Emma Barton-Smith; Nicolas Deffet; Hèline Dolvelde; Félix Leseultre; Raquel Marques
Comment awaiting moderation.
BARBONI Ilona, MARINELLI Laura, OZTURK Aylin
a. Article 6(2)(c) is based on the fact that as soon as an embryo has been destroyed when it would have created life, it cannot be protected by a patent right. In contrast, if the embryo cannot have the capacity to develop into a human being, then a patent right can be granted. It seems to us that a balance has… Read more
a. Article 6(2)(c) is based on the fact that as soon as an embryo has been destroyed when it would have created life, it cannot be protected by a patent right. In contrast, if the embryo cannot have the capacity to develop into a human being, then a patent right can be granted. It seems to us that a balance has been found there.
Furthermore, as soon as the use of embryos has a purely economic or scientific research purpose, no patent rights can be granted. At this level, the balance of interests has been found in the fact that if the technique is used to treat embryos, then patent rights can be granted but only for that.
b. In the article, it is mentioned that Article 6(2) lists the different cases in which a patent right can never be granted. In these various cases of exclusion, we find the commercialization of the use of human’s embryos. We believe that it would be useful to exclude any commercialization from the use of the human body for purely and simply economic purposes.
c. We do not believe that this decision necessarily has a negative impact on scientific research in Europe. Indeed, on the economic aspect, national or European subsidies are granted to laboratories. Therefore, they are not prejudiced by this decision.
d. The two cases are different, in the case of in vitro fertilized ova, it takes considerable medical interventions to hope that the ova will one day become a human being. As a result, without intervention, it is as if the embryo was originally dead. As a result, we are not in the same conditions as in the Brüstel case. In the present case, to be more precise, the court should have said that “without medical interventions, if the ova is not fertilized, even artificially, by a paternal gene, then it fits within the conditions for obtaining a patent right.
e. In the present case, a margin of discretion is given to the national courts and not an absolute discretion. In this sense, even if they can interpret the concept, the CJEU can still overrule the decision if they consider that the national court didn’t follow the European vision.
f. We will make a parallel here with the labour court in Belgium. In this area of law, the session is always held by 3 judges, one “jurist” judge, and two people who took the oath (who didn’t study law but come from the workplace, who have a better knowledge of the field than the presiding judge). In this sense, it would be interesting to apply this legal technique at the level of the CJEU when dealing with this type of issue, by incorporating judges with experience in the area of the biological research.
Anna Salvi, Nadège Rontani, Julie Fort and Antoinette Huberlant
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As far as we are concerned, we first thought the article 6(2)(c) of Directive 98/44/EC offers a proper balance between those interests.… Read more
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As far as we are concerned, we first thought the article 6(2)(c) of Directive 98/44/EC offers a proper balance between those interests. We consider the human dignity as being more important than the scientific research. But from a different perspective, we could ask ourselves if the fact that we know those kinds of practices could save some person from neural diseases, but we don’t use it, isn’t there some sort of failure to respect human dignity? That is why the German interpretation of the CJEU’s definition of embryo is an interesting point of view to take into account.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
No. Since the article 6(2) of Directive 98/44/EC is using the formula “in particular” before the enumeration of the unpatentable comportments, we could totally imagine other cases falling within the scope of this article. With the rapidity of technological progress, we shall certainly face situations the directive couldn’t have foreseen at the time it was enacted.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
A balance of interests has to be made, on the one hand, scientific searches have the right to be recognized for their research, but on the other hand, it need to be controlled for ethical purposes. European regulations are, on the ethical stage more human oriented than U.S. regulations that aspire to have a liberal and business oriented state of mind. Talking about the tombstone of stem research might be excessive, but it must be taken into consideration that research might be more limited.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
When the court redefined the term of embryo, one might have assumed a more explicit and precise definition of it. However, an inaccuracy still occurs especially concerning the term of “commencement”. First of all, the CJUE leaves member States to their own definition of Human embryo which leads us to cultural contradictions. Indeed, every Member State has it’s own meaning of appearance of signs of life according to it’s culture. Secondly, The CJEU could have given more specific guidelines to justly orientate Member States. Furthermore, different characteristics could have been added as well even if the confrontation of science, ethics and Intellectual property law can be tricky.
e. Both in Brustle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardize the European harmonisation of patents?
Such a situation could indeed jeopardize the European harmonization of patents, since the different member states would be able to provide different definitions of the notion of « embryo ». Under those circumstances and depending on the definition provided, patents in some countries would contain embryos, while patents in other countries wouldn’t. This means that people could work on something without even knowing that this particular work is illegal in some countries. Therefore, it would be easier if the Court of Justice explicitly provided what is protected by the patent and what isn’t.
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
The judiciary field is more able to answer to ethical questions than the scientific and political fields. For instance, if all scientists agree on the description of a notion, the judge will be able to answer to a judiciary question about this notion; However, it’s going to be different in every country because the law is adopted by MP’s and those people are representing the people of the country. And population in every country is different, they have different opinions which will lead to the fact that judges are different too. We can make an analogy with the UE which follows the same reasoning. It would be easier for judges to have some experts, it will help them to see what the public opinion is and to judge according to that.
a) Yes, it does. Here, the importance of the interpretation by the Court is crucial, because the wording of the article is fixed while scientific discoveries are continually made. These discoveries have to be considered in the light of this Directive, and doing so, the court must take into account their novelty.
b) The list is probably not exhaustive in… Read more
a) Yes, it does. Here, the importance of the interpretation by the Court is crucial, because the wording of the article is fixed while scientific discoveries are continually made. These discoveries have to be considered in the light of this Directive, and doing so, the court must take into account their novelty.
b) The list is probably not exhaustive in a field (= inventions) that has that particularity to evolve constantly. Knowing that, a margin of appreciation must be left to the Court of Justice of the European Union in order to keep an eye on the consistency.
c) It’s true that the decision raised a sort of inequality, because by reducing the patentability of stem cells to cells that cannot begin a process of development of a human being, the Court limits opportunities for scientific researches and innovations in Europe. However, there is an exception that reopens the possibilities in this field: “a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo”. It be an open-door to the restriction. Unfortunately, this condition of the treating of the human embryo remains restrictive and it doesn’t let a total freedom to the inventors.
d) No, because the CJEU clearly defines what an embryo is: any human egg that is able, after fertilization, to begin the process of development of a human being. The margin of discretion that the Court leaves to national courts is only with regards to the determination of the capacity of the cell to develop into a human being or not. And to do so, the CJEU does not leave the possibility to the courts to decide according to their good will if a stem cell is able to begin the process of human development, but in the light of scientific developments which in principle should be certain and consistent.
f) The real problem isn’t the question of the qualification of the judges in the field concerned, but the assistance that must be brought to them. Indeed, science isn’t the only fields that deals with complex concepts, almost all the fields have their specificities that are likely to create difficulties in the legal reasoning. However, it would be impossible to require experts for each field dealt by the Court. We must rather try to provide judge’s right-hand men specialised in the different areas, especially the scientific field. The solution could be to create little groups of independent European experts while they face those cases concerning specialised technical matters.
Intellectual Property Law : Work 3
Exercice 1. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As long as it is interpreted as “if it turns into a human life, you can’t… Read more
Intellectual Property Law : Work 3
Exercice 1. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As long as it is interpreted as “if it turns into a human life, you can’t use it”, a proper balance is insured between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection. However, it is still interesting to add here that cells are treated as an invention (since possible to put a patent on them) when they actually aren’t. Nobody invented cells, they are just used or not.
Exercice 2. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
“The Netherlands did not think to However the Netherlands saw in article 6 (2) a non-complete list, the Court quotes recital 38 of the directive which specifies that the list is non-exhaustive. The Court, furthermore, held that “the grant of a patent does not preclude legal limitations or prohibitions applying to research into patentable products or the exploitation of patented products, as the 14th recital of the preamble to the Directive points out. The purpose of the Directive is not to replace the restrictive provisions which guarantee, outside the scope of the Directive, compliance with certain ethical rules which include the right to self-determination by informed consent”. Indeed, the directive doesn’t’ preclude the application of provisions restricting, for example, the exploitation of certain inventions”, found on https://www.droit-technologie.org/actualites/the-directive-9844-ec-for-the-legal-protection-of-biotechnological-inventions-a-commentary-of-its-articles/
Exercice 3. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Art 6 of the Directive is an « ethical clause » which aim to protect human dignity and the scientific research about stem cells obtained by embryos. The ethical ground in Europe is no comparable with other parts of the world, and in this sense of CJEU’s approach was adequate and coherent with the values shared at European level. We do agree with the argument concerning this subject. Also, the scientific research concerning the use of human embryos for commercial or industrial purposes is prohibited by article 6 of the Directive. There is a purpose to avoid any innovation and research in that area but it doesn’t concern the entire biotechnological innovation in Europe. The existence of such a restriction in Europe is in part due to the perception of ethical limits that are not shared by other nations. Innovation and scientific research can lead to several abuses from the scientific community and in order to avoid this the European Union, and member states, decided to put restrictions into the Directive 98/44/CE by defining the legal notion of humain embryo in patent law and the limits.
Exercice 4. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
We think that the meaning of « commencement of the process of development of a human being » is sufficiently clarified by the directive 98/44/EC. The EU identified and defined the concepts and ideas in a clear way with the purpose to make sure that it will not be a misunderstanding and that it will be no intention to violate the rules and that scientific research will no try to develop something prohibited by the law.
Exercice 5. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents ?
The Court of Justice of the EU gives a definition of the embryo, and under which circumstances it can not be patentable. It gives a certain appreciation of that definition to the national courts which can review cases according that definition. Thus, there is a harmonization of patents to a certain point. However, it must be remembered that the appreciation of the notion of embryo will differ according to one’s culture and certain countries could subject more moral principles and could be stricter in the application of this principle.
Nevertheless, the court of justice has a final say in the decisions. When a party does not agree with the decision given by the national courts it can appeal to the court of justice who will bring back order if a national court diverge too much from the European harmonization.
Exercice 6. A provocative question : do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters ?
One can always do research about the subject he or she has to judge; it can be argued that a jurist, with no scientific background whatsoever is not the best to judge of complex scientific matters. However, it is the role of the lawyers who defend these cases to explain what is at stake, and how this subject, this scientific concept has to be understood. Even scientific matters can not be left unresolved just because they are deemed too complex.
They have to be judged and discussed as any concept, and even so when they touch legal concept such as patent, which is organized by courts and laws. These subjects could not be left to the only appreciation of scientists, who are often ready to do anything and who could put patents only to protect their personal interest even if it could be detrimental to others. There have to be third parties to judge of this cases.
a. Yes, I think it does. This article based on morality prevents people from abusing of human embryos for self-interested purposes. However, there is an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo. But is it actually better to sacrifice a human embryo at the expense of… Read more
a. Yes, I think it does. This article based on morality prevents people from abusing of human embryos for self-interested purposes. However, there is an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo. But is it actually better to sacrifice a human embryo at the expense of another one? I don’t think so.
But this is only the interpretation regarding the use of fertilized eggs. There is also an interpretation of the CJEU regarding an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis. Because in the light of current scientific knowledge, that ovum does not, in itself, have the inherent capacity of developing into a human being. So, this means that a human embryo would not be sacrificed to the expense of another one.
b. No, this list is certainly not exhaustive. Another biotechnical applications affecting human dignity could be regarding abuse of human bodies being artificially dead or so on.
c. On one hand, I agree with the argument that says that the CJEU approach in the Brüstle judgement negatively affected biotechnical innovations in Europe. But on the other hand I understand the (moral) point of view of the court and I am not against their judgement given at the time.
d. I think their definition of “commencement of the process of development of a human being” is clear enough (for non-scientists). We understand that a non-fertilised ovum stimulated by parthenogenesis cannot lead to human life unlike a fertilized ovum that will further develop and that inevitably will end up as a human life.
e. Indeed, I think this margin of discretion on determining whether a biological material falls under the definition of embryo left by the CJEU to the national courts could jeopardise the European harmonisation of patents. However, the member states are still sovereign and have the authority to decide for themselves how they want to interpret the definition of an embryo.
f. The CJEU doesn’t have all the knowledge it takes to make an informed decision on the matter. However, they are jurists by profession, and will be far more impartial than scientists. The best solution is that the court receives all the needed (scientific) information from both parties in order for them to make the optimal decision.
Exercice 1. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As long as it is interpreted as “if it turns into a human life, you can’t use it”, a proper balance… Read more
Exercice 1. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As long as it is interpreted as “if it turns into a human life, you can’t use it”, a proper balance is insured between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection. However, it is still interesting to add here that cells are treated as an invention (since possible to put a patent on them) when they actually aren’t. Nobody invented cells, they are just used or not.
Exercice 2. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
“The Netherlands did not think to However the Netherlands saw in article 6 (2) a non-complete list, the Court quotes recital 38 of the directive which specifies that the list is non-exhaustive. The Court, furthermore, held that “the grant of a patent does not preclude legal limitations or prohibitions applying to research into patentable products or the exploitation of patented products, as the 14th recital of the preamble to the Directive points out. The purpose of the Directive is not to replace the restrictive provisions which guarantee, outside the scope of the Directive, compliance with certain ethical rules which include the right to self-determination by informed consent”. Indeed, the directive doesn’t’ preclude the application of provisions restricting, for example, the exploitation of certain inventions”, found on https://www.droit-technologie.org/actualites/the-directive-9844-ec-for-the-legal-protection-of-biotechnological-inventions-a-commentary-of-its-articles/
Exercice 3. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
The existence of such a restriction in Europe is in part due to the perception of ethical limits that are not shared by other nations. Innovation and scientific research can lead to several abuses from the scientific community and in order to avoid this the European Union, and member states, decided to put restrictions into the Directive 98/44/CE by defining the legal notion of humain embryo in patent law and the limits. Art 6 of the Directive is an « ethical clause » which aim to protect human dignity and the scientific research about stem cells obtained by embryos. The ethical ground in Europe is no comparable with other parts of the world, and in this sense of CJEU’s approach was adequate and coherent with the values shared at European level. We do agree with the argument concerning this subject. Also, the scientific research concerning the use of human embryos for commercial or industrial purposes is prohibited by article 6 of the Directive. There is a purpose to avoid any innovation and research in that area but it doesn’t concern the entire biotechnological innovation in Europe.
