ALRC’s views

21.38 DP 68 acknowledged the strong support in submissions for the introduction of some form of medical treatment defence, while noting that much of this support was from organisations involved in providing healthcare or representing the interests of healthcare consumers. Even within this group of stakeholders, support for the idea was not universal: some submissions presented reasons for rejecting a medical treatment defence because of concerns about the effect of such a defence on investment and innovation in genetic medical technologies, or medical technologies generally.

21.39 The ALRC does not recommend any amendment to the Patents Act to enact either: (a) a medical treatment defence of general application; or (b) a defence applying specifically to the use of patented genetic materials and technologies in medical treatment.

21.40 The United States is the only developed country to have enacted a medical treatment defence, although the need for such a defence does not arise in many jurisdictions because methods of medical treatment are excluded from patentability.[46] There is little experience in the practical application of such a defence.

21.41 There may be sound arguments for a United States-style medical treatment defence in order to protect medical practitioners who engage in medical or surgical procedures on the human body from patent infringement actions. However, this is a matter beyond the Terms of Reference of this Inquiry, with its more limited focus on patents over genetic materials and technologies.

21.42 The limited ambit of the United States defence means that it probably does not apply to medical treatment involving gene patents. Gene patents most often relate to products and processes for use outside the human body, notably in connection with genetic sequencing and diagnostic genetic testing. While gene patents are sometimes used in procedures on the human body, for example in connection with gene therapy, such use is rare and still largely experimental.

21.43 There are genuine difficulties in framing the scope of any new medical treatment defence. These include defining what medical activities the defence should cover, and defining the persons or organisations that should be able to invoke it. These difficulties would be exacerbated if the defence were to apply only to patents on genetic materials and technologies. Distinguishing genetic medical technology from other medical technology would be difficult, especially in relation to in vitro diagnostics,[47] as would any distinctions required between commercial and non-commercial genetic testing.

21.44 Other problems would arise in relation to framing the defence in a way that is consistent with Australia’s obligations under the TRIPS Agreement. As discussed above, a medical treatment defence applicable to genetic materials and technologies may be inconsistent with those provisions that require technological neutrality.

21.45 The ALRC remains of the view that it would be premature to propose a medical treatment defence where there is no demonstrated harm. Such a significant diminution of patent rights would have the potential to reduce innovation and investment in some areas of medical technology.

21.46 As discussed in Chapter 20, it has not been established that gene patents have had any significant adverse impact, to date, on healthcare provision in Australia. Patent holders have not been active in enforcing gene patents against healthcare providers. If gene patents are found to have an adverse impact on healthcare provision, a number of reforms are available to address the problem, other than the enactment of a new medical treatment defence. These include: changes to laws and practices concerning patentability, which are relevant to some gene patents (Chapter 6); enacting a new experimental use exemption from infringement (Chapter 13); encouraging Commonwealth, state and territory health departments to exercise existing legal options to facilitate access to patented inventions where particular gene patents have an adverse impact on the provision of healthcare (Chapter 19);[48] and clarification of the Crown use and compulsory licensing provisions of the Patents Act (Chapters 26 and 27). These options present fewer practical difficulties than the introduction of a medical treatment defence.

[46] IP Australia, Submission P86, 16 April 2004.

[47] Genetic testing can refer to molecular genetic testing that directly analyses DNA or RNA, but other biochemical tests of non-genetic substances, as well as some medical imaging processes, may provide strong indicators of particular genetic disorders.

[48] These include rights of Crown use and compulsory licensing under the Patents Act 1990 (Cth) and recourse to laws dealing with anti-competitive conduct.