Existing exclusions from patentability

7.5 The Patents Act excludes certain categories of subject matter from patentability and grants the Commissioner of Patents the discretion to refuse a patent application for other types of inventions.^[2] As discussed below, the existing grounds of excluded and excludable subject matter are limited and have been interpreted narrowly by IP Australia.

Human beings and the biological processes for their generation

7.6 ‘Human beings, and the biological processes for their generation’ are excluded from patentability.^[3] This provision has not been considered judicially, and its precise scope remains unclear. IP Australia’s Manual of Practice and Procedure (the Manual)states that inventions that are ‘clearly encompassed’ by the provision include: human beings, foetuses, embryos or fertilised ova; methods of in vitro fertilisation or cloning methods that generate human beings; and processes—beginning with fertilisation and ending with birth—that are wholly biological and result in a human being.^[4]

7.7 It seems unlikely that s 18(2) excludes many inventions involving genetic materials and technologies from patentability. In particular, the Manual states that ‘human genes, tissues and cell lines’ are outside the scope of s 18(2) and will be patentable, if the other requirements set out in the Patents Act are satisfied.^[5] However, the application of s 18(2) to inventions involving human stem cells and stem cell technologies has been a matter of some debate. This issue is discussed in Chapter 15.

Contrary to law

7.8 Section 50(1)(a) of the Patents Act provides that the Commissioner of Patents has the discretion to refuse an application for a standard patent on the ground that its use would be ‘contrary to law’.^[6]

7.9 The Manual states that the discretionary power conferred on the Commissioner of Patents under s 50(1)(a) should be invoked only ‘in the clearest of circumstances’.^[7] The Manual also states that the provision should be relied on to exclude an invention only if an unlawful use, and no alternative or additional lawful use, has been described in the application.^[8]

7.10 Section 50(1)(a) has limited application to inventions involving genetic materials and technologies because a patent applicant will generally be able to identify a lawful use for such an invention.

Food or medicine produced by mere admixture

7.11 The Commissioner of Patents may also refuse to accept an application for a standard patent that claims an invention capable of being used as a food or medicine for humans or animals and that is merely a mixture of known ingredients, or is a process to produce such substance by mere admixture.^[9] It is unlikely that this exclusion would apply to genetic materials and technologies or other biotechnology inventions.^[10]

Plants and animals

7.12 Finally, with respect to innovation patents only, plants and animals and the biological processes for the generation of plants and animals are not patentable inventions.^[11] This provision is currently under review by the Advisory Council on Intellectual Property (ACIP). ACIP released an Issues Paper on this subject in 2002 and is preparing a report for the Australian Government.^[12]