Leslie Chong is a JD candidate at Osgoode Hall Law School.
The European Court of Justice’s (ECJ) has ruled against the patentability of human embryonic stem (hES) cell lines and, in doing so, it has articulated the standard for acceptable practice in the use and commercial exploitation of stem-cell research in the EU.
In its decision, the Court held that any (totipotent) stem cell carrying the capacity to evolve into a human being must be legally classified as a human embryo and must therefore be excluded from patentability. Also excluded from patentability are those procedures that require the destruction or modification of the embryo in order to harvest other (pluripotent) stem cells.
This prolonged legal battle between Mr. Oliver Brüstel, the Director of the Institute of Reconstructive Neurobiology at the University of Bonn in Germany, and Greenpeace, an environmental group based in Amsterdam, is nearly over. Having been granted a patent in 1991 for his “technique to generate nerve cells from established hES cell lines,” it had sparked both an ethical and legal debate in the EU. However, it was Greenpeace that eventually challenged the patent citing that “that the destruction of human embryos involved in deriving the cell lines was ‘contrary to public order’ and breached guidelines set out in the European Patent Convention.”
While German courts (known to have some of the more restrictive patent laws in the EU) have favoured Greenpeace, Mr. Brüstel had hoped for a better outcome before the ECJ, “It’s crazy that you are allowed to work on some hES cell lines in Germany and develop them for clinical purposes, but patenting your methods is deemed to be contrary to public order. Consultation with the European Court of Justice will hopefully contribute to harmonization of patent practice in Europe.” Despite the fact that laws governing patents (and their rules on ethical research) may vary from country-to-country, ECJ rulings are highly persuasive in EU member states, and this judgment may have a far-reaching impact on more patent-‘liberal’ countries such as UK and Sweden. This ruling will now be considered (although these opinions have rarely been overturned) by the 13 judges on the European court’s Grand Chamber, with a decision on the matter to be rendered within a few months.
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I wonder whether and to what extent this ruling might affect the stem-cell and gene-patent debates (and pending lawsuits) in the U.S. The stem-cell patent issue hasn’t gotten nearly as much attention as have gene patents. I wonder whether that might have anything to do with the fact that a U.S. research team recently obtained a patent on a process for genetically-engineering stem cells, thus rendering moot many bioethical concerns surrounding the issue.
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