Waiting game with human gene patent law
By Jason Major
TechNyou
The Australian Senate’s, Community Affairs References Committee last week released its long-awaited report into gene patents, with a specific focus on the patenting of human genes.
The brief version
I have yet to read it in full (it’s 190 pages), but based on the executive summary it seems the committee has formed strong opinions, but stopped short of making explicit recommendations about whether the patenting of human genes should be allowed, or not.
Although the report states that it heard a number of cases where the provision of healthcare or the conduct of medical research in Australia has been impeded because of human gene patents, at this stage they claim the evidence did not show that gene patents are systematically leading to adverse effects in these areas.
They also state there is sufficient uncertainty remaining about the effect of human gene patents and so have recommended mechanisms such as monitoring and auditing functions be installed to improve the quality of the data and provide greater clarity on the issues. That is, they want more and better quality info before committing to any sort of firm recommendation.
Opinion versus recommendation
Although the committee didn’t get carried away with recommendations they occasionally got opinionated, and this is possibly more indicative of how the committee feels on a more personal level. One of their more strongly worded opinions relates to the concept of a human gene as an invention. A quote from the report: “The Committee strongly rejects the reasoning which says that, for the purposes of the Patents Act 1990 (the Act), genetic information that is ‘isolated’ from its naturally occurring state in the human body may be classed as an invention, and therefore properly be the subject of a patent (where the other requirements of patentability are satisfied).”
But they then go onto to say, “However, a number of considerations persuaded the Committee that it would not, at this point in time, recommend that the Act be amended to expressly prohibit the patenting of genes.”
Some of the committee’s reluctance to make specific recommendations for or against gene patenting comes from legal developments happening here and in the US.
In the USA, a legal challenge to the validity of two human breast cancer gene patents was recently decided in a US District Court and found that isolated genetic materials are not patentable. Should this decision be confirmed by a higher court on appeal, the finding will become binding on the practices of the United States Patent and Trademark Office (USPTO), and is expected to have implications for IP Australia.
Australia also has a similar challenge to the breast cancer (BRCA) gene patents happening in the Federal Court. If the court finds that isolated genetic materials are not
patentable, IP Australia will need to adjust its approach to gene patenting.
On top of this there is expected to be a Private Member’s bill introduced into Australian Federal Parliament that will attempt to amend the Human Genes and Biological Materials Bill 2010 and ultimately prevent the patenting of human genes and biological materials existing in nature.
So if there is a gene for patience, it would be worth gold at the moment, but possibly not for long. And the period of uncertainty will continue for those anxious Biotech CEOs
More info
Image: dna-structure.com
Telomerase reverses ageing process
Nature News: 28 November 2010
Premature ageing can be reversed by reactivating an enzyme that protects the tips of chromosomes, a study in mice suggests.
Protecting chromosome tips doesn't just prevent ageing. It can reverse it.Peter Lansdorp/Visuals Unlimited/Corbis
Novel genetic circuits rewire human cells
Nature News: 25 November 2010
Biologists have engineered DNA to coax cells to differentiate – or die – on demand.
Synthetic genetic switches have a variety of uses, including causing diseased cells to kill themselves, or become susceptible to drugs. Kristine Chang and Stephanie Culler, Stanford University
What role for nano in healthcare for developing nations?
By Jason Major
Technyou
The news web site SciDev Net has collated a series of news, feature and opinion articles investigating the potential of nanotechnology to improve health care in developing nations.
Some of the questions raised and explored include the following:
Is nanotechnology an unrealistic investment for these countries?
Will it be affordable?
Is there a lack of information on what nanotechnology can do for healthcare in developing countries?
Should governments and the private sector fund nanotechnology research in these countries?
What are the risks and what policies would ensure the best use of an expensive technology?
And what specific areas relevant to health needs should be prioritised?
Looking past the techno fix
All the articles are worth a read, but will I draw your attention to one article contributed by Donald Maclurcan, an honorary research fellow with the Institute for Nanoscale Technology at the University of Technology, Sydney.
