Article 6(2)(c) of the European Biotech Directive excludes inventions which use human embryos for industrial or commercial purposes from patentability. Interpreting this exclusion, the European Court of Justice decided yesterday that an invention is not patentable if the claimed process requires the destruction of a ‘human embryo’.
The case concerned Greenpeace’s application to the German Federal Patent Court to revoke a patent (the Brustle patent) relating to the formation of new nerve cells from stem cells obtained from a human embryo, and the use of those cells to treat diseases such as Parkinson’s Disease. Interpretation of the Biotech Directive was referred to the European Court of Justice, which decided that a ‘human embryo’ is anything which is capable of developing into a human being. Consequently, a fertilised human ovum is a human embryo as soon as it is fertilised, as is an unfertilised ovum (containing its own, or donor DNA) which has been stimulated to divide and further develop. The Court decided that such a stimulated but unfertilised ovum is equally capable of commencing the process of developing into a human being.
The Court referred the matter back to the German Court to determine whether the invention the subject of the patent in suit uses cells which are capable of commencing the process of developing into a human being. If the German Court finds that stem cells at the blastocyst stage are embryos which are necessarily destroyed by the claimed invention, the invention will not be patentable.
What would Australia courts have had to say about the Brustle patent?
In Australia, s18(2) of the Patents Act provides that human beings, and the biological processes for their generation, are not patentable inventions. There is no definition of “human being” or “biological processes for their generation” in the Patents Act, and so far, Australian Courts have not been asked to consider the matter.
The current form of s18(2) was proposed by Senator Harradine when the 1990 Act was debated, long before it was possible to isolate a human embryonic stem cell (which I understand to be around 1998, but feel free to correct me). The section was intended to preclude patents “involving human life forms” and “genetic manipulations of the human species”, however Senator Harradine was particularly concerned about patenting humans, or genetically modified humans.
A 2004 Patent Office decision (Fertilitescentrum AB and Luminis Pty Ltd's application  APO 19) tells us that a “human being” is anything in the process of generation, from the time of fertilisation of an ovum (or other process that gives rise to an equivalent entity) until the time of birth. The prohibition on patenting “human beings” was thought to prohibit the patenting of anything which might claim the status of a human being, including a fertilised ovum and all of its subsequent manifestations.
The Patent Manual of Practice and Procedure also takes a restrictive approach to s18(2). It specifically provides that fertilised human ova and equivalents, zygotes, blastocysts, embryos, foetuses, and totipotent human cells, including those that are the products of nuclear transfer procedures, are excluded from patentability. Similarly, processes and methods of culturing embryos and methods of obtaining embryonic stem cells (whether that process involves fertilisation of an ovum, nuclear transfer or activation of gametes) are specifically precluded.
Consequently, we think that both the Patent Office and an Australian court would have come to much the same conclusion as the European Court, and would be likely to revoke the patent, as we expect the German Court will do.
However, it is important to remember that it is still possible to obtain patent protection, both here and in Europe, for inventions which can be applied to stem cell research and other areas which might be said to relate to biological processes for the generation of human beings, by patenting products and methods which can be applied to such processes. For example, methods of genetic analysis and preservation of gametes, which clearly have an application to the biological processes for the generation of human beings, remain patentable.
It is also noteworthy that that the Australian Senate Legal and Constitutional Affairs Committee recently recommended against the passing of a Private Member’s Bill proposing the exclusion of all biological materials which are identical or substantially identical to those found in nature from patentability. Had this Bill been passed of course, any invention relating to biological material that exists in nature, human or otherwise, would have been outside the realm of patentability.
No doubt it will not be long before an Australian court is required to draw the line in this very grey area.