02 January, 2015

Can You Patent Embryonic Stem Cells? - The ECJ Ends the Fight, For Now

As was discussed quite extensively on this very blog some months ago, the genesis of human life and its formidable times are a topic riddled with controversy and a myriad of viewpoints, yet the topic has not come to contention much in the judiciary. Since the opinion of Attorney General Villalon, discussed by this very writer in the link above, the actual decision of the European Court of Justice has been anticipated by many, especially in light of the potential future of stem cell research in the EU. The ECJ's decision is hugely important in a world-wide context, potentially seeing a precedent which will either hinder or enable other similar jurisdictions to allow or disallow similar patents, even in light of the Myriad Genetics saga in the US.

The case in question, International Stem Cell Corporation v Comptroller General of Patents, Designs and Trade Marks, for the uninitiated, deals with two patent applications, filed by the International Stem Cell Corporation, relating to stem cells; more specifically "...methods of producing pluripotent human stem cell lines from parthenogenetically-activated oocytes and stem cell lines produced according to the claimed methods, and... the isolation of pluripotent stem cells from parthenogenetically-activated oocytes, and product-by-process claims to synthetic cornea or corneal tissue produced by these methods". To put things into more simplistic terms, the applications (GB0621068.6 and GB0621069.4) relate to the usability of stem cells or their production from oocytes (female egg cells). A more detailed expression of the facts and the prior judgments can be found in this writer's article discussing the Attorney General's opinion.

A parent's dream, endless potential (Source: Bizarro Comics)

The Court was therefore faced with the same question posed to the Attorney General: "...whether Article 6(2)(c) of Directive 98/44 must be interpreted as meaning that an unfertilised human ovum whose division and development to a certain stage have been stimulated by parthenogenesis constitutes a ‘human embryo’ within the meaning of that provision" and be unpatentable under the Directive. The interpretation of the Article in question hinges heavily, as discussed by the Attorney General, on the ECJ's earlier decision in Oliver Brüstle v Greenpeace, where the Court saw that "...any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ within the meaning and for the purposes of the application of Article... since that fertilisation is such as to commence the process of development of a human being". This is a key distinction, as the cells in ISCC's applications would not be capable of development into a human being. Even with this in mind the Court saw that "...a non-fertilised human ovum must be classified as a ‘human embryo’" as the cells, when harvested, are still capable of being fertilized and possess the potential to develop into a human foeatus, thus falling within the meaning of a 'human embryo'.

The Attorney General saw things differently in his interpretation of the law, and the Court in the case in hand agreed with him: "...a non-fertilised human ovum must necessarily have the inherent capacity of developing into a human being" to fall under the definition of a 'human embryo', contrary to Brüstle. ISCC's patents cover the use of cells in a state where they cannot possibly be fertilized and multiply, thus not, under the Court's current considerations, be classified as a 'human ebryo', and be exempt from patenting. The Court then summarized its position very well: "...where a non-fertilised human ovum does not fulfil that condition, the mere fact that that organism commences a process of development is not sufficient for it to be regarded as a ‘human embryo’... [and] [b]y contrast, where such an ovum does have the inherent capacity of developing into a human being, it should... be treated in the same way as a fertilised human ovum, at all stages of its development".

In the end the ECJ rejected the notion that ISCC's patents would encompass a 'human embryo', and accepted the patenting of stem cells, so long as they are truly incapable of development, either inherently or through genetic manipulation (which ISCC indicated it would be doing to the cells in their applications). What this decision demonstrates is a much more open approach to patenting stem cells, and in this writer's opinion, represtents a healthy and morally correct approach to stem cells and patents, especially in light of potential future developments in the field and a correct application of the law. 

Whether the courts will face any new cases dealing with different, potentially more nuanced and 'grey' approaches to stem cells or genetics in general in the future remains to be seen, but the potential dvelopment in the area is exciting, both from a human perspective and a legal one as well. 

Source: IPKat

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