Those of you who read my recent post critiquing the Friends of the Earth report on nanotech in which I emphasised the need for greater integration between the techno-fix of the science and the socio/political/cultural….etc aspects of our world.
Maclurcan explores just this concept, stating that if nanotechnology is going to have any value in a role to improve health in developing nations it will require more than technological ‘fixes’. “We also need awareness of the gender, geographic, cultural, societal, philosophical and religious biases that are built in to technologies throughout the various phases of R&D,” he says.
Patients at Uganda clinic
Image: Flickr/US Army africa
First construction of 3D nano structure on surfaces
University of Nottingham: 23 November 2010
Scientists have demonstrated that 3-D molecular structures can be built on a surface, a development that could help shape the future of nanotechnology.
Image courtesy of University of Nottingham
3D molecular structure
Opposing voices in embryonic stem cell debate missing in action?
By Jason Major
TechNyou
Positive news abounds about the commencement of clinical trials using embryonic stem cells, but the voice of opposition seems to have faded, at least in the media. Why has this happened?
Two clinical trials are now underway using embryonic stems cells. A third using fetal stem cells was announced last week.
And they’re off
Last month it was the company Geron injecting ESCs into patients with spinal cord injury. Coming in a close second (not that it is a race – or is it?) is Advanced Cell Technologies using the ESCs to treat Stargardt’s macular dystrophy, a disease leading to early blindness.
ReNeuron and the University of Glasgow announced last week they were using neural stem cells, apparently from a 12 week old fetus, to treat stroke. Although not technically ESCs, such cells are as morally controversial as embryonic stem cells, especially among the pro-life groups.
What’s with the media?
The media have been thoroughly positive in their framing of these stories with only peripheral mention that there may be groups opposed to the use of embryonic stem cells. See below for links to a selection of media stories.
It seems only yesterday that where there was a story on research into ESCs there a loud voice taking up significant column inches berating the world for thinking ESCs were morally acceptable. Where has this voice gone?
The mere mention of GM food or nanoparticles generates a torrent of opposition voices, often in the headline – “Frankenfish” being the more colourful of recent news headlines.
I wonder if the media purposely avoided seeking comment from the key ESC opponents, or if the groups themselves sought not to provide it. Either way, my question is why. What has happened in the past couple of years to have this happen? Has the debate been had and society (or media editors) decided that ESCs are acceptable? I doubt the fact that both trials involving the ESCs were privately funded had any influence, but I could be wrong.
I am not suggesting that the opposition voice should be there, that is not for me to judge. But I am curious about why it has disappeared as I am sure the same people and groups who opposed it before, still do. A cursory glance of the blog-o-sphere seems to confirm this.
Links to news stories on recent ESC trials
Biofortified crops ready for developing world debut
SciDev Net: 17 November 2010
A range of crops rich in micronutrients will be launched from next year, but is the developing world ready for them?
Stem cell trial for blindness gets green light
New Scientist: 22 November 2010
Twelve people left almost blind by a hereditary condition that strikes in childhood are to receive the world’s first eye therapy derived from human embryonic stem cells.
Nanotech: overheated promises and hot air
By Jason Major
TechNyou
Friends of the Earth recently released a report, Nanotechnology, climate and energy: Over-heated promises and hot air? The report sets out to debunk industry’s promise of using nanotechnologies to solve the world’s energy and environmental problems.
All well and good, but apart from giving the industry marketing guys are poke in the eye, my examination of the exec summary, highlights and a few chapters found it devoid of anything revelatory, certain nothing apocalyptic. Its content has already been reported on or acknowledged elsewhere. The fact they are quoting or using science-based references alone suggests the issues they highlight are already acknowledged, at least in the scientific community.
If it is just the lay person they are trying to reach, then fine. It is a report that helps put the nano science and potential applications and issues into some perspective. But if it is those in policy, regulation, communication or involved the actual scientific research they are trying to influence I think they are simply stating the obvious, although there will likely be many in these fields that disagree about the best way to resolve the issues FOE raise.
