Europe's highest court has issued a controversial ruling which effectively prohibits the patenting of inventions that involve the use of human embryonic stem cells. The ruling of 18 October 2011, which settles a long-standing dispute that originated in a German National court, is expected to have a profound impact on European patent law and thereby on research and investment in this field, potentially affecting medical advances in the treatment of diseases such as Parkinsons and diabetes.
Why the Court of Justice of the EU got involved
Research in the field of biotechnology has enormous potential in the development of new treatments for diseases, but the ethics of patenting of inventions arising from such research has been hotly debated.
In an attempt to harmonise the patenting of biotechnological inventions in the European Union (EU) and to clarify what subject matter is patentable and what is not, a Directive was passed in 1998 and this is generally known in patent circles as the Biotech Directive.
The Biotech Directive states that inventions are not patentable where their commercial exploitation would be contrary to public order or morality, and it specifically prohibits the use of human embryos for commercial or industrial purposes. However, the Biotech Directive neither provides a definition of the term "human embryo", nor does it explain what acts constitute the "use of a human embryo".
This has created uncertainty surrounding the patentability of inventions relating to human embryonic stem cells (hES cells), which culminated in the referral by a German court of several questions regarding this issue to the Court of Justice of the EU (CJEU).
The key questions addressed by the Court
What is a "human embryo"?
It is widely accepted that at some point between the moment of conception and birth, human development involves an embryonic stage. However, no uniform definition of the term “human embryo” is available.
The Court decided to adopt a very broad definition of this term. Its definition covers any fertilised egg from the moment of fertilisation and includes all subsequent stages during the process of the development and formation of the human body, notably the blastocyst stage (a ball of about 100 cells). It also includes any cell capable of commencing the process of development of a human being, such as a human egg into which the genetic material of an adult human cell has been introduced.
Interestingly, the Court shied away from deciding whether a stem cell isolated from an embryo at the blastocyst stage also constitutes a human embryo. Such stem cells are typically considered to be pluripotent, i.e. capable of giving rise to all different cell types of human, but unable to develop into a full human being. By leaving it to the national courts to make this determination, the Court failed to provide a definitive answer as to what constitutes a human embryo, and hence failed to ensure uniform treatment of this issue across all EU member states.
Does the exclusion also apply to scientific research?
The Biotech Directive mentioned above refers to uses of human embryos for industrial or commercial purposes, raising the question of whether the exclusion also applies to scientific research. The Court held that scientific research is considered to have commercial purpose if patent protection is sought for it. Consequently, the initial aim of the research is immaterial, because the very process of applying for patent protection renders the research commercial and hence places it within the exclusion from patentability.
The only exception to the exclusion concerns inventions for a treatment or diagnosis that would benefit the embryo itself.
What types of inventions are affected by the exclusions?
Prior to the ruling, it was unclear whether the exclusion applied only to a process that does indeed use a human embryo, or whether it has a broader effect. The ruling establishes that if the implementation of the invention necessitates the destruction of a human embryo, it is excluded from patentability. Crucially, it is immaterial how far removed the destruction is from the invention, so the exclusion covers not only those inventions which directly involve the destruction of an embryo, but also those requiring the use of a human embryonic stem cell which was originally derived from an embryo – no matter how long ago this derivation took place.
The Court was keen to ensure that the exclusion cannot be circumvented by skilful claim drafting. Thus, the ruling makes it clear that the exclusion applies regardless of whether or not the claims recite a step of using a human embryo. It also applies even if the description of the technical teaching claimed does not refer to the use of human embryos.
In practical terms, this means that not only are methods which include a step of destroying a human embryo unpatentable, but also any methods or products which involve the use of human embryos – or cells originally obtained through the destruction of an embryo - as their base material. Thus, in the case of an invention concerning a process for the generation of neural cells from hES cells, setting out in the description that the starting material involved cells obtained from a long established cell line, and avoiding any reference to human embryos in the description and claims, will not escape from the exclusion.
For the avoidance of any confusion, it is worth noting that the patentability of inventions concerning non-embryonic stem cells, for example adult stem cells (which are typically regarded as being less useful in medical applications) is not affected by the ruling.
Why is the ruling such big news?