Exercice 4. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
We think that the meaning of « commencement of the process of development of a human being » is sufficiently clarified by the directive 98/44/EC. The European Union identified and defined the concepts and ideas in a clear way with the purpose to make sure that it will not be a misunderstanding and that it will be no intention to violate the rules and that scientific research will no try to develop something prohibited by the law.
Exercice 5. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents ?
The Court of Justice of the European Union gives a definition of the embryo, and under which circumstances it can not be patentable. It gives a certain appreciation of that definition to the national courts which can review cases according that definition. Thus, there is a harmonization of patents to a certain point. However, it must be remembered that the appreciation of the notion of embryo will differ according to one’s culture and certain countries could subject more moral principles and could be stricter in the application of this principle.
Nevertheless, the court of justice has a final say in the decisions. When a party does not agree with the decision given by the national courts it can appeal to the court of justice who will bring back order if a national court diverge too much from the European harmonization.
Exercice 6. A provocative question : do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters ?
One can always do research about the subject he or she has to judge; it can be argued that a jurist, with no scientific background whatsoever is not the best to judge of complex scientific matters. However, it is the role of the lawyers who defend these cases to explain what is at stake, and how this subject, this scientific concept has to be understood. Even scientific matters can not be left unresolved just because they are deemed too complex. They have to be judged and discussed as any concept, and even so when they touch legal concept such as patent, which is organized by courts and laws. These subjects could not be left to the only appreciation of scientists, who are often ready to do anything and who could put patents only to protect their personal interest even if it could be detrimental to others. There have to be third parties to judge of this cases.
a)
I think this article protects human dignity because it prohibits the use of patent on human embryo and that notion is interpreted very broadly, indeed, the CJEU stated that “any human ovum after fertilisation must be considered falling under the legal definition of embryo, because that fertilisation is such as to commence to process of development of a human being”.… Read more
a)
I think this article protects human dignity because it prohibits the use of patent on human embryo and that notion is interpreted very broadly, indeed, the CJEU stated that “any human ovum after fertilisation must be considered falling under the legal definition of embryo, because that fertilisation is such as to commence to process of development of a human being”. This restriction can thus limit researches in this filed.
b)
The list contained is definitely not comprehensive, science evolves and there will be new uses of human embryos. Furthermore, a list can never be fully comprehensive.
c)
The restriction in Europe can indeed make stem cell researches more complicated. However, it’s not entirely true because there are exceptions: “a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo”. Thus, the restriction isn’t “complete”, the use of stem cells and embryos isn’t completely prohibited, patent can still be granted in those circumstances.
d)
We’ve seen that this definition led to uncertainty because it was interpreted differently (indeed, according to the German Court “blastocysts are not human embryos and stem cells can be patented as long as their production does not cause the destruction of an embryo..”). So that proves the definition given by the Court isn’t clearly defined and should be given more details in order to prevent any misuse of this definition.
e)
Leaving a certain margin of appreciation to different Member States can of course have an influence on the harmonisation of European patent. The definition of embryos isn’t the same everywhere and those differences are sometimes a sensitive matter that lead to controversies. The question of the definition of the embryo should be dealt at the European level to, on one hand, prevent any unclarities about the definition, and, on the other hand, to allow an harmonisation on the European level and thus allowing to grant patent on certain well-defined criteria.
f)
This question can be asked in many different circumstances, for example, can a judge decide correctly on a matter relating to cars when the judge doesn’t know anything about cars? I think that the judges having to deal with such complex matter is part of the job, indeed, how can we expect judges to know everything about anything? A creative solution which isn’t really creative as it already exists, is that it’s essential that the judges are assisted by experts in the matter, otherwise it’s true that they can’t really be of any help. Judges could also follow special formations in relation to the subject they have to deal with, but at the same time, we can’t expect the judges to know everything, there will always be subjects about which the judges won’t know much, but that doesn’t mean they can’t have an external point of view and decide with the help of an expert.
A)
The Article 6(2)(c) of Directive 98/44/EC as interpreted by the CJEU ensure a proper balance between human dignity and the public interest in research and innovation. Indeed the CJUE interpreted the notion of human embryo linked to the provision fore-mentioned in a way compatible with the protection of human dignity.
The CJUE admits that “the exclusion from patentability concerning the… Read more
A)
The Article 6(2)(c) of Directive 98/44/EC as interpreted by the CJEU ensure a proper balance between human dignity and the public interest in research and innovation. Indeed the CJUE interpreted the notion of human embryo linked to the provision fore-mentioned in a way compatible with the protection of human dignity.
The CJUE admits that “the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c ) of the Directive also [apply to the] use for scientific research”. But the CJUE also introduce the following exception “ patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo ”. Obviously, this exception do not cover the destruction of human embryos or their use as a base material.
According to our point of view, it also shows that the CJUE gives more importance to the human dignity and the public interest in research and innovation than it does to the economical aspect.
B) Paragraph 2 of this Directive enumerates a list of inventions that, in any case, cannot be patented. Among them, there are the “uses of human embryos for industrial or commercial purposes”. The court gives a large scope to the notion of human embryos. Therefore, many situations are concerned by this provision, including human ovum after fertilisation and “unfertilised ova, whose development process can be artificially stimulated”. We think that the list should be more precise in a way that it includes, at least, those situations.
C) The European and American approach are different. Both have advantages and weaknesses but we cannot affirm that one is better that the other. In Europe, we give more importance to the human dignity whereas in the US, research and biotechnological innovation are privileged.
D)
We don’t think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle. Indeed, in the case International Stem Cell, the CJUE only formulates the “inherency test” to determine if a non-fertilised ovum can be defined as an embryo. The CJUE doesn’t give more information concerning the notion of “commencement” than it gives in Brüstle. It only precises that if a stem cell cannot develop to term and so they don’t have the inherent capacity of developing into a human being, they cannot be included in the definition of human embryo.
E)
Yes because scientifical researches can evolve differently from one state to another. So the way a state interprets the scope of the definition of human embryo could also differ depending on the State.
F)
No it cannot. In such technical cases, judges should be assisted by experts. This conclusion doesn’t only apply to the scientifical domain but also to every other specialized fields such as (architecture, technology, etc.).
Marie Marchetti, Romane Martens, Elsa Kraemer, François Denis
a) Article 6 (2)(c) obviously protects human dignity since it’s prohibiting patents on human embryos. Human embryo is a notion interpreted broadly. However, it seems that this restriction can limit research and innovation in this field. Science evolves really fast, faster than law. The directive will thus have to be adapted to new considerations and protect new inventions. If not, scientists… Read more
a) Article 6 (2)(c) obviously protects human dignity since it’s prohibiting patents on human embryos. Human embryo is a notion interpreted broadly. However, it seems that this restriction can limit research and innovation in this field. Science evolves really fast, faster than law. The directive will thus have to be adapted to new considerations and protect new inventions. If not, scientists won’t invest in new researches.
b) No. The directive itself underlines it at 38th “whereas”. I don’t have notion in the biotechnological field so I can’t mention any technology that would not be protected by the directive, but I am sure it exits.
c) We believe that terms need to be clarified and analysed more in depth. Therefore, the clarification in the International Stem Cell Corporation case was welcome.
d) Yes, since in the International Stem Cell Corporation case, CJEU made a distinction between cells that would have the capacity to develop into human beings and cells that wouldn’t. Human dignity is a cardinal principle both in many national rights and in European right, we believe that both rights should be put in balance and that the right to human dignity should weigh more. That is in the end what matters for people to know in order to protect human dignity.
e) Indeed, leaving a certain margin of discretion necessarily leads to a jeopardizing of the European harmonization of patents. As we know, the question regarding at which level a biological material falls under the definition of “embryo” is a touchy question leading to heated debates. In this sense, I would recommend that this question was dealt with on the European level, and that one decision would be taken by consensus if possible. By doing so, it would harmonize the patents and it would thus be easier for a European Member State to deal with the question.
Nevertheless, every Member State has its own historical, ethical and sociological background. In that sense, it can be understood that the national court of Poland is not going to have the same position on the question than the Netherlands for example.
f) This question is indeed difficult to answer to. At first sight, I believe that the responsibility of jurists (may they have a knowledge of scientific concept or not) is to stay impartial and to settle a dispute. The jurist has, in that sense, followed a cursus and has legal tools: he is qualified to do so. Beyond that certainty, it’s obvious that jurists aren’t some kind of “Gods” supposing to know everything in all domain. This is typically the problematic tackled with this question. I think that (in the first step at least), when dealing with scientific questions, the jurist has to concede its incompetence. This leads to the interdisciplinary approach of the legal world: it’s even more interesting to work with other professions to assure the global knowledge of the case dealt with and to be sure that all the aspects are covered (the legal ones, as well as the medical ones, with observations made by laboratory workers doctors for example).
Secondly, if I had to foresee any creative solution, I would suggest to insert a particular class or Master (whatever) in the legal cursus to inform the jurists about technical matters. It could also be implemented compulsory conferences on scientific concepts that would have to be necessarily followed by the jurists.
In Europe, human embryos are excluded from patentability on morality grounds.
* Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I believe that the fact of applying this principle to unfertilized ova… Read more
In Europe, human embryos are excluded from patentability on morality grounds.
* Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I believe that the fact of applying this principle to unfertilized ova whose development process can be artificially stimulated can slow down and have a negative impact on the public interest in research and innovation. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) should not be applied for scientific research.
* Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I don’t think so. The fact that they are talking about « ordre public and morality » makes the notion really wide and the provision does not contain any further specification or a clear definition of human embryos.
* The Brьstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
i agree with the fact that by adopting a broad definition of the notion of embryo, derived from the principle of dignity, can slow down the innovations of the scientific community in Europe. The fact that the definition is wide and ambiguous can cause a disruptive effect on patentability in this area and on the downstream research in comparaison to countries outside the EU.
* In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brьstle?
Although the Court clarified what the concept of embryo represents, i think the latter remains unclear. The Court reported that at the state of the art, the stem cells cannot develop to term and that for that reason they do not have the capacity of developing into humain being. The Court clarified that by saying that an unfertilized human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo.
* Both in Brьstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, I think that the CJEU should impose the same scope of the concept (and make it clearer by defining its contours in a precise way) within the different countries of the EU so as not to leave too much room for appreciation to the national courts in order to have a certain homogeneity and consistency.
* A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
II believe that jurists should be assisted by expert committees or specialists in these highly specialized scientific fields in order to address highly specialized technical issues. For example, jurists of national courts shouldn’t be left alone with the decision of verifying in light of scientific developments, whether a stem cell obtained from embryos at the blastocyst stage (like those object of the Brüstle’s patent) are able to commence the development process.
Questions for discussion
Alice Van Buylaere
In Europe, human embryos are excluded from patentability on morality grounds.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that this article is a really good… Read more
Questions for discussion
Alice Van Buylaere
In Europe, human embryos are excluded from patentability on morality grounds.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that this article is a really good idea at the basis. It leaves a great freedom to researches and innovation, while really protecting human dignity. It only considers unpatentable a few things that it considers as contrary to the public order (or morality) when there is commercial exploitation, like the process for cloning human beings. Most of the population would agree with this decision I think.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I think the list should be more comprehensive. It only gives four things that shall be consider unpatentable because of their commercial exploitation that would be contrary to the public order or morality. I think not only the cloning of human beings, the modification of the germ line identity of human beings, the uses of human embryos for industrial or commercial purpose and the process for modifying the genetic identity of animals which are likely to cause them suffering without any substantial benefit for man or animal, and also animals resulting from such process are not the only biotechnological application affecting human dignity that could deserve protection. For example, I think about the process for modifying the genetic identity of animal which are likely to cause human suffering by eating the genetically modified food.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other countries, notably the US, there not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
I understand the criticisms of some people because it is not a universal decision. But at the same time, it is not because a country doesn’t make restrictions that another shouldn’t.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
No I think the meaning wasn’t clear enough. It talks about commencement of the process of development of a human being, then it says whatever the stage at which that takes place, it also talks about prior destruction of human embryos. Even more, it has an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo. We are a bit lost while reading all of that.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonization of patents?
Yes, and no. I think that is good that each national court has a certain margin of discretion and still has a legal framework to help it take a decision.
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
I think the CJEU cannot adequately decide legal questions with complex scientific concepts. A solution would be that, in cases that concern highly-specialised technical matters, the Court was composed by half of jurists and half of scientists.
a. I think that the first interpretation by CJEU gave an unrealistic legal definition of the human embryo because it vaguely attached it to the human dignity. It is a criteria that gives too much of a wide sense. Indeed at first even “a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis” must be considered… Read more
a. I think that the first interpretation by CJEU gave an unrealistic legal definition of the human embryo because it vaguely attached it to the human dignity. It is a criteria that gives too much of a wide sense. Indeed at first even “a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis” must be considered an embryo even if it was after realised that “an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being”. My personal opinion is that the human dignity must always prevail the public interest in research and innovation, otherwise where would you brake once you opened the door towards the non respect of human dignity?
b. The list at article 6(2) is not to be seen as a comprehensive one. I don’t see another biotechnological application affecting human or animal dignity but such an issue could arise, that’s why it is required to be a non-comprehensive list.
c. It is not true to say that there are no restriction about stem cells research in the US. The United States National academies released its “Guidelines for Human Embryonic Stem Cell Research” and about ten states have banned or restricted the area. It has not been the tombstone of stem cells research in Europe because you can still use it for scientific research if it doesn’t requires the prior destruction of human embryos. The CJEU did affect negatively biotechnological innovation in Europe but necessarily in order to respect morality standards.
d. I don’t think the Court did, “having the inherent capacity of developing into a human being” is something that can be debated and the court will probably have to respond in concreto several times in order to clarify the definition.
e. Yes it could if the states have differentiated morality standards.
f. I believe that a Court of jurist is the best option since they have a great understanding of the principle of human dignity. I could suggest a scientific composed Court to whom the CJEU could refer to ask prejudicial questions on a scientific matter in order to understand the actual scientific state of knowledge we are able to give on the question and how the scientific doctrine would respond.