Not the silver bullet
One of the key points FOE make is that industry has over-promised and under-delivered with nanotech. With any new technology there is hype and expectations, but eventually, as the knowledge progresses, realities will emerge.
OK, for the average non-scientist out there who gets his technological insights from the newspaper and TV he may have notions of nanobots, space elevators and cheap solar energy, but in my world involving the scientists and related institutions, communicators such as myself, and even governments we are well aware of the realities of nanotech. For any problem people try to solve with technology there will be 100s of good ideas, but only a handful will turn out to be viable. And this takes time and robust science to work it out. Thin-film nano solar cells do have issues, as pointed out in the report, but are still potentially a good idea. Nobody I know is running around saying we have solved the problem, perfected the technology….or anything of that ilk. It will take time to find which ideas, or which scientific advance will be viable – if any. Those that are too dangerous or simply uneconomic will eventually disappear. And just because the research effort may not deliver for another 10-20 years doesn’t mean we shouldn’t fund the research. Science rarely progresses in revolutionary leaps.
Infiltration by stealth?
FOE also make the point that intentionally manufactured nanoparticles are already found in a wide range of other products, such as cosmetics, sunscreens, clothing and paints. And that most nanoparticles are not developed or used for energy efficiency or to reduce a product’s environmental footprint.
Correct, in the same way the modern electric vacuum cleaner was not designed for energy efficiency or to reduce the environmental footprint. It was designed to clean carpets. Personally, I have no problem with my grandmother’s old manual carpet cleaner with the rotating brushes. We can all make that choice. But does that mean we should prevent people applying the knowledge for these purposes. If that is the case you could ban a lot of other non-nano things as well – eg vacuum cleaners, leaf blowers, whipper snippers. Actually the last two should be banned – noisy, smelly, pointless things that destroy my serenity.
And yes, the manufacturing of some nanomaterials is incredibly energy intensive and can release harmful emissions, especially as pointed out in the report, carbon nano tubes. This is certainly a valid point and one for consideration, but this is all very early stage science. We are still grappling with the absolute basics here. They seem to leave out science’s attempts to address the issues they raise. For example, recent research out of MIT has found a potentially greener way to grow carbon nanotubes. Initial results suggest they can reduce emissions of harmful by-products at least tenfold and, in some cases, by a factor of 100. It also cut the amount of energy used in the process by half.
Professor Paul Mulvaney’s lab in the University of Melbourne’s Bio21 Institute has a PV cell based on quantum dot technology that is 7% efficient, but it is based on CdTe (Cadmium Tellurium), so is toxic. In the US, they claim they can recycle these chemicals and there will be no environmental fallout. Even so, Mulvaney and other labs worldwide are working on alternatives. Mulvaney’s lab is trying to make thin film semiconductors using nanocrystals as an ink from materials such as Cu2S, FeS2 (pyrite) and CuInSe2.
(For those wondering – Cu: copper; S: Sulfur; Fe: iron; In: Indium; Se: selenium)
We have the technology
The one point FOE do make which needs greater public debate is our apparent obsession with the technological fix. That is, to solve the problems we face we just need to generate a technology to overcome it when in fact there are is raft of social and ethical issues that underpin our behaviour that also need to be considered and incorporated into any scientific process. For example, short of one of those revolutionary scientific leaps, focusing on growing more food per hectare is not going to feed a growing population unless we go some way to sorting out the issue of poverty, wastage, corruption, war and so on… In my opinion, there is a lot of talk about the need for this integration of the science and social, but not much translation into action. It is happening on a small scale and the acknowledgement that it is important is also growing, but there is considerable room for improvement.
There may be revelations in the later chapters of this report and I am happy to be enlightened, should anyone have comments or further thoughts about this.
Other commentary on the FOE report
Review suggests limit exposure to carbon nanotubes
University California Berkeley 16 Nov 2010
A risk review suggests that product designers and others should provisionally treat CNTs “as if” they are hazardous.