Despite not being specifically excluded under s18 of the Australian Patents Act, technology utilising embryonic stem cells (ESCs) is not able to be patented in Australia.
With the technology forming a critical pillar of regenerative medicine and therefore having the potential to help realise treatments for some of the world’s most wicked diseases, and since Australia has such a strong reputation for cutting edge biological invention, why is this so?
The story of modern regenerative medicine begins in 1998, in the laboratories of Jamie Thompson at the University of Wisconsin. Working on rhesus monkeys, Thompson’s group showed for the first time that you could program ESCs to differentiate into pluripotent cells.
This gave rise to one of the key pillars of regenerative medicine – the ability to replenish cells in degenerative disorders. The breakthrough also brought with it a small, but growing minority who began to voice more loudly their objections to such use. Primarily, these objections arose from the need to use spare embryos donated from couples undergoing IVF.
These ethical and political concerns intertwined with the patentability of ESCs in Australia in an unexpected way.
The legislative framework
In Australia, section 18(2) of the Patents Act specifically excludes the patentability of ‘humans and biological processes for their generation’. The amendment was introduced during the Patents Bill 1990 by conservative catholic senator, Brian Harradine, almost as an after-thought.
In the second reading of the Bill, the Hon Simon Crean, the Minister for Science and Technology was sufficiently concerned by the absence of comment from the Opposition to voice his opinion. Stating that ‘flexibility was needed’, Mr Crean pointed out numerous scientific advances that were not anticipated by the preceding Patent Acts and suggested that the amendment should not be viewed as restricting patentability. Yet the repercussions of the hurried exclusion, incorporating concerns along the political, theological and ethical spectrum, while not explicitly defining what constitutes a ‘human being’, are felt even today, over 20 years later.
Why Australian patent applications are rejected
A quick review of recent patent applications claiming methods or uses of ESCs reveals numerous applications that have lapsed due to failure to gain acceptance. This is because, based on a 2004 decision of the Commissioner of Patents , they automatically trigger a s18(2) exclusion from patentability on the basis that an ESC can only be created in a process that involves the establishment of human life via a fertilized ovum, no matter how early. A review of these objections reveals that the IP Australia takes a hardline stance on patents directed to the utilisation or generation of ESCs, regardless of whether embryos are created, destroyed or arise from surplus Assisted Reproductive Technology embryos.
Yet given that the initial consternation arising from Senator Harradine’s conservatism was an objection to the potential destruction of embryos, and with the passage of time, it is interesting to reflect on whether or not such a hardline stance would hold up in a challenge to the Commissioner of Patents refusal to progress patent applications directed to ESCs.
A 2016 challenge did marginally move the goalposts: if the patent claims relate to parthenotes and parthenogenesis, IP Australia considers them no longer to fall under the umbrella exclusion of s 18(2). Parthenogenesis, in which researchers use chemicals to induce the egg to begin developing as if it had been fertilized. The egg—called a parthenote—behaves just like an embryo in the early stages of division. However, because it contains no genetic material from a father, it cannot develop into a viable fetus. This result was achieved by the patent applicant taking the issue to a hearing – a high stakes step which might have resulted in more weight to the Commissioner’s decision to reject applications under s18(2) rather than a relaxation of the position.
Time for a more modern approach?
In 2001, President George W Bush introduced restrictions on federal funding for research involving embryonic stem cells. This meant that projects that did not utilize already derived stem cell lines would not be eligible for funding. In a move meant to circumvent these restrictions, California voters in 2004 voted 59% in favour of the establishment of the California Institute for Regenerative Medicine (CIRM), a $3 billion dollar stem cell research agency. Unlike Australia, politicians struck while the stem cell iron was hot, and built on the optimism generated by early stem cell research. Fast forward to 2021 and California is now an international hub for regenerative medicine. The majority of CIRM’s research grants have been awarded to universities like Stanford, USC and UCLA, where researchers have made significant advances in stem cell research.
It has been over 20 years since the modern regenerative medicine story started, and ESC research is moving into clinical phases all over the world, including in Australia. Research has progressed from merely identifying these cells,[5] to now knowing how to replicate the intrinsic cues to trigger the differentiation of ESCs to beating heart cells.[6] Perhaps it is time to again revisit the exclusion from a legal and judicial perspective. Drawing inspiration from the words of Bruce Lehman, the former Commissioner of the USPTO, we are not patenting life – we are patenting technology.
If you would like to discuss the patentability generally in stem cells, or have a more specific query about embryonic stem cell technology, contact us.
[1] C Limon, ‘Human beings as non-patentable inventions’ in Yoriko Otomo and Edward Mussawir (eds), ‘Law and the Question of the Animal: A Critical Jurisprudence’, 57.
[2] Commonwealth, Parliamentary Debates, Senate, 16 October 1990, 2954 (Simon Crean, Minister for Science and Technology).
[3] Fertilitescentrum AB and Luminis Pty Ltd. (2004) (APO 19)
[4] International Stem Cell Corporation [2016] APO 52
[5] Martin, G. R. Proc. Natl Acad. Sci. USA 78, 7634–7638 (1981) and Evans, M. J. & Kaufman, M. H. Nature 292, 154–156 (1981).
[6] Murray, C. E. & Keller, G. Cell 132, 661–680 (2008).
