Thursday, 2 October 2014
The Full Federal Court of Australia in its very recent judgement in the matter of Yvonne D'Arcy and Myriad Genetics has catapulted gene patents once more onto the political agenda since it is now clear, despite the lodgement of an appeal to the High Court, that this issue can only be definitively resolved through legislation to amend the Patents Act. This decision is the reverse of the virtually identical case against Myriad in the US, where the US Supreme Court found in a unanimous nine-zero decision last year that human genes, whether isolated or not, are products of nature and as such are not patentable subject matter.
The US Supreme Court's unanimous judgements in both the Myriad case and a prior case of Mayo and Prometheus supported the decision by the US government to overturn three decades of US patent policy. This decision means that genetic materials isolated from the human body should never have been patented, in the same way that coal extracted from the earth and cotton fibres extracted from cotton seeds could never be. The Full Federal Court ignored this concern, arguing instead:
This case is not about the wisdom of the patent system.
… … …
It is not about whether, for policy or moral or social reasons, patents for gene sequences should be excluded from patentability.
That abrogation of responsibility was, respectfully, a mistake the US Supreme Court did not make.
Patents over human DNA, a material that no-one invented, would, as the US justices warn, 'impede the flow of information that might permit, indeed, spur, invention'. Americans are now free to use DNA to develop new products, while Australians are not. Which is the more desirable policy outcome? Both the US and Australian patent systems share a common ancestry going back hundreds of years with the objective of encouraging and rewarding inventions, not discoveries. Knowing which genetic mutations are linked to breast cancer is a discovery; and isolating those genetic mutations is not an invention.
It often comes as an unwelcome surprise to Australians to learn that at present anyone can patent human genes, with the result that no-one else, including scientists, medical researchers or doctors carrying out tests, can access those genes without obtaining an expensive licence from the patent holder. People often ask how it is even possible for a corporation to have received a patent over a gene when no-one invented our genes, not even the defective cancer-causing ones; when genes are clearly a product of nature.
The companies holding gene patents argue that by removing a gene from the body that is, by isolating it, by putting it in a test tube—they have invented it. IP Australia, which has been granting these patents for the last two decades, agrees with this, and on 5 September the Australian Federal Court too agreed with this proposition, finding that Myriad's isolation of the human genes linked to breast and ovarian cancer is an invention under Australian patent law.
It is true that in 2004 the Australian Law Reform Commission considered these issues without calling for legislative reform regarding gene patents, but it did so largely in the view that the international position on the law was that isolated genes could be patented. That conclusion has turned out to be wrong in view of the US Supreme Court's decision.
It is salient to mention that, when the Senate Constitutional and Legal Affairs Committee considered the Patent Amendment (Human Genes and Biological Materials) Bill 2010 and recommended that it not proceed, the majority report was particularly concerned that the scope of the proposed change covered all biological material rather than just genetic material. Since then the US Supreme Court has definitely ruled that that distinction makes no difference. Any biological material extracted from nature, whether it be bacteria or a human genetic mutation linked to breast cancer, cannot be patented if it is 'not markedly different to anything found in nature'. Merely isolating or purifying biological materials is not enough to make them eligible for a patent monopoly under US patent law.
During the hearing of the case, US Supreme Court Justice Sotomayor noted that she could bake a chocolate chip cookie from natural ingredients—salt, flour, eggs and butter—and that, if she combusted those ingredients in a totally new way, she could get a patent on that. But she could not imagine getting a patent on the basic items of salt, flour and eggs simply because she'd created a new use or a new product from those ingredients.
Similarly, there is no objection to patents being granted over inventions such as medicines, vaccines, therapies and new methods for diagnosis that use genetic materials in them. The objection is to the patenting of the underlying genetic materials themselves because (a) no-one invented these materials—they are products of nature—and (b) the patents prevent others accessing fundamental genetic information needed to diagnose disease and develop new health treatments.
Neither the ALRC nor the parliamentary committee had the advantage of the recent US Supreme Court decision. Unfortunately, because of the full Federal Court decision, that difficult task remains before us. As I have done consistently, I will continue to argue for the Australian parliament and government to resolve this issue in favour of our common ownership and access to what at the end of the day should be the private property of no-one and everyone. This requires a simple amendment to the Patents Act.