Summary
The post analyses the European Court of Justice's decision on the patentability of embryonic stem cells, particularly in the context of the Oliver Brustle v. Green Peace case. The ECJ concluded that patents requiring the destruction of human embryos are unpatentable under EU law, regardless of whether the embryos are created in laboratories or obtained otherwise. The decision is rooted in the interpretation of the Biotech Directive and aims to balance scientific advancement with ethical considerations. The author also reflects on the current state of stem cell research and the potential drawbacks of granting patents in this nascent field. Public funding and further scientific development are suggested as preferable until practical challenges in stem cell therapy are addressed.
Background
The patentability of biotechnological inventions involving human embryonic material has long generated legal and ethical controversy across jurisdictions. In Europe, the central question is whether inventions that depend on the prior destruction of human embryos fall within the exclusions from patentability set out in Article 6 of Directive 98/44/EC on the legal protection of biotechnological inventions (the Biotech Directive).
The case arose from a German patent held by Oliver Brustle, a professor at the University of Bonn. Mr Brustle’s patent covered isolated and purified neural precursor cells derived from embryonic stem cells, together with the process of producing them. In November 2009, Greenpeace sought a declaration from the German Federal Court of Justice that the patent was unlawful, on the ground that it contravened Article 2 of the German Patent Act, which prohibits the grant of patents on any use of human embryos for industrial or commercial purposes. Mr Brustle replied that the embryos used in the research were created under laboratory conditions and were intended for research purposes only.
The German Federal Court of Justice noted that the Biotech Directive did not define the expression “human embryo” and referred three questions of interpretation to the European Court of Justice (ECJ) for a preliminary ruling.
Questions Before the Court
The referring court asked the ECJ to determine:
- What constitutes a “human embryo” for the purposes of Article 6 of the Biotech Directive?
- Whether the exclusion covers the use of embryos only where those embryos are directly exploited in the industrial or commercial process that is the subject of the patent, or whether it also applies where scientific research using embryos is merely the necessary preliminary step to obtaining a patentable result?
- Whether an organism obtained by parthenogenesis falls within the definition of a human embryo.
Arguments
Mr Brustle argued that his research aim was scientific rather than industrial or commercial, and that the embryos used were not taken from the female womb but were prepared in a laboratory for research purposes only. He submitted that this distinction should take the invention outside the scope of the exclusion.
Greenpeace maintained that any process which requires the prior destruction of a human embryo, at whatever stage, cannot escape the exclusion from patentability simply because the final patented product does not itself consist of an embryo.
Findings
The ECJ gave its ruling in the case Oliver Brustle v Greenpeace. The Court held that the term “human embryo” must be given a broad and autonomous interpretation for the purposes of the Biotech Directive. It stated that the term encompasses:
- any human ovum after fertilisation;
- any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted; and
- any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis.
On the key question of the scope of the exclusion, the Court held that a patent cannot be granted for an invention which requires, as a technical precondition, either the prior destruction of human embryos or their use as base material, even if the description of that invention does not refer to the use of human embryos. The Court stated that the use of human embryos for purposes of scientific research which constitutes the subject matter of a patent application cannot be distinguished from industrial and commercial use, and therefore cannot escape the exclusion from patentability. As per Article 6, the exclusion is mandatory and cannot be circumvented by characterising the intended use as purely scientific.
The Court examined the questions in light of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Biotech Directive and affirmed that use of human embryos for industrial or commercial purposes shall be considered unpatentable.
Significance of the Decision
The ECJ ruling in Brustle v Greenpeace has significant implications for the patentability of biotechnological inventions in the European Union. Any patent relating to embryonic stem cells that requires the destruction of a human embryo at any stage of the process, whether the embryo originates from the female womb or is created in vitro, will be considered non-patentable under European law, regardless of whether the intended use is industrial or purely for research.
The decision also has practical consequences for the direction of stem cell research funding. If the patent route is unavailable for certain embryo-derived biotechnological processes, there is a stronger case for public funding of such research until technical challenges relating to enablement and safety are resolved, so that the eventual commercialisation of any resulting therapy is not foreclosed by the absence of patent protection.
The German Federal Court of Justice subsequently applied the ECJ’s interpretation and annulled Mr Brustle’s patent.
Contributed by Vinita Radhakrishnan.
Disclaimer: This article is for general information and does not constitute legal advice. Readers should consult a qualified attorney before acting on any matter discussed here.