On the 10 March 2011, the Advocates General of the European Court of Justice [ECJ] gave an opinion on the interpretation of Article 6(2)(c) of the Directive 98/44/EC. This opinion concerns the patentability of embryonic stem cells, as summarized below:
- The concept of the human embryo starts from the fertilized embryo and extends through to the development of the human body. Manipulation of an unfertilized human ovum that results in a totipotent cell(s) capable of developing into a human is also to be considered a human embryo.
- Pluripotent embryonic stem cells do not themselves have the capacity to develop into a human being, and on these grounds are not included within the meaning of “the concept of the human embryo”;
- However, not only “the use of human embryos for industrial or commercial purposes” must be excluded from patentability, but also inventions whose practise necessitates the prior destruction of human embryos or their use as starting material must be excluded from patentability.
What prompted the issue of this opinion:
Greenpeace eV (16) fought a successful annulment action at the Bundespatentgericht (Federal Patent Court) against a German patent, whose claims concerning “precursor cells obtained from human embryonic stem cells” and “processes for the production of precursor cells” were declared invalid. The patent concerned “isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects”.
The patentee, Mr Brüstle, appealed the Court’s judgment. In turn, the Court found their eventual decision depended on the interpretation of Article 6 the Directive 98/44. The court decided to stay the proceedings, until the ECJ issued their opinion on a set of questions put to them by the Court.
What was the key question to the ECJ with respect to patentability of embryonic stem cells:
3. Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching
(a) because the patent concerns a product whose production necessitates the prior destruction of human embryos,
(b) or because the patent concerns a process for which such a product is needed as base material?’
In the Advocates General’s opinion, as summarized above, said technical teaching is to be considered unpatentable.
Where do embryonic stem cells come from?
The current sources of embryonic stem cells are human embryos, produced by in vitro fertilization; aborted fetuses, and asexually produced human embryos. According to the Advocate General’s opinion, all such sources fall within the definition of a “human embryo”. However, existing human embryonic stem cell lines (see NIH’s Register) provide an alternative source of embryonic stem cell, whose use would not necessitate the destruction of human embryos.
How important is the Advocates General’s opinion?
Advocates General are members of the ECJ, where there are eight of them. Their role is to provide the Court with a completely independent legal solution to the cases for which they are responsible. The Advocate General’s opinion, although often in fact followed, is not binding on the Court.
Does the Advocates General’s opinion further understanding of Article 6(2)(c) of the Directive 98/44/EC?
The opinion is entirely consistent with a Decision of the Enlarged Board of Appeal (EBoA) of the EPO dated 25 November 2008 (G2/06). The EBoA, were also asked to decide whether the EPC (Rule 28(c) EPC) excluded the patentability of human embryonic stem cells. The EBoA similarly decided that patentability was excluded under the EPC for stem cells that could only be obtained by destruction of human embryos. The EBoA decision was requested in respect of deciding on the patentability of the WARF stem cells.
The EBoA decision points to the fact that neither the EU legislator nor the EPC legislator chose to define the term “embryo”, nor give it a restrictive meaning, as to do so would undermine the intension of the legislator. Thus the Advocate General takes us a step forward in giving his opinion as the “concept of the human embryo”. His opinion is also non-restrictive, consistent with the legislator, in that the human embryo is seen to encompass the embryo from fertilisation, and includes totipotent human embryonic cells, whether induced by parthenogenesis or nuclear implant.
Neither the Advocate general’s Opinion, nor G2/06, directly address the patentability of embryonic stem cells where the cells are obtainable from existing embryonic stem cell lines. To the extent that a claimed invention concerns human embryonic stem cells that can be produced and used without the destruction of a human embryo, such an invention does not appear to be excluded by Rule 28(c) EPC in view of Article 6(2)(c) of the Directive 98/44/EC.
Advocates General Opinion: Case C-34/10 at:
Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions:
NIH’s Register of human embryonic stem cell lines: http://stemcells.nih.gov/research/registry/
G2/06 – Stem cells: http://www.epo.org/law-practice/case-law-appeals/eba.html