20 October 2011

The European Court of Justice has ruled that human embryonic stems cells are not patentable subject matter in the EU.

Article 6 of the Biotechnology Directive, 98/44/EC, provides:

1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

A Mr Brüstle had a patent in Germany relating to isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects. It would appear this involved use of isolated and purified precursor cells having neural or glial properties, obtained from embryonic stem cells. That in turn appears to have involved removal of stem cells from the embryo at the blatocyst stage which, in turn, resulted in destruction of the embryo.

Greenpeace sought to invalidate it.

The ECJ had to consider first the meaning of human embryo:

– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive;

However:

– it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.

Secondly, the ECJ considered that the use of human embryos in research for patentable subject matter was prohibited by paragraph 6(2)(c), but use for the development of therapeutic or diagnostic purposes applied to human embryos could be patentable if useful.

Thirdly, the ECJ ruled that:

Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

IPKat here; Scientific American here; Patent Docs here.  Lid dip Ian Pascarl and Penny Smith

S 18(2) of our Act provides:

(2) Human beings, and the biological processes for their generation, are not patentable inventions.

As a result of that prohibition, the Deputy Commissioner has rejected the patentability of

40. Claims 10 to 23 are directed to a method of growing preblastocyst human embryos. It is a method applied to a human embryo. The method has clear advantages in better simulating the natural environment, and reducing apoptosis of cells in the blastocyst, resulting in greater success in implantation, and babies of greater body mass and having fewer complications compared to IVF babies born without the benefit of the method – all of which demonstrates that the process is one that directly relates to the generation of a human being. The process is a biological process – it is a process involving the presence of a chemical such that the in vitro environment better simulates the natural fallopian tube environment. I am satisfied that these claims fall within the ambit of `biological processes for {the generation of human beings}’ as proscribed by s.18(2).

Fertilitescentrum AB and Luminis Pty. Ltd [2004] APO 19. There is presumably some scope to patent embryonic stem cells at least where they do not relate to the biological processes for the generation of human beings. Thus, in H Bion Inc v Commissioner of Patents [2010] FCA 539 a patent application entitled “Embryonic Stem Cell Line and Method of Preparing the Same was accepted. The acceptance was subsequently withdrawn, however, on grounds of fraud or misrepresentation. The decision does not make it clear what the fraud related to.