I am a Patent Attorney, and one of my specialist areas is medical technology. I read the article by Prof Oliver of the Cancer Council in yesterday’s Crikey and heard him interviewed today on ABC Local Radio about his objections to the patenting of genes.
Unfortunately, most of Prof Oliver’s concerns are based on misunderstandings of the patent system, and in any case, the preventing of patents for gene sequences would not achieve his desired result.
Preventing gene sequence patents would not resolve the problem which Prof Oliver cites involving patents by Miriad Genetics covering the BRCA1 and BRCA2 gene sequences that were licensed to Genetic Technologies in Australia. Patents for gene sequences normally would not cover only the gene sequences alone, but would primarily be directed to the commercial applications for those genes, such as to a method for testing for breast cancer utilising the BRCA1 & 2 mutations, and to test kits for carrying out such tests.
Prof Oliver in his radio interview made it clear he had no objection to patents covering these other commercial applications, and so his proposed change to the patent law would actually achieve nothing of significance.
Fears about gene patents restricting pure research are false. It has always been accepted that academic research is not covered by patents. However, the Australian Patents Act does not presently make this explicit, although there are currently some proposals to add this provision. In fact, no researcher has been found to be infringing a patent in Australia, and is unlikely to ever be, even with the current provisions in the law, provided that the research does not have a strong commercial component.
In recent times, some uncertainty about this point has arisen due to a court case in New Zealand, where some academic research was carried out that had been funded by a competitor of a patent owner that had substantial commercial ramifications. This court decision was surprising, and I think is doubtful whether Australian courts would follow it anyway in similar circumstances.
Naturally occurring products, including genes, are not patentable unless they achieve the normal patenting requirements of being new and inventive, which would require a way to distinguish the new product from its natural version. As an example, say someone extracts a component from mung beans that they discover can cure cancer of the big toe, which they identify and call “mungbeanium”.
They can obtain a patent covering mungbeanium “in substantially pure form”, a pharmaceutical preparation of mungbeanium containing pharmaceutical diluents and carriers, and a method of treating cancer in the big toe using mungbeanium. This patent could not monopolise mung beans, although it would stop other people making up the extract and treating big toe cancer, or selling the extract for this purpose.
Now, if another researcher discovers the gene sequence for a mutation that increases the likelihood of a person getting cancer of the big toe, then that person can patent the commercial applications for this invention, such as a method of testing for big toe cancer using a genetic probe utilising this gene sequence, and can patent genetic test kits containing the gene sequence. They can patent the gene sequence itself, because of a unique property of genes, whereby a single strand gene sequence will bond to a complementary sequence, enabling the test kit to indicate the presence of that specific gene sequence in a sample being tested.
You can see that by excluding the patenting of gene sequences themselves would not affect patents being granted to the other aspects of the diagnostic tests.
With the Miriad Genetics BRCA1 & 2 gene sequence patents, the test kits used would still be sourced from the licensees, and they can still charge whatever they like for them, as well as determine which laboratories they sell them to, whether or not patents exist for the genes themselves. Changing the patent law in this regard will not alter this situation.
Not to mention that the Australian Patent law has other features that can be used if the patent system is misused, such as compulsory licensing provisions, and some exemption for government use of patents in some circumstances.
I note that the complaint is not that laboratories should not pay the going rate for test kits from manufacturers, but that they should not have to pay the component of the cost that accrues to the inventors and developers of the kit. Ethically this seems suspect, to me.
Australia is developing a substantial medical technology expertise, and interfering with the patent system in this field will be a disadvantage. Sufferers from cancer will hope that manufacturers of cancer treatments and test kits will continue to provide their products in the Australian market, despite the considerable costs in doing so. Adding unnecessary complications to the patent system just in Australia is unlikely to encourage this.