The ruling is very much at odds with established practice at the EPO. The EPO's Enlarged Board of Appeal (its highest instance) ruled in 2008 that an invention is not excluded from patentability under the morality clause if the invention could be worked without necessarily requiring the destruction of a human embryo. In practice, the EPO was happy to grant patents for inventions concerning hES cells, provided that at the filing date of the patent application it was possible to obtain hES cells from an established cell line. A cell line is a culture of cells and scientists may obtain cell samples from institutions which store the cell lines. hES cell lines are usually established by removing a cell from a blastocyst, a process which typically destroys the blastocyst. The EPO's view up until now seemed to be that the way in which that cell line was initially established is immaterial. The EPO only concerned itself with the question whether people were able to work the invention without causing any (further) destruction of embryos. National Offices such as the UK Intellectual Property Office adopted a largely similar approach.
By contrast, the Court has ruled that the origin of a cell line cannot be ignored, and that working with a cell line effectively constitutes working with a material obtained through the destruction of human embryos. Thus, the ruling effectively closes a loophole in current EPO practice regarding the patentability of inventions concerning the use of hES cells.
Was this outcome inevitable?
The EPO, arguably a better authority on issues relating to patent law that the CJEU, had found its own way of addressing this sensitive issue, and it is disappointing that the Court had apparently no regard for the approach proposed and adopted by the EPO.
The Court took into consideration the German law on the protection of embryos, which allows research on hES cells from certain established cell lines, provided that various conditions are met, particularly that they were obtained from an embryo generated by IVF (in vitro fertilisation) to induce a pregnancy, but then became redundant. Germany has one of the world's strictest laws regarding the protection of embryos, so it is perhaps surprising that the Court apparently felt that even imposing restrictions on patentability akin to the criteria set out in German law would not be sufficient to satisfy the morality clause of the Biotech Directive.
How does this affect current practice?
The ruling is binding on all EU member states, so National Patent Offices will have to change their practice to conform with the ruling. Whilst the EPO is not bound by the ruling, it is expected that it too will change its practice in accordance with the ruling. Not to do so would result in a paradoxical situation where the EPO would grant a patent which would be invalid in the member states.
The examination of pending applications in this field will thus almost certainly be affected, and the refusal of these applications is to be expected, unless a limitation to non-excluded subject matter is possible, for example where the invention is applicable to both adult and embryonic stem cells. Under EPO practice, claim amendments must find basis in the application as filed, but an amendment to limit the claim to exclude subject matter that is excluded from patentability need not have basis. Such an amendment may be a viable way forward for some applicants, but in cases where the entire invention concerns hES, such an amendment may not be possible because it would exclude the entire invention, or it is unlikely to leave the applicant with any useful scope of protection.
Granted patents will remain in force unless their validity is challenged, but the ruling may now open the floodgates for validity challenges on the ground of exclusion from patentability. Some patent holders may decide to cut their losses and refrain from paying annuities, thus allowing their patents to lapse.
Is it game over for stem cell patents in Europe?
The CJEU is the highest court of the EU, so there is no possibility of appealing against the ruling. However, this does not necessarily mean the end to patents in Europe in the field of human embryonic stem cells. For example, the ruling is based on the premise that the removal of a cell from a blastocyst necessarily entails the destruction of that embryo. Whilst this was the accepted view for many years, more recently there have been reports of the generation of hES cell lines which did not involve the destruction of the embryo, so there is perhaps room to argue that certain inventions do not involve the destruction of a human embryo. Further advances in this field may well generate additional ways of implementing inventions in such a way that the morality clause is not breached.
What other effects will the ruling have?
It is important to appreciate that this ruling concerns patentability, so human embryonic stem cell research has not been made illegal. The ruling therefore does not directly impact on stem cell research. However, it is expected to have a significant indirect effect. Prior to this ruling, leading stem cell scientists raised profound concerns about the impact of a ban on patents for inventions involving the use of human embryonic stem cells. In a letter to Nature, they highlighted the role of patenting in the development of new medical treatments and postulated that without the possibility of patent protection, investment which was needed to fund innovative stem cell treatments would dwindle. Since the ruling issued, these concerns have been reiterated by researchers and companies alike.
Thus, the ruling is expected to stifle commercial investment in Europe, but other sources of investment may also be affected. In particular, there have already been calls for EU research funding to be reviewed in light of the Court's decision. It remains to be seen whether companies may be driven abroad, where they can protect the fruits of their research, or whether they will in fact be drawn to the EU because the ban on patents reduces the risk of patent infringement.
Barbara Rigby, Associate
First published in World Intellectual Property Report, December 2011
