On 18 October 2011, the Court of Justice of the European Union (“ECJ”) answered three preliminary questions in Brüstle v. Greenpeace (Case C-34/10). The ECJ judgment offers guidance on the concept of a ‘human embryo’ and essentially states that techniques that use or destroy human embryos do not qualify for patent protection.
Stem cell research is a field of biotechnology which is generally held to have an enormous potential for developing new treatments for many diseases for which no cure is currently available. However, adult stem cells, which can be obtained without harm to the person, are held to be less useful for research than embryonic stem cells, whose harvesting generally requires the destruction of human embryos.
In an attempt to protect human embryos, Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions (the “Biotech Directive”) provides that all inventions involving the “use of human embryos for industrial or commercial purposes” are excluded from patent protection. However, the Biotech Directive does not define ‘human embryos’.
In the facts underlying the case at hand, Dr. Brüstle of the University of Bonn filed on 19 December 1997 a patent application for a technique to turn embryonic stem cells into nerve cells, a promising method to cure numerous neurological diseases. Greenpeace challenged the patent, arguing that stem cell research destroys and exploits human embryos. The German Supreme Court (Bundesgerichtshof) submitted to the ECJ three preliminary questions on the exclusion of patent protection for inventions resulting from embryonic research.
The first question concerned the concept of an embryo: when does a human ovum become a human embryo? The answer to this question determines which stages of development can be researched and result in inventions that do not fall short of the exception contained in Article 6(2)(c) of the Biotech Directive.
According to the ECJ, an ovum becomes a human embryo and is protected as soon as it is ”capable of commencing the process of development of a human being”. As such, the concept of the human embryo is interpreted broadly. It covers any fertilized human ovum, but also some technically non-fertilized human ova, such as a non-fertilised human ovum whose division and further development has been stimulated by parthenogenesis, a method of asexual reproduction via cell division.
By its second question, the German Supreme Court wished to know whether the prohibition to use human embryos for industrial or commercial purposes under Article 6(2)(c) of the Biotech Directive also covers the use of human embryos for purposes of scientific research.
In its judgment, the ECJ held that applying for patent protection implies an industrial or commercial purpose. Hence, all research which uses human embryos is precluded from patent protection, irrespective of whether the aim of the research includes industrial or commercial application. The ECJ’s position on this point is in line with the practice of the Enlarged Board of Appeal of the European Patent Office. It is important to note that the Biotech Directive which is interpreted by the ECJ does not prohibit research on embryos as such, but merely excludes from patent protection in the EU the inventions that result from such research.
In its final question, the German Supreme Court sought to know whether an invention is excluded from patent protection when the purpose of the invention is not to use a human embryo if the production requires the destruction of a human embryo. In other words, would it be possible to circumvent a ban on patenting stem cell techniques discussed in the previous question by patenting the invention discovered – which does not directly involve the destruction of an embryo – rather than the technique used to discover it – which usually involves the destruction of an embryo to obtain embryonic stem cells.
The ECJ closed this loophole to work around the exclusion from patent protection by stating that all inventions requiring the destruction of human embryos are unpatentable, regardless of the way the invention is formulated.
The ECJ judgment excludes, in very clear terms, patent protection for inventions derived from embryonic stem cells. The practical consequences are difficult to predict. In principle, no new patents will be granted in the EU for inventions involving embryonic stem cells. Existing patents can be declared invalid if they fall short of the exception contained in Article 6(2)(c) of the Biotech Directive. Although the European Patent Office is not an EU institution, the EPO is expected to apply the principle established by the ECJ.
The ECJ judgment does not explicitly prohibit research of human embryos (as is the case in the USA). Nevertheless, it is likely that stem cell research in the EU will run out of funding if it cannot give rise to patentable inventions. By contrast, some argue that the Brüstle judgment could have the effect of attracting stem cell research to the EU where it stays clear of the risk of patent infringement.
On the other hand, the ECJ leaves open the possibility for techniques for obtaining stem cell lines from human embryos that does not involve the destruction of the embryo.
