Exclusion of genetic materials and technologies

7.13 The existing exclusions from patentability do not place any significant constraints on the patenting of genetic materials or technologies. It has been suggested that some types of inventions involving genetic materials and technologies should not be patentable subject matter. This section discusses possible new exclusions from patentability relevant to genetic materials and technologies.

Reform proposals in Australia

7.14 One way to exclude genetic materials and technologies, or a subset of them, from patentability would be through an exclusion directed specifically to genetic inventions. Such an exclusion was proposed in 1990 during consideration of the Patents Bill 1990 (Cth).^[13] The amendment, which was rejected by the Senate Standing Committee on Industry, Science and Technology, would have presumptively excluded genes, genetic material and genetically modified organisms from patentability.^[14]

7.15 A similar amendment to the Patents Act was proposed in 1996.^[15] The proposed amendment provided that naturally occurring genes, gene sequences, or descriptions of the base sequence of a naturally occurring gene or gene sequence would not be regarded as novel or inventive for the purposes of s 18 of the Patents Act.^[16]

Reform proposals in other jurisdictions

7.16 There have been suggestions in other countries that some genetic materials should not be patentable. In 2001, the Canadian House of Commons Standing Committee on Health (the Canadian Standing Committee) expressed concern that the Patent Act 1985 (Canada) did not specifically disallow patenting of human genes, DNA sequences and cell lines. The Canadian Standing Committee recommended that the patenting of ‘human materials’ should be prohibited.^[17]

7.17 However, in general, such a sweeping approach to reform has been rejected. For example, the Ontario Government report, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare (Ontario Report) rejected the Canadian Standing Committee’s call for a complete ban on gene patents and instead suggested a range of proposals to achieve an ‘appropriate balance between the public interest in accessing the health benefits offered by genetic technologies and maintaining the economic and commercial incentives that fuel this research’.^[18]

7.18 There have also been international statements suggesting that genes and genetic sequences should be excluded from patentability. The United Nations Educational, Scientific and Cultural Organisation (UNESCO) Universal Declaration on the Human Genome and Human Rights states that ‘the human genome in its natural state shall not give rise to financial gains’.^[19] Similarly, the International Bioethics Committee of UNESCO has stated ‘there are strong ethical grounds for excluding the human genome from patentability’.^[20]

7.19 In March 2000, the European Parliament called on the European Patent Office (EPO) to ensure that patent applications in the European Union do not violate the principle of non-patentability of human genes or cells ‘in their natural environment’.^[21] This resolution, originally made in the context of concerns about human cloning, was subsequently reiterated in connection with the patenting of the BRCA1 and BRCA2 genes associated with predisposition to breast and ovarian cancer.^[22] However, as discussed in Chapter 6, genetic materials are generally considered to be patentable if they have been isolated from nature.

Submissions and consultations

7.20 In DP 68, the ALRC indicated that it did not support amending the Patents Act specifically to exclude genetic materials and technologies from patentable subject matter.^[23] Many submissions and consultations supported this position.^[24] Some submissions indicated that technology-specific exclusions from patentability are undesirable because such an approach limits the ability of patent law to adapt flexibly to new technologies as they arise.^[25] It was said that such an approach might ultimately increase the complexity and cost of obtaining patent protection.^[26] Further, a few submissions commented that technology-specific exclusions might not be effective. IP Australia submitted:

Such measures invariably lead to uncertainty over the bounds of the subject matter, involved debate over individual cases, and increased cost and uncertainty for users of the system. Such measures may eventually prove at least partially ineffective, as it may be possible to draft claims to avoid the intent of the exclusion. Defining the bounds of a technology is a non-trivial issue.^[27]

7.21 Submissions also commented on the potential negative effects of excluding genetic materials and technologies from patentability.^[28] Some submissions were concerned about the potential for detrimental effects on the biotechnology industry and the development of new genetic products and technologies, if genetic materials were not patentable.^[29] Others indicated that it would be undesirable to adopt a position that differed greatly from the approach to patenting genetic inventions in other countries.^[30]

7.22 However, a small number of submissions to the Inquiry considered that genetic materials—particularly genetic sequences—should not be patentable.^[31] In general, these submissions did not specifically endorse an amendment to exclude genetic materials from the scope of patentable subject matter. Rather, they encouraged the ALRC to review whether genetic materials should be patentable,^[32] or focused on the application of the existing patentability requirements to genetic materials and technologies—including the question whether the subject matter of some gene patents constitutes a ‘discovery’ or an invention.^[33]

ALRC’s views

7.23 In the ALRC’s view, there are significant impediments to amending the Patents Act to exclude genetic materials from patentability. In Canada, it has been said of such an exclusion that ‘the momentum of the biotech industry, the long history of patentability of gene sequences and the impact and complexity of existing international trade agreements make this, at present, an impractical and unrealistic option’.^[34]

7.24 Similar considerations apply in the Australian context. Importantly, excluding genetic materials from patentability could have detrimental effects on the Australian biotechnology industry. Jurisdictions that have substantial biotechnology research and commercialisation programs appear to agree that patents on inventions involving gene sequences should generally be permitted.^[35] While the fact that other jurisdictions generally accept patents on genetic sequences is not conclusive of the approach that should be adopted in Australia, it is reason to question whether amending the Patents Act to implement such an exclusion from patentability is desirable.

7.25 Submissions encouraged the ALRC to consider the global nature of the biotechnology industry and patent rights.^[36] The Australian biotechnology industry relies on foreign investment and partnerships with overseas entities to commercialise the results of research involving genetic materials and technologies. Australia’s adoption of a position that diverges from the general international consensus would likely have adverse implications for Australia’s participation in the global biotechnology market. For example, it might affect adversely the extent to which foreign entities participate in, and provide capital investment for, research and commercialisation of genetic materials and technologies in Australia.

7.26 Further, excluding genetic materials from patentability may conflict with Australia’s international obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS Agreement).^[37] As discussed in Chapter 4, the TRIPS Agreement provides that patents shall be available for any inventions, and that patent rights shall be enjoyable without discrimination as to ‘the field of technology’.^[38] Excluding genetic materials from patentability may be inconsistent with these provisions.

7.27 Even assuming that the express exclusion of genetic materials from patentability is consistent with Australia’s international obligations, it may be argued that such an exclusion would not provide a complete, or even a satisfactory, solution to the problems said to be associated with the grant of some gene patents.^[39] There would be considerable difficulty involved in defining the scope of any exclusion relating to genetic materials—for example, would proteins produced by genetic materials be covered? Excluding inventions involving gene sequences from patentability may only ‘invite patent attorneys to engage in creative drafting’.^[40]

7.28 The ALRC does not consider that the Patents Act should be amended to exclude genetic materials or technologies from patentability. Such a reform would pose a significant risk to Australia’s biotechnology industry, raise problems for Australia’s compliance with the TRIPS Agreement, and be difficult to implement effectively.