End of the road for stem cell patents in Europe?

The Court of Justice of the European Union indicated this week that any invention which necessitates, or has required, the destruction of a human embryo is not patentable in Europe. The Court’s decision on the patentability of inventions involving or relating to human embryos is already causing concern for researchers and companies in this field in Europe.

The Background
The decision arose following the referral of questions to the CJEU made in proceedings brought by Greenpeace, seeking the annulment of a German patent relating to neural precursor cells and processes for their production. The cells originated from human embryos.

Inventions relating to human embryos are specifically defined as being unpatentable by Article 6(2)(c) of the Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (OJ 1998 L 213, p. 13; ‘the Directive’). The relevant sections of Article 6 of the Directive read:

“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:
(c) uses of human embryos for industrial or commercial purposes;”

The European Patent Office has, to date, taken Article 6 (and the equivalent provisions in the EPC) to mean that an invention that necessitates the destruction of human embryos, at the time of filing a patent application, will not be patentable. But inventions relating to, for example stem cells obtainable from other sources at the time of filing, may be patentable.

The questions referred to the CJEU
Guidance was sought on the meaning of the term “human embryo” and on how strictly Article 6(2)(c) of the Directive should be applied. Three questions were referred, as follows:

‘1. What is meant by the term “human embryos” in Article 6(2)(c) of [the Directive]?
(a) Does it include all stages of the development of human life, beginning with the fertilisation of the ovum, or must further requirements, such as the attainment of a certain stage of development, be satisfied?
(b) Are the following organisms also included:
–  unfertilised human ova into which a cell nucleus from a mature human cell has been transplanted;
–  unfertilised human ova whose division and further development have been stimulated by parthenogenesis?
(c) Are stem cells obtained from human embryos at the blastocyst stage also included?
2. What is meant by the expression “uses of human embryos for industrial or commercial purposes”? Does it include any commercial exploitation within the meaning of Article 6(1) of [the Directive], especially use for the purposes of scientific research?
3. Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching:
– because the patent concerns a product whose production necessitates the prior destruction of human embryos,
– or because the patent concerns a process for which such a product is needed as base material?’

The Answers
Question 1
The definition applied to the term “human embryos” by the Court was very broad. The term is to be taken to encompass:
“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’ within the meaning of Article 6(2)(c) of the Directive;”

In summary, if something is capable of commencing the process of development of a human being, it is considered to be an embryo.

The door was left open, though, on the part (c) of the question, the Court stating that it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive.

The question of whether a stem cell itself is an embryo has therefore been handed back to the German referring court and we will have to wait  for their answer. The decision on this point will be binding only on German courts, but might influence other European courts in their interpretation of this point. One would imagine that the same burden would be applied - can the stem cell commence the process of becoming a human?

Question 2
In answering the second question, the Court pointed out that to be patentable, an invention must be considered to be susceptible of industrial application. In other words, if an invention relating to a human embryo meets the requirements of industrial applicability so as to be patentable, it is likely to also meet the standard for Article 6(2)(c), meaning the invention is either industrially applicable, but excluded subject matter, or it is not excluded, but is not patentable as it is not industrially applicable. It seems this part of Article 6(2)(c) will not offer much scope for argument.

It was clarified that the use of a human embryo for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, as indicated in the preamble to Article 6(2)(c) of the Directive.

Question 3
This question basically asked if it is possible to circumvent Article 6(2)(c) of the Directive by simply not referring to the embryo, or the destruction thereof, in the claimed invention. This might be the case where a claim encompasses a cell derived from an embryo, but where the embryo is not specifically mentioned. The Court made it clear that this is not allowable.

The case in question concerned the patentability of an invention involving the production of neural precursor cells, which presupposes the use of stem cells obtained from a human embryo at the blastocyst stage, requiring the destruction of that embryo. The Court concluded that use of stem cells obtained in this manner encompasses the use of a human embryo within the meaning of Article 6(2)(c) of the Directive regardless of when the destruction occurs, even if it is at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells.

In conclusion, the Court indicated that Article 6(2)(c) of the Directive excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

The Impact
The decision does appear to limit the scope of patentability of embryonic cells. Strictly, any invention that requires the destruction of an embryo (as defined by the decision) will not be considered patentable. The key word, though, in the answer to question 3, may well be “necessitates”. We will have to wait and see whether inventions which do not necessitate, but which could involve the destruction of an embryo, are considered to be excluded from patentability. Such an invention could be one which includes stem cells which could be either embryonic stem cells or induced pluripotent stem cells. Will claims to such cells be allowable or will it be necessary to specifically exclude embryonic cells from the claim? Further, is destruction of an embryo the crucial step? If a cell can be obtained from an embryo without destroying it, as is now possible, does use of that cell constitute use of the embryo? If the Patent Offices and national Courts apply the decision strictly, the scope for patentability may well be significantly narrowed.

Researchers within the field are already indicating that this is causing grave concern. What will it mean for stem cell research if the use of embryonic stem cells is not patentable in Europe? Of course, the decision will not affect the patentability of such inventions outside Europe, so will researchers be driven away from the EU as their inventions cannot be protected locally or, in fact, be drawn here because there is less chance of infringement? 

Further Action
Whilst the CJEU’s decisions are not binding on its future decisions, it will take quite a dramatic shift for the Court’s position to change. We will have to wait and see how the decision is implemented by the national courts, though, and, of course for the German court to decide on whether a stem cell obtained from a blastocyst is itself an embryo. The position is certainly not yet fixed.

Rachel Wallis
Life Sciences & Chemistry Group