The European Court of Justice (CJEU) has cleared the way for the patenting of human parthenotes for industrial and commercial purposes, clarifying the definition of 'human embryo' excluded from patentability in European Law.
The case follows the rejection of two patent applications by the UK's Intellectual Property Office on the grounds that they fall under the definition of 'human embryos' and are as such excluded from patentability by the 'Biotech Directive', implemented in national law by the Patents Act 1977.
Although the patent applications concern a method of producing stem cells, cell lines and tissue from parthenogenetically-activated oocytes- parthenotes - the CJEU had earlier in Brüstle defined 'human embryos' under the Biotech Directive as anything capable of commencing the process of development of a human being (reported in BioNews 630). This, it said, covered 'any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis'.
In this case, the UK's Comptroller General of Patents upheld a decision that it was bound by the Brüstle decision to reject the applications, but agreed the Biotech Directive's definition of 'human embryo' required further guidance from the European Court. Henry Carr QC, hearing an appeal brought by the US company, International Stem Cell Corporation (ISCC), that had made the patent applications, therefore asked the CJEU to clarify if human parthenotes fall under the term 'human embryo' in the Biotech Directive (reported in BioNews 702).
Commentators on the Brüstle decision have pointed out that since human parthenotes have a single set of DNA, they are technically unable to develop into human beings and should not be considered to be 'human embryos'. Last July an advisor to the CJEU, Advocate General Cruz Villalón, said that parthenotes should not be excluded from patentability on that basis (reported in BioNews 763, see also BioNews 765) - and the CJEU, giving its decision in December, agreed on this point.
To be a 'human embryo', the court said 'non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being'. It clarified that the mere fact that a parthenogenetically-activated human ovum commences a process of development is not sufficient for it to be regarded as a 'human embryo'.
The Biotech Directive, which aims to protect the dignity and integrity of the person, while also promoting biotechnological innovation through the patent system, excludes the 'human body' from patentability. The use of 'human embryos' for industrial or commercial purposes is specifically listed as 'contrary to ordre public or morality' and is not patentable.
The Brüstle decision clarified that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use, offering a wide definition of a 'human embryo'. The decision has had significant consequences for embryonic stem (ES) cell research where cell lines are derived from embryos. Controversially, it also seemed to capture efforts to derive ES cell lines by alternative means avoiding potential ethical conerns - such as using parthenotes.
Commenting previously on the issue, Rosalind English, of One Crown Office Row, points out that saying a 'human body' cannot be patented to protect the dignity of the person is problematic. 'This may be of considerable interest and even charm to lawyers, but it
amounts to nonsense in the lab, where whole entities such as "human
embryos" or "the human body" simply don't exist,' she said.
Before Brüstle was clarified by the CJEU, other courts had applied the decision narrowly. The German court that had referred the initial question over the patent application that led to Brustle ultimately determined that the application could proceed in its amended form, applying Brustle to conclude that the in vitro ES cells in question were not capable to developing into a human being on their own, and were therefore patentable (reported in BioNews 684, see also BioNews 686).