Methods of Medical Treatment Within Australian and United Kingdom Patents Law

Abstract

The accommodation of methods of medical treatment within Australian and United Kingdom ('UK') patents law has been controversial since the first patent applications in respect of such methods were filed in the early 20th century. For the last 30 years that controversy has been accepted as having a moral basis, the issue being whether the public interest in encouraging research and innovation in the medical arena through the provision of patent-related incentives for creators of new and useful therapeutic methods on the one hand is outweighed, on the other, by the various public policy objections to permitting the monopolisation of such methods. Those objections include fears that the monopolisation of medical methods would: (a)hinder medical research by restricting the free availability of knowledge; (b) be inconsistent with the teaching of medical students and practitioners; (c)expose medical practitioners and patients who use and accept the use of a patented method without a licence to liability for patent infringement; and (d)enable patentees to exact unreasonable payments for life-saving or potentially life-saving techniques. The controversy regarding the patentability of methods of medical treatment has not always been understood as an ethical one. Prior to 1971 the inherent patentability of methods of medical treatment was expressly regarded by both Australian and UK decision makers as turning on the essentially black letter law question of the nature of an 'invention', a question that only arose in those jurisdictions after the introduction of modern patents legislation. Reconception of the issue from 1971 in moral terms can be attributed to a number of possible causes, including the recovery by decision makers from the initial shock caused by the prospect of allowing patents for potentially life-saving treatment, and the general increase in community (and judicial) interest in the morality of science and its implications for patents law. However, it can also be viewed as a recognition by the judiciary of the questions that have always laid at the heart of the issue concerning methods of medical treatment and patents law namely, whether methods of medical treatment should be patentable and, as a precursor to that question, to what extent (if any) legal constructions of the term 'invention' and patent eligibility generally can legitimately and openly accommodate ethical and other public policy considerations. There is a great deal of literature concerning the specific public policy arguments for and against the patenting of methods of medical treatment, and it is not the purpose of this article to review such arguments nor to argue for their resolution along particular lines. Rather, the purpose of the article is to consider by historical analysis the relationship between decision makers' responses to medical method patents and their conceptions of inherent patentability generally. The thesis advanced in the course of such consideration can be summarised as follows. First, for the last 100 years much of the important jurisprudence relating to inherent patentability in the UK and Australia has derived from cases involving methods of medical treatment. Secondly, those cases are distinguished by the failure of decision makers to resolve convincingly or consistently: (a) the basis for the exclusion from patentability of methods of medical treatment; and (b) the extent (if any) to which legal constructions of inherent patentability can legitimately accommodate ethical and other (non-commercial) public policy considerations. And thirdly, this failure is largely responsible for the unduly restrictive legal principles that governed inherent patentability in Australia and the UK until 1959 and methods of medical treatment until the 1970s. It is also responsible for the ongoing uncertainty on the part of Australian decision makers concerning the relevance of morality and public policy generally to inherent patentability. Central to this thesis are the issues noted above concerning what an 'invention' is and whether patents law, in its various 20th century guises, permits decision makers to consider moral issues when determining a subject matter's prima facie eligibility for patent protection. At a time of increasing public and legal debate regarding both the ability of certain new technologies to be treated as inventions and the moral implications of such treatment, an historical account of the development of decision makers' responses to these issues has never been more important. That account serves, among other things, as a reminder of the potential consequences for law of dressing public policy decisions in black letter principle, or of otherwise assuming inherent (un)patentability without proper consideration of the foundations for that assumption.