course that he is a” intellectual property law expert” with no mention of appropriate qualifications in the biology. (FYI, I am a PhD research scientist specializing for over 35 years in molecular genetics and I played a role in the Human Genome project.)

    There really is no great issue with Big Pharma or Biotech obtaining patents for inventions based on genes, eg. drugs targeting particular genes or specific mutations in genes. As has been pointed out endlessly by other scientists and indeed by many in biotech itself, removing the ability to lock up a gene in a patent would have almost zero impact on the development of drugs or processes based on genes; indeed it would free it up since one of the big logjams for companies as much as universities, is the problem of patent stacking whereby dozens of different patents owned by dozens of different entities need to give their permission or be negotiated with.

    But what the USPTO has done is awarded a single company all rights in any future application that depends on or relates to a specific gene. It was always recognized as nonsense and quite unjustifiable on existing patent law, but as usual in the US companies threw money and lobbying power at it and as usual the weight of money achieved what they wanted.

    A particularly egregious example (that I have written on previously, cannot lay my hands on it) is of the HIV receptor. It is a particular membrane protein involved in ion transport into the C4 cells. It turned out that a biotech company had patented this gene several years earlier because they had targeted this gene as a family of transporters likely to be of importance in certain processes in which they saw potential. The patent gave them all rights to develop an anti-HIV therapy even though it was unknown and totally unanticipated that the gene/protein played this adventitious role in HIV infection. In fact when the patent was granted (and it was a large suite of patents on target genes by this company and it was notorious at the time) the company didn’t have a single explicit application for this gene, yet they were allowed to have dibs on all future applications/developments based on this gene, even if they didn’t contribute one cent to the future research, as of course they had not in the HIV case. Clearly ridiculous and inhibitory to advances in development of HIV therapy.

    And NO, there is no “need to consider the impact of biotechnology on agriculture, health and medicine, energy and climate change” because, as I state above, if there is an actual invention based on a gene there is no problem gaining a patent. But the patent will not depend on rights to the gene, nor will any patent inhibit anyone else developing a product or process depending on that gene.

  • 4
    JimDocker
    Posted Wednesday, 16 May 2012 at 4:39 pm | Permalink

    Very proud to have Melissa Parke as my local member.

  • 5
    wood elijah
    Posted Monday, 21 May 2012 at 2:36 pm | Permalink

    Interesting post Michael. Don’t disagree with it. Though as an expert in the molecular genetics and not the law, I think you should be aware of some other bits and pieces (and unlike Rimmer I also have one of those PhD thingys, in molecular biochemistry/cell signaling).

    As you played a role in the Human Genome Project, you would of course be acutley aware that the human genome and the genomes of a number of other common species have been sequenced and and are easily available on the internet. This means that an application for a “gene patent” or for any other genetic material in the genome of a human or other common animal or plant is not new, or lacks novelty. Thus, I hope you do realise that since the publication of the human genome project, it has not been possible to obtain a “gene patent”. I think Luigi Palombi said himself there are only about 400 patents that haven’t yet expired (but soon will) that claim isolated human genes. Another few years and this is a totally non-issue. But why not bring the amendment to s18(2) in now anyway just to knock off those 400. Doesn’t bother me. But, just so you are aware, these days it is not much to get all excited about.

    As for your comments on simplicity, you have obviously forgotten (I haven’t) the dramatic advances in genetic and sequencing techologies over the last 35 years. Water baths anyone?

    removing the ability to lock up a gene in a patent would have almost zero impact on the development of drugs or processes based on genes” agree.

    indeed it would free it up since one of the big logjams for companies as much as universities, is the problem of patent stacking whereby dozens of different patents owned by dozens of different entities need to give their permission or be negotiated with”. Now redundant since Raising the Bar Act experimental use exemption came into force a month ago. University and any other Aussie researchers may now research to their hearts content without fear of patent infringement (not that 99.9% did before) so long as they don’t seek to make money from the claimed product/method in a patent (applies to any technical field).

    Reading the proposed amendments to s18(2) in the Lateline show, a concern is the removal of what’s known as diagnostic patents (Re: BRCA1/2) by s18(2)(c) . Whilst this has good intentions, I don’t think the result has been thoroughly considered. Say US, Europe and AUS remove diagnostic patents and I’m a Myriad, GTG or other. Instead of patenting my new diagnostic test for, lets say breast cancer, I keep it as a trade secret. I convince doctors to use my new test by showing them graphs of it’s accuracy but don’t have to explain in much detail on how it works or what genes/mutations I am looking at. A doctor sends away for the $3000 test because it is the best one available by a long shot and that’s how much I want to charge. The doctor gets back a yes/no or % answer i.e. there is no way to reverse engineer the test. End result. The company can maintain the monopoly for potentially far greater than 20 years, no govt. labs can make their own version, no researchers can make advances on the test, basically the community can’t benefit from the advancement other than to purchase a test for a specific person. This is the obvious result if diagnostic genetic tests are no longer patentable. Currently, the company gets a patent, everyone can read the published patent application and see how the test is done, researchers make better versions of the test without fear of infringment, the govt can always use crown use provsions if it wants it for the country regardless of monopoly, other companies can seek a compulsory licence through the courts if the company won’t play nice and give them one when asked, and after 20 years everyone can sell or use the test and have the instructions to do it. What do you think is the better outcome for the community?? This is the compromise of the patent system: public disclosure for temporary monopoly

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