An interpretation of s18(2) is provided in Fertilitescentrum AB and Luminis Pty Ltd [2004] APO 19 [2004] APO 19 and the decision gives guidance as to which inventions would be excluded from patentability. Fertilitescentrum AB and Luminis Pty Ltd addresses what constitutes a 'human being' and thereby what constitutes 'biological processes for their generation'. In the decision, the Deputy Commissioner reasoned that:

"The correct interpretation of s18(2) is ascertained by recognising a human being as being in the process of generation from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth."

and

"The prohibition of 'human beings' is a prohibition of patenting any entity that might reasonably claim the status of a human being, including a fertilised ovum and all its subsequent manifestations."

Furthermore:

"The prohibition of ‘biological processes (for the generation of human beings)’ clearly covers all biological processes applied from fertilisation to birth-so long as the process is indeed one that directly relates to the generation of the human being."

Additional guidance as to exclusions under s18(2) is provided in Woo-Suk Hwang [2004] APO 24 [2004] APO 24 which relates to patentability of an inter-species hybrid embryo. In the decision, it was deemed that activation of an ovum by non-natural means is, in principle, analogous to fertilisation by natural means, and the presence of mitochondrial DNA from a non-human donor did not override the essential 'human' characteristic of a hybrid embryo wherein the nuclear DNA was human DNA.

Exclusions Under Subsection 18(2)

It therefore follows that the exclusion under s18(2) of human beings from patentability extends inter alia to:

fertilised human ova and equivalents;
zygotes, blastocysts, embryos and foetuses; and
totipotent human cells, including those cells that are the products of nuclear transfer procedures.

Biological processes for generating human beings which would be excluded from patentability include inter alia:

methods of in vitro fertilisation;
processes for intracytoplasmic sperm injection;
processes for cloning at the 4-cell stage;
processes for cloning by replacing nuclear DNA;
processes or methods of growing or culturing fertilised ova, zygotes or embryos etc.; and
processes or methods for introducing transgenes and donor genetic or donor cytoplasmic material into fertilised ova, zygotes, or embryos etc.

Methods and processes that involve the creation of a human embryo are also excluded from patentability. For example, methods for obtaining embryonic stem cells which comprise a step(s) for making an embryo would contravene s18(2). The exclusion applies regardless of the manner in which the embryo is generated, that is, the exclusion extends to methods in which an embryo is generated by fertilisation of gametes, nuclear transfer, activation of gametes, or parthenogenesis etc.

Breach of Prohibition of Human Cloning for Reproduction Act

Examiners should be aware that in some circumstances, inventions relating to human embryos and methods of using human embryos which contravene s18(2), may also be in breach of the Prohibition of Human Cloning for Reproduction Act 2002 and/or the Research Involving Human Embryos Act 2002. For example, it is unlawful to create a human embryo by a process other than fertilisation of a human egg by human sperm and it is unlawful to create an embryo for any purpose not related to assisted reproductive technology (ART). In Australia, embryonic stem cells may only be lawfully obtained from surplus ART embryos under the provisions of a licence granted by the National Health and Medical Research Council Licensing Committee.

In situations where an invention also contravenes the Prohibition of Human Cloning for Reproduction Act and/or the Research Involving Human Embryos Act, the invention is objectionable under s50(1)(a) as being 'contrary to law' and examiners should include an objection to this effect in their report.

Patentable Inventions

Examples of inventions considered not to contravene s18(2) include:

processes for cryopreservation of gametes;
methods for pre-implantation genetic analysis of gametes; and
processes or methods for determining the developmental progress or viability of a fertilised ovum, blastocyst or embryo, by analysis of culture or incubation media.

Note that within the above range of inventions, there will inevitably exist a 'grey area' where it is not clear whether an invention contravenes s18(2).

If examiners are unclear whether an invention constitutes a human being or a biological process for the generation of a human being and whether such a being or process is also contrary to law, they must refer the matter to a supervising examiner. The supervising examiner should then discuss the matter with an Assistant General Manager.

Stem Cells

Stem cells are cells with the ability to divide indefinitely in culture and the capacity to differentiate into other cell types.