A. This is a rather technical question and it is difficult for us to answer since we are not specialists in human rights, nor in economics and even less in biology. In our view, the position adopted by the ECJ in its interpretation of Article 6(2)(c) of Directive 98/44/EC is legitimate. It respects the values it imposes on itself in… Read more
A. This is a rather technical question and it is difficult for us to answer since we are not specialists in human rights, nor in economics and even less in biology. In our view, the position adopted by the ECJ in its interpretation of Article 6(2)(c) of Directive 98/44/EC is legitimate. It respects the values it imposes on itself in its founding texts by placing respect for human dignity before economic interests. As far as patent protection in this area is concerned, this raises more questions. Indeed, if adequate protection is not granted, there is a risk of fewer innovations. However, these are essential for the progress of medicine. There is a tension here between the desire to preserve human dignity and the desire to guarantee it through appropriate medical care.
B. Since paragraph 1 states that “Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality”, we consider that the list in the second paragraph is extensible. It must be considered that the inventions contained therein are necessarily and mandatorily prohibited. But other inventions that go against morality and disturb public order will also be. We could imagine that the article also provides for a ban on cloning given all the ethical debates it raises.
C. We believe that, in general, just because other countries adopt certain practices does not necessarily mean that we should follow them. Should we, like some U.S. states, apply the death penalty? Should we, like many emerging countries, reduce wages to ensure high economic competition? The debate here is on the ethical side. In our view, in retrospect, we can see that the definition given in the Brüstle judgment was too broad. It may have had a negative impact for some time. Nevertheless, it is better to be too cautious than too permissive on this subject. To avoid such differences between countries, common regulations should be adopted at the international level.
D. The British court referred a question to the ECJ for a preliminary ruling to clarify the meaning of the term’commencement of the process of human development’. In order to know what is the standard for determining whether a cell can evolve towards an individual, thus hindering patentability. The Court made an important distinction by re-examining its notion of precedent for human embryos for the second time.
It appears from the Court’s observations that an unfertilized human egg whose division and development were stimulated by parthenogenesis had the capacity to become a human being.
In International Stem Cell Corporation, the Court of Appeal indicated that, at the state of the art, the stem cells under discussion cannot develop to their full potential and therefore do not have the inherent capacity to become a human being.
On this basis, the Court concluded that: an unfertilized human egg whose division and subsequent development have been stimulated by parthenogenesis does not constitute a “human embryo” within the meaning of this provision if that egg does not, in itself, have the inherent capacity to transform itself into a human being, which is within the jurisdiction of the national court.
In this conclusion, the Court seems to have sufficiently clarified the expression “the beginning of the process of a human being’s development”.
E. Yes, this situation could be quite compromising in terms of European patent harmonisation because it does not put all EU countries on an equal footing in scientific research by leaving a margin of appreciation to national courts. As a result, some countries could, for example, be much more advanced in the scientific field than others, and this would lead to a certain kind of illegality.
F. It seems obvious that a Court composed of lawyers cannot adequately decide legal questions dealing with such complex scientific concepts. In our opinion, they should be surrounded by professionals in the field, such as specialized doctors or scientists who can give an objective opinion on the issue.
Nastasya Hodjeff, Sacha Szmir, Nicolas Papageorges, Victoria Markiewicz, Fanny Deprelle
A. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
We are confronted with an ethical problem which is important in Europe. Two observations should be done. On one hand, if… Read more
A. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
We are confronted with an ethical problem which is important in Europe. Two observations should be done. On one hand, if it is necessary to make researches concerning the public health, we have to be more flexible because it can save a lot of people. On the other hand, if it is only for economic profit it is unacceptable because it will be only for business reasons. As a result, it is contrary to ethical values of Europe. In conclusion, it is still a main concern today which need a lot of reflections.
B. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
The ethical clause of the directive is not complete because the CJue has broadened some of the concepts in this list to give them a broader scope. The Cjue has extended this list to non-fertilized ova and ova after fertilization, which must therefore receive the same protection as embryos.
C. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
It is true that the CJUE’s approach in Brüstle restricts the research for stem cells since stem cells derived from embryo’s cannot be patented and since the term embryo itself is interpreted in a very broad way. In the word “embryo” are understood an ovum after fertilisation and a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis. But I would not say that this decision is the tombstone for the search for stem cell since a margin of appreciation is always given to the state in determining whether stem cell obtained from embryos at the blastocyst stage are able to commence the development process and since a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo.
D. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
the interpretation of embryo is wide and As a consequence the CJEU said that any human ovum after fertilisation must be considered falling under the legal definition of embryo, because “that fertilisation is such as to commence the process of development of a human being” (§35 Brüstle judgment). according to the court it is the main the notion of embryo. the CJEU applied this principle also to unfertilised ova. The Court stated that “a non-fertilised human ovum which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis” must be considered an embryo.
The International Stem Cell Corporation contested, alleging that the object of its patent application was substantially different from the one discussed in Brüstle. Because the stem cells obtained from parthenogenetically-activated ovocytes are not able to develop into a human being. event the UK agree and asked a preliminary question to CJEU to clarify the meaning of “commencement” of the process of developement of a human being. This means that the defintion wasn’t clear at the begining and after a distinction was made.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
it is the national court that has to verify, in light of scientific developments, whether a stem cell obtained from embryos at the blastocyst stage (like those object of the Brüstle’s patent) are able to commence the development process. So we can see here that every country could have a different interpretation of what an embryo is because its sense is wide. If everybody has a different definition then patents are granted differently from a country to another and it could be dangerous for the european harmonisation.
F. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
The European court of justice, composed by jurists, can adequately decide legal questions dealing with complex scientific concepts because she is the only one who can give an accurate interpretation of the law. The court is the best to ask for clarification. Moreover, appeal to the European court of justice allows to ensure EU law is interpreted and applied the same in every EU country. Finally, the European court of justice is impartial so there is no biased approach.
Alice Hubens, Antoine Thill, Dian Diang Djata, Claire Sponar, Bagnarol Sarah
G. K. Chesterton said, “When people begin to ignore human dignity, it will not be long before they begin to ignore human rights”. It shows that human dignity is something important because its non-compliance has far more far-reaching consequences than one might imagine. The CJEU by its interpretation shows that they are aware of that fact. In the first interpretation,… Read more
G. K. Chesterton said, “When people begin to ignore human dignity, it will not be long before they begin to ignore human rights”. It shows that human dignity is something important because its non-compliance has far more far-reaching consequences than one might imagine. The CJEU by its interpretation shows that they are aware of that fact. In the first interpretation, they are very protective of this right. The balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection was not reached. But they achieved this balance, the second time when they narrowed the definition of “embryo”. But the concept of human dignity is always evolving. If the four restrictions given in article 6 may seem enough right now, they may be insufficient in two years. For example, today the animal cause is coming to the forefront more and more. Of the four patent prohibitions given by this Directive, only one concerns animals. It is very portable that the list grows longer in the future knowing that a majority of people may not be satisfied with so little.
Moreover, the list is influenced by what’s considered in the country as something that violates human dignity. Ideologically, people complaining about different standards in other continents go against the very principle of human dignity, which is a vague concept whose interpretation varies from one country to another. Like human rights, they can be more or less protected according to the mores of the country from which they come (subject to those universally accepted as a human right). On an economic level, however, their criticism makes sense, as it creates a clear imbalance and risks simply shifting activities to another country.
However, it should be remembered that the directive concerns patents. Many will argue that the directive must concern patents. This does not mean, therefore, that the act itself is illegal, but rather that the person who exercises these experiences cannot be protected by property rights. This argument has tended to diminish the importance of this article with regard to the protection of human dignity. However, in reality, the two go hand in hand, and in fact, this article contributes to the protection of human dignity.
The CJUEU precised the concept of embryo by formulating the “inherency test” in International Stem Cell. It refers to the ability of such living materials to develop into a human being. Having said that, the Court concluded that a non-fertilised ovum stimulated by parthenogenesis was excluded from the definition of embryo, habilitating the corporation to patent such an element. However, the ruling does not explain exactly what the notion of “significant intervention” means, even though it appears to be essential to determine if a cell is considered as an embryo (if it can develop itself into human being without great medical assistance).
The CJUE left a margin of discretion to national courts to determine whether a biological material falls under the definition of embryo, in light of scientific developments. Such a ruling seems to recognize a certain level of independence for member states in interpreting article 6(2)(c) of Directive 98/44/CE. Indeed, national courts are thought to develop a more appropriate approach to this touchy ethical debate in order to fit better with national mentalities and values. But by doing so, European harmonization of patents is put at risk: national jurisdictions could follow different paths, being prejudicial to the free commerce clause. Goods and services directly linked with patents related to human cells’ manipulations could be prohibited in some EU countries, causing potential discriminations between EU firms or citizens in their access to such biological technologies. Nevertheless, we can also predict a future harmonization of national approaches to the definition of embryo by the need of countries to remain competitive in comparison with other member states. Indeed, UK Intellectual Property Office, for instance, may wish to review their existing guidelines (preventing the patentability of human cells) in order to remain competitive with Germany whose Federal Court opened the way to such patents.
Should judges let decide scientific experts on such highly specialized legal questions? We are convinced it is not the best solution to respond to this growing difficulty for jurists. We think this debate should not be avoided by giving the power of decisions to scientific experts, and even to judges. Legislator bodies must deal with this issue by identifying precisely what is an embryo and what is not. The public debate must spread in order to find a consensus on those ethical questions.
1). Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
The Court made a broad interpretation of Article 6(2)(c) of Directive 98/44/EC and said that the process of development of a human… Read more
1). Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
The Court made a broad interpretation of Article 6(2)(c) of Directive 98/44/EC and said that the process of development of a human being is the core of the notion of embryo. They applied this principle to fertilised but also to unfertilised ova (whose development process can be artificially stimulated).
I believe that this interpretation is a proper balance between all the parameters mentioned in the question. With this definition, human dignity and public interest are certainly ensured in accordance to Article 1 and 3 of the EU Charter of Fundamental Rights or Article 53 of the Munich Convention (see legislation). But at the same time, in order to promote research and innovation, the court mentioned an exception: “a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo”. Furthermore, the German Court “allowed the possibility to get patent if related to other methods for obtaining the same result without damaging the embryo”. For example, blastocysts are not human embryos and stem cells can be patented as long as their production does not cause the destruction of an embryo.
This means that ethical issues are respected and that, at the same time, scientists can develop other methods allowed to get patent.
2. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I believe it is important that all members of the European community have the same definition of the words that are used in this list (such as the word “embryo” or “suffering” which is something subjective). Otherwise their will be a lot of interpretations and incomprehension’s.
Of course, there are other biotechnological application that deserve protection explicitly. For example, transplantation of animal organs into human body, abortion, euthanasia, etc.
3. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
The fact that other countries don’t have such restrictions has clearly an influence on the research made about this subject. But the CJEU decided to defend human dignity before science. I believe that it is fundamental and they tried to propose other methods that can be patent, they made an exception and the fact that some inventions can’t be patent doesn’t mean that they can’t be used. Their is a nuance. It doesn’t affect biotechnological innovation in Europe
4.In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
I think that in this case the definition is clear but in other situations it could be useful to point out some other details. Furthermore, the European community should agree on a common definition.
5. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
No, I think it is normal that the national state keeps some sovereignty. But again the principle of human dignity should be a priority and it would be great that the European community agrees on a common definition.
6. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
It is fundamental that in this kind of cases, some professionals, experts, scientists give their meanings. It is the Court’s duty to take them in account. They can’t decide on (only) legal basis!
1) Yes because the fact that is not patentable do not hinder scientific progress. It only excludes to make economic profit out of it by granting a monopoly. As far as we concerned, the patentability of human embryos does not bypass the right to human dignity.
2)Some might want to outlaw patentability of human embryo used for gestational surrogacy on the… Read more
1) Yes because the fact that is not patentable do not hinder scientific progress. It only excludes to make economic profit out of it by granting a monopoly. As far as we concerned, the patentability of human embryos does not bypass the right to human dignity.
2)Some might want to outlaw patentability of human embryo used for gestational surrogacy on the basis of morality enshrined in the ethical clause.
In our opinion, human cloning should also be banned even in the therapeutic cloning case of designer babies.
3)No because under certain conditions, scientific and therapeutic researchers is allowed. Only patentability is excluded.
4)Yes. Embryos are patentable if they never lead to human life.
5)Yes because it could lead to a forum shopping. In our opinion, the European legislator should define it.
6)Like in the Tribunal du travail in Belgium, we think that scientists from both sides should be judges for theses technical matters along with traditional judges.
a. I believe that the article 6 (2) (c) constitute a good balance between human dignity and public interest in the sense that it constitutes a good compromise between the two. But it also think that it is a bit incomplete because it doesn’t establish enough precise exceptions, it establishs a kind of general rule but doesn’t developp the exeptions to… Read more
a. I believe that the article 6 (2) (c) constitute a good balance between human dignity and public interest in the sense that it constitutes a good compromise between the two. But it also think that it is a bit incomplete because it doesn’t establish enough precise exceptions, it establishs a kind of general rule but doesn’t developp the exeptions to this rule much. In my opinion it doesn’t take enough into account the different levels of public interests ..
b. In my opinion the use of dead person’s bodies should also deserve a specific protection against industrial and commercial pruposes, the directive’s list is obviously not an exhaustive one.
c. It is possible that the Brüstle judgement will a little bit slow down the stem cells researches in Europe, because in vitro stem cells are probably more expensives and hard to get that ordinary human embryos but it is not an inpassable obstacle to research. In my opinion it is only going to affect the researchs in the short term because there is surely gonna be progresses in in vitro cells’ production and because some other countries may be inspired by this EU legislation and adopt similar rules.
d. I think that the Court has well esthablished the commencement of the process of development of a human being when they said in the judgment « that fertilisation is such as to commence the process of development of a human being ». I don’t say that thereisn’t ever gonna be any questions on it but I can’t imagine any clearer response to it that Brüstle one.
e. I believe that yes, the margin of discretion left to the national courts makes the patents’ situation in europe less homgeneous but still not at a to high scale because of the case law of the CJEU that has to be taken into account by every european countries. Futhermore, a certain margin of appreciation is always necessary in order to respect countries’sovereignty, which is the key of international relations.
f. I think that if jurists cannot always be able to deal with complex scientific elements in the case of the CJEU, the jurists are supported by a certain number of experts to help them. The cases treated by the CJEU are so importants that they are studied and analysed very seriously, in this sense I’m not very worried about it.
a) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that the interpretation of the CJEU seeks to strike a balance between human dignity and the public interest in research… Read more
a) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that the interpretation of the CJEU seeks to strike a balance between human dignity and the public interest in research and innovation, leaving in the background the economic reasons for patent protection. With regard to the balance between the first two interests, I think that, with its decision on Oliver Brüstle v. Greenpeace (C-34/10) , the Court gave great importance to ethical and moral reasons, leaving limited space for scientific research. However, the Court itself has shown that it understands the importance of research in the International Stem Cell Corporation case. I therefore believe that the balance, although not perfect, can be calibrated with the passing of time and the advancement of scientific techniques.
b) Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
The list contained at Article 6(2) of Directive 98/44/EC is to be understood as an illustrative and non-exhaustive list. It will then be up to the legal community to understand what other behaviour may be covered, also taking into account the progress and innovations of scientific research.
c) The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Yes, I share that criticism. By broadly interpreting the concept of the ‘human embryo’, the Court has not left much room for action to research and scientific innovation.
d) In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
No, I think that the concept of ‘commencement of the process of development of a human being’ established in Brüstle is a nuanced concept, which does not guarantee certainty. Moreover, considering that a certain margin of action is left to the national courts in deciding what falls within the definition of an embryo, I think that there will be no uniformity of application. Also for this reason, I believe that the Court will be called upon to give a new opinion on the subject in the coming years.
e) Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, as I said before, I believe that the lack of clarity of the concepts expressed by the Court may lead to a lack of uniformity of application and a consequent lack of harmonisation of the patent systems in the different Member States.
f) A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
I believe that, when the Court is faced with such complex scientific issues, it should take a long time to be able to understand the subject through many hearings of the highest technical experts. I do not think it would be correct to leave these decisions to scientists, as they do not have sufficient knowledge of the legal system; knowledge necessary to balance all the delicate interests at stake. I believe, however, that a greater role should be played by politics: it is politicians, as an expression of the citizens, who represent the changes in the sensitivity of society on ethical and moral issues.
A. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
In general it does. The list given here seems reasonable, and does not constitute too much of a burden for scientific research in… Read more
A. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
In general it does. The list given here seems reasonable, and does not constitute too much of a burden for scientific research in my opinion (except for the point about embryos, but I will discuss this topic later).
B. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
In a near future, scientists could be able to create functional human gametes in a laboratory setting, thus outside the human body. They could produce gametes useful for reproduction purpose. On the bright side, this would allow infertile men and women to finally have their own biological child. But on the other hand, this will also allow solo reproduction (i.e. having a baby only with your cells), or multiplex parenting (a baby could have 4 parents for instance) which is already way more questionable in an ethical point of view. Therefore, if this technology was to be created, I think that it could be useful to extend the list of this Article 6… (http://blog.practicalethics.ox.ac.uk/2019/01/human-in-vitro-gametogenesis-and-the-same-sex-marriage-debate/)
C. The Brьstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
I agree with this argument. Stem cells researches looked like an exciting prospect for a future medical breakthrough. Researcher in Europe will be tempted to continue their research in the US, and to leave Europe. If I am correct, stem cells research needs to use embryo cells. And i don’t really get why it is an issue. If a women was to abort, why couldn’t we use some of the cells of the embryo before? Since the research in stems cells are promising, this would be for the greater good. If we manage to ensure that this does not create a business, with women trying to abort as much as possible to sell embryo cells, I don’t really see any issue here.
D. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brьstle?
I am not quite sure, but I am not a specialist. In my understanding, this clarification only allow us to exclude embryos who do not have the potential capacity to develop into a human being from the spectrum of this disposition. I couldn’t tell if this clarification is sufficient or not.
E. Both in Brьstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
It could in theory. There are now 28 member States in the EU. Some are progressivist, others very conservatives. In countries such as Poland, Cyprus, or Ireland, abortion for instance is only legal in certain given scenarios. With this context, I don’t see a prosperous future for stem cells researchers in these countries…
F. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
It is clear that this is not an ideal solution. I think that in these highly-specialized technical matters, the CJEU could use the help of some amici curiae, who would enlighten the Court with their knowledge and advises. Their opinion would only count as an advise, and the final word would remain in the judges’ hands, but this would give more weight and relevance to the decisions taken by the CJEU.
Kreusch Aurélie, Devogele Sophie, Servais Elisa, Andre Celia
Human embryos at the bar: the blurring lines between law and science in patent protection.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that the CJUE ensure a proper balance… Read more
Human embryos at the bar: the blurring lines between law and science in patent protection.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that the CJUE ensure a proper balance between human dignity, the public interest in research and innovation and the economic justification at the basis of patent protection because the Court makes the difference between embryos that will not have the capacity to develop into human being that can be used in science and be protected by patent law and embryos that will lead to the development of a human being that cannot be patented. Human integrity, scientific research and patent protection are three interests protected by EU law. Indeed, scientific research, inventions and innovations play a significant role in the industrial development of our society and for this reason it must be protected by patent law. Legal protection is the only way to make scientific research profitable and promote its advancement. Nonetheless, scientific research as well as patent law are submitted to the respect of the fundamental’s principles. The protection of human integrity and dignity are absolutes rights that no rules can derogate, because there is no more important that human life. Accordingly, CJUE issued that embryos cells even for scientific research cannot be patented because those cells will lead to the development of human being.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I do not think that the list contained at article 6 (2) of the Directive is a comprehensive list. The list cover plenty of notions. CJUE plays a significant role in the interpretation of the directive by trying to support scientific advancement without offending public morality. The Court gives a wider or a tight interpretation of the notions that are listed in the directive according to the evolution of the society while respecting public order, morality, ethic and fundamental rights. Genomic editing in precise and specific fields could be added at that list, because in some circumstances it need protection. Genomic editing are technologies that allow genetic material to be added, removed, or altered at particular locations in the genome. The CRISPR-Cas9 is an illustration of editing genome that have been recently developed. This biotechnological is necessary to the prevention and treatment of human diseases but it also enable scientists to change physical traits, like eye colour. The ethical problem with CRISP-Cas9 comes when people use genome editing for traits such as athletic ability, height, increasing brain power or personality traits that are not important for health. This can lead to deviations and affect human dignity. Furthermore, genome editing will increase disparities in access to health care and it can even create classes of individuals defined by the quality of their engineered genome. Genetic test also deserves some protection and could be added at the list with some exceptions. Even though, genetic tests help to prevent cancer, people who submit to the test and that have high-risk hereditary cancer syndromes have problems with health insurance because of the information provided to the insurance. Hence, genetic tests are substantial for scientific research, prevention of cancer and treatment but it also deserve some protection because it can affect human dignity.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
I partially agree with this argument. Indeed, it definitely restricted a lot more the patentability than before but on the other hand this protection is essential because we are talking about potentials human’s life. It is a good thing that the notion of « embryo » is seen in a broad view because there must be no discrimination in this field. The stem cell is protected whether it is fertilized or not, both situations are under the notion of « embryo ». I don’t think that it is the tombstone of the research because this field won’t stop evolving because of some restrictions. It might make it more difficult but this field is so essential that scientists would always continue to search and find new elements. Believe that we cannot give patent on everything because human’s life is sacred.
I don’t think so. According to the CJEU, « Any human ovum after fertilisation must be considered falling under the legal definition of embryo », and so cannot be the subject of a patent. The goal here is to frame in a broad way the patentability of stem cell. I thing that more regulations are not a bad thing for Europe but it still need to be reasonable and in accordance with the other countries.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
The definition of “human embryos” has been difficult to apprehend over years. To make this notion understandable, we studied 2 important judgments: the Brüstle judgment and the International Stem Cell Corporation Case. According to me, the term of “human embryos” is better defined in the first judgment (Brüstle judgment). Indeed, the CJEU stated that “any human ovum after fertilisation must be considered falling under the legal definition of embryo, because “that fertilisation is such as to commence the process of development of a human being”. In this case, we went further with the notion of unfertilised ova, whose development process can be artificially stimulated. In the International Stem Cell Corporation Case, the Court has not sufficiently clarified the meaning of “commencement of the process of development of a human being”. This case only underlined the fact that “the stem cells obtained from parthenogenetically-activated ovocytes are not able to develop into a human being”. Not clear enough! That’s why the UK Court intervened and asked to the CJEU to clarify the meaning of “commencement” of the process of development of a human being.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, of course it can, especially when the Court says that the “national court has to verify, in light of scientific developments, whether a stem cell obtained from embryos at the blastocyst stage are able to commence the development process”. But all states are not equally advanced in the scientific field. Therefore, two states could draw different conclusions out of the same fact and it would be legally accepted because it’s authorized by the CJEU. So, it can indeed jeopardise European harmonization of patents and maybe lead to dangerous consequences. If a country A declares that a certain biological material falls under the definition of embryo, then it’s protected by patent law. But if country B declares that it does not, then searchers might tend to go working in the country B because they could experience more.
Leaving a margin of appreciation is something good and sometimes necessary, but we have to be careful to what we leave to the states so that it won’t create discrimination among the EU members.
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
I think judges ‘knowledge is first and foremost legal. It’s normal that they are not specialized in science, it’s not their job. Therefore, I think that no, a court of jurists cannot adequately decide legal questions dealing with complex scientific concepts. One solution could be to have experts in the court that could help judges understand scientific issues that are very technical. The idea would not for the expert to give its opinion on the case, but rather to explain the technical matters of the case to the judges so that they can make an informed decision.
1) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
No, I find article 6 (2) to be overly cautious about Human dignity. Innovation is being heavily restricted by this directive. Fertilized or… Read more
1) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
No, I find article 6 (2) to be overly cautious about Human dignity. Innovation is being heavily restricted by this directive. Fertilized or unfertilized human ovum won’t be used in scientific research anymore, since the potential breakthroughs it could yield cannot be patented. Without an economic incentive, the field of stem cells study will be abandoned in favor of more profitable projects. The only exception concerns inventions that have therapeutic or diagnostic purposes. As for the economic basis of patent protection, it is also being put aside for the same reason. If inventions can be created, but not patented, anyone pursuing the study of stem cells won’t be able to earn any profit from it. This directive essentially neutralizes the economic function of the patent. In the end, the CJEU preserved human dignity and public morality at the cost of innovation and intellectual property rights.
2) Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
The list at article 6 (2) includes the most important issues concerning the risks of biotechnology. However, I do not believe it is complete, there will certainly be new inventions that might threaten human dignity in the future. If inventions related to non-fertilized ovum can be protected from patenting, then so should the ones that are using human spermatozoa. The aim of the CJEU is to prevent the manipulation of human and animal DNA, to accomplish this objective, human embryos from both male and female should be protected.
3) The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Yes. By preventing the patentability of inventions on human embryos, the CJEU probably dissuaded many investors or scientists from innovating in the field. If there is no patent, then the opportunity for profit will be meager, maybe even non-existent. And without any economic incentive, nobody will want to waste their money by doing research in a field that isn’t profitable anymore. However, the CJEU did not prohibit patentability for therapeutic or diagnostic purposes. Stem cells research would still exist in Europe and it would be oriented toward medical innovations. Europe will probably be left behind in terms of scientific innovations compared to the US, nevertheless, new inventions in the medical field will still be made.
4) In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilized ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
The explanation given by the Court makes it very clear that the prohibition of patents applies to cells that have the capacity to develop into human beings. However, the judgement does not explicitly mention what is meant by the “development of a human being”. It is not explained whether the prohibition applies to cells that will form a fetus, or cells that may be used to replicate human body parts. Worse still, the Court leaves the appreciation of the inherent capacity of cells to develop into human beings to the National Courts. Instead of giving a definitive explanation, the CJEU lets the other states of the European Union deal with this issue.
5) Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardize the European harmonization of patents?
Yes, by leaving a margin of appreciation to the member states, the harmonization of patents across the Union will be disturbed. If each national Court is free to determine what constitutes the development of a cell to a human being, patentability might be allowed or forbidden depending on the country.
6) provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly specialized technical matters?
Jurists alone may not be able to give a satisfactory solution to the current problems without any scientific knowledge. Since these issues on cells can be very complex, I believe it would be better for the Court to consult or summon a specialist in the field. The same way some cases require a person specialized in a certain field to establish concrete facts, the CJEU should also call upon scientists or specialists in stem cell research. This would allow jurists to give a sound judgement based upon the current scientific knowledge.
The CJEU decision on Oliver Brüstle vs Greenpeace (C-34/10) – prepared by Rossana Ducato, post-doc researcher at UCLouvain and USL-B
1) In today’s world, we all understand how science and technology has helped and is still helping us. It saved millions of people, all around the world and it’s still doing. In order to use the wide sense of article Article 6(2)(c)… Read more
The CJEU decision on Oliver Brüstle vs Greenpeace (C-34/10) – prepared by Rossana Ducato, post-doc researcher at UCLouvain and USL-B
1) In today’s world, we all understand how science and technology has helped and is still helping us. It saved millions of people, all around the world and it’s still doing. In order to use the wide sense of article Article 6(2)(c) of Directive 98/44/EC for the therapeutic or diagnostic purposes aimed at treating the human embryo, we believe that no limit should be given. The public interest and research and innovation first aim, is and should be to help and save lives. If the uses are for that, then we should give them the full access. It becomes tricky when we talk about the human dignity, cause in fact, where is the limit to consider what an “embryo” or a “commencement “is ?.Everyone has their own thinking, wether being influenced by science or by their religion. If the Court believes that, at the state of the art, the discussed stem cells cannot develop to term and, therefore, they do not have the inherent capacity of developing into a human being, we believe that human dignity is given less protection compared to the others, since every country can decide, some will totally ignore the human dignity to give innovation more power.
2) The list will have to be more exhaustive, new developments are already taking place (nucleotide polymorphisms, bioinformatics) that are not provided by the very general terms of the directive.
3) yes, but we believe that a certain precision should be given.
4) Exactly, that’s the biggest problem! Everyone will have their way to “rule” in such a sensitive concept. The question of embryo is important since it also concerns abortion. So automatically the way countries are gonna define those words, will have an impact on other things that are extremely sensitive and important. We cannot let countries, taking the power on this question cause for exemple: a country like Poland will not accept any access for innovation , because of their believes.
