In what is expected to be a milestone case, the Court of Justice of the European Union (CJEU, formerly the ECJ) is shortly going to rule on questions relating to the patentability of inventions involving the use of human embryos. Whatever the outcome of the Decision, it is likely to have a significant impact on existing and future patents, and hence on scientists and companies working with human embryonic stem cells in Europe.
The patentability of biotechnological inventions in the European Union (EU) is governed by European Directive 98/44/EC, which was passed in 1998 and is generally known in patent circles as the Biotech Directive1. The aim of the Biotech Directive was to harmonise biotech patent law across the EU and to clarify what subject matter is patentable and what is not. Most countries in the EU have implemented this Directive into their national laws, and even the European Patent Office (EPO, which is legally not bound by the Biotech Directive) has brought its laws into line with it.
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 under this morality clause. 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.
However, the CJEU has recently been asked to address some questions regarding what constitutes a "human embryo" and to clarify what is meant by "uses of human embryos". The questions before the CJEU were sent to them by the German Federal Patent Court in the Brüstle v Greenpeace case2. It is hoped that the CJEU's Decision will clarify the law, creating more certainty for patent holders and scientists alike, but there are fears that the Decision may in fact create uncertainty regarding the validity of patents in this field, as well as having a negative impact on scientific progress and business.
A controversial Preliminary Opinion on these questions has already been issued by the Advocate General in March this year3. Perhaps the most controversial part of this Opinion concerns pluripotent stem cells, i.e. cells are removed from human embryos and which can develop into various specialised cell types, but which cannot form an entire organism. Advocate General Bot conceded that pluripotent stem cells should not considered to be a “human embryo”. However, he argued that the origin of the pluripotent stem cells cannot be ignored, indicating that pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, whether by its destruction or its modification. He also alleged that the removal of pluripotent stem cells from a human embryo necessarily entails the destruction of the human embryo.
Mr Bot's comments have been interpreted by some as an indication that all inventions relating to human pluripotent stem cells should be excluded from patentability, which would represent a significant departure from the current practice of the European Patent Office (EPO).
The EPO's Enlarged Board of Appeal, i.e. its highest instance, has already independently considered this same issue. In contrast to Mr. Bot, the EPO's Enlarged Board decided that an invention relating to human embryonic stem cells is excluded from patentability if the human embryonic stem cells could only be obtained by a process which necessarily destroys a human embryo (Case G2/06)4.
The Decision of the Enlarged Board of Appeal has been put into practice by the EPO in an interesting manner. Provided that a suitable human embryonic stem cell line was deposited with a suitable institution, or was available from a public source such as a stem cell bank, prior to the filing date of a patent application which relates to the human stem cell-based invention, the EPO is satisfied that putting the invention into practise does not necessarily require the destruction of a human embryo. The EPO does not concern itself with the historical origin of such cell lines; the only question is whether the claimed invention could be performed without necessitating the destruction of an embryo at the filing date of the patent application.
The Advocate General's Opinion is seen by many to represent a departure from this established EPO practice, although his comments could be interpreted as being concerned with the immediate origin of a pluripotent stem cell, rather than the historic origin of a pluripotent stem cell line. It is regrettable that the Advocate General has failed to provide clear guidance regarding the use of established human embryonic stem cell lines, and it remains to be seen whether the CJEU will be clearer on this issue.
There is also arguably some room to challenge the Advocate General's allegations. In particular, he has asserted that the removal of pluripotent cells from a human embryo necessarily entails the destruction of the embryo. This may reflect a lack of familiarity with the field, because there have been reports of the generation of human embryonic stem cell lines which did not involve the destruction of the embryo4.
The Advocate General's Opinion is not binding on the CJEU, and several groups have urged the CJEU not to follow his opinion. For example, leading stem cell scientists have raised profound concerns about the impact of a possible ban on patents for techniques using human embryonic stem cells. In a letter to Nature5, 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.
The Decision of the CJEU is expected within the next few months. Once issued, it will be binding on all EU countries and, although it is not binding on the EPO, it is highly likely that the EPO will follow it. Consequently, the CJEU decision will probably govern the examination of pending and new European patent applications, but European patents which have already granted will remain in force (until challenged), although their validity may be in doubt, which is expected to create some legal uncertainty.
We hope that regardless of whether the CJEU chooses to follow the Advocate General's Opinion, or whether the Decision will be more in line with current EPO practice, it will provide clear guidance regarding the patentability of inventions concerning established human embryonic stem cell lines. Regrettably, we expect that some legal uncertainty will remain even after the Decision has issued.
1 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31998L0044:EN:HTML
2 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:100:0019:0019:EN:PDF
3 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:62010C0034:EN:HTML
4 http://archive.epo.org/epo/pubs/oj009/05_09/05_3069.pdf; see also http://www.dehns.com/cms/document/patentability_of_stem_cells.pdf
5 Chung et al. "Human Embryonic Stem cell Lines generated without Embryo Destruction", Cell Stem Cell 2, 2008, 113-117
