By Dr Chris Dent
The recent discussion around the patenting of genetic materials is remarkable for its stridency. Witness, for example, the current Senate Committee review of the Patent Amendment (Human Genes and Biological Materials) Bill 2010. This post is not to add another voice that speaks the “truth” of a particular position but it is a step back to consider a key principle that constrains the nature and content of other participants.
My perspective is that the debate invites passionate responses because it is sited at the junction of four different (and competing) bodies of knowledge and/or practices:
- patent law;
- the science of genes;
- the nature of entities that seek to commercialise advances in the sciences; and
- the politics of public health.
Taken together, these different bodies mean that the debate is (necessarily) incomplete.
This is not the place for a detailed exploration of patent law. It is sufficient to say that the system started over 400 years ago in a time without significant state infrastructure or a scientific world view that privileged rigorous experimentation (outside the alchemists and their alembics). Since then, the system has adapted to multiple new technologies, different understandings of economics and varied forms of governance. As a result, it is now a complex beast that has highly technical understandings of what is “novel” and “inventive” (both of which are tested against the “prior art” but what constitutes the prior art for each test is different). The law has been developed, in part by the legislature, in part by the courts (to fill the gaps left by Parliament), and in part by the patent office (to fill gaps not yet considered judicially). It is itself, a regulatory technology aimed at encouraging innovation – there is no should about it. There are just rules.
But, some will say, the patenting of genetic material is against these rules, that a genetic invention is not “an artificially created state of affairs”. The problem here is that there is no statement of Australian law saying this. Until an appellate court (to respect the doctrine of precedent) or the Parliament says otherwise, these patents may be granted – whether they are valid depends on a court ruling. It may be stretching it to apply the maxim nulla poena sine lege, but without clarity that such patents are invalid, innovators in the area of gene science are equally allowed to seek a patent for a development with industrial application that has not been forbidden.
Science of genes
Of the four bodies of knowledge, this is the one I know least about. It is, however, central to issue of the patentability of genetic materials. I am not even going to attempt a summary of it. I will, however, assert that it takes years of university training to be an expert in the area – in the same way it takes years of training to understand the nuances of patent law. Even a judge ruling on a dispute over a patent over genetic material does not, despite the best efforts of the professors who act as witnesses, become expert in the science generally – though she or he may have a good grasp of the specifics of the invention in question.
Nature of organisations
Not all organisations that seek to commercialise innovations are profit-driven companies. Those that are have a focus on providing a return on the investment of the owners of the firm. Two issues arise from this. First, it is these entities that the rationale for patents is aimed at. Patents, under current economic theories, are to encourage investment in research and development. Other types of organisations also have a role in the development of genetic innovation, like small start-ups and universities. Neither of these are beholden to shareholders; however, it is not clear that either are immune from a desire to gain patents – in order to gain future funding or for profile purposes. The second matter of importance is that it takes skill to successfully run a company (whether it be research intensive or not) – skills that have developed over years in business. For someone outside business to dictate how to make a profit in a competitive industry is as disrespectful as to accuse a geneticist of not understanding the science of genes.
Politics of public health
The politics of public health relates to the way in which the debate occurs in practice. People and organisations (including government agencies) express an opinion, sometimes backed up by evidence sometimes not, in the public domain – talk-back radio, newspapers, in response to government publication and in Senate Committee hearings. The debate is not a free-for-all; there are (often unspoken) rules and forums of engagement. The debate is also coloured by party political affiliations and economic policy perspectives (including higher education funding and costs of healthcare borne by taxpayers). As with the other three bodies of knowledge, the development of policy by those internal, and external, to the government is a matter of learnt practices – to acknowledge, and accommodate, the interests of diverse stakeholders is not a straightforward task.
A key feature of the debate is the dominance of binaries. Much of the discussion focuses on, for example, patent protection versus competition; consumers versus companies; or simply right versus wrong. The approach of this post appears to add another: those within/trained by a particular body of knowledge versus those outside that discourse. The additional binary, however, offers an acknowledgment, and explanation, of the incompleteness of the debate.
The additional binary encapsulates and explains the others as each of these discourses has its own central “truth” that guides the actions of its members. The exclusionary nature of these bodies of knowledge produces an awareness of the “other” – those who remain uninitiated and outside the discourse. That is, the difference in truths and language means that there is a limited capacity for communication with those outside each body of knowledge – an outsider cannot easily comprehend the intricacies of patent law or the science of genes; they can understand it in broad terms (so the communication does not fail totally), but not enough to allow full communication.
In short, the limited understanding across discursive boundaries may be seen in terms of incompleteness or “failure” – there can never be complete, or total, communication. Unless all participants are schooled, to the same extent, in all aspects of the debate, there will always be a degree of miscommunication. Tied to this is that the purposes of the participants differ: the motives of a geneticist are different, for example, than those of a lawyer. The differences in constitutive actions renders problematic the pursuit of complete understanding. This acknowledgement that the debate is (necessarily) incomplete should not be seen as a negative. That there is no resolution itself acknowledges the ongoing processes of governance.
The acknowledgement that the debate is, and will be, incomplete does not mean progress will not be made. There is, after all, no such thing as the “perfect” law; there is, as a consequence, law reform. Of course, progress in this context is a contingent term – what represents progress for one side may be seen as a backward step for the other. Nonetheless, the more communication that acknowledges issues of communication (and this may include the use of empirical research to demonstrate or discount a discourse-bound assertion) the greater the potential for shared fragments of understanding. The competing motivations and practices of the different bodies of knowledge problematises the possibility of total understanding – the efforts that go to shared knowledge and practices offer common ground and a reduction in the issues of translation across discourses.
Chris Dent is a senior research fellow at the Intellectual Property Research Institute of Australia at the Melbourne Law School
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For an example of recent discussion on gene patenting see Fortnightly Review author David Brennan’s recent piece in The Conversation.