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In 2012 Member States and the European Parliament agreed on the "patent package" - a legislative initiative consisting of two...

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Post Brustle: is an unfertilised ovum actually an "embryo"

In the case of International Stem Cell Corporation (ISCC) v Comptroller General of Patents the High Court has referred a question to the Court of Justice of the European Union (CJEU) regarding whether an unfertilised human ovum activated to divide in a process known as parthenogenesis can be considered an embryo.

Readers will recall from Autumn 2012 Patent issues that CJEU case 34/10 Oliver Brüstle v Greenpeace ruled that inventions necessarily involving destruction of an embryo were not patentable, but left several question marks as to what constitutes "an embryo".  The CJEU ruled that inventions that necessarily involve the destruction of human embryos were excluded from patentability and stated that the concept of ‘human embryo' within the meaning of Article 6(2)(c) of Biotechnology Directive 98/44/EC must be understood in a wide sense. Both fertilised human ova and non-fertilised human ova whose division and further development have been stimulated by parthenogenesis were deemed to qualify as "human embryos" and therefore excluded from patentability.

Biotechnology Directive Article 6

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.

Parthenogenesis is a process that creates a parthenote which has many of the characteristics of an embryo in the early stages of division but, because it was created from an unfertilised ovum, cannot develop further to become a human being. The cells that form the early state of a human embryo are known as ‘totipotent' and can go on to differentiate into any cell type, e.g. liver cells, heart cells, etc, whereas, the cells that form the parthenote are ‘pluripotent' and cannot differentiate into the full range of cells required to create a foetus.

Is an unfertilised human ovum of pluripotent cells an "embryo"?
The referral by the High Court in the case of International Stem Cell Corporation (ISCC) v Comptroller General of Patents seeks to clarify the meaning of the phrase ‘capable of commencing the process of development of a human', as the parthenote is incapable of actually developing into a human being.

The Judge gave a preliminary judgment and stated that in his opinion a parthenote does not fall under the exclusion of the Directive and is therefore patentable. This has implications for treatment of a broad range of serious medical conditions. The IP Federation, which represents the views of many of the major biotechnology companies, has been advocating for this outcome. We will keep readers apprised of developments in this case in future issues.