5) No it cannot, todays generation and the is different. We cannot let people that doesn’t have any knowledge about an issues take action on that. We should give their place to scientist that actually have worked on that, human right activist,.. We should give more places to those who know the issues and knows how it works. We actually should not have permanent people, every issues should have their own debate with people that are in the issues, that are living the problem or are working on it.
a. The article 6 (2) (c) excludes from patentability “human embryo”. The cell to be excluded from patent must be able to develop itself into a human being. An another hypothesis of exclusion from patent refers to a cell in which the process of science (production of an another cell) would damage the human embryo.
The CJEU gives an exception:… Read more
a. The article 6 (2) (c) excludes from patentability “human embryo”. The cell to be excluded from patent must be able to develop itself into a human being. An another hypothesis of exclusion from patent refers to a cell in which the process of science (production of an another cell) would damage the human embryo.
The CJEU gives an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo.
Therefore, we can see that in the field of scientific research, researchers still have the possibility to patent biological invention as long as they respect the CJEU’s criteria. We can’t consider that human dignity weights too high compared to other interest such as the economic interest. According to me, there is a proper balance. Nowadays, we cannot be constraint to immobilism ! We must go forward in the light of the therapeutic or diagnostic purposes notwithstanding the conservative background of human dignity. The CJEU protects efficiently the human dignity following the criteria of exclusion.
b. The list is not comprehensive due to the evolution in the field of scientific invention. The §1st : when commercial exploitation would be contrary to ordre public or morality, the patent would be denied. By principle, ordre public or morality evole !! We tend to recognize a larger part in science. On the other hand, biotechnological application (invention) appears faster than the move in social norms. That’s why EU must keep the list face to reality, and create new type of exclusion from patent. Simply, the criteria’s changed from Brüstle judgement to the International Stem Cell action, this shows how the appreciation of opportunity of patent is moving and how the list is required to evolve.
c. I do agree with this argument. it is sure that the Brüstle judgement slowed down researches in the domain of activity of embryo which can develop into human being because the potential invention could not be patent. For the large medecine companies no benefit would be allow to them whereas scientists in US could easily find companies to finance their researches. This lighter legal framework is more propitious to invention.
The CJEU approach negatively affect biotechnological innovation in Europe due to the need to respect the restriction and the lack of freedom in the light of an economics outcome. Of course researches can be made but the reward (patent) would not be possible !!
d. The Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle. Indeed, the Court said that stem cells which have the inherent capacity of developing into a human being are excluded from the patent framework. According to me, we can clearly understand the application field of the EU regulations whether the cell can develop itself into a future human being. The Court has envisaged the hypothesis of an unfertilized human ovum. Therefore the Court has used examples.
e. The CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo, I think that the situation cannot jeopardise the European harmonisation of patents as such. Indeed, the CJEU as already said has clearly stated the criteria’s whether the patent is or not possible. Therefore, the power of decision comes to the states to apply and follow the guideline given by the EU legal framework. States should have the approximate same appreciation in the matter of patentability of biotech inventions. The EU already regulate the matter, let the states apply and decide the national cases.
f. A Court composed by jurists, can’t adequately decide legal questions dealing with complex scientific concepts. I propose that a group composed by experts from different countries are asked to summit a rapport on the subject saying what they find doable and reasonable. An another solution more autonomous could be a treaty in order to put the states as such into the negociation and come up with a decision (treaty). We can use a similar instrument to the “convention collective de travail” in the EU law. Of course, judges don’t know the technical and underground aspect of biotech invention and patent relate to it.
a) I believe that the CJUE tried to reach a balance. Blocking all patent would for sure limit (if not kill) science from further progresses. Indeed, being able to patent ensures scientists an economic reward, encouraging them to invest in scientific research in the field of biotechnology. But at the same time, the directive and its interpretation by the CJEU… Read more
a) I believe that the CJUE tried to reach a balance. Blocking all patent would for sure limit (if not kill) science from further progresses. Indeed, being able to patent ensures scientists an economic reward, encouraging them to invest in scientific research in the field of biotechnology. But at the same time, the directive and its interpretation by the CJEU does not allow to patent everything! For moral reasons and in order to preserve human dignity, stem cells that have the inherent capacity to turn into human beings cannot be patent. It seems to me that a certain balance is reached here.
b) The directive mentions the impossibility to patent “processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes”. I believe that the modifying of the genetic identity of the animal should be better protected. Don’t the animals deserve a protection similar to ours? At least no matter if the animal is suffering or not, if the process of modification of its genetic identity has no benefit to man or animal, patentability should not be allowed.
c)For sure, the Brüstle decision restrains stem cells researches in Europe and not elsewhere. So, in that field, Europeans would be disadvantaged. But, at the time the CJUE simply wanted to protect human dignity over economic and scientific advantages. So, I do not agree with the argument: what comes first is human dignity as a fundamental right. This comes before the competitiveness of the European biotechnical industry.
d) No, I believe that the CJUE still fails to provide general guidelines and more precise classifications of cells that would allow a harmonization of the stem cells patentability. The CJUE should have been clearer and should have established herself at what point does an organism develop into a human being.
e) Yes. First, because of the lack of general guidelines defining when an organism develops into a human being, leaving a big margin of interpretation to member states is a threat to a harmonious interpretation. Indeed, the CJEU provides that it is the role of national courts to determine whether the “inherency test” is conclusive or not. Different state may arrive to different conclusions! Let’s note that national courts can also decide to prohibit the patentability of stem cells on the basis of art. 6 (1) and its reference to public order. At the end of the day, art. 6 can thus be applied differently according to different national interpretations. The CJEU thus fails to pave the way to a harmonious interpretation of article 6 (1 and 2) of the Biotech Directive.
f) I believe that sometimes judges do not have the technical education required to understand cases that are very specific. We could argue that the CJEU was based on wrong information’s and did not quite understand the issue in the Brüstle case. Indeed, a few years later in the Stem Cell Corporation case, the Court changed its interpretation completely! In the first case the CJEU decided that “unfertilized human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being”. On the contrary, in the second decision, the CJEU ruled that “an unfertilized human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, that ovum does not, in itself, have the inherent capacity of developing into a human being”. A solution to address this knowledge gap would be to force judges to consult experts on very technical issues and to force them to follow the opinions submitted by experts in those technical fields.
Cantalupi Giulia
1. Article 6 of Directive 98/44/EC is the so-called ethical clause. The second paragraph establishes a list of inventions that cannot be patentable; among them, letter (c) states that human embryos used for industrial or commercial purposes proposes are excluded. The ECJ first underlines that its role is neither of a medical nor of ethical nature but must be… Read more
Cantalupi Giulia
1. Article 6 of Directive 98/44/EC is the so-called ethical clause. The second paragraph establishes a list of inventions that cannot be patentable; among them, letter (c) states that human embryos used for industrial or commercial purposes proposes are excluded. The ECJ first underlines that its role is neither of a medical nor of ethical nature but must be restricted to a legal interpretation of the relevant provisions of the Directive (§30). The context and the aim of this Directive is to exclude patentability in any situation where respect for human dignity could be affected: that is why the notion of ‘human embryo’ must be understood in a wide sense (§34). The Court held that stem cells obtained from a human embryo at the blastocyst stage (as in Brüstle’s patent) should be included within the concept of ‘human embryo’, as established in Article 6(2)(c) (§37). It is obvious that the Court’s ratio legis follows the Directive main objective which is to protect human dignity: yet I do not think that this interpretation provides a good balance between human dignity and public innovation/research. The problem is that with this decision, the ECJ not only stepped over the line separating the interpretation from the creation of law (in providing a definition of ‘human embryo’) but it raises serious issues about future research into the domain of regenerative medicine. Since the Court has chosen not to confine its analysis to the patent context (by giving a broad definition of the notion of ‘human embryo’) this decision could seriously stifle the biomedical domain in favor of human dignity. The overly generic ECJ’s interpretation was not confirmed by the German Court which ruled that despite the fact that blastocyst can potentially commence the process of development, actually they are ‘functionally dead’. Therefore, they are not human embryos (“functionally dead”) so that stem cells can be patented (as long as their production does not cause the destruction of an embryo). From an economic standpoint, this ruling has brought some problems in the commercial exploitation of stem cell inventions in the pharmaceutical industry. In fact, as the inventor has to transfer the right to commerce the new technology only by assignment or licensing because without an exclusive right, the production of new medicines will turn out into a huge economic risk for pharmaceutical industries.
2. I think that the list contained in Article 6(2) of Directive 98/44/EC is a comprehensive one; even if it is very short, all four listed processes are unambiguous. Once again, since those processes are not fully described they are amenable to a broad interpretation by Member States. This can lead, as we have seen in Oliver Brüstel v. Greenpeace, national courts asking for clarification of the notion in order to give a preliminary ruling. I do not foresee any other biotechnological application affecting human dignity that could deserve protection explicitly.
3. I do believe that that decision of the CJEU negatively affected biotechnological innovation in Europe. In USA (and Asia) morality exclusions on patents is more liberally applied or barely exist. Both USA and Japan foresee morality exclusion on patents, but Europe seems to stand alone in its strict application of the morality-based exclusion on human ES cells. The USA addressed the morality of stem cell use by strict legislation on public funding rather than on restricting patentability. This is one of the main reasons why restrictions on stem cell patents in Europe may be a concern for the pharmaceutical industry which prefers collaboration with academic partners in the USA where private scientific innovation is better protected.
4. International Stem Cell contested the refusal of the UK Intellectual Property Office to register for a patent related to non-fertilized human ova. This time the case was different since stem cells obtained from parthenogenesis-activated oocytes are not able to develop into a human being. The CJEU was thus asked to clarify the meaning of ‘commencement’. The Court held that the stem cells in question cannot fully develop, and therefore, they do not have the inherent capacity of developing into a human being. I do not think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being”. In this case the Court is only referring to these specific cells, it does not give a broad definition of ‘commencement’ as it was done for the notion of ‘human embryo’ in Brüstle.
5. The margin of discretion left to national courts in determining whether a biological material falls under the definition of embryo given by the CJEU in these two decisions could stifle the European harmonization of patents. This is because each domestic court will be able to give various nuances of the notion, creating differences in the legal protection of biotechnological inventions. As a consequence, such differences could create barriers to trade and hence hamper the proper functioning of the internal market.
6. I believe that a Court composed by only jurists cannot be able to decide adequately on complex cases, specifically those involving important questions in the scientific field. For example, in many circumstances, it turns out most of the lawyers working on biotechnological patent cases were formerly engineers or highly- specialized people quite able to understand the technicalities of the case. This could be also applicable to courts. Especially the European Court (at least the President), whose aim is to give clear answers on the interpretation of EU law, should be assisted /supported by a body of highly specialized staff.
Question a) Yes, we think the interpretation of the court is correct. Indeed, even if it is important to have innovation in the scientific world to cure several diseases, the notion of human dignity is, according to us, more important. Stem cells taken from embryos shouldn’t be something put up in the market nor a basis for having a patent.… Read more
Question a) Yes, we think the interpretation of the court is correct. Indeed, even if it is important to have innovation in the scientific world to cure several diseases, the notion of human dignity is, according to us, more important. Stem cells taken from embryos shouldn’t be something put up in the market nor a basis for having a patent. Therefore, the interpretation of Article 6(2)(c) of Directive 98/44/EC done by the CJEU does ensure a proper balance between all the different interests at stake in the case.
Question b) Yes, we think the list is comprehensive and already offers a large scope of protection. According to us, there isn’t any other biotechnological application affecting human dignity that could deserve protection explicitly.
Question c) It seems to be a problem for the development of biotechnological innvoation in Europe if Europeans cannot use the way of research forbidden by the Brüstle Judgment
Nevertheless, this ban is based on morality grounds. It’s why the European decision can be understandable because the Court held on the basis of the article 6 of the Directive 98/44/CE which a political choice of the EU.
Question d) The legal definition of embryo given in Brüstle is that « any human ovum after fertilisation must be considered falling under the legal definition of embryo, because “that fertilisation is such as to commence the process of development of a human being” (§35 Brüstle judgment). ».
As we can see, the wording of the Court in the Brüstle judgment is very general and not very precise. It’s why I think the Court clarified as it can the the meaning of this wording.
Question e) Yes it could. Indeed if countries start to define differently the notion of « embryo » then, patents could contain embryos for certain countries and not contain embryos for other countries. Consequently, people could work on something which is illegal for some countries and isn’t for others within the EU. If people doesn’t agree on what is protected by the patent, depending on inclusivity of the country’s opinion, third partie could exploit a part of the invention without even knowing that he’s doing it illegally.
Question f) Currently, a lot of ethical questions try to find a judiciary answer as scientific and political field aren’t able to do so, unanimously and undeniably. If at least, the all scientific community agree on what is an embryo and what isn’t, then maybe, with the experts’ help, juges will be able to answer this question. Nevertheless, as laws are adopted by MPs who are representing the people, each country will have its opinion on the question and consequently judges too. The analyze can be easily transferred to the UE. If judges were to be forced to have a panel of experts which would be representatives of the dominant points of view on these technical matters, judges might be in a better position to answer those kind of questions.
Answers to Questions About Embryos and all those stuffs :
Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think The article 6(2) of the Directive as interpreted by… Read more
Answers to Questions About Embryos and all those stuffs :
Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think The article 6(2) of the Directive as interpreted by the CJEU ensure a proper balance because it is enough precise by saying and precising that the use of human embryos “for industrial or commercial purposes” is unpatentable. In that way, that ensure the respect of what can be called “Ordre Public”, by forbidding any kind of economic exclusivity on any part that comes from human body, this going with the CJEU Consideration going deeper, stating that even an ovum is not fertilized, it can be considered as embryo when it is stimulated by parthenogenesis because it has a creative aptitude. Globally, those things are also protected at the national level by the National Law.
Moreover, this provision find its legitness in the way that even patenting embryos is illegal, it protects public researches and innovation, what can be seen with the precision quoted before, because the purposes of those researches are not industrial or commercial application but progress, science and human knowledge.
Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
This list, contained at Article 6(2) of the Directive, can be considered as comprehensive, considering that it protects that is europeanly seen as necessary for public order and health protection, like cloning or modifying the germ line genetic identity of human beings, what we consider as basic deontology in Europe.
It may be important to say that this point of view is different in North America, where the notion “deontology” is more flexible, where the acceptance is broader, that’s why we often receive mails containing offers poposing us to practice some genetic tests so we can find our genetic lineage, in reality, our genetic informations are after sell by those companies to advertising one.
in the future, when will arrive “Human enhancement” like bionic organs, that will make humanity progress, the research on that will have to be controlled so we cannot create people like what we see in Dystopian Movies.
