The recent Opinion of the Advocate-General1 suggests that a clarification and moderation of the Court of Justice of the European Union’s (CJEU) approach to the patentability of stem cells may be on the horizon. If followed, the law in Europe will change and diverge from other jurisdictions, such as Australia. Such a change is likely to boost investment and patent filings in stem cell technologies in Europe.
In Europe, uses of human embryos for industrial or commercial purposes are excluded from patentability under the Biotech Directive2. However, what constitutes a ‘human embryo’ is not defined. In the 2011 case of Brüstle3, the CJEU interpreted the concept broadly, ruling that any human ovum after fertilisation must be regarded as a ‘human embryo’ since fertilisation commences the process of development of a human being.
In addition, a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted (i.e. somatic-cell nuclear transfer) and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis (i.e. parthenotes) were also deemed to fall within the concept of ‘human embryos’. This was on the basis that, according to written observations presented to the Court (which reflected scientific understanding at the time), they are also capable of commencing the process of development of a human being. Further, inventions which do not claim the use of human embryos but require their prior destruction or their use as base material, are also excluded from patentability.
This broad interpretation of ‘human embryos’ by the CJEU was met with wide-spread criticism and concern that the unavailability of patent protection might discourage investment in research and development, causing stem cell research in Europe to grind to a halt.
ISCC v Comptroller General of Patents
The issue is again before the CJEU for consideration following the UK Intellectual Property Office’s decision to reject ISCC’s applications to patent a technology that produces stem cells from parthenotes on the grounds that, following Brüstle, the inventions entail the use of ‘human embryos’. On appeal to the English High Court, ISCC argued that parthenotes, which lack paternal DNA, are in fact incapable of becoming a human being and that therefore the restrictions on patentability elucidated in Brüstle do not apply.
Given the uncertainty as to what the CJEU meant by ‘capable of commencing the process of development of a human being’ and whether it would have extended the concept of ‘human embryos’ to encompass parthenotes had it known they inherently lack this capability, the English High Court referred the issue to the CJEU for clarification in June 2013.
Opinion of Advocate-General Cruz Villalón
The Advocate-General considers that the critical question in determining whether a parthenote constitutes a ‘human embryo’ is whether it is capable of developing into a human being i.e. whether it is functionally equivalent to a fertilised ovum. Critically, it was accepted by all parties that as parthenotes lack paternal DNA they are ‘pluripotent’, meaning they cannot develop the extra-embryonic tissues needed to develop into a viable human being. This was not known at the time of the CJEU’s ruling in Brüstle and on this basis, the Advocate-General has recommended that the CJEU allow patenting of parthenotes by excluding them from the term ‘human embryos’. Allowing for future developments in stem cell technology, the Advocate-General added that parthenotes that acquire the capability to develop into a human through genetic modification will not be excluded from the concept of ‘human embryos’ (and will therefore be excluded from patentability).
The Opinion is not binding on the CJEU, whose decision is not expected for several months, but provides a good indication of the likely outcome. It is expected the EPO will follow the ruling of the CJEU (although it is not obliged to do so) which is likely to invigorate stem cell research in Europe.
There is no provision in the Australian Patents Act that expressly excludes stem cells per se or methods of using stem cells from patentable subject matter. However, the Australian Patents Act does expressly exclude ‘Human beings, and the biological processes for their generation…’4 from patentable subject matter, although what constitutes a ‘human being’ is not defined. Whether a stem cell technology is patentable in Australia depends on whether it triggers this exclusion.
In addition, the Australian Patents Act allows an application for a standard patent to be refused on the ground that use of the invention would be contrary to law5. This provision can be invoked to refuse patenting of stem cell technologies on the basis of legislation that prohibits certain acts concerning embryos and certain stem cell technologies, including the Prohibition of Human Cloning Act 2002 (Cth) and the Research Involving Human Embryos Act 2002 (Cth).
The Australian Patent Office commonly uses the potency of a cell as a guide to determine whether the cell is a ‘human being’ and therefore excluded from patentability: totipotent cells that can divide and produce all of the differentiated cells in an organism including extra-embyronic tissues are excluded from patentability, but pluripotent or multipotent stem cells that cannot differentiate into all cells of an organism are patentable.
There has been no judicial consideration of what constitutes a ‘human being’ under the Australian Patents Act. However, in 20046 the Australian Patent Office interpreted the prohibition on patenting of ‘human beings’ as prohibiting the patenting of any entity that might reasonably claim the status of a human being, including a fertilised ovum and all its subsequent manifestations.
The Australian Patent Office also considered the patentability of an invention directed to a method of creating a de-nucleated cow embryo that instead contained human nuclear DNA7. Despite the resulting hybrid embryo containing bovine mitochondrial DNA, the delegate held that the essentially human characteristic of the embryo remained such that the inter-species hybrid embryo was ‘properly described as human’.8
Based on these decisions, it appears that the Australian Patent Office takes the view that the manner in which the ‘human being’ is created is irrelevant if the result is the generation of an embryo with human characteristics. As a result, fertilised human ova (and equivalents), zygotes, blastocysts, embryos, foetuses and totipotent human cells are excluded from patentability.9 Also in line with these decisions, the exclusion ‘biological processes for their generation’ is deemed to encompass all biological processes for generating human beings applied from fertilisation to birth.10
This highlights where Australia differs from the Advocate-General’s position, and is more aligned with Brüstle, in that 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.11
A key tension arising from this position is certain stem cells are patentable because they lack an inherent capacity to generate an entire human being (e.g. pluripotent or multipotent stem cells), whereas certain embryos which lack the capacity to generate an entire human being are nonetheless currently excluded from patentability. Given the current position of the Australian Patent Office, it is highly likely that a parthenote would be excluded from patentability. This position is unlikely to change until there is judicial consideration or the legislation is amended to define what is meant by a ‘human being’ and ‘biological processes for their generation’.
What does this mean for patent applicants?
If the law changes in Europe, patent applicants stand to benefit as the potential to commercialise innovation in stem cell technologies through European patent protection is likely to encourage investment and fuel cross-jurisdictional collaborative research.