Home' Australasian BioTechnology : Vol 28 No 2 Contents Australasian BioTechnology | Volume 28 | Number 2
THE AUSTRALIAN STEM CELL
BY BRYAN LEAW (PHD), TRAINEE ATTORNEY, WATERMARK INTELLECTUAL PROPERTY
Stem cells have been a particularly shiny
beacon in regenerative medicine due to the
ever-growing observations of their therapeutic
benefits in the laboratory.
Stem cells are undifferentiated cells with unlimited
potential to regenerate cells lost as a result of disease,
and thus restore normal function. More recently,
studies have shown stem cells to have reparative
properties, homing in on sites of injury and stimulating
tissue repair. These remarkable discoveries beg the
question – how can they be protected, and to what
extent, by intellectual property rights?
What stem cells are patentable?
Stem cells are patentable in Australia as long as they
meet the requirements laid out in the Patents Act 1990
(Cth) as interpreted by the courts. According to the
most recent guidance, a patentable invention requires
an intervention by a technologist so that biological
materials claimed are removed from their natural
a demonstrable use.
The exception is where embryonic stem cells
are involved, as section 18(2) of the Patents Act
specifically excludes ‘human beings and the biological
processes for their generation’ from patentability. This
stance contrasts with other major intellectual property
The United States: arguably the most liberal, it only
disbars patent claims ‘directed to or encompassing
a human organism’.
Three key patents are held
by the Wisconsin Alumni Research Foundation for
human embryonic stem cell use.
Europe: stem cell patents are only granted if the
biological materials are accurately described and
1 United States Public Law No 188–199, s 634.
have industrial application. Previously, stricter laws
completely banned stem cell patents, but this ban
was overturned in 20142.
The United Kingdom: ‘Use of embryos for
commercial purposes is not patentable’, nor are
totipotent cells that ‘have the potential to develop
into an entire human’3
. In the United Kingdom, a
distinction between totipotent and multipotent cells
has been made. This is an important distinction
for stem cell clinical trials, as some meet the
multipotency criteria (ability to differentiate into
multiple cell types) but not totipotency (ability to
differentiate into an entire organism). In Australia,
claims for stem cells isolated from their natural
environment and cultured into cell lines for use in
therapeutic application are typically allowed. This
extends to products created by the cells: synthetic
genetic DNA sequences, proteins expressed by a
gene, or isolated DNA coding for a gene sequence4.
In its guidelines, IP Australia makes clear that human
embryos, totipotent human cells and processes
involving the creation of embryos are not patentable5.
This is because section 50(1) provision of the Patents
Act empowers the Commissioner to reject patents that
are ‘contrary to law’6
. The relevant statutes relating to
stem cell patents are the Research Involving Human
Embryos Act 2002 (Cth) and Prohibition of Human
Cloning for Reproduction Act 2002 (Cth), which both
include a provision that it is unlawful to create a
human embryo except for the purposes of assisted
2 Case C-364/13, International Stem Cell Corporation v. Comptroller General of Patents,
Designs & Trademarks  EU:C:2014:2451.
3 United Kingdom Patent Office, ‘Inventions Involving Human Embryonic Stem Cells’,
Practice Notice, April 2003, <www.patent.gov.uk/patent/notices/index>.
4 IP Australia, Australian Patents for: Microorganisms; Cell Lines; Hybridomas; Related
Biological Materials and their Use; & Genetically Manipulated Organisms, <www.ipaustralia.
gov.au/pdfs/patents/ specific/biotech.pdf> at 16 June 2004.
5 Section 126.96.36.199.1 Stem Cells, IP Australia, Manual of Practice and Procedure (7 June 2018)
6 The relevant statutes relating to stem cell patents are the Research Involving Human
Embryos Act 2002 (Cth) and Prohibition of Human Cloning for Reproduction Act 2002
(Cth), which include a provision that it is unlawful to create a human embryo except for the
purposes of assisted reproductive technology.
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