EU Court gives the go ahead on certain stem cells – Olivia Hart

22 December 2014 by Guest Contributor

International Stem Cell Corporation v Comptroller General of Patents [2014] EUECJ C-364-13, 18 December 2014 – read judgment 

This was a referral to the European Court of Justice (CJEU) requesting clarification of Article 6(2) of Directive 98/44/EC protecting biotechnological inventions (“the Biotech Directive”). We posted earlier about the High Court decision leading up to the referral concerning two GB patent applications that both involve the ‘parthenogenetic activation of oocytes’. The Court asked for clarification on what exactly defines a human embryo and what precisely is the developmental potential of a parthenote. 

Ever since scientists came upon the idea of using embryonic stem cells for therapeutic purposes there has been a something of an ethical furore around the topic. So the pressure has been on to find alternatives. Parthenotes – products of unfertilised egg division – have been proposed as candidates. However even research using parthenotes may fall foul of the law’s protection of ‘human dignity’. 

Background

Human embryonic stem cells are cells that have are derived from the inner cell mass of a blastocyst (an early form of an embryo). These cells can divide and proliferate indefinitely and can be induced to differentiate into any type of cell in the human body (red blood cells, epidermal cell, hepatic cell etc). We have already seen the therapeutic value of cells with the potential for curing any human defect or disease ranging from diabetes to paralysis. The problem is that these stem cells are derived from terminated embryos. This goes against many religious, social and cultural ways of thinking and therein here lies the problem.

The word parthenote originates from the term ‘parthenogenesis’ which describes the growth and development of an embryo without fertilisation. In the natural world this most commonly happens in asexual organisms. These organisms do not require a second gamete (sperm) to fertilise and stimulate the growth of the embryo. Instead the embryo grows and contains only one set of chromosomes. This of course does not occur naturally in humans. Without external manipulation the human ovum cannot grow and develop into a zygote without fertilisation from a sperm. In vitro however, parthenogenesis can be induced. This is done by mimicking the chemical imbalance caused by sperm at the point of fertilisation. If this imbalance is successfully simulated then the oocyte will be stimulated to divide. These are called parthenotes.

These parthenotes can be induced to develop to various different stages, but never to term. In humans these parthenotes never surpass the blastocyst stage. However, strictly speaking, the term blastocyst is not correct. A blastocyst is the precursor to the embryo, both of with are a mass of fertilised cells. The parthenotes have not been fertilised; they have merely been stimulated to act in similar way to fertilised cells.

The Court’s decision

According to the Biotech Directive the human embryo is unpatentable for two principal reasons.

Under EU law, a patent defines a process or concept that is a new invention or that which involves an inventive step. In the case of biotechnology this means that the process, item or material may involve natural biological materials but it must involve a technical process that has been designed by the applicant. Therefore the simple discovery of any biological material cannot be described as inventive and is therefore non-patentable. This arises from Directive 98/44 Article 3

Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.

and Article 5(1) and (2)

The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.

The second reason is that the patenting of the human embryo relates to the use of the human body as a commodity and infringes the integrity of the person. This also relates to the ethical issues that are implicated when considering human embryos and embryonic stem cells and the potential offence this commodification may cause.

Article 16 in the preamble to Directive 98/44

Whereas patent law must be applied so as to respect the fundamental principles safeguarding the dignity and integrity of the person;

Article 37 in the preamble to Directive 98/44

Whereas the principle whereby inventions must be excluded from patentability where their commercial exploitation offends against ordre public or morality must also be stressed in this Directive 

The distinction in the present case arises out of the classification of a human embryo. An embryo is a collection of diploid cells – diploid indicating that two sets of chromosomes are contained within each cells nucleus. Therefore a parthenote derived from a human oocyte is not an embryo because it contains only a single set of DNA. Therefore, all mention of the human embryo in the directive is irrelevant to the current application.

There are other reasons why parthenotes are not unpatentable under the Directive.

1. Human parthenotes are not naturally occurring; they are created in the laboratory through stimulation using technical means. Therefore, they can be an invention using biological materials, created by a clear technical process.
2. Parthenotes are unable to develop into a human being; they lack the paternal DNA. As a result they do not fly in the face of fundamental principles safeguarding the dignity and integrity of the person and do not offend against the ordre public or morality. This is to say that while parthenotes initially divide and grow in a way that is similar to a human embryo, the manipulation and premature termination of their growth could never be classed as the prevention of a human life.

Hence, the court concluded that an ovum stimulated to divide by parthenogenesis does not constitute it to be a human embryo. So parthenotes are patentable.

Olivia Hart is a postgraduate student of Biotechnology at the University of Warwick

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