Should gene patents be treated differently?

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]