02.08.2010
21.33 Many submissions favoured the introduction of some form of medical treatment defence.[31] The scope of the desirable defence was expressed in varying ways, often as an exemption for genetic (or all diagnostic) testing from claims of patent infringement, at least where performed on a ‘non-commercial’ basis.[32] In addition to such broad prescriptions for reform, which tended to focus on ensuring that medical genetic testing conducted by public sector laboratories was covered by the defence, submissions suggested a range of ways in which the defence should be framed. These submissions sometimes referred to the United States medical treatment defence as a model.[33]
21.34 A number of submissions were opposed outright to the idea of a new medical treatment defence[34] because such a reform might unjustifiably undermine patents on genetic technologies[35] and would permit ‘free-riding’ in relation to medical inventions.[36] It was noted that such a defence had never been considered necessary to protect the use of pharmaceuticals by medical practitioners and was unlikely to be needed in respect to genetic materials and technologies.[37]
21.35 After highlighting the difficulties involved in framing the scope of a new medical treatment defence, DP 68 asked whether, in the absence of a general defence relating to medical treatment, the Patents Act should be amended to enact a new defence to claims of patent infringement based on the use of genetic materials and technologies in diagnostic or therapeutic treatment.[38]
21.36 There was some support for this idea.[39] The Department of Health and Ageing, stated that a defence for the use of genetic materials and technologies in medical treatment would be appropriate ‘based on the relative simplicity, or lack of genuine inventive step, in most instances, in developing diagnostic tests once the location and structure of a gene has been characterised’.[40] However, most of the submissions that addressed the issue opposed the introduction of a new defence.[41] The potential adverse effects on innovation and development in medical technology were highlighted.[42]
21.37 Submissions suggested that there was insufficient justification for any new defence, and no reason to distinguish genetic technologies from other medical technologies.[43] The constraints of the TRIPS Agreement were also noted.[44] The Institute of Patent and Trade Mark Attorneys of Australia stated:
limitations as to the scope of protection for genetic materials and information will significantly reduce the attractiveness for investment in research and may significantly hamper development. It is difficult to see any justification for treating genetic materials and information in a different manner to the regime that operates in respect of pharmaceutical substances. The existence of patent protection for pharmaceuticals undoubtedly nurtures significant investment in research and development.[45]
[31] Australian Association of Pathology Practices Inc, Submission P10, 24 September 2003; Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003; Breast Cancer Network Australia, Submission P22, 30 September 2003; Cancer Council Australia, Submission P25, 30 September 2003; Cancer Council Tasmania, Submission P40, 29 September 2003; Cancer Council South Australia, Submission P41, 9 October 2003; Royal College of Pathologists of Australasia, Submission P26, 1 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; Caroline Chisholm Centre for Health Ethics Inc, Submission P38, 17 October 2003; South Australian Government, Submission P51, 30 October 2003.
[32] See Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), [22.40]–[22.41].
[33] See, eg, Human Genetics Society of Australasia, Submission P31, 3 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003; AusBiotech Ltd, Submission P58, 7 November 2003.
[34] Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; A McBratney and others, Submission P47, 22 October 2003; Davies Collison Cave, Submission P48, 24 October 2003.
[35] Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003.
[36] A McBratney and others, Submission P47, 22 October 2003.
[37] Davies Collison Cave, Submission P48, 24 October 2003.
[38] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Question 22–1.
[39] Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; South Australian Department of Human Services, Submission P74, 15 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004. Others supported the introduction of a general medical treatment defence: J Hinojosa, Submission P87, 16 April 2004; Cancer Council Australia, Submission P96, 19 April 2004.
[40] Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004.
[41] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; F B Rice & Co, Submission P84, 16 April 2004; Department of Health Western Australia, Submission P89, 16 April 2004; Western Australian Department of Industry and Resources, Submission P90, 16 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Queensland Government, Submission P103, 22 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004; Genetic Support Council WA (Inc), Submission P119, 13 May 2004. The Department of Health and Ageing and the Department of Industry, Tourism and Resources specifically opposed the introduction of a general medical treatment defence: Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004.
[42] Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; Western Australian Department of Industry and Resources, Submission P90, 16 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004.
[43] F B Rice & Co, Submission P84, 16 April 2004; Queensland Government, Submission P103, 22 April 2004.
[44] Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004.
[45] Institute of Patent and Trade Mark Attorneys of Australia, Submission P106, 27 April 2004.