In an important and potentially far-reaching ruling for the biotechnology and pharmaceutical industries, the European Court of Justice ruled today that stem cell processes which require the use and prior destruction of human embryos are not patentable. The ruling is expected to have substantial impact on stem cell research in Europe and on patent filing strategies for companies interested in obtaining patents for processes and methods related to stem cell research.
The opinion in Oliver Brüstle v. Greenpeace e.V. results from an appeal brought by a German stem cell researcher. Brüstle first obtained a patent in 1997 on a process using precursor cells obtained from human embryo stem cells to treat certain neurological diseases. Greenpeace later succeeded in annulling the Brüstle patent in a German court. On appeal, the German federal court of justice asked the ECJ to consider whether uses of human embryos for industrial or commercial purposes is within the legal protection available to biotechnological inventions.
The ECJ’s ruling means that under EU law, stem cell processes resulting from human embryo research, and the use of human embryos for the purposes of scientific research, are generally not patentable. It is not yet clear, however, what impact the decision will have on biotechnology patent practice across Europe. While European Patent Office practice also mandates that human embryonic stem cell inventions are not patentable, the EPO is effectively an independent body not bound by EU law – and many EPO member countries are not EU member states. It also remains to be seen how national patent offices will interpret the ECJ decision.
One reason for that is that the ECJ declined to be specific – and significantly, the ECJ did not rule that Brüstle’s patent was invalid. The ECJ left open the issue of whether stem cells obtained at a particular stage were included within the concept of a human embryo, since the description of the stem cell process in the Brüstle patent does not specifically refer to the use of human embryos. Therefore, it remains for each national patent office to interpret the ECJ decision and decide how it should be followed. The ECJ decision can also be interpreted narrowly to limit the prohibition on patentability to processes resulting from the destruction of human embryos – meaning that it is not clear what, if any, the ruling will have on stem cell research within the EU, since alternative methods for obtaining stem cells without the use or destruction of human embryos would not be affected by the ECJ decision.
Regardless, the biotechnology and pharmaceutical industries are likely to feel a wide impact. It will now be much more difficult to obtain patents on processes for, and by extension therapeutics from, stem cell research from human embryos in the European Union. And the ruling may significantly alter international intellectual property protection strategies, as patent applicants consider how to maximize patent protection to obtain a return on research investment. Applicants should therefore carefully analyze patentability in each European country and consider filing in each jurisdiction directly, outside of the EPO filing framework, while national patent laws interpret the specific impact of the ruling on EU law.