The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
As said in the previous question, the notion of “deontology” is broader and more restrictive in Europe than in the US for example. In facts in terms of industrial and economic application, having a strict deontology as what we have is protective of the human body, but that strictness can be a drawback in terms of scientific progress and innovation. The scientist that are working on the human functioning science are really restricted in Europe in terms of researches and experiences what can slow down the progress. That’s what happened for stem cells and that’s the reason why Europe falls behind in terms of scientific discovery comparing to other Countries or Region.
In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
No, the Court’s decision in Brüstle did not clearly address the question of whether the term “human embryo” includes organisms likely to trigger a human being’s development process regardless of whether that process could be completed. According to Comptroller General, there is also uncertainty as to whether the Court relied on arguments reflecting an inaccurate understanding of the technical framework as it exists to date.
Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
This binding aspect of one of the essential provisions of the text of the directive seems to me to argue in favour of the more uniform interpretation possible of the concept of human embryo within the Union, rather than imposing a strict definition. I do not see how such a categorical ban, which applies to all Member States, could exist on the basis of concepts which are not common. If we do not let a certain freedom to definit a such important term to Member States, they will probably transpose anything. Therefore, it is our view that the concept of human embryo must find a community meaning.
A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
In my opinion, a single college of judges and jurists is not able to legislate on this issue alone. If the legal body is recognized as wanting to pacify and regulate laws on biology and ethics in order to protect individuals, it cannot impose laws on a subject as scientific as this one, without any medical basis or knowledge of biology. I think that long philosophical debates are necessary in order to find a common and European vision that is closest to all. I am therefore in favour of a collegial body of jurists, sociologists and scientific experts to avoid such questions.
IGNACZUK Sara, DEVROEDE Hortense
1) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
This does not seem to be the case. Of course the CJEU needs to take into consideration certain… Read more
IGNACZUK Sara, DEVROEDE Hortense
1) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
This does not seem to be the case. Of course the CJEU needs to take into consideration certain moral values when deciding a case, which in this instance is human dignity. In many of its decisions, the Court puts a lot of efforts in underlying that the EU is a community build on common values and not merely a common economic market. But, in this case, it did that in a wrong fashion. If the Court’s decision has some burdensome effects on the public interest in research and innovation, this should be at least based on a more solid explanation. In fact, the CJEU relied on the notion of human dignity without indicating its meaning or purpose in relation to scientific and commercial issues. It presupposed that it was something given. It also failed in considering any other values that might be relevant for such a legal question. It tried to find a balance between the defense of human dignity and the support for innovations in the scientific field by prohibiting patents when the research involves the use of human embryos possessing the ‘inherent capacity’ to become a human being. However, without explaining in what sense human dignity is incompatible with the granting of patents in the case where the scientific process involves the use of human embryos, the balance seems to be odd. And this is even more alarming in the sense that such a decision may have burdensome effects on further development and commercialisation of cellular therapies research in the EU. The question here is not that the CJEU ruling is illegitimate, in fact it might be rightful, but it is not sufficiently motivated to justify such a blow on the progress of science.
2) Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
This list does not seem to be exhaustive. In fact, if its aim is to list biotechnological applications that are undermining human dignity, there are many others, and maybe even more important items than the simple use of human embryos possessing the ‘inherent capacity’ to become a human being for purposes of scientific research, that should be included in the enumeration. We might of course think about the technique of animal cloning, but also about the use of biological techniques to improve peoples’ skills, performances or strength (for example in the sportive field), or about the DNA surgeries used to create tailor-made children.
3) The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Yes, it did, but probably less than we might expect. In fact, there is an inherent commercial feature to patents, which means that depriving inventors of property rights over their findings might have the effect of cutting off their wings and retain them from continuing their researches. A possible solution for them would probably consist in focussing in researches that do not involve embryos possessing the ‘inherent capacity’ to become a human being. But, even if this does not happen, there are maybe other ways of preventing a complete slowing down on the brakes. Here it is up to the EU Member States to intervene. Even if the CJEU rejects patents for scientific innovations which imply the use of human embryos, Member States that still find an interest in supporting unpatentable researches might do that through for example inventive taxes or by providing a strong legal protection for such innovations.
4) In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
Not really, and this is a possible reason behind the CJEU’s deferral to national courts of the task of deciding when a given use of parthenotes meets the conditions of the inherency test. And it entitled national courts with the conduct of this test without giving them any guidelines. The reason for that seems to be the fact that this is a question of inherently factual issues. In such a case, the answer must be given on the basis of the state of the scientific acquaintance at the time the ruling is delivered by the concerned domestic court.
5) Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, it does. And this can be illustrated through some actual examples that show that there are very dissimilar hESC regulatory regimes in the EU Member-States. For instance, Germany prohibits researches involving human embryos as well as the importation of stem cell lines from other countries. The U.K. and Sweden on the contrary allow such researches and even provides for comprehensive regulatory frameworks for that purpose. Other nations like Austria or Italy forbid such researches in their countries but allow importations of stem cell lines from abroad.
Source : http://cilj.co.uk/2016/04/22/2999/.
6) A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If yes, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
According to me, it is not necessary true that CJEU’s jurists do not have the required knowledge to deal with scientific issues. If there is a problem, for me it lays elsewhere. The major issue is that cases involving complex scientific concepts need deeper examination and probably even very individualized review, which is obviously not possible in the case of an overworked CJEU that has to deal quickly and with very limited means with hundreds of cases each year. An evident solution would consist in providing the Court with external assistance that would help it to correctly understand complex scientific concepts. The idea is to establish an effective collaboration between the judiciary and scientists that would alleviate the CJEU’s work, enable faster decision making and provide for a more sophisticated and suitable reasoning to the issues at stake.
Human embryos at the bar: the blurring lines between law and science in patent protection
Questions for discussion
In Europe, human embryos are excluded from patentability on morality grounds.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the… Read more
Human embryos at the bar: the blurring lines between law and science in patent protection
Questions for discussion
In Europe, human embryos are excluded from patentability on morality grounds.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection ?
For me, the ethical clause is not clear enough. The invention considered unpatentable are those that are contrary to ordre public or morality, but what’s actually « ordre and morality » ? The interpretation of these terms can differ from country to country, from person to another and so on. However, an invention can be patended if th invention covers uses for therapeutic or diagnostic purposes aimed at treatint the human embryo. As a result, the balance between all this stay for me very unclear and very tight.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
Of course for me, that list is comprehensive but is can be still understood and interpreted very largely. It’s important to understand the meaning of each terms to know if we agree or not. Each terms can be questionned and viewed in different ways. In addition to that the list might surely be longer with all the technology advences that we did. I cannot guve any exemple of what can be added to the list but I’m sure there are some missing points.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
The CJEU approach is not to be seen negatively but rather to protect the human dignity.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
The court said that « an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being ». It only defined what can be develop into a human beaing and not the precise moment of the commencement. We do not know from which moment we can call the phase as commencement. So the term is actually not defined at all.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Well, yes it can jeopardise the European harmonisation of patents if every countries have a different interpretation. However, on the one side, for such question, national courts, since they have their own national values that enforce their national identity, and their own priority, it’s normal to let them choose the defintion of embryo which falls under their values. On the other hand, it became more difficult to judge if two countries have different interpretations ; who’s gonna win the case ? Which interpretation is gonna be superior ?
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
Of course not. The jurists cannot adequately decide legal questions dealing with scientific concepts. On this kind of case, they should call a group of expert that will give them advices based on their knowledge. Moreover, a group of civilians should also have to share their point of view on the specific matter since it concern public order and morality. And then, based on the different opinion of the population and the expert (+ based also on a legal basis) the jurists have to decide.
a. The directive does not provide a definition of human embryos but the Court held that the Directive is meant to protect human dignity and that's why the notion of human embryos must be understood in a wide sense. Following the Court, the organism that starts the process of development into a human being is the notion of human embryo.… Read more
a. The directive does not provide a definition of human embryos but the Court held that the Directive is meant to protect human dignity and that’s why the notion of human embryos must be understood in a wide sense. Following the Court, the organism that starts the process of development into a human being is the notion of human embryo.
b. At first appearance, the list seems to be exhaustive. That’s why they decide to make a specific list. If that list was not complete, they would not have made it.
c. According to us, this argument isn’t a really good argument. The CJUE approach affects biotechnological innovation in Europe like the UK Court and the German Court. Indeed, the German Court confirmed the unpatentability of neural precursors cells entailing the destruction of a human embryo. However, it allowed the possibility to get patent if related to other methods for obtaining the same result without damaging the embryo. Interestingly, in applying the CJEU definition of human embryo, the German Court found that, despite blastocyst can potentially commence the process of development described by the CJEU.
d. The Court hasn’t sufficiently developed and clarified the meaning. Indeed, the stem sells cannot develop to term and, therefore, they do not have the inherent capacity of developing into a human being.
e. Yes, if every european State could decide of what biological material falls under the definition of embryo, it can jeopardise the patent of an embryo.
f. No, we think that judges should be accompanied by scientists to conduct their thinking and speak with full knowledge of the facts.
Comments for Human embryos at the bar: the blurring lines between law and science in patent protection
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a. Article 6(2)(c) is based on the fact that as soon as an embryo has been destroyed when it would have created life, it cannot be protected by a patent right. In contrast, if the embryo cannot have the capacity to develop into a human being, then a patent right can be granted. It seems to us that a balance has been found there.
Furthermore, as soon as the use of embryos has a purely economic or scientific research purpose, no patent rights can be granted. At this level, the balance of interests has been found in the fact that if the technique is used to treat embryos, then patent rights can be granted but only for that.
b. In the article, it is mentioned that Article 6(2) lists the different cases in which a patent right can never be granted. In these various cases of exclusion, we find the commercialization of the use of human’s embryos. We believe that it would be useful to exclude any commercialization from the use of the human body for purely and simply economic purposes.
c. We do not believe that this decision necessarily has a negative impact on scientific research in Europe. Indeed, on the economic aspect, national or European subsidies are granted to laboratories. Therefore, they are not prejudiced by this decision.
d. The two cases are different, in the case of in vitro fertilized ova, it takes considerable medical interventions to hope that the ova will one day become a human being. As a result, without intervention, it is as if the embryo was originally dead. As a result, we are not in the same conditions as in the Brüstel case. In the present case, to be more precise, the court should have said that “without medical interventions, if the ova is not fertilized, even artificially, by a paternal gene, then it fits within the conditions for obtaining a patent right.
e. In the present case, a margin of discretion is given to the national courts and not an absolute discretion. In this sense, even if they can interpret the concept, the CJEU can still overrule the decision if they consider that the national court didn’t follow the European vision.
f. We will make a parallel here with the labour court in Belgium. In this area of law, the session is always held by 3 judges, one “jurist” judge, and two people who took the oath (who didn’t study law but come from the workplace, who have a better knowledge of the field than the presiding judge). In this sense, it would be interesting to apply this legal technique at the level of the CJEU when dealing with this type of issue, by incorporating judges with experience in the area of the biological research.
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a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As far as we are concerned, we first thought the article 6(2)(c) of Directive 98/44/EC offers a proper balance between those interests. We consider the human dignity as being more important than the scientific research. But from a different perspective, we could ask ourselves if the fact that we know those kinds of practices could save some person from neural diseases, but we don’t use it, isn’t there some sort of failure to respect human dignity? That is why the German interpretation of the CJEU’s definition of embryo is an interesting point of view to take into account.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
No. Since the article 6(2) of Directive 98/44/EC is using the formula “in particular” before the enumeration of the unpatentable comportments, we could totally imagine other cases falling within the scope of this article. With the rapidity of technological progress, we shall certainly face situations the directive couldn’t have foreseen at the time it was enacted.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
A balance of interests has to be made, on the one hand, scientific searches have the right to be recognized for their research, but on the other hand, it need to be controlled for ethical purposes. European regulations are, on the ethical stage more human oriented than U.S. regulations that aspire to have a liberal and business oriented state of mind. Talking about the tombstone of stem research might be excessive, but it must be taken into consideration that research might be more limited.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
When the court redefined the term of embryo, one might have assumed a more explicit and precise definition of it. However, an inaccuracy still occurs especially concerning the term of “commencement”. First of all, the CJUE leaves member States to their own definition of Human embryo which leads us to cultural contradictions. Indeed, every Member State has it’s own meaning of appearance of signs of life according to it’s culture. Secondly, The CJEU could have given more specific guidelines to justly orientate Member States. Furthermore, different characteristics could have been added as well even if the confrontation of science, ethics and Intellectual property law can be tricky.
e. Both in Brustle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardize the European harmonisation of patents?
Such a situation could indeed jeopardize the European harmonization of patents, since the different member states would be able to provide different definitions of the notion of « embryo ». Under those circumstances and depending on the definition provided, patents in some countries would contain embryos, while patents in other countries wouldn’t. This means that people could work on something without even knowing that this particular work is illegal in some countries. Therefore, it would be easier if the Court of Justice explicitly provided what is protected by the patent and what isn’t.
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
Show lessThe judiciary field is more able to answer to ethical questions than the scientific and political fields. For instance, if all scientists agree on the description of a notion, the judge will be able to answer to a judiciary question about this notion; However, it’s going to be different in every country because the law is adopted by MP’s and those people are representing the people of the country. And population in every country is different, they have different opinions which will lead to the fact that judges are different too. We can make an analogy with the UE which follows the same reasoning. It would be easier for judges to have some experts, it will help them to see what the public opinion is and to judge according to that.
