The Court of Justice of the European Union (ECJ) ruled this week that scientific research patents cannot be granted for human embryonic stem cell products under European Union (EU) law. The patent in issue, held by Dr. Oliver Brüstle, Director of the Institute of Reconstructive Neurobiology at the University of Bonn, concerns isolated and purified neural precursor cells derived from human embryonic stem cells, their derivation process, and use for treatment of neural defects. Soon after the patents were granted in 1997, Greenpeace Germany filed a successful challenge annulling the patents in the German Federal Patent Court. Dr. Brüstle appealed to the German Federal Court of Justice, which then referred the case to the ECJ for a preliminary ruling on the legal questions raised by the case.
EU law prohibits the patenting of uses of human embryos for industrial or commercial applications. The main question before the ECJ was whether this prohibition extends to patents on uses of human embryos for scientific research purposes. The Court answered yes, noting that while the aims of scientific research differs from industrial or commercial pursuits, the “grant of a patent implies, in principle, its industrial or commercial application.” In answering the other questions posed in the case, the ECJ also ruled that the meaning of human embryo includes a fertilized human ovum, a non-fertilized human ovum into which the nucleus of a human somatic cell has been transplanted, a non-fertilized human ovum whose further development is stimulated by parthenogenesis, and stem cells derived from human blastocysts. According to the court, the crucial consideration in classifying an entity as a human embryo is whether the technique used to create it (fertilization, parthenogenesis, nuclear transfer, derivation, etc.) commences the process of development of a human being.
The ruling effectively excludes any human embryonic stem cell inventions or products from being patented for any purpose. Without the incentives and protections of the patent system, some are speculating that the ruling will cast a chill on stem cell research in the EU, and may cause researchers to either turn to iPS research or migrate to jurisdictions with more permissive patent regimes. While I agree that the ruling will have some impact on research conduct and progress, I think it is too early to assess what that impact might be. The role that intellectual property (IP), especially patents, play in the context of biotechnology is nuanced, and there is currently no strong evidence to suggest that IP actually promotes the benefits associated with it in the biotech context. So claims that this would affect collaboration, cause brain drain, impact funding, research translation, etc., depend on the assumption that patents play a significant role in all these areas, a view that is much contested.
The ruling, though preliminary, it is binding on all national courts and tribunals in EU member states.
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