The European Court of Justice Rules on the Patentability of Human Embryonic Stem Cells: No Patents for Inventions Relying on Human Embryos as Source Material

摘要

The European Court of Justice (ECJ) recently decided case C-34/10 on the patentability of human embryonic stem cells (hESCs),1 concluding that totipotent cells are not eligible for patent protection. The ECJ went even one step further, to conclude that any use of a human embryo (except for its own sake) is considered to contravene ordre public. The Decision is binding on all member states of the EU, but not on the European Patent Organization and some of its member states, which are not members of the EU. The legal landscape in Europe regarding the question of patentability of hESCs is complex. For example, Germany and Italy allow manipulating hESC only if they originate from cell lines established prior to a cut-off date (1 January 2002 in Germany). Belgium, Czech Republic, Denmark, Greece, Spain, Finland, France, the Netherlands, Portugal, Sweden, and the United Kingdom allow the procurement of hESCs from supernumerary embryos (initially produced for in vitro fertilization). Belgium, Spain, Sweden, and the United Kingdom even allow the creation of human embryos for procuring hESCs. The ECJ decision C-34/10 now adds a further piece to the complex legal landscape in Europe. The Court interpreted the controlling European Directive 98/44/EG3 (the Directive) in a very restrictive manner. The Directive, once established to promote the biotechnology industry by creating a common standard for patentability of biotechnological inventions all over Europe, has now become a hindrance for some parts of theindustry. The restrictive interpretation of the ECJ will have a strong influence on the future decisions of national courts in the EU member states, and possibly even on the future case law of the EPO, as well as on funding of this technology in Europe.