The Court of Justice of the European Union ('CJEU') has invalided a patent concerning the use of human embryonic stem cells (hESCs)1, which required the prior destruction of human embryos, contrary to the European Patent Office ('EPO') granting practice. Raising the question whose approach is correct?
On 18 October 2011, the CJEU delivered its much anticipated decision in Oliver Brüstle v Greenpeace e.V. (case C-34/10) on a referral by the German Federal Supreme Court concerning the patentability of inventions relating to the use of hESCs. The decision as expected largely followed the opinion of the Advocate-General Bots, which was delivered in March 2011.
The CJEU, in interpreting the term 'human embryos' in Article 6 of the European Directive 98/44/EC on the legal protection of biotechnological inventions (the 'Biotechnology Directive'), ruled that an invention will not be patentable if the subject matter of the patent application requires the prior destruction of human embryos or their use as a base material, 'whatever the stage at which that takes place'. This will be so even if the subject matter claimed in the patent application makes no reference to the use of human embryos.
The decision of the CJEU applies throughout the European Union ('EU') and cannot be appealed. While the decision may have provided useful clarification as regards the interpretation of 'human embryos,' as far as patentability is concerned, opinions are sharply divided as to the correctness of the decision and its implications within Europe.
The main proceedings were initially brought in the Bundespatentgericht (German Federal Patent Court) by the environmental activist network Greenpeace in 2004 against a German patent (DE19756864) granted to neuroscientist Oliver Brüstle in 1999. The patent covers methods of isolating and purifying neural precursor cells, processes for their production from embryonic stem cells and their use for treatment of neural defects.
Greenpeace challenged Brüstle's patent on the grounds that the claims to the neural precursor cells derived from hESCs were contrary to public order and morality provisions of the German patent law, as well as they contravened the prohibition on the patentability of inventions claiming the use of human embryos for industrial or commercial purposes under Article 6(2)(c) of the Biotech Directive. The Federal Patent Court concurred and declared the patent invalid.
Brüstle appealed the decision to the Bundesgerichtshof (German Federal Court of Justice), which stayed the proceedings and referred the following questions to the CJEU for a preliminary ruling:
- the meaning of the term 'human embryos' in Article 6 of the Biotech Directive and the stages of development of human body it covers;
- the meaning and scope of the exclusion of 'uses of human embryos for industrial or commercial purposes' and whether this exclusion applies to uses in scientific research; and
- the extent to which the above exclusion applies to technical teachings if the use of human embryos is a necessary precondition of the teaching, even though that use does not form part of the technical teaching.
Article 6(1) of the Biotech Directive provides that inventions shall not be patentable where their commercial exploitation would be contrary to public order or morality. Article 6(2)(c) expressly excludes from patentability uses of human embryos for industrial or commercial purposes. Given the moral, ethical and religious differences of opinions among the EU Member States on what constitutes a human embryo, the term 'human embryos' was left undefined in the Biotech Directive.
CJEU's Decision and its implications
The CJEU made clear that it is up to the courts of EU Member States to decide what was contrary to public order or morality and that it will not raise questions of a medical and ethical (also religious) nature. However, the express prohibition under Article 6(2)(c) was capable of legal interpretation by the CJEU and the term 'human embryos' must have a unanimous conception and a Community understanding. The term must be understood in a wide sense accounting for respect for human dignity.
The CJEU interpreted 'human embryos' to mean any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division and further development have been stimulated by parthenogenesis. The court felt it was necessary to import the latter two into the definition of 'human embryos,' even if these cells are not the object of fertilization, they are, by virtue of the technique used to obtain them, capable of commencing the process of development into a human being.
However, the CJEU maintained that it is up to the referring court to establish, in light of scientific development, whether a stem cell obtained at the blastocyst2 stage constitutes a 'human embryo' and therefore included in the concept of 'human embryos'. This is a modification to the point established by the Advocate General Bots, who opined that pluripotent cells fall outside the definition of 'human embryos.' This modification is indented to avoid the future patentability of pluripotent embryonic stem cells should their future manipulation and development into a human being becomes successful.
With regards to the second question (uses of human embryos for industrial or commercial purposes), the CJEU held that the use of hESCs for teaching purposes fell within the scope of the exclusion under Article 6(2)(c); since it implied an industrial or commercial application. The Court, however, carved out from this exclusion uses for therapeutic or diagnostic purposes as it is stated in Recital 42 in the preamble to the Directive:
'(42) Whereas, moreover, uses of human embryos for industrial or commercial purposes must also be excluded from patentability; whereas in any case such exclusion does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it.'
Finally, the CJEU decided that Article 6(2)(c) also excludes from patentability an invention where the technical teaching requires prior destruction of human embryos or their use as base material, regardless of whether the description of the technical teaching claimed does not refer to the use of human embryos. The Court, mindful of the skilful ways in which patent claims may be drafted to exclude any reference to use and/or destruction of human embryos, extended the exclusion to cover such technical teachings.
If destruction of human embryos is key to exclusion from patentability, then one could, by implication, argue that patent applications based on hESCs available from established cell lines grown in the laboratories and stored in stem cell banks prior to the Brüstle decision, and which do not require the further destruction of human embryos, are not deemed to be immoral and therefore fall outside the patentability exclusion.
Of interest here is the 2008 decision of the Enlarged Board of Appeal of the EPO in G2/06 ('WARF Decision'). The WARF Decision also concerned the meaning of Rule 28(c) of the European Patent Convention (its equivalent provision Article 6(2)(c) of the Biotech Directive). In that decision, the EPO ruled that claims directed to products which, as described in the application at the filing date, could be prepared exclusively by a method which necessarily involved the destruction of an embryo from which the product was derived, even where the method was not part of the claim are immoral and therefore unpatentable. Notwithstanding the WARF Decision, it has been the practice of the EPO to allow patent applications based on stem cell lines that are available before May 2003 and which are filed after this date. These applications have not been deemed to be immoral by the EPO.
The complication however stems from the CJEU's confirmation of the Advocate General Bots' comments which emphasised taking the full history of the invention when deciding on the morality of the invention:
'The fact that destruction may occur at a stage long before the implementation of the invention is irrelevant.'
This seems to indicate that inventions which required the past destruction of human embryos are also deemed immoral by the CJEU and hence unpatentable. In light of the above, and since the EPO is not bound by the CJEU's decisions, it is not currently clear whether the EPO will continue with its practice or follow the CJEU'S decision. There also appears to be no indication from the Court whether the decision is retrospective, leaving entities with existing patents relating to stem cell technologies vulnerable to the CJEU decision.
Accordingly, the implications of the decision are far from clear. Many scientists have expressed deep concern about the effect that this decision may have on the European stem cell industry, not to mention its impact on academic stem cell research and its retention in Europe. Many fear that banning patents in this field will make it harder to attract investment into European stem cell companies, also leading to a 'brain drain' of researchers to the US for instance.
It also remains to be seen whether this judicial setback alone will impede the stem cell research field in Europe, and how the EU Member States will deal with the moral dilemma of funding and authorising stem cell research under conditions which they lay down. Advance in technology may make it possible to extract material from human embryos without destroying them and therefore the invention may fall outside the exclusion. Future cases may shed light on this point.
1.Stem cells are pluripotent (i.e. able to differentiate into specialized cell types and tissues) and can be obtained from both adult and embryonic tissues. They have great potential in cell based therapies and could be ultimately used in treatments to repair or replace various damaged tissues.
2. A blastocyst is an embryo that has developed for five to six days after fertilization. It is during blastocyst that totipotent cells (those are capable of developing into any cell type) give way to pluripotent cells.
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