Human Beings and Biological Processes for Their Generation

Date Published

Under sec 18(2), human beings and the biological processes for their generation are specifically excluded from patentability.

Case Law

An interpretation of sec 18(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 s.18(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."


"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."


"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 sec 18(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 sec 18(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 sec 18(2). The exclusion applies regardless of the manner in which the embryo is generated, i.e. the exclusion extends to methods in which an embryo is generated by fertilisation of gametes, or nuclear transfer, or 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 sec 18(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 sec 50(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 sec 18(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:  Within the above range of inventions, there will inevitably exist a 'grey area' where it is not clear whether an invention contravenes sec 18(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.