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6.11 The criteria that must be satisfied to obtain a gene patent are the same as those that apply to patents over inventions involving any other type of technology. An initial question arises as to whether genetic materials and technologies are so different as to justify specific legislative criteria for patentability, which would apply only to this type of technology.
Submissions and consultations
6.12 DP 68 proposed that IP Australia should assess patent applications relating to genetic materials and technologies according to the same legislative criteria for patentability that apply to patent applications relating to any other type of technology.[5]
6.13 The weight of submissions supported this proposal and did not favour creating requirements for patentability that would apply only to genetic materials and technologies.[6] Submissions generally considered that the establishment of special rules for gene patents was neither necessary nor desirable.[7]
6.14 Some submissions suggested that implementing specific requirements for gene patents might add complexity to the Australian patent system, both in relation to inventions involving genetic materials and technologies and for other new technologies that may arise in the future.[8] IP Australia commented that technology-specific provisions ‘invariably lead to uncertainty over the bounds of the subject matter, involved debate in individual cases, and increased cost and uncertainty for users of the system’.[9] IP Australia also observed that ‘such measures may eventually prove at least partially ineffective, as it may be possible to draft claims to avoid the intent of [any] exclusion’.[10]
6.15 Other submissions considered that imposing particular requirements for gene patents would lead to inconsistency between the way in which genetic materials and technologies are treated under Australian patent law and the patent laws of other jurisdictions. Submissions suggested that such a divergence would create unnecessary difficulties for Australian entities seeking to obtain patent protection in foreign jurisdictions[11] and might have adverse implications for the place of the Australian biotechnology sector in the global economy.[12] A number of submissions commented that special rules for genetic materials and technologies might conflict with the requirement in art 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS Agreement)[13] that patent protection shall be available for inventions without discrimination as to the field of technology.[14]
6.16 However, some submissions considered that ‘the uniqueness of human genes’ might result in patents that are inappropriately broad and suggested that patent examiners should take this into account when granting patents over genetic materials and technologies.[15] The Department of Health and Ageing submitted:
A patent on a particular gene or gene sequence has the practical effect of monopolising the knowledge and exploitation of the gene. In effect, it patents the particular condition or characteristic. In doing so it prevents work on alternative ways of dealing with the condition or characteristic and may limit the capacity to invent around the patent.[16]
6.17 IP Australia did not consider that this issue warranted the application of special requirements for patentability.[17] Issues surrounding the appropriate scope of gene patent claims are addressed at the end of this chapter.
ALRC’s views
6.18 In the ALRC’s view, concerns about the patenting of inventions involving genetic materials and technologies should not be addressed by the introduction of legislative requirements that would relate only to the patentability of this type of invention. Such an approach may set an undesirable precedent for the way in which the patent system should accommodate new technologies in the future. The current requirements for patentability are technology-neutral and are able to adapt to new technologies as they arise. Introducing specific rules for inventions involving genetic materials and technologies may suggest that special requirements for patentability should be implemented for future technologies that raise a different set of issues. Such an approach would unnecessarily fragment and complicate Australian patent law.
6.19 Requirements that would apply only to genetic materials and technologies are also undesirable from an international perspective. Special rules would represent a departure from attempts to harmonise the patent laws of various jurisdictions.[18] Further, they would result in a marked divergence from approaches to inventions involving genetic materials and technologies adopted by other major economies, such as the United States, Europe and Japan. This approach is likely to have significant implications for the willingness of foreign entities to participate in the Australian biotechnology sector, and for the ability of Australian entities to commercialise genetic inventions overseas. In addition, as discussed in Chapter 4, the adoption of patentability requirements that would apply solely to inventions involving genetic materials and technologies may be inconsistent with Australia’s obligations under the TRIPS Agreement.[19]
Recommendation 6–1 Patent applications relating to genetic materials and technologies should be assessed according to the same legislative criteria for patentability that apply to patent applications relating to any other type of technology.
[5] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 6–1.
[6] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; South Australian Department of Human Services, Submission P74, 15 April 2004; Medicines Australia, Submission P75, 15 April 2004; Human Genetics Society of Australasia, Submission P76, 16 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; F B Rice & Co, Submission P84, 16 April 2004; GlaxoSmithKline, Submission P85, 16 April 2004; IP Australia, Submission P86, 16 April 2004; Department of Health Western Australia, Submission P89, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004; Sydney IVF Limited, Submission P98, 19 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; National Health and Medical Research Council, Submission P107, 19 April 2004; Queensland Law Society, Submission P118, 7 May 2004; Genetic Support Council WA (Inc), Submission P119, 13 May 2004.
[7] See, eg, Medicines Australia, Submission P21, 30 September 2003; L Palombi, Submission P28, 1 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; Department of Industry Tourism and Resources, Submission P36, 13 October 2003; Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; Genetic Technologies Limited, Submission P45, 20 October 2003; A McBratney and others, Submission P47, 22 October 2003; National Health and Medical Research Council, Submission P52, 31 October 2003; IP Australia, Submission P56, 4 November 2003.
[8] G Suthers, Submission P30, 2 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; A McBratney and others, Submission P47, 22 October 2003; Department of Health Western Australia, Submission P89, 16 April 2004.
[9] IP Australia, Submission P56, 4 November 2003. See also G Suthers, Submission P30, 2 October 2003; South Australian Department of Human Services, Submission P74, 15 April 2004; Human Genetics Society of Australasia, Submission P76, 16 April 2004; Department of Industry Tourism and Resources, Submission P97, 19 April 2004.
[10] IP Australia, Submission P56, 4 November 2003.
[11] Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003.
[12] Genetic Technologies Limited, Submission P45, 20 October 2003; South Australian Department of Human Services, Submission P74, 15 April 2004.
[13] Agreement on Trade-Related Aspects of Intellectual Property Rights (Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization), [1995] ATS 8, (entered into force on 1 January 1995). See Ch 4.
[14] See, eg, GlaxoSmithKline, Submission P33, 10 October 2003; A McBratney and others, Submission P47, 22 October 2003; Davies Collison Cave, Submission P48, 24 October 2003; Department of Health Western Australia, Submission P53, 3 November 2003; Queensland Government, Submission P57, 5 January 2004; Queensland Government, Submission P103, 22 April 2004. However, a small number of submissions suggested that the TRIPS Agreement is equivocal on the issue of technology neutrality: Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004; M Rimmer, Submission P73, 15 April 2004.
[15] Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003; G Suthers, Submission P30, 2 October 2003; Human Genetics Society of Australasia, Submission P31, 3 October 2003; E Milward and others, Submission P46, 20 October 2003; Commonwealth Department of Health and Ageing, Submission P65, 28 January 2004; South Australian Department of Human Services, Submission P74, 15 April 2004; Department of Health Western Australia, Submission P89, 16 April 2004; Genetic Support Council WA (Inc), Submission P119, 13 May 2004.
[16] Commonwealth Department of Health and Ageing, Submission P65, 28 January 2004.
[17] IP Australia, Submission P56, 4 November 2003. See also Australian Health Ministers’ Advisory Council, Submission P49, 23 October 2003.
[18] See Ch 4.
[19] In particular, TRIPS Agreement, art 27.