Das EuGH-Urteil "Brüstle versus Greenpeace'' (Rs. C-34/10): Bedeutung und Implikationen für Europa

The article deals with the ECJ's ruling on the patent eligibility of human embryonic stem cells (-34/10, Bruestle v. Greenpeace). The decision has implemented a comprehensive definition of »human embryo« and a broad interpretation of the term »use«, including purposes of scientific research; thus any invention, which requires either the prior destruction of human embryos or their use as base material, is excluded from patentability. This ruling is consistent with relevant decisions of the Enlarged Board of Appeal of the European Patent Office and of the German Federal Patent Court. The broad interpretation of exceptions from patentability also corresponds to the history, the wording and the rationale of the EU's Biotech Directive (98/44/EC) and hence the will of the European legislator. As a consequence, a further vertical constitutionalisation of European patent law has taken place. Patent law also became redesigned as a regulatory instrument of public policy for the »soft« governance of biomedical innovation. The implications of the judgment for European stem cell research are contested. The paper argues that the ruling offers great opportunities for free, mostly publicly funded basic research on human embryonic stem cells. Possible destimulating effects for venture capital and private investment have to be put into perspective with empirical results. A comparison with the different patent regime in the U.S. demonstrates that the economics of stem cell therapy are delicate, even when patentability is provided and hundreds of millions of research dollars invested. Despite a most weighty patent portfolio Geron, the major company in the field, has halted the world's first clinical trial and abandoned research on human embryonic stem cells altogether. This setback reflects the various scientific problems inherent in stem cell research. So far, basic questions regarding safety and efficacy of human embryonic stem cells remain unresolved. Therefore, researchers should not promise too much too soon. The ECJ's judgment has harmonized European patent law and contributed to an institutional co-evolution between the European Union and the European Patent Organisation; however, it also revealed a number of democratic deficits. In addition, the EPO's granting practice concerning the contested patent is disclosed. The case sheds light upon broader controversies on benefits as well as costs of patents, and on ethical boundaries in intellectual property rights. Der Beitrag setzt sich mit dem Urteil des EuGH zur Patentierbarkeit menschlicher embryonaler Stammzellen auseinander. Die Implikationen des Urteils für die europäische Stammzellforschung werden kontrovers diskutiert. Der Beitrag argumentiert, dass das Urteil große Chancen für die freie, öffentlich finanzierte Grundlagenforschung an menschlichen Stammzellen bietet. Mögliche destimulierende Wirkungen für Venture Kapital und private Investitionen sind angesichts empirischer Ergebnisse zu relativieren. Der Kontrast mit dem andersartigen Patentregime in den USA zeigt die Schwierigkeiten der Stammzellökonomie auf, selbst wenn die Patentfähigkeit gegeben ist und hunderte Millionen Dollar in die Forschung investiert werden. Das EuGH-Urteil trägt zu einer Harmonisierung des europäischen Patentrechts bei und führt zu einer institutionellen Ko-Evolution zwischen Europäischer Union und Europäischer Patentorganisation, offenbart dabei jedoch einige demokratische Defizite. Zudem legt der Beitrag die konkrete Patenterteilungspraxis des EPA zum Streitpatent offen. Der Fall wirft ein Licht auf Kontroversen um Nutzen und Kosten von Patenten sowie ethische Grenzen bei geistigen Eigentumsrechten.