1 May 2010Biotechnology

What next for stem cell research?

When, in the course of case G2/06 (the WARF application), the Enlarged Board of Appeal of the European Patent Office (EPO) was invited to seek the assistance of the Court of Justice (the court) in construing Article 6 of the Biotechnology Directive, it must have come as no surprise to observers that it declined this invitation. The enlarged board was not persuaded by the potential awkwardness of the court subsequently reaching an alternative view as to the patentability of embryonic stem cell lines.

We might shortly find out what effect contrary rulings of these parallel institutions will have. The court is to rule on certain questions relating to the patentability of embryonic stem cells in C34/10 (Brüstle v. Greenpeace). The enlarged board has already ruled that certain embryonic stem cell lines are not patentable. Its decision, which in practice may be of limited scope, is almost certainly wrong.

Article 6(1) of the Biotechnology Directive provides that inventions shall be considered to be unpatentable where their commercial exploitation would be contrary to ordre public or morality. It continues in 6(2):

“[T]he following in particular shall be considered unpatentable:…..(c) uses of human embryos for industrial and commercial purposes.”

The same provision is found in Rule 28(c) of the implementing regulations of the European Patent Convention (EPC). Rule 26(1) provides that the Biotechnology Directive shall be used as a supplementary means of interpretation.

Article 6(2)(c) is universally regarded as being poorly drafted. Patents are necessarily capable of industrial application, so the qualification of “industrial purposes” is difficult to understand; moreover, it is unclear what limitation is intended by the use of the word “commercial”. How does one distinguish those “uses” of embryos that are patentable from those uses that are not?

This rule was subject to a last-minute amendment at the Council of Ministers. Prior to the amendment, the rule excluded “methods in which human embryos are used”. According to Rapporteur Rothley’s presentation to the European Parliament, the amendment was designed to accommodate the UK’s position on embryo use.

The UK has, legally and scientifically speaking, been at the forefront of embryo research, following the report of the Warnock Committee in 1984. It is safe to say that the amendment—no doubt drafted in the small hours of the morning without the assistance of experienced patent practitioners—was intended to be limiting.

The question that subsequently arose in G2/06 was whether that exclusion had an impact on claims related to embryonic stem cell cultures in those cases where the stem cell cultures can only be prepared by destroying an embryo. Embryonic stem cell cultures are derived from those embryos created during IVF that are not going to be implanted (referred to as ‘supernumerary’).

In the UK, such embryos have to be terminated after a defined period of storage. The cell line is created by taking a cell from the inner cell mass when the embryo is 7 to 14 days old. The cases to date have proceeded on the basis that in taking that cell, the embryo will cease to be viable.

“The creation of embryonic stem cell lines, involving the termination of an embryo that is to be terminated in any event, certainly does not fall within the category of that which is universally described as abhorrent”

The key to understanding Article 6(2)(c) of the directive comes from an appreciation that it is but an example of that which is contrary to morality as defined in Article 6(1). It is not open to member states that are signatories of TRIPS to refuse to grant patents in areas of technology unless they are contrary to morality or ordre public. Consequently, if an interpretation of Article 6(2)(c) results in the exclusion of matter that is not contrary to morality then this is a dependable indication that the interpretation of this provision needs to be re-examined.

For this reason, in G2/06, the enlarged board was invited by WARF, the patentee, first to answer whether the patenting of stem cells is contrary to morality (question 3) before answering whether this is contrary to Rule 28(c) (question 2).

It accepted this invitation and the major part of the oral proceedings was concerned with this question of substantive morality. Surprisingly, in its written decision, the board declined to answer question 3, having found the stem cell cultures to be unpatentable under Rule 28(c) in any event. Notwithstanding this reticence, the decision does leave a loose end that one can tug at to reveal the error.

The error is found in paragraph 29 of the decision, where it is mentioned that the destruction of a human embryo may be considered to be contrary to morality. This is wrong.

As a matter of European jurisprudence, something is only contrary to morality if it is universally regarded as such: it is not for examiners to pick and choose what is moral depending on their subjective opinions. As correctly stated by the opposition division in Leland Stanford (2002), the fact that a technology is controversial is beside the point; the morality provisions seek to exclude extreme subject matter that is universally regarded as abhorrent, such as letter bombs and antipersonnel mines.

The creation of embryonic stem cell lines, involving the termination of an embryo that is to be terminated in any event, certainly does not fall within the category of that which is universally regarded as being abhorrent. If this is not apparent on its face, then one can have regard to the opinions of the group of advisors on the ethical implications of biotechnology to which reference is made in the directive.

They confirmed, in Opinion No. 15, that it is difficult to see any specific argument that would prohibit the extending of embryo research into stem cell research aimed at alleviating human suffering. One could further look at the European Court of Human Rights’ decision in Evans v. United Kingdom, where it was held that a fertilised embryo in storage does not have a right to life. One could go even further and observe that embryonic stem cell research has been actually funded by governmental institutions, including the European Commission.

It follows that whatever Article 6(2)(c) of the directive is seeking to exclude, it cannot be the creation of embryonic stem cell lines, if it is to be consistent with Article 6(1) and TRIPS. That does however leave the question: what is it for?

Two possibilities are mentioned here. The first is that the rule might be addressing a concern that relates to the commercialisation of the body. Such commercialisation is considered immoral and underlies the prohibition against selling blood or body parts. In contrast, there is no moral objection to commercialising cell lines derived from human tissue by a technical process. One can purchase human-derived tissue-culture cell lines from many commercial sources.

Article 5 of the Biotechnology Directive provides that the human body is not patentable but that an element isolated from the human body is. Thus, there is no objection taken to the patenting of human-derived cell lines. If this is the purpose behind the objection to the patenting of uses of embryos then it would follow that the objection is limited to embryos per se.

Once one accepts that there is nothing, legally speaking, immoral in terminating a supernumerary embryo then one can ask: why should the embryo be given greater protection against commercialisation than the newly born child? Although tissue from a newly born child cannot be patented, cell lines derived from such a child can. It should therefore follow that a cell taken from an embryo cannot be patented but stem cell lines created from such a cell can.

The second possibility is that, by using the term “industrial and commercial processes”, the legislature was contemplating a class of activities that are plainly abhorrent, such as the use of embryos in a process to make cosmetics or in the production of attenuated viral vaccines.

The questions that the court has been asked to address in C34/10 are perhaps not well structured in that there is no independent question addressing whether the creation of embryonic stem cell cultures is contrary to morality. Nevertheless, it will be interesting to see if the court can grapple with the fundamental purpose of Article 6(2)(c) without feeling the need to pander to those interest groups who object to all activities that result in termination of an embryo.

Those perspectives may appropriately be held in private but have no relevance to this particular debate. It will be ironic if just as the US is lifting its prohibition on the funding of embryonic stem cell research, the ECJ is to follow the EPO in ruling that such activity is immoral.

Justin Turner QC practises at 3 New Square, Lincoln’s Inn. He can be contacted at:

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