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a) Yes, it does. Here, the importance of the interpretation by the Court is crucial, because the wording of the article is fixed while scientific discoveries are continually made. These discoveries have to be considered in the light of this Directive, and doing so, the court must take into account their novelty.
b) The list is probably not exhaustive in a field (= inventions) that has that particularity to evolve constantly. Knowing that, a margin of appreciation must be left to the Court of Justice of the European Union in order to keep an eye on the consistency.
c) It’s true that the decision raised a sort of inequality, because by reducing the patentability of stem cells to cells that cannot begin a process of development of a human being, the Court limits opportunities for scientific researches and innovations in Europe. However, there is an exception that reopens the possibilities in this field: “a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo”. It be an open-door to the restriction. Unfortunately, this condition of the treating of the human embryo remains restrictive and it doesn’t let a total freedom to the inventors.
d) No, because the CJEU clearly defines what an embryo is: any human egg that is able, after fertilization, to begin the process of development of a human being. The margin of discretion that the Court leaves to national courts is only with regards to the determination of the capacity of the cell to develop into a human being or not. And to do so, the CJEU does not leave the possibility to the courts to decide according to their good will if a stem cell is able to begin the process of human development, but in the light of scientific developments which in principle should be certain and consistent.
f) The real problem isn’t the question of the qualification of the judges in the field concerned, but the assistance that must be brought to them. Indeed, science isn’t the only fields that deals with complex concepts, almost all the fields have their specificities that are likely to create difficulties in the legal reasoning. However, it would be impossible to require experts for each field dealt by the Court. We must rather try to provide judge’s right-hand men specialised in the different areas, especially the scientific field. The solution could be to create little groups of independent European experts while they face those cases concerning specialised technical matters.
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Intellectual Property Law : Work 3
Exercice 1. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As long as it is interpreted as “if it turns into a human life, you can’t use it”, a proper balance is insured between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection. However, it is still interesting to add here that cells are treated as an invention (since possible to put a patent on them) when they actually aren’t. Nobody invented cells, they are just used or not.
Exercice 2. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
“The Netherlands did not think to However the Netherlands saw in article 6 (2) a non-complete list, the Court quotes recital 38 of the directive which specifies that the list is non-exhaustive. The Court, furthermore, held that “the grant of a patent does not preclude legal limitations or prohibitions applying to research into patentable products or the exploitation of patented products, as the 14th recital of the preamble to the Directive points out. The purpose of the Directive is not to replace the restrictive provisions which guarantee, outside the scope of the Directive, compliance with certain ethical rules which include the right to self-determination by informed consent”. Indeed, the directive doesn’t’ preclude the application of provisions restricting, for example, the exploitation of certain inventions”, found on https://www.droit-technologie.org/actualites/the-directive-9844-ec-for-the-legal-protection-of-biotechnological-inventions-a-commentary-of-its-articles/
Exercice 3. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Art 6 of the Directive is an « ethical clause » which aim to protect human dignity and the scientific research about stem cells obtained by embryos. The ethical ground in Europe is no comparable with other parts of the world, and in this sense of CJEU’s approach was adequate and coherent with the values shared at European level. We do agree with the argument concerning this subject. Also, the scientific research concerning the use of human embryos for commercial or industrial purposes is prohibited by article 6 of the Directive. There is a purpose to avoid any innovation and research in that area but it doesn’t concern the entire biotechnological innovation in Europe. The existence of such a restriction in Europe is in part due to the perception of ethical limits that are not shared by other nations. Innovation and scientific research can lead to several abuses from the scientific community and in order to avoid this the European Union, and member states, decided to put restrictions into the Directive 98/44/CE by defining the legal notion of humain embryo in patent law and the limits.
Exercice 4. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
We think that the meaning of « commencement of the process of development of a human being » is sufficiently clarified by the directive 98/44/EC. The EU identified and defined the concepts and ideas in a clear way with the purpose to make sure that it will not be a misunderstanding and that it will be no intention to violate the rules and that scientific research will no try to develop something prohibited by the law.
Exercice 5. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents ?
The Court of Justice of the EU gives a definition of the embryo, and under which circumstances it can not be patentable. It gives a certain appreciation of that definition to the national courts which can review cases according that definition. Thus, there is a harmonization of patents to a certain point. However, it must be remembered that the appreciation of the notion of embryo will differ according to one’s culture and certain countries could subject more moral principles and could be stricter in the application of this principle.
Nevertheless, the court of justice has a final say in the decisions. When a party does not agree with the decision given by the national courts it can appeal to the court of justice who will bring back order if a national court diverge too much from the European harmonization.
Exercice 6. A provocative question : do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters ?
One can always do research about the subject he or she has to judge; it can be argued that a jurist, with no scientific background whatsoever is not the best to judge of complex scientific matters. However, it is the role of the lawyers who defend these cases to explain what is at stake, and how this subject, this scientific concept has to be understood. Even scientific matters can not be left unresolved just because they are deemed too complex.
Show lessThey have to be judged and discussed as any concept, and even so when they touch legal concept such as patent, which is organized by courts and laws. These subjects could not be left to the only appreciation of scientists, who are often ready to do anything and who could put patents only to protect their personal interest even if it could be detrimental to others. There have to be third parties to judge of this cases.
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a. Yes, I think it does. This article based on morality prevents people from abusing of human embryos for self-interested purposes. However, there is an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo. But is it actually better to sacrifice a human embryo at the expense of another one? I don’t think so.
But this is only the interpretation regarding the use of fertilized eggs. There is also an interpretation of the CJEU regarding an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis. Because in the light of current scientific knowledge, that ovum does not, in itself, have the inherent capacity of developing into a human being. So, this means that a human embryo would not be sacrificed to the expense of another one.
b. No, this list is certainly not exhaustive. Another biotechnical applications affecting human dignity could be regarding abuse of human bodies being artificially dead or so on.
c. On one hand, I agree with the argument that says that the CJEU approach in the Brüstle judgement negatively affected biotechnical innovations in Europe. But on the other hand I understand the (moral) point of view of the court and I am not against their judgement given at the time.
d. I think their definition of “commencement of the process of development of a human being” is clear enough (for non-scientists). We understand that a non-fertilised ovum stimulated by parthenogenesis cannot lead to human life unlike a fertilized ovum that will further develop and that inevitably will end up as a human life.
e. Indeed, I think this margin of discretion on determining whether a biological material falls under the definition of embryo left by the CJEU to the national courts could jeopardise the European harmonisation of patents. However, the member states are still sovereign and have the authority to decide for themselves how they want to interpret the definition of an embryo.
f. The CJEU doesn’t have all the knowledge it takes to make an informed decision on the matter. However, they are jurists by profession, and will be far more impartial than scientists. The best solution is that the court receives all the needed (scientific) information from both parties in order for them to make the optimal decision.
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Exercice 1. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
As long as it is interpreted as “if it turns into a human life, you can’t use it”, a proper balance is insured between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection. However, it is still interesting to add here that cells are treated as an invention (since possible to put a patent on them) when they actually aren’t. Nobody invented cells, they are just used or not.
Exercice 2. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
“The Netherlands did not think to However the Netherlands saw in article 6 (2) a non-complete list, the Court quotes recital 38 of the directive which specifies that the list is non-exhaustive. The Court, furthermore, held that “the grant of a patent does not preclude legal limitations or prohibitions applying to research into patentable products or the exploitation of patented products, as the 14th recital of the preamble to the Directive points out. The purpose of the Directive is not to replace the restrictive provisions which guarantee, outside the scope of the Directive, compliance with certain ethical rules which include the right to self-determination by informed consent”. Indeed, the directive doesn’t’ preclude the application of provisions restricting, for example, the exploitation of certain inventions”, found on https://www.droit-technologie.org/actualites/the-directive-9844-ec-for-the-legal-protection-of-biotechnological-inventions-a-commentary-of-its-articles/
Exercice 3. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
The existence of such a restriction in Europe is in part due to the perception of ethical limits that are not shared by other nations. Innovation and scientific research can lead to several abuses from the scientific community and in order to avoid this the European Union, and member states, decided to put restrictions into the Directive 98/44/CE by defining the legal notion of humain embryo in patent law and the limits. Art 6 of the Directive is an « ethical clause » which aim to protect human dignity and the scientific research about stem cells obtained by embryos. The ethical ground in Europe is no comparable with other parts of the world, and in this sense of CJEU’s approach was adequate and coherent with the values shared at European level. We do agree with the argument concerning this subject. Also, the scientific research concerning the use of human embryos for commercial or industrial purposes is prohibited by article 6 of the Directive. There is a purpose to avoid any innovation and research in that area but it doesn’t concern the entire biotechnological innovation in Europe.
Exercice 4. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
We think that the meaning of « commencement of the process of development of a human being » is sufficiently clarified by the directive 98/44/EC. The European Union identified and defined the concepts and ideas in a clear way with the purpose to make sure that it will not be a misunderstanding and that it will be no intention to violate the rules and that scientific research will no try to develop something prohibited by the law.
Exercice 5. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents ?
The Court of Justice of the European Union gives a definition of the embryo, and under which circumstances it can not be patentable. It gives a certain appreciation of that definition to the national courts which can review cases according that definition. Thus, there is a harmonization of patents to a certain point. However, it must be remembered that the appreciation of the notion of embryo will differ according to one’s culture and certain countries could subject more moral principles and could be stricter in the application of this principle.
Nevertheless, the court of justice has a final say in the decisions. When a party does not agree with the decision given by the national courts it can appeal to the court of justice who will bring back order if a national court diverge too much from the European harmonization.
Exercice 6. A provocative question : do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters ?
One can always do research about the subject he or she has to judge; it can be argued that a jurist, with no scientific background whatsoever is not the best to judge of complex scientific matters. However, it is the role of the lawyers who defend these cases to explain what is at stake, and how this subject, this scientific concept has to be understood. Even scientific matters can not be left unresolved just because they are deemed too complex. They have to be judged and discussed as any concept, and even so when they touch legal concept such as patent, which is organized by courts and laws. These subjects could not be left to the only appreciation of scientists, who are often ready to do anything and who could put patents only to protect their personal interest even if it could be detrimental to others. There have to be third parties to judge of this cases.
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a)
Show lessI think this article protects human dignity because it prohibits the use of patent on human embryo and that notion is interpreted very broadly, indeed, the CJEU stated that “any human ovum after fertilisation must be considered falling under the legal definition of embryo, because that fertilisation is such as to commence to process of development of a human being”. This restriction can thus limit researches in this filed.
b)
The list contained is definitely not comprehensive, science evolves and there will be new uses of human embryos. Furthermore, a list can never be fully comprehensive.
c)
The restriction in Europe can indeed make stem cell researches more complicated. However, it’s not entirely true because there are exceptions: “a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo”. Thus, the restriction isn’t “complete”, the use of stem cells and embryos isn’t completely prohibited, patent can still be granted in those circumstances.
d)
We’ve seen that this definition led to uncertainty because it was interpreted differently (indeed, according to the German Court “blastocysts are not human embryos and stem cells can be patented as long as their production does not cause the destruction of an embryo..”). So that proves the definition given by the Court isn’t clearly defined and should be given more details in order to prevent any misuse of this definition.
e)
Leaving a certain margin of appreciation to different Member States can of course have an influence on the harmonisation of European patent. The definition of embryos isn’t the same everywhere and those differences are sometimes a sensitive matter that lead to controversies. The question of the definition of the embryo should be dealt at the European level to, on one hand, prevent any unclarities about the definition, and, on the other hand, to allow an harmonisation on the European level and thus allowing to grant patent on certain well-defined criteria.
f)
This question can be asked in many different circumstances, for example, can a judge decide correctly on a matter relating to cars when the judge doesn’t know anything about cars? I think that the judges having to deal with such complex matter is part of the job, indeed, how can we expect judges to know everything about anything? A creative solution which isn’t really creative as it already exists, is that it’s essential that the judges are assisted by experts in the matter, otherwise it’s true that they can’t really be of any help. Judges could also follow special formations in relation to the subject they have to deal with, but at the same time, we can’t expect the judges to know everything, there will always be subjects about which the judges won’t know much, but that doesn’t mean they can’t have an external point of view and decide with the help of an expert.
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A)
The Article 6(2)(c) of Directive 98/44/EC as interpreted by the CJEU ensure a proper balance between human dignity and the public interest in research and innovation. Indeed the CJUE interpreted the notion of human embryo linked to the provision fore-mentioned in a way compatible with the protection of human dignity.
The CJUE admits that “the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c ) of the Directive also [apply to the] use for scientific research”. But the CJUE also introduce the following exception “ patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo ”. Obviously, this exception do not cover the destruction of human embryos or their use as a base material.
According to our point of view, it also shows that the CJUE gives more importance to the human dignity and the public interest in research and innovation than it does to the economical aspect.
B) Paragraph 2 of this Directive enumerates a list of inventions that, in any case, cannot be patented. Among them, there are the “uses of human embryos for industrial or commercial purposes”. The court gives a large scope to the notion of human embryos. Therefore, many situations are concerned by this provision, including human ovum after fertilisation and “unfertilised ova, whose development process can be artificially stimulated”. We think that the list should be more precise in a way that it includes, at least, those situations.
C) The European and American approach are different. Both have advantages and weaknesses but we cannot affirm that one is better that the other. In Europe, we give more importance to the human dignity whereas in the US, research and biotechnological innovation are privileged.
D)
We don’t think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle. Indeed, in the case International Stem Cell, the CJUE only formulates the “inherency test” to determine if a non-fertilised ovum can be defined as an embryo. The CJUE doesn’t give more information concerning the notion of “commencement” than it gives in Brüstle. It only precises that if a stem cell cannot develop to term and so they don’t have the inherent capacity of developing into a human being, they cannot be included in the definition of human embryo.
E)
Yes because scientifical researches can evolve differently from one state to another. So the way a state interprets the scope of the definition of human embryo could also differ depending on the State.
F)
Show lessNo it cannot. In such technical cases, judges should be assisted by experts. This conclusion doesn’t only apply to the scientifical domain but also to every other specialized fields such as (architecture, technology, etc.).
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a) Article 6 (2)(c) obviously protects human dignity since it’s prohibiting patents on human embryos. Human embryo is a notion interpreted broadly. However, it seems that this restriction can limit research and innovation in this field. Science evolves really fast, faster than law. The directive will thus have to be adapted to new considerations and protect new inventions. If not, scientists won’t invest in new researches.
b) No. The directive itself underlines it at 38th “whereas”. I don’t have notion in the biotechnological field so I can’t mention any technology that would not be protected by the directive, but I am sure it exits.
c) We believe that terms need to be clarified and analysed more in depth. Therefore, the clarification in the International Stem Cell Corporation case was welcome.
d) Yes, since in the International Stem Cell Corporation case, CJEU made a distinction between cells that would have the capacity to develop into human beings and cells that wouldn’t. Human dignity is a cardinal principle both in many national rights and in European right, we believe that both rights should be put in balance and that the right to human dignity should weigh more. That is in the end what matters for people to know in order to protect human dignity.
e) Indeed, leaving a certain margin of discretion necessarily leads to a jeopardizing of the European harmonization of patents. As we know, the question regarding at which level a biological material falls under the definition of “embryo” is a touchy question leading to heated debates. In this sense, I would recommend that this question was dealt with on the European level, and that one decision would be taken by consensus if possible. By doing so, it would harmonize the patents and it would thus be easier for a European Member State to deal with the question.
