LLM, King’s College London; Phd candidate in IP Law, EDSJ Grenoble
On the October 18th, 2011, the European Court of Justice (CJEU) issued a long-awaited judgment in the Oliver Brüstle vs Greenpeace[i] case. The Court had to answer several major questions concerning the patentability of stem cells and the definition of a human embryo[ii].
Based on morality grounds, the Court ruled that such invention was not patentable according to the EU Directive 98/44 on the legal protection of biotechnological inventions (Biotechnology Directive)[iii]. This decision raised a lot of concerns in the scientific and research fields, as it may have severe consequences on the stem cell industry. In order to understand this complicated matter, the background of the decision has to be clearly defined before looking at the case in itself.
What are Stem cells?
Stem cells are biological cells that can divide and differentiate into diverse specialized cell types and can self-renew to produce more stem cells. In mammals, there are two broad types of stem cells: embryonic stem cells, which are isolated from the inner cell mass of blastocysts, and adult stem cells, which are found in various tissues. Once an ovocyte has been fertilized with sperm, the development begins by the division of cells which all have the capacity to develop into a complete human being. Those cells called “totipotent cells”. They have the ability to subsequently divide, and can be artificially produced using cloning methods.
About five days after fertilization, the diversification process between the cells starts. Those cells are then called “pluripotent cells” and do not have the ability to develop into a complete human being anymore. These “pluripotent cells” are the stem cells use in the Oliver Brüstle[iv] invention, which was the subject of the case before CJEU. The removal of said cells may damage or destroy the blastocyst, which contains all the stem cells that later (after implantation in the uterus) turn into a human being.
Stem cells could be used to cure a lot of diseases relating to blindness, baldness, neurological diseases and cancers. The industry is currently making significant improvements in the creation of cures for those diseases.
What does the Mr Brüstle’s invention refer to?
Mr Brüstle filed a German patent in December 1997, which concerned isolated and purified neural precursor cells processed from embryonic stem cells and removed at the blastocyst stage. The application specified that the transplantation of such cells into the nervous system was a promising method of treatment of numerous neurological diseases, like Parkinson’s disease.
By nature, that type of cell exists only during the brain’s development phase, and the patent at issue sought to make it possible to resolve the technical problem of producing an almost unlimited quantity of isolated and purified precursor cells having neural properties, obtained from embryonic stem cells. As such, the invention did not refer to the use of a human embryo.
What rules apply to the stem cell industry?
Stem cell research involves the use of embryonic cells. Thus, the Directive 98/44 was created to determine the patentability of stem cell – based inventions. In Article 6(2)(c), the Directive excludes the patentability for an invention that “uses of human embryos for industrial or commercial purposes”. However, the Directive does not define the notion of a human embryo[v], or the exact meaning of an industrial or commercial purpose.
How did this case end up before the CJEU?
The patent was challenged in Germany by Greenpeace on the grounds of morality. The Bundespatentgericht (Federal Patent Court) ruled that the patent was invalid[vi] because it covered precursor cells obtained from human embryonic stem cells, processed for the production of those precursor cells. The defendant appealed against that judgment to the Bundesgerichtshof (Federal Court of Justice)[vii].
According to the Federal Court, as Article 6(2)(c) of the Directive 98/44 did not allow the Member States any discretion as regards to the fact that the processes and uses listed therein were not patentable[viii], the reference made in German law[ix] to assess the notion of human embryo was not a Union standard. Thus the concept of an embryo used in one Member State’s law cannot be interpreted differently from that of the corresponding concept in Article 6(2)(c) of the Directive. The problem is that no interpretation of such concept had been done by the CJEU in regard of the said directive.
As a result, on November 12th, 2009, the Bundesgerichtshof decided to refer to the CJEU in order to clarify this concept and to determine whether the human embryonic stem cells which served as base material for the patented processes constituted ‘embryos’ within the meaning of Article 6(2)(c).
Therefore, the Court of Justice had to determine the meaning of the term of “human embryos” in Article 6(2)(c) especially the stage of development required to qualify as an embryo. Furthermore, the expression “uses of human embryos for industrial or commercial purposes” in the Article 6(1) had to be defined. Finally, the other major question was to determine if the technical teaching had to be considered unpatentable even if it does not claim the destruction of a human embryo.
Precedents in the area of human embryo
Before the Brüstle case, the European Patent Organisation (EPO) had to consider similar questions in the Warf (Wisconsin Alumni Research Foundation) decision (G2/06) dated November 25th, 2008.
Based on the same rules as Article 6(2)(c) from the Directive[x], the EPO stated that any invention that would involve the destruction of a human embryo was non patentable[xi], but also that the patentability of inventions involving stem cells was not excluded in and of itself.
Many expected the Advocate General to take a position similar to that taken by the EPO in Brüstle case. Clearly, there was no doubt that the Mr. Brüstle application was going to be destroyed on the same basis.
Opinion of the Advocate General
The Advocate General Yves Bot gave a broad definition of a human embryo, stating that “totipotent cells carrying within them the capacity to evolve into a complete human being must be legally classified as human embryos and must therefore be excluded from patentability” [xii].
Similarly, he considered that “the blastocyst stage of development, reached around five days after fertilisation, must also be classified as an embryo, since, the principle of human dignity, to which the directive refers, is a principle which must be applied not only to an existing human person, to a child who has been born, but also to the human body from the first stage in its development, i.e. from fertilisation.”
What did the Court rule?
Following the General Advocate opinion, the Court gave a very broad interpretation on what should be considered as a human embryo, and therefore would be unpatentable.
Indeed, the Court ruled that “any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’”.
