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15 November 2011

Patenting Embryonic Stem Cells in Europe: Decision in Brustle v Greenpeace C-34/10

On 18 October 2011, the European Court of Justice (ECJ) gave its decision in Brüstle v Greenpeace (C-34/10) regarding the patentability of human embryonic stem cells (hESCs) in Europe. This Decision is largely in line with the Opinion of the ECJ Advocate General issued in March this year.

Background

The case began in 2004, when Greenpeace filed a successful invalidity suit in the German Federal Patent Court against a German patent in the name of Dr Oliver Brüstle of the University of Bonn. The patent, DE 197568664,　was filed on 19 December 1997, and concerned isolated and purified neural precursor cells produced from hESCs used to treat neurological diseases. The ECJ referral originated from an appeal brought by Dr Oliver Brüstle against the decision of the German Federal Patent Court that his patent was invalid.

In Europe, the Biotechnology Directive (98/44/EC) (the Directive) rules out patentability for certain inventions, including "uses of human embryos for industrial or commercial purposes". Accordingly, the ECJ was asked by the German Federal Court of Justice for its interpretation of the concept of a 'human embryo', which is not defined in the Directive, under European law in order to determine whether Dr Brüstle's patent should be excluded from patentability.

Questions Referred to the ECJ

Several questions were referred to the ECJ, as follows:

The first question: What is meant by "human embryo" within the context of the Directive?
The ECJ (Court) was asked whether the exclusion from patentability of the human embryo covers all stages of life from fertilisation of the ovum or whether other conditions must be met, for example that a certain stage of development be reached.

The Court pointed out that firstly that it was not called upon to address questions of a medical or ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the Directive.

Because the legislature intended to exclude any possibility of patentability where respect for human dignity could be affected, it follows, in the view of the Court, that the concept of 'human embryo' must be understood in a wide sense. Accordingly, the Court considered that any human ovum must, as soon as fertilised, be regarded as a "human embryo" if that fertilisation is such as to commence the process of development of a human being. The term "human embryo" also covers those artificially stimulated or manipulated (but unfertilised) cells which are capable of commencing the process of development of a human being.

Additionally, as regards pluripotent stem cells obtained from a human embryo at the blastocyst stage, - those which are concerned by the invention covered in Dr Brüstle's patent - the Court found that it is for the referring court to ascertain, in the light of scientific developments, whether they are capable of commencing the process of development of a human being and, therefore, are included within the concept of 'human embryo'.

Interestingly, this point is not in line with the Opinion of the Advocate General that pluripotent embryonic stem cells not be regarded as "human embryos" because they do not in themselves have the capacity to develop into a human being, but that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, whether its destruction or its modification.

Unfortunately, the ECJ, although asked to decide whether pluripotent cells are excluded from patentability, have referred this back to the German referring court.

The second question: What was meant by the expression 'uses of human embryos for industrial or commercial purposes'.
This question focused on whether there was a distinction between using embryos for scientific research and using them in a purely commercial process. It acknowledged that the aim of scientific research can be distinguished from industrial or commercial application, however, the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and cannot therefore avoid exclusion from patentability. Consequently, the Court concluded that scientific research entailing the use of human embryos cannot access the protection of patent law.

There is one qualification, however, which is based on a Recital in the Directive. The patentability of uses of human embryos for industrial or commercial purposes is not prohibited under the Directive where it concerns the use for therapeutic or diagnostic purposes which are applied to the human embryo and which are useful to it, for example to correct a malformation and improve the chances of life.

The third Question: Patentability where the patent specification is silent on using human embryos but they are nevertheless required
This final question addresses the patentability of an invention involving for example, the production of Dr Brüstle's neurological precursor cells. In this case a patent specification may not necessarily mention the use of human embryos, however there is a supposition that firstly, stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell entails the destruction of that embryo.

Because not excluding such an invention from patentability would allow a patent applicant to avoid the non-patentability by skilful drafting of the claim, the Court held that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process, as in the Brüstle case, does not refer to the use of human embryos.

Conclusion

In summary, the European Court of Justice (ECJ) has ruled that the concept of a 'human embryo' must be defined in its broadest sense and that stem cell processes which require the prior destruction of human embryos or are based upon the use of human embryos, even if the patent does not refer to the use of human embryos, are not patentable. Thus, this decision will have patenting implications for scientists engaged in embryonic stem cell research that might wish to protect their invention in Europe and for pending patents and patent applications in this area. However, induced pluripotent cells (iPS cells), which are not obtained by the destruction of a human embryo, appear to remain patentable in Europe.

The ECJ has said that the question over whether stem cells obtained from a human embryo at a blastocyst stage (the subject matter of Dr Brüstle's patent) are included within the concept of 'human embryo' was a decision for the referring court. Thus, it will now be up to the German Federal Court to apply the ECJ's ruling in making its final ruling on Brüstle's patent and to decide whether pluripotent cells are excluded from patentability. However, if the German Federal Court follows the Opinion of the Advocate General, then it is likely that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, whether its destruction or its modification.

The ECJ's ruling is also binding on other National Courts hearing similar cases. However, due to differences between the laws of the National Courts, it is unlikely that this ECJ Decision will bring harmony to this area of patent law.

The full decision of the ECJ is available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62010CJ0034:EN:HTML and the full impact of this decision on stem cell research in Europe remains to be s