Nevertheless, every Member State has its own historical, ethical and sociological background. In that sense, it can be understood that the national court of Poland is not going to have the same position on the question than the Netherlands for example.
f) This question is indeed difficult to answer to. At first sight, I believe that the responsibility of jurists (may they have a knowledge of scientific concept or not) is to stay impartial and to settle a dispute. The jurist has, in that sense, followed a cursus and has legal tools: he is qualified to do so. Beyond that certainty, it’s obvious that jurists aren’t some kind of “Gods” supposing to know everything in all domain. This is typically the problematic tackled with this question. I think that (in the first step at least), when dealing with scientific questions, the jurist has to concede its incompetence. This leads to the interdisciplinary approach of the legal world: it’s even more interesting to work with other professions to assure the global knowledge of the case dealt with and to be sure that all the aspects are covered (the legal ones, as well as the medical ones, with observations made by laboratory workers doctors for example).
Show lessSecondly, if I had to foresee any creative solution, I would suggest to insert a particular class or Master (whatever) in the legal cursus to inform the jurists about technical matters. It could also be implemented compulsory conferences on scientific concepts that would have to be necessarily followed by the jurists.
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In Europe, human embryos are excluded from patentability on morality grounds.
* Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I believe that the fact of applying this principle to unfertilized ova whose development process can be artificially stimulated can slow down and have a negative impact on the public interest in research and innovation. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) should not be applied for scientific research.
* Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I don’t think so. The fact that they are talking about « ordre public and morality » makes the notion really wide and the provision does not contain any further specification or a clear definition of human embryos.
* The Brьstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
i agree with the fact that by adopting a broad definition of the notion of embryo, derived from the principle of dignity, can slow down the innovations of the scientific community in Europe. The fact that the definition is wide and ambiguous can cause a disruptive effect on patentability in this area and on the downstream research in comparaison to countries outside the EU.
* In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brьstle?
Although the Court clarified what the concept of embryo represents, i think the latter remains unclear. The Court reported that at the state of the art, the stem cells cannot develop to term and that for that reason they do not have the capacity of developing into humain being. The Court clarified that by saying that an unfertilized human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo.
* Both in Brьstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, I think that the CJEU should impose the same scope of the concept (and make it clearer by defining its contours in a precise way) within the different countries of the EU so as not to leave too much room for appreciation to the national courts in order to have a certain homogeneity and consistency.
* A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
II believe that jurists should be assisted by expert committees or specialists in these highly specialized scientific fields in order to address highly specialized technical issues. For example, jurists of national courts shouldn’t be left alone with the decision of verifying in light of scientific developments, whether a stem cell obtained from embryos at the blastocyst stage (like those object of the Brüstle’s patent) are able to commence the development process.
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Questions for discussion
Alice Van Buylaere
In Europe, human embryos are excluded from patentability on morality grounds.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that this article is a really good idea at the basis. It leaves a great freedom to researches and innovation, while really protecting human dignity. It only considers unpatentable a few things that it considers as contrary to the public order (or morality) when there is commercial exploitation, like the process for cloning human beings. Most of the population would agree with this decision I think.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I think the list should be more comprehensive. It only gives four things that shall be consider unpatentable because of their commercial exploitation that would be contrary to the public order or morality. I think not only the cloning of human beings, the modification of the germ line identity of human beings, the uses of human embryos for industrial or commercial purpose and the process for modifying the genetic identity of animals which are likely to cause them suffering without any substantial benefit for man or animal, and also animals resulting from such process are not the only biotechnological application affecting human dignity that could deserve protection. For example, I think about the process for modifying the genetic identity of animal which are likely to cause human suffering by eating the genetically modified food.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other countries, notably the US, there not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
I understand the criticisms of some people because it is not a universal decision. But at the same time, it is not because a country doesn’t make restrictions that another shouldn’t.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
No I think the meaning wasn’t clear enough. It talks about commencement of the process of development of a human being, then it says whatever the stage at which that takes place, it also talks about prior destruction of human embryos. Even more, it has an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo. We are a bit lost while reading all of that.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonization of patents?
Yes, and no. I think that is good that each national court has a certain margin of discretion and still has a legal framework to help it take a decision.
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
Show lessI think the CJEU cannot adequately decide legal questions with complex scientific concepts. A solution would be that, in cases that concern highly-specialised technical matters, the Court was composed by half of jurists and half of scientists.
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a. I think that the first interpretation by CJEU gave an unrealistic legal definition of the human embryo because it vaguely attached it to the human dignity. It is a criteria that gives too much of a wide sense. Indeed at first even “a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis” must be considered an embryo even if it was after realised that “an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being”. My personal opinion is that the human dignity must always prevail the public interest in research and innovation, otherwise where would you brake once you opened the door towards the non respect of human dignity?
Show lessb. The list at article 6(2) is not to be seen as a comprehensive one. I don’t see another biotechnological application affecting human or animal dignity but such an issue could arise, that’s why it is required to be a non-comprehensive list.
c. It is not true to say that there are no restriction about stem cells research in the US. The United States National academies released its “Guidelines for Human Embryonic Stem Cell Research” and about ten states have banned or restricted the area. It has not been the tombstone of stem cells research in Europe because you can still use it for scientific research if it doesn’t requires the prior destruction of human embryos. The CJEU did affect negatively biotechnological innovation in Europe but necessarily in order to respect morality standards.
d. I don’t think the Court did, “having the inherent capacity of developing into a human being” is something that can be debated and the court will probably have to respond in concreto several times in order to clarify the definition.
e. Yes it could if the states have differentiated morality standards.
f. I believe that a Court of jurist is the best option since they have a great understanding of the principle of human dignity. I could suggest a scientific composed Court to whom the CJEU could refer to ask prejudicial questions on a scientific matter in order to understand the actual scientific state of knowledge we are able to give on the question and how the scientific doctrine would respond.
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A. This is a rather technical question and it is difficult for us to answer since we are not specialists in human rights, nor in economics and even less in biology. In our view, the position adopted by the ECJ in its interpretation of Article 6(2)(c) of Directive 98/44/EC is legitimate. It respects the values it imposes on itself in its founding texts by placing respect for human dignity before economic interests. As far as patent protection in this area is concerned, this raises more questions. Indeed, if adequate protection is not granted, there is a risk of fewer innovations. However, these are essential for the progress of medicine. There is a tension here between the desire to preserve human dignity and the desire to guarantee it through appropriate medical care.
B. Since paragraph 1 states that “Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality”, we consider that the list in the second paragraph is extensible. It must be considered that the inventions contained therein are necessarily and mandatorily prohibited. But other inventions that go against morality and disturb public order will also be. We could imagine that the article also provides for a ban on cloning given all the ethical debates it raises.
C. We believe that, in general, just because other countries adopt certain practices does not necessarily mean that we should follow them. Should we, like some U.S. states, apply the death penalty? Should we, like many emerging countries, reduce wages to ensure high economic competition? The debate here is on the ethical side. In our view, in retrospect, we can see that the definition given in the Brüstle judgment was too broad. It may have had a negative impact for some time. Nevertheless, it is better to be too cautious than too permissive on this subject. To avoid such differences between countries, common regulations should be adopted at the international level.
D. The British court referred a question to the ECJ for a preliminary ruling to clarify the meaning of the term’commencement of the process of human development’. In order to know what is the standard for determining whether a cell can evolve towards an individual, thus hindering patentability. The Court made an important distinction by re-examining its notion of precedent for human embryos for the second time.
It appears from the Court’s observations that an unfertilized human egg whose division and development were stimulated by parthenogenesis had the capacity to become a human being.
In International Stem Cell Corporation, the Court of Appeal indicated that, at the state of the art, the stem cells under discussion cannot develop to their full potential and therefore do not have the inherent capacity to become a human being.
On this basis, the Court concluded that: an unfertilized human egg whose division and subsequent development have been stimulated by parthenogenesis does not constitute a “human embryo” within the meaning of this provision if that egg does not, in itself, have the inherent capacity to transform itself into a human being, which is within the jurisdiction of the national court.
In this conclusion, the Court seems to have sufficiently clarified the expression “the beginning of the process of a human being’s development”.
E. Yes, this situation could be quite compromising in terms of European patent harmonisation because it does not put all EU countries on an equal footing in scientific research by leaving a margin of appreciation to national courts. As a result, some countries could, for example, be much more advanced in the scientific field than others, and this would lead to a certain kind of illegality.
F. It seems obvious that a Court composed of lawyers cannot adequately decide legal questions dealing with such complex scientific concepts. In our opinion, they should be surrounded by professionals in the field, such as specialized doctors or scientists who can give an objective opinion on the issue.
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A. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
We are confronted with an ethical problem which is important in Europe. Two observations should be done. On one hand, if it is necessary to make researches concerning the public health, we have to be more flexible because it can save a lot of people. On the other hand, if it is only for economic profit it is unacceptable because it will be only for business reasons. As a result, it is contrary to ethical values of Europe. In conclusion, it is still a main concern today which need a lot of reflections.
B. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
The ethical clause of the directive is not complete because the CJue has broadened some of the concepts in this list to give them a broader scope. The Cjue has extended this list to non-fertilized ova and ova after fertilization, which must therefore receive the same protection as embryos.
C. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
It is true that the CJUE’s approach in Brüstle restricts the research for stem cells since stem cells derived from embryo’s cannot be patented and since the term embryo itself is interpreted in a very broad way. In the word “embryo” are understood an ovum after fertilisation and a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis. But I would not say that this decision is the tombstone for the search for stem cell since a margin of appreciation is always given to the state in determining whether stem cell obtained from embryos at the blastocyst stage are able to commence the development process and since a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo.
D. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
the interpretation of embryo is wide and As a consequence the CJEU said that any human ovum after fertilisation must be considered falling under the legal definition of embryo, because “that fertilisation is such as to commence the process of development of a human being” (§35 Brüstle judgment). according to the court it is the main the notion of embryo. the CJEU applied this principle also to unfertilised ova. The Court stated that “a non-fertilised human ovum which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum which division and further development have been stimulated by parthenogenesis” must be considered an embryo.
The International Stem Cell Corporation contested, alleging that the object of its patent application was substantially different from the one discussed in Brüstle. Because the stem cells obtained from parthenogenetically-activated ovocytes are not able to develop into a human being. event the UK agree and asked a preliminary question to CJEU to clarify the meaning of “commencement” of the process of developement of a human being. This means that the defintion wasn’t clear at the begining and after a distinction was made.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
it is the national court that has to verify, in light of scientific developments, whether a stem cell obtained from embryos at the blastocyst stage (like those object of the Brüstle’s patent) are able to commence the development process. So we can see here that every country could have a different interpretation of what an embryo is because its sense is wide. If everybody has a different definition then patents are granted differently from a country to another and it could be dangerous for the european harmonisation.
F. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
The European court of justice, composed by jurists, can adequately decide legal questions dealing with complex scientific concepts because she is the only one who can give an accurate interpretation of the law. The court is the best to ask for clarification. Moreover, appeal to the European court of justice allows to ensure EU law is interpreted and applied the same in every EU country. Finally, the European court of justice is impartial so there is no biased approach.
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G. K. Chesterton said, “When people begin to ignore human dignity, it will not be long before they begin to ignore human rights”. It shows that human dignity is something important because its non-compliance has far more far-reaching consequences than one might imagine. The CJEU by its interpretation shows that they are aware of that fact. In the first interpretation, they are very protective of this right. The balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection was not reached. But they achieved this balance, the second time when they narrowed the definition of “embryo”. But the concept of human dignity is always evolving. If the four restrictions given in article 6 may seem enough right now, they may be insufficient in two years. For example, today the animal cause is coming to the forefront more and more. Of the four patent prohibitions given by this Directive, only one concerns animals. It is very portable that the list grows longer in the future knowing that a majority of people may not be satisfied with so little.
Moreover, the list is influenced by what’s considered in the country as something that violates human dignity. Ideologically, people complaining about different standards in other continents go against the very principle of human dignity, which is a vague concept whose interpretation varies from one country to another. Like human rights, they can be more or less protected according to the mores of the country from which they come (subject to those universally accepted as a human right). On an economic level, however, their criticism makes sense, as it creates a clear imbalance and risks simply shifting activities to another country.
However, it should be remembered that the directive concerns patents. Many will argue that the directive must concern patents. This does not mean, therefore, that the act itself is illegal, but rather that the person who exercises these experiences cannot be protected by property rights. This argument has tended to diminish the importance of this article with regard to the protection of human dignity. However, in reality, the two go hand in hand, and in fact, this article contributes to the protection of human dignity.
The CJUEU precised the concept of embryo by formulating the “inherency test” in International Stem Cell. It refers to the ability of such living materials to develop into a human being. Having said that, the Court concluded that a non-fertilised ovum stimulated by parthenogenesis was excluded from the definition of embryo, habilitating the corporation to patent such an element. However, the ruling does not explain exactly what the notion of “significant intervention” means, even though it appears to be essential to determine if a cell is considered as an embryo (if it can develop itself into human being without great medical assistance).
The CJUE left a margin of discretion to national courts to determine whether a biological material falls under the definition of embryo, in light of scientific developments. Such a ruling seems to recognize a certain level of independence for member states in interpreting article 6(2)(c) of Directive 98/44/CE. Indeed, national courts are thought to develop a more appropriate approach to this touchy ethical debate in order to fit better with national mentalities and values. But by doing so, European harmonization of patents is put at risk: national jurisdictions could follow different paths, being prejudicial to the free commerce clause. Goods and services directly linked with patents related to human cells’ manipulations could be prohibited in some EU countries, causing potential discriminations between EU firms or citizens in their access to such biological technologies. Nevertheless, we can also predict a future harmonization of national approaches to the definition of embryo by the need of countries to remain competitive in comparison with other member states. Indeed, UK Intellectual Property Office, for instance, may wish to review their existing guidelines (preventing the patentability of human cells) in order to remain competitive with Germany whose Federal Court opened the way