Whit such a definition, regarding the Article 6(2)(c) a stem cell obtained at a blastocyt stage may be considered as a human embryo. As a result, it belongs to each national jurisdiction to determine if a blastocyt constitutes an embryo.[xiii]
Regarding the assessment of the Article 6(2)(c) the Court stated that “the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.”
Given this definition, the application of said Article to the Mr. Brüstle patent application (which did not claim the use of human embryos) led to the application being excluded from patentability: “Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”
As this decision is taken through the eye of patent law and does not refer to the statute of a human embryo as such[xiv], its consequences remain uncertain.
Thus, the fact that the Court used a moral compass[xv] to determine whether this invention was patentable or not is probably the most discussed point. Human dignity is a very difficult notion to define, and the assessment of such concept may recover important differences between national and European Courts[xvi]. However, it is difficult to tell where the moral compass should be held, especially if it may stop medical research. Using an extreme analogy, could the application of human dignity lead to the refusal to patent a mobile device invention because of the use of slave labour in mine precious metals?[xvii] Of course, the commercial use of rare metals is not contrary to human dignity as such but in the end, the mining of said materials in bad conditions may affect human dignity.
What consequences on the stem cell industry?
The first consequence concerns all granted patents for which inventions involve the destruction of a human embryo, as defined by the Court. They are now deemed to be immoral and thus not patentable.
Therefore, even if such patents still remain in force, they are no longer enforceable before a court. As a result, the value of those assets has dropped to almost nothing.
As the decision has a binding effect on the national courts of the EU Member States, national patent courts will apply this decision strictly. The EPO will probably change its practice to conform to this decision[xviii], as the implementation of this decision does not involve any modification in the European Patent Convention. This is something that has to be commended. The collaboration between the EPO and the CJEU[xix] and the absence of differences in the assessment of the rules is something that will probably be helpful to the construction of the future unitary patent system.
Regarding the economic consequences, a lot of concerns have been raised by the stem cells industry. Whereas Greenpeace and few religious groups welcomed this decision, many scientific organisations now believe that this could be the end of the European stem cell industry[xx].
Even if this decision does not prevent from maintaining research activities in this litigious field of technology, the business model of this industry is based on its ability to raise funds. This activity is very costly, and the best way to attracts investors until today has been to get intellectual property protection. Now if investors cannot obtain patent protection for such inventions in Europe, are they still going to invest in European stem cell companies?
In opposition to this argument, researches made in Europe can still be patented in other countries such as the USA but the fear is that European stem cells companies will be driven out of Europe to the USA, mostly for cost reasons.
Ironically, the main goal of the Directive 98/44 was to enhance and protect biotech investments in Europe. As written in paragraph (2) of said directive:
“In the field of genetic engineering, research and development require a considerable amount of high-risk investment and therefore only adequate legal protection can make them profitable.”
As the application of the Directive now involves the absence of protection by the patent system, it is hard to understand how the research industry in this area will keep on growing.
[i] Case C-34/10 Brüstle  ECR I-0000.
[ii] J.Sándor, M.Varju, ‘Patenting stem cells in Europe: The challenge of multiplicity in European Union law’ (2012) 49 Common Market Law Review, Issue 3, pp. 1007–1037
[iii] Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. OJ 1998 L 213, p. 13.
[iv] Prof. Dr. Oliver Brüstle is a neuropathologist and a renowned expert in stem cell research. He serves as Professor of Reconstructive Neurobiology at the University of Bonn Medical Center.
[v] Specifically, the Directive does not define the development stage when a human embryo is considered to be created.
[vi] The decision was based on the immorality of the invention (“sittendwidrig”).
[vii]Judgment of the Court (Grand Chamber) para 20 CJUE, not yet published.
[viii] See Case C-377/98 Netherlands v Parliament and Council , para 39, and Case C-456/03 Commission v Italy , para 78.
[ix] See Section 2(2) of the German Patent Act. <http://www.wipo.int/wipolex/en/text.jsp?file_id=238776>
[x] In July 1998, the EPO, which is not an EU organisation, made a modification of the European Patent Convention in order to include a similar version of the Biotechnology Directive.
[xi] As long as the invention implies the use of human embryo to a ‘commercial or industrial purpose’
[xii] Press Release No 18/11, March 10, 2011.
[xiii] The Court stated that it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44. Para 38 of Brüstle case.
[xiv] The Court stated that: “As regards the meaning to be given to the concept of ‘human embryo’ set out in Article 6(2)(c) of the Directive, it should be pointed out that, although, the definition of human embryo is a very sensitive social issue in many Member States, marked by their multiple traditions and value systems, the Court is not called upon, by the present order for reference, to broach questions of a medical or ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the Directive”. Para 30 of Brüstle case.
[xv] The Court used the concept of human dignity as a legal motivation: “The context and aim of the Directive thus show that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected. It follows that the concept of ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive must be understood in a wide sense” Para 34 of Brüstle case.
[xvi] For example, in the Commune de Morsang-sur-Orge case dated October 27th 1995 and dealing with dwarf tossing in nightclubs, the French Conseil d’Etat ruled that the respect of human dignity would be legally sufficient to make dwarf tossing illegal, even with personal consent. Contrary to this the ECHR, in the KA and AD Vs Belgium case dated February 17th 2005, ruled that human dignity would not be sufficient to prohibit extremely violent sexual act as long as personal consent was given.
[xviii] Even if formally the EPO does not have to conform with the CJEU decisions.
[xix] The CJEU made several references to the WARF case, unlike the Advocate General.
[xx] See for example a statement made on December 7th 2011 by the Alliance of German Scientific Organizations. <http://www.idw-online.de/pages/en/news455110>