Reform of gene patent law, or not
Should we be able to patent something that already exists and that you haven’t invented? You can if it is a human gene. The issue has polarized views, inflamed passions, and prompted an Australian Government senate enquiry.
The Australian Government’s Senate Standing Committee on Community Affairs is holding an enquiry into the patenting of genes. That is, should we be able to patent a human gene or that of any other living organism, or the protein products of that gene.
You may ask how you can patent something that already exists and that you haven’t invented, key criteria if one is to be granted a patent on anything. There are many people asking this, but the question is more complex that it appears and it has polarized those involved and the passions are scolding hot.
The latest dog fight leading to this enquiry started last year when the company Genetic Technologies and its US mate Myriad Genetics Inc. wanted all labs performing genetic testing for the BRCA 1 and BRCA 2 breast cancer genes to ‘cease and desist’ such nefarious activities because they were infringing their patents on the BRCA 1 and 2 genes. Up until then, Genetic Technologies allowed other laboratories in Australia to freely perform the BRCA testing, which meant patients could get the test cheaply or for free. But in November (2008) GTG got a new board and they wanted to do things differently, which could have seen patients paying more than $1000 for a single test. A month later they backed down and decided to continue to allow companies free access to the testing technologies.
Gene patent law in Australia
At the moment, you cannot patent a gene or gene sequence in its natural state. You have to isolate them and reproduce them and they have to have a function ascribed to them to be patentable – see IPRIA submission to senate enquiry
A key aspect of the debate is whether even the isolation and reproduction of a gene constitutes an invention or something novel. Its interpretation, as illustrated in the BRCA test spat, has potential effects on human health, equity of access to associated care and the potential advancement of technologies and knowledge that could lead to improved treatments.
But even in the eyes of the law, the debate is wider and more complex than this. There are social, scientific, legal and economic forces interacting here, and looking at the arguments and some of the submissions to the senate enquiry so far, these aspects are being considered – and delivered more passionately than the legal aspects.
So, will shutting down the ability to patent genes stifle investment in R&D? Or does a patent on a gene hinder research? What is the best balance? Personally, I have no idea, but I do struggle with the concept that even the isolations and copying of a gene is somehow an invention. I differentiate this from manipulating a gene in someway, for example, to turn it into a vaccine as happened with the cervical cancer vaccine. Nor do I have no issue with research groups or industry obtaining patents per se. If it costs more than $1billion to get a pharmaceutical drug to market then a company needs some protection against the risk and a chance to make a quid. But an isolated or copied gene is, to me, still effectively in its natural state.
Early in the year I went to a public forum on gene patenting run by the Uni Melbourne’s Intellectual Property Research Institute who have done some research into this topic.
If I read the feeling in the room correctly – and there were some strong feelings – then I think most people in the room were against the idea of gene patenting, even if was an intuitive feeling rather than based on any hard evidence. But gut feelings don’t have much sway in these games.
A summary of the speakers at the forum can be found on page 11 of the submission to the senate in Melbourne on 3 August.
From what I have read and heard so far, there is possibly enough impetus and public sentiment to force a reform of the law regarding gene patents, if for no other reason than the patent law is a bit too antiquated for the new era of genetics and other emerging technologies – something that has been raised in many reports including submissions to the senate enquiry, but it is early days and the wheels of government turn slow.
More reading
An interesting read for anyone trying to get beyond the media overview of this debate can be found in this article by Matthew Rimmer published in the Melbourne Journal of International Law. A discussion about the need for reform using the rush to patent the genome of the SARS virus as a case study
Ian Fraser Editorial, The Australian 8 August – Former Australian of the year and inventor of the cervical cancer vaccine, he is firmly against the patenting of genes
And so is this guy, Luigi Palombi, an intellectual property lawyer from ANU speaking here to the ABC’s Law Report, but he is not media shy or afraid to express his opinion on this topic as any web search will show.
From what i could understand.. if we were to patent a gene, human or not, even if it is to be in it’s natural state, i believe that a time would come when these patented genes will be used in order to manipulate genes to create ‘Superior’ organisms, much in the way they did in GATTACA generating a different social class away from racial discrimination. (Yes i am still a year 12 student and GATTACA is still fresh in my mind, sorry for the reference). But this probably won’t be possible for a few years yet however, but with emerging technologies who knows? However i do believe that doing these test to create new vaccines as was done with cervical cancer, would be beneficial to society as it would contribute greatly, but if it were patented to some giant corporation which charged large sums of money to test, it would obviously greatly limit the extent at which this research could progress to and the parts of society which would benefit this research. It could be used for deadly diseases and viruses perhaps, but money is the obstacle which has to be overcome. As far as gene manipulation itself goes, I’m against cloning and the creation of a baby/person with altered genes which would make them superior, but to create organs for those with the need is also a thing which requires discussion.. so they deserve it? what have they done to require such a transplant? is it heridtary? disease? cancer? brought on by abusive drinking? smoking? all of those facters must be considered.
Yes who knows with emerging technologies, but as with any emerging (or existing) technology, it is not so much the science, but how we as a society choose to use or apply it. And you are not the lone ranger with your concerns about giant corporations with large sums of money and their need to make ever increasing profits, but it can sometimes be a double-edged sword because these companies are often the only people with enough money to develop these new drugs or treatments for disease, and their argument is that the only way to protect the years of research and millions of dollars is through patents. In other words they need someway to hedge against the risk of investing in something that might ultimately fail – and many drugs being tested do fail or never make it to market. There are alternatives out there such as Open Source – see Cambia at http://www.cambia.org
And finally yes, who gets access to technologies such as a recently grown liver, an alcoholic with cirrhosis or a teenager with genetically-linked liver failure? Unless the technology has advanced that far that we can grow livers like carrots – but that is a long way off. It is an interesting debate to be had.
Jason
GNTIS