The European Court of Justice in Luxemburg ruled on October 18, 2011 in a landmark decision in the case C-34/10 Oliver Bruestle v Greenpeace e.V. and barred embryonic stem cell patents in Europe.
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.”
Professor Bruestle, a German neurology professor and one of the leading stem cell research pioneers, is the holder of the disputed German patent. The patent, filed on December 19th 1997, concerns isolated and purified neural precursor cells, methods for the production of such neural precursor cells from embryonic stem cells, and the use of such neural precursor cells for the treatment of neural defects such as Parkinson or Alzheimer. The patent seeks to resolve the technical problem of using embryonic stem cells to produce an almost unlimited quantity of isolated and purified precursor cells having neural or glial properties. Professor Brustle’s patent was issued in Germany as DE 19756864 in 1999.
Greenpeace e.V. sought a fundamental decision on how the protection of human embryos is to be laid out under EU (patent) law, and therefore chose to oppose Professor Bruestle’s patent. Greenpeace wanted the patent to be declared invalid for moral reasons (“ordre public”), in light of ethical objections to the commercialization of human life. In its view, § 2 II 2 of the German Patent Act (“PatG”) and the German Stem Cell Act would not allow patent DE 19756864. On application by Greenpeace e.V., the Bundespatentgericht (Federal Patent Court, Germany) ruled on December 5th, 2006 that Prof. Bruestle’s patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells. Professor Bruestle appealed the Federal Patent Court’s decision to the Bundesgerichtshof (Federal Court of Justice, Germany).
Relevant Aspects of EU and German National Law
The Bundesgerichtshof, hearing Prof. Bruestle’s appeal, decided to refer several questions to the European Court of Justice (“ECJ”) for a preliminary ruling. Referral to the ECJ was necessary as the patentability of Bruestle’s patent under the PatG, depended on the definition of certain terms under the EU directive on which the pertinent part of the PatG was based. According to Article 267 of the Treaty on the Functioning of the European Union, a national court shall bring the interpretation of acts of the institutions of the Union (Directive 98/44/EC in this case) in a pending case in front of the ECJ. In its role as the highest European Court, the ECJ decides questions concerning the interpretation of EU Law in order to guarantee a common understanding within the European Union. The need for a uniform application of the European Union law requires 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 Patent Act, has to be in accordance with the Directive.
Specifically, the outcome of the application for annulment by Greenpeace depended on the interpretation of the concept of ‘human embryo’ as used in the EU Directive (98/44/EC) on the Legal Protection of Biotechnological Inventions. This so-called EU Biotechnology Directive rules out patentability for certain inventions, including “uses of human embryos for industrial or commercial purposes.”
On a fundamental level, the issue was whether the technical teaching of Brustle’s patent was excluded from patentability under § 2 II 1 No. 3, of the German Patent Act, which states: “patents shall not be granted in respect of the uses of human embryos for industrial or commercial purposes.” The answer to this question, in turn, depended on the interpretation that should be given to Article 6 (2) (c) of the EU Biotechnology Directive 98/44/EC, which states: “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.”
§ 2 II 1 No. 3, of the German Patent Act is derived from this EU Directive. EU 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, legal uncertainties and disputes such as this one.
Article 6 (2) (c) of the Directive does not allow the Member States any discretion regarding the fact that the processes and uses listed therein are not patentable. In other words, § 2 II of the German Patent Act – 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.
One of the questions that the Bundesgerichtshof asked the ECJ to address was the meaning of the term “human embryos.” The EU Directive itself, as the primary legal source, 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.” ECJ Judgment at ¶ 28. This result would create an obstacle to inter-Community trade and thus be contra-productive for the Internal Market, one of the major goals of the European Union (as laid out in Article 26 of the Treaty on the Functioning of the European Union).
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.” Id. at ¶ 34. “[Al]though [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.” Id. at ¶ 32. 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.” Id. at ¶ 38.
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.” Id. at ¶ 39.
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.” Id. at ¶ 52. “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.” Id. at ¶ 49.
After having received clarification regarding the interpretation of EU law, the Bundesgerichtshof must now decide on Bruestle’s appeal on the annulment of his patent. As the ECJ pointed out, “[a]s regards stem cells obtained from a human embryo at the blastocyst stage, it is for the [Federal Court of Justice] 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.’” Id. at ¶ 37. Given Germany’s broad understanding of the beginning and end of “human life” for historical and ethical reasons, it seems very likely that Bruestle’s appeal will not be successful, and his patent will remain invalid.
The ECJ’s decision only ruled upon the unpatentability, but not the research with stem cells itself. Prof. Bruestle commented on the ruling that “[i]t 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.”
Paradoxically, stem cell research has been broadly funded by the European Union in recent years. Consequently, many pharmaceutical and biotechnological companies locate their research headquarters in Europe – often next to very good universities or national laboratories where the necessary highly qualified and specialized human resources can be found. Therefore, the decision might not directly affect European stem cell research in the way Professor Bruestle fears. In fact, the pharmaceutical and biotechnology industry’s reaction towards the decision in various newspaper statements has not been that negative. The industry will simply have to patent its inventions in the rest of the world.
by Claudia Langer, Attorney at Law admitted to the German Bar, Ph.D. Researcher and Visiting Scholar at UC Berkeley Law School