Stem cells have been a particularly shining beacon in regenerative medicine due to the ever-growing observations of their therapeutic benefits in the laboratory.
Stem cell therapies are today thought to have regenerative and reparative properties. The traditional definition of stem cells is that they 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, honing to 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) (Patents Act) as interpreted by the Courts. According to the most recent guidance a patentable invention requires (among others):
- an intervention by a technologist so that biological materials claimed are removed from their natural state; and
- 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 IP destinations:
- USA: Arguably the most liberal, 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 have industrial application. Stricter laws previously completely banned stem cell patents, but this ban was overturned in 2014;
- UK: ‘Use of embryos for commercial purposes is not patentable’, nor are totipotent cells that ‘have the potential to develop into an entire human’.
 United States Public Law No 188–199, s 634
 Case C-364/13, International Stem Cell Corporation v. Comptroller General of Patents, Designs & Trademarks  EU:C:2014:2451
In the UK 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 sequence of a gene.
In its guidelines IP Australia has makes clear that human embryos, totipotent human cells and processes involving the creation of embryos are not patentable. This is because the section 50(1) provision of the Patents Act empowers the Commissioner to reject patents that are “contrary to law”. 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. Despite this, Australia is considered one of the more liberal jurisdictions worldwide in protection of embryonic stem cell research. This is reflected in a recent patent office decision which found that a blastocyst produced by parthenogenesis (unfertilised activation) does not have the potential to develop into a human being and hence the claimed methods defined patent eligible matter. This is a step forward for the law surrounding the field of regenerative medicine in Australia which is rapidly advancing into clinical trials.
 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.
 Section 188.8.131.52.1 Stem Cells, IP Australia, Manual of Practice and Procedure (7 June 2018) <http://manuals.ipaustralia.gov.au/patents/Patent_Examiners_Manual.htm>
 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.
 International Stem Cell Corporation  APO 52 (16 August 2016)
State of the research & patents in Australia
Translational research leading to clinical trials has mainly utilised multipotent adult stem cells in alignment with global stem cell research trends. The Australian Clinical Trials website reveals 15 clinical trials actively recruiting patients in Australia citing stem cell therapies. The clinical trials are evenly split between Phase I (dose escalation) and Phase II/III (safety and efficacy). These cells serve several therapeutic functions:
- self-renewal: these cells are multi-potent and can replenish missing cells;
- therapeutic cargo: these cells can release proteins and other factors that can reduce injury;
- modulatory: these cells can interact with host cells to stimulate recovery.
Australian researchers play a critical role in stem cell research at a global level. Scientist members of Stem Cells Australia were cumulatively granted AUD$30M from 2011-2017, and published over 700 research articles. In the last 5 years 613 stem cell-related patents have been submitted to IP Australia, with 334 granted to date (55%). The majority of the patents protect the stem cell types listed above that are currently in clinical trials. This makes sense as these are these cells are closest to market and hence have clear attributed commercial value. Interestingly, American assignees hold 52% of granted stem cell patents – the leading assignee Anthrogenesis Corp is a US biotech company harvesting placental stem cells from tissues discarded after deliveries (Figure 1).
Figure 1 | Analysis of stem cell patent holders in Australia. Source: Derwent Innovation Analytics
Stem cell patents bring with them unique challenges. A patent typically lasts up to 20 years, but the design, registration and completion of a clinical trial that meets the strict regulatory and ethical requirements for stem cell therapy could take 10 to 15 years. That US entities are more protective of their IP might be a reflection of the innovation landscape in the USA, and a greater willingness (and available capital) to do so. This is also reflected in the continued investment of US entities in securing IP. As Professor Alta Charo, a leading authority on law and bioethics puts it quite eloquently, ‘with no patent, there is no return [on investment]’.
Stem cell therapy will likely be the leading form of regenerative medicine moving forward. Increasing numbers of registered clinical trials reflect the growing belief in the observed therapeutic and reparative properties of stem cells in vitro and in in vivo models of disease. Australian researchers occupy the upper echelon of stem cell research, but currently US assignees hold the vast majority of Australian stem cell patents. The biological patent landscape is becoming increasingly dynamic and contested. Therefore, the strategic use of patents will be important not only for commercialisation and bringing new products to market but also to generate new channels for funding and perpetuating stem cell research.
Previously published in the August 2018 edition of Australian Biotechnology, The journal of the AusBiotech.
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