22 August, 2014

Can You Patent Embryonic Stem Cells? - Preliminary Thoughts

Sometimes people seeking patents just seem to want to be the focus of hatred or controversy, especially when it comes to newer areas of medicine or scientific progression. Although this blog has discussed more unsavory topics, such as patenting clones or the method of selecting desirable traits for your child, the field constantly brings forward more interesting questions posed to the judiciaries of various countries. It so happens yet another such a question has been posed, this time pertaining to the potential patenting of embryonic stem cells; a topic which has been discussed at length by our neighbors across the pond in the US.

The case in question is International Stem Cell Corporation v Comptroller General of Patents, initially having been dealt with in the High Courts of the UK, having since been referred to the European Court of Justice for clarification. Although the opinion delivered is of the Advocate General Cruz Villalon's, it still remains an important indication of the potential direction of the ECJ's ultimate decision on the question, but is no way binding.

What the matter dealt with were two patent applications filed by the International Stem Cell Corporation, namely GB2431411 and GB2440333 (application numbers GB0621068.6 and  GB0621069.4 respectively), which effectively sought to patent certain applications for the use of human stem cells taken from embryos. Upon first inspection the patents were rejected by the UK Intellectual Property Office, based on the ECJ's previous decision in Oliver Brüstle v Greenpeace almost three years ago, which sought to decide what the definition of a 'human embryo' was under Directive 98/44/EC. This decision was important for the case in hand as it effectively limits the patentability of embryos, through which embryonic stem cells, for commercial or industrial purposes. The decision in Brüstle was why the patents were rejected at first instance, and serves as a platform from which the Advocate General formulated his view on the case.

To give more exposition on the patents at hand, as said above, they both deal with specific applications involving human stem cells extracted from embryos. Application GB0621068.6, titled "Parthenogenic activation of human oocytes for the production of human embryonic stem cells", to put in incredibly simplistic terms, deals with the production and cultivation of stems cells from unfertilized oocytes (female egg cells) through the manipulation of oxygen tension. These cells are often referred to as "parthenotes", which can turn into practically any cell type in the human body. Application GB0621069.4 deals with the use of said parthenotes to produce synthetic corneas. What is worth noting is that the ECJ saw, in Brüstle, that "...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’". This would, through superficial assessment, include Stem Cell Corporation's inventions and therefore prevent them from being patented.

The distinguishing factor for the Stem Cell Corporation, in their argument, is that the cells harvested have been modified so that they cannot continue human development; a reason under which the UK IPO rejected the application: "...Brüstle was intended to exclude from patentability only organisms capable of commencing the process of development which leads to a human being". This would run contrary to Schedule A2 of the Patents Act 1977 and the Directive it implements. According to the Stem Cell Corporation "...the inventions in question concern parthenogenetically-activated oocytes [ which are] not 'capable of commencing the process of development of a human being...' due to the phenomenon of genomic imprinting" and are therefore beyond the interpretation of Brüstle and the legislation.

The Advocate General's opinion is an interesting one, as he argues that "[t]he wording of Article 6(2) [of the Directive] itself makes clear that the list of prohibitions is non-exhaustive", which leads to an issue of whether the Directive would therefore include a non-developmentally capable parthenote. Mr. Villalon proposed that "[t]he non-exhaustive character of the list in Article 6(2) of the Directive implies that the exclusion of a parthenote from the concept of human embryo contained in Article 6(2)(c) of the Directive, does not prevent a Member State from excluding parthenotes from patentability based on Article 6(1) of the Directive".

Mr. Villalon furthered this point by arguing that the Directive is not one which is meant to be the 'law of bioethics'. Interpreting the Directive can lead to a discussion of morality and public impression; a discussion the judiciary will have to address to a degree. He leaves the matter more for Member States to decide, to see whether they deem the prohibition of embryonic patents a necessity in light of morality of public order.

Discussing submissions from the UK, France, Sweden and the Stem Cell Corporation, in addition to his understanding of the Brüstle case, Mr. Villalon did come up to a conclusion where he saw that the term 'human embryo' should not include developmentally incapable parthenotes: "Unfertilised human ova whose division and further development have been stimulated by parthenogenesis are not included in the term ‘human embryos’ in Article 6(2)... of [the] Directive... as long as they are not capable of developing into a human being and have not been genetically manipulated to acquire such a capacity".

Whether the ECJ sees things like the Advocate General will remain to be seen, but the opinion at least leaves the option of embryonic patents relating to cells which are not able to develop into a human being. This is a promising sign in light of future developments in the field of using stems cells to treat humans, yet still limiting it to ones where there is a lesser issue of morality, i.e.  the development of a human being. This writer for one is quite keen on reading the Court's opinion upon its publications, along with a healthy amount of others I am sure.

Source: PatentlyO

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