Glen Gordon may understand patent law but he certainly does not understand science. This article is extremely misleading in its’ use of what I assume to be legal and or patent method terms such as “test kits” to propose that these are what are being protected by the patent rather than the actual human genes. You certainly could develop a “test kit” for a cancer predisposition mutation however you could also use a dozen other methods to probe for such a known mutation all of which are standard, unpatented, everyday, basic molecular biology methods and certainly not in any way innovative or inventive.
Later he states flat out that you can in fact patent human genes:
“They can patent the gene sequence itself, because of a unique property of genes, whereby a single strand gene sequence will bond to a complementary sequence, enabling the test kit to indicate the presence of that specific gene sequence in a sample being tested.”
The description of the “invention” here is in fact simply a description of what occurs in all dividing cells in every living organism. It is a basic, natural, property of biology and certainly not an invention. This goes to the heart of the argument as to why genes, gene sequences and so called “test kits” which are really just basic science can even be patented since there is simply no innovative or inventive step, merely discovery.
There is certainly plenty of investment of time and money in such research but this in itself does not merit patentability. Further once the discovery of a mutation is made the incidental cost of testing for it is practically zero. The cost of visiting your doctor to have a sample taken and paying the lab worker to run the test far outweigh the cost of the actual compenents of the test. The fact is that in the case of the BRCA genes the company that owns the patents was (and perhaps still is) charging a ludicrous ammount for the testing as well as demanding the rights to use the private patient data for further proprietary research.
As for such patents not affecting (academic) research on such basic and essential components of every cell in our bodies, this is simply false. Almost every single dollar of funding for even the most academic of research is tied to the hope and indeed expectation of a commercial outcome at some stage whether that is the researcher’s aim or not. Thus gene patents have the power to not only stop such research at any stage they often stop it from even starting since granting bodies and institutions will demand to know if the IP is going to be “encumbered”.
Far from being some kind of protection for hard earned inventions gene patents are an unwarranted reward of monopolistic power over, and to demand usurious rates for, what is essentially the raw and very personal information which provides the blueprint for our very being.
And very far from encouraging competition and research, gene patents provide their owners with the ability to stifle and strangle further research.
Finally the argument that Australians should hope for the current system to continue in the hope of gettin better treatment is surely a very sick joke. Australia’s very poor record in truly private R&D funding is well known and Australia’s excellent and hard earned reputation for bio-medical research and discoveries is almost entirely funded by tax payers either through the government or through their donations to medical charities.
Glen Gordon has made a series of extraordinarily misleading statements in his article ost of which Stuart Skabo has covered.
“It has always been accepted that academic research is not covered by patents. ” Sadly not true, even if most patent holders do not bother with much research use because of the cost factor (especially in a tiny place like Australia). The patents on PCR and the enzymes involved have cost academic research labs a minor fortune over the years. And it was a bunch of French academics who were performing BRCA1 tests that were sued by Myriad and who in turn took Myriad to court.
Stuart Skabo is correct about Oliver’s statement that it is not a problem for test kits to be patented. Myriad does not hold patents on all the possible means of testing for the BRCA mutations (many of which were not invented at the time), instead they tried (successfully so far) to claim all possible existing and future tests of those mutations were “owned” by Myriad. The mutations are entirely natural and were discovered and not invented by Myriad and others, but there would be fierce competition for test kits and methods if those patents did not inhibit the field.
The facts are that the USPTO was out of its depth when it had to start pronouncing on biological patents, and then overrun by sheer numbers which itself was a strategy of the patent lawyers and biotech industry. Allowing patenting of natural DNA sequence and naturally occurring variants (mutations) was an incredible folly. All scientists I know have always believed that to be true, and the only exceptions usually turn out to have a vested interest rather than a rational argument. These legalistic arguments of course have not happened in Australia because we have simply adopted American practice (where legal firepower determines the outcome). As a market we do not matter but it might be nice if we showed the way and started unravelling this absurd and counterproductive patent law that hands a pure monopoly to single entities for mere discoveries of nature.