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.