IP Alert: The EU Court of Justice Rules Certain Stem Cell Procedures and Products Are Unpatentable
October 29, 2011
On October 18, 2011, the European Union's Court of Justice ruled
that certain stem cell procedures requiring the destruction of human embryos are unpatentable. More specifically, the court ruled that under EU law, patents may not be obtained for processes that require a base material obtained by destroying human embryos or for products that require the prior destruction of human embryos. This EU ruling may have a significant impact on pharmaceutical and biotech companies engaged in stem cell research that involves the destruction of human embryos.
The case was brought by Greenpeace EV against a researcher at the University of Bonn in Germany. Greenpeace sued in Germany to invalidate the researcher's German patent, which was directed generally to a process for converting embryonic stem cells into nerve cells. The converted nerve cells were intended for the treatment of various neurological diseases, and particularly for the treatment of Parkinson's disease.
In an initial ruling, German's Federal Patent Court invalidated the patent. The court ruled that the patent was invalid to the extent it covered precursor cells derived from human embryonic cells and covered processes for producing such precursor cells. The researcher appealed the matter to Germany's Federal Court of Justice, which asked the EU's Court of Justice to address several questions.
First, the court was asked to interpret the meaning of "human embryo" under the applicable EU provisions. The court interpreted this language broadly as covering an early stage of development in which a human ovum is capable of commencing the process of development of a human being.
Second, the court was asked to determine whether EU law applied to the use of human embryos for purposes of scientific research. The court ruled that the use of human embryos for scientific research could not be distinguished from the use of human embryos for industrial or commercial purposes. Thus, the use of human embryos could not be justified on the basis that they were being used for research purposes only. The court, however, also noted that procedures having therapeutic or diagnostic purposes as specifically applied to and useful for human embryos would be patentable, but those procedures were not at issue in this matter.
Third, the court was asked to determine whether EU law applied to a patent that did not specifically refer to the use of human embryos, although the destruction of human embryos was required to practice the invention. The court ruled that an invention was unpatentable where practice of the invention required the destruction of human embryos, even if this destruction was not specifically referred to in the application. Also, the court stated that one cannot avoid the prohibition through artful claim drafting. Thus, an invention is unpatentable if it involves a product whose production requires the prior destruction of human embryos or involves processes requiring a base material obtained by the destruction of human embryos.
As indicated above, the consequences of this EU ruling may be significant for pharmaceutical and biotech companies engaged in stem cell research. It may limit the research and commercialization of stem cell technologies involving the destruction of human embryos. Further, although the ruling applies to the EU, it may affect the actions and research funding outside the EU, including that of U.S.-based companies, because such companies may not be able to obtain patent coverage for the EU market. As an alternative, companies may be encouraged to develop, or continue to develop, stem cell technologies that do not require destruction of human embryos, such as use of stem cells derived from human adult cells.
For more information on this decision, please contact Fitch Even partner Rudy Kratz, the author of this alert.