The Legal And Economic Implications Of The ECJ’s Decision On The Brüstle Patent

The European Court of Justice (ECJ) in Luxemburg ruled on Tuesday, October 18, 2011 in a landmark decision in the case C-34/10 Oliver Brüstle v Greenpeace e.V. and barred a broad range of human embryonic stem cell patents in a market consisting of more than half a billion people.  In its ruling, the Court said that “a process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.”

In order to understand the decision and its significant importance not only for Europe, but also modern research in general, one has to understand the cell-biological background of the case as well as the legal and economic concept of the European Union. The following article will provide the necessary understanding.


Professor Brüstle, a German neurology professor and one of the leading stem cell research pioneers, holds a German patent, filed on December 19, 1997, which concerns isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects such as Parkinson or Alzheimer. The patent at issue seeks to make it possible to resolve the technical problem of producing an almost unlimited quantity of isolated and purified precursor cells having neural or glial properties, obtained from embryonic stem cells. He obtained the German patent DE 19756864 in 1999.

On application by Greenpeace e.V., the Bundespatentgericht (Federal Patent Court, Germany) ruled that Prof. Brüstle’s patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells.

Greenpeace wanted a fundamental decision on how the protection of human embryos is to be laid out under EU (patent) law, especially with regard to commercial interests and ethical objections in the commercialization of human life.

The Bundesgerichtshof (Federal Court of Justice, Germany), hearing Prof. Brüstle’s appeal, decided to refer questions to the ECJ for a preliminary ruling concerning the interpretation of the concept of ‘human embryo’ as used in the EU Directive (98/44/EC) on the legal protection of biotechnological inventions. The EU Biotechnology Directive 98/44/EC rules out patentability for certain inventions, including “uses of human embryos for industrial or commercial purposes”.

In its role as the highest European Court, the ECJ decides upon questions concerning the interpretation of EU Law in order to guarantee a common understanding of EU law within the European Union. National courts such as the Federal Court of Justice in Germany cannot decide upon questions regarding the interpretation of European law.

The outcome of the application for annulment by Greenpeace depended on whether the technical teaching of the patent at issue is excluded from patentability under Paragraph 2(2), first sentence, point 3, of the German Patent Act (PatG) which states that “patents shall not be granted in respect of the uses of human embryos for industrial or commercial purposes.” The answer to this question depended on the interpretation that should be given in particular to Article 6(2)(c) of the Directive. It states that “inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality (…); in particular uses of human embryos for industrial or commercial purposes (…) shall be considered unpatentable.”

Paragraph 2(2), first sentence, point 3, of the German Patent Act (PatG) is derived from the EU Biotechnology Directive. Directives harmonize law within the EU, and the Member States have to implement the legal meaning of the Directive into their national statutes – in this case into the German Patent Act – a process that leaves space for interpretation and thus legal disputes.

Article 6(2)(c) of the Directive does not allow the Member States any discretion as regards the fact that the processes and uses listed therein are not patentable. In other words, the second sentence of paragraph 2(2) of the PatG, in particular the concept of embryo which it uses, cannot be interpreted differently from that of the corresponding concept in Article 6(2)(c) of the Directive.

The need for a uniform application of the European Union law and the principle of equality require that the terms of a provision of European Union law, which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope, must normally be given an independent and uniform interpretation throughout the EU. Thus the national law, the German PatG, has to be in accordance with the Directive.


Among others, the ECJ had to answer the question “what is meant by the term ‘human embryos.’”  Even though the Directive itself does not define the term “human embryo”, the ECJ underlined that an autonomous concept of European Union law must be applied when looking for the definition for the purposes of a uniform interpretation of law within the EU: “The lack of a uniform definition of the concept of human embryo would create a risk for the authors of certain biotechnological inventions being tempted to seek their patentability in the Member States which have the narrowest concept of human embryo and are accordingly the most liberal as regards possible patentability, because those inventions would not be patentable in the other Member States.” This result would create an obstacle to trade and be contra-productive for the Common European Market.

Thus the Court sought the definition within the EU law and concluded that “the concept of ‘human embryo’ has to be understood in a wide way” because “the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could be thereby affected.”  “Although (the EU) seeks to promote investment in the field of biotechnology, use of biological material originating from humans must be consistent with regard for fundamental rights and, in particular, the dignity of the person.” Therefore “any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted and any non-fertilized 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.”

Furthermore “the concept of ‘uses of human embryos for industrial or commercial purposes’ within the meaning of Article 6(2)(c) of the Directive also covers the use of human embryos for purposes of scientific research.”

In addition to this, “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 fact that destruction may occur 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 the mere production of which implied the destruction of human embryos is, in that regard, irrelevant.”

After having received clarification regarding the interpretation of EU law, the Federal Court of Justice in Germany has now to decide upon the Brüstle’s appeal on the annulment of his patent. As the ECJ pointed out, “as regards stem cells obtained from a human embryo at the blastocyst stage, it is for the (Federal Court of Justice, Germany) to ascertain whether they are capable of commencing the process of development of a human being and, therefore, are included within the concept of ‘human embryo’.” Given Germany’s broad understanding of “human life” for historical as well as ethical reasons, it seems to be very likely that Brüstle’s appeal won’t be successful and thus his patent keeps annulled.


Economic implications

The ECJ’s decision only ruled upon the unpatentability, but not the research with stem cells itself. Nevertheless, the ruling could affect pharmaceutical and biotechnology companies currently engaged in stem cell research and in implementing treatments. Universities and their research laboratories only deliver research results, but the development of medical treatment and therapies based on their results has been the job of the industry. Companies might only be willing to support research if they can protect its outcome which is usually done with the help of patents. Consequently, funding could be given to more research friendly jurisdictions. If so, it would put Europe as a location for innovative research at risk. Leading scientists could emigrate to the United States and Asia, where their work can be patented.

Paradoxically, stem cell research has been broadly funded by the European Union over the last years. Therefore, the pharmaceutical and biotechnology industry’s reaction towards the decision has also not been negative.

Professor Brüstle said after the ruling: “It means that fundamental research can take place in Europe, but that developments that follow from that cannot be implemented in Europe. It means European researchers can prepare these things, but others will pick the fruits in the US or Asia. That is very regrettable.”