A pluripotent stem cell is able to differentiate into any cell type in the body of the mature organism;
A multipotent stem cell has a more restricted differentiation potential compared with a pluripotent stem cell; and
A totipotent stem cell has the ability to differentiate into any cell type of the species from which it is derived. Any human cell type, as well as a complete human being, is able to be generated from a single human totipotent cell.

Stem cells are further classified according to their tissue of origin.

Stem cell technologies are to be considered and are examined in the same light as other technical inventions. These guidelines essentially clarify the patentability of stem cell technologies in relation to s18(2) and s50(1)(a) and do not remove the obligation to review applications involving these technologies for compliance with all other statutory requirements.

Human Embryonic Stem Cells

Human embryonic stem cells are derived from the inner cell mass of the human blastocyst and are considered to be pluripotent because of their capacity to differentiate into cell types of mesodermal, ectodermal, and endodermal lineages. Human embryonic stem cells are not considered totipotent because these stem cells or their differentiated derivative cells do not have the capacity to develop into an entire human being.

Given the interpretation of 'human being' set forth in Fertilitescentrum AB and Luminis Pty Ltd [2004] APO 19 [2004] APO 19, it follows that human stem cells and human stem cell lines per se are patentable because these cells are not considered to be human beings or potential human beings within the meaning of s18(2).

Human embryos, however, are considered to be human beings within the meaning of s18(2). Consequently, human embryos and processes for generating or culturing human embryos for any purpose, including the harvest of stem cells, are not patentable. The exclusion extends to all means of generating human embryos and includes generation of embryos by nuclear transfer, altered nuclear transfer, activation of gametes, and parthenogenesis.

Human Adult Stem Cells

Adult stem cells are derived from various postnatal and adult tissues such as cord blood, bone marrow, adipose tissue, and neural tissue. There are some reports of pluripotent adult stem cells, however, the majority of adult stem cells appear to be multipotent in that they have the capacity to develop into cells of only one or two of either the mesodermal, ectodermal, or endodermal lineages. These stem cells do not have totipotent capacity to generate a human being.

As adult stem cells are derived from non-embryonic tissues, both adult stem cells per se and processes for their isolation from non-embryonic tissues and organs are patentable with respect to s18(2).

Human Totipotent Stem Cells

A totipotent cell can be derived from fertilised oocytes and cells of an embryo up to about the 8-cell stage. They have the inherent capacity to generate an entire human being. Consequently, these cells and methods or processes of obtaining human totipotent cells are not patentable under s18(2).

Human/Non-Human Hybrid Totipotent Cells and Stem Cells

The provisions of s18(2) relate only to human beings and methods of their generation. Consequently, non-human cell types and methods of their isolation from non-human animals are patentable.

A question arises, however, as to the patentability of cells derived from inter-species hybrids or chimeras. In Woo-Suk Hwang [2004] APO 24 [2004] APO 24, it was considered that the presence of human nuclear DNA in a cell is sufficient to confer 'human being' characteristics on the cell. It follows that if totipotent cells were or could be derived from inter-species hybrids with 'human being' characteristics, the cells and the methods of their generation would not be patentable.

Stem cells derived from inter-species embryos with 'human being' characteristics are considered to be human stem cells and are patentable, however all processes for the generation and culture of the inter-species embryo are not patentable under s18(2).

Relevance of Subsection 50(1)(a)

Under s50(1)(a), a patent may be refused if the invention is contrary to law. In some cases, inventions relating to stem cells derived from human embryos may be in breach of the Prohibition of Human Cloning for Reproduction Act 2002 and/or the Research Involving Human Embryos Act 2002. The legislation includes the provision that a human embryo may only be created by fertilisation of a human egg by a human sperm, and that it is an offence to create embryos by other means, for example, by combining cells or cellular material from a human and another species or by cloning embryos. In situations where the process or method for generating human embryonic stem cells appears to contravene either the Prohibition of Human Cloning for Reproduction Act and/or the Research Involving Human Embryos Act, an objection under s50(1)(a) is to be taken.

Amended Reasons

Amended Reason	Date Amended
	18 Oct 2023
Published for testing	06 Jun 2023

5.6.8.14 Human Beings and Biological Processes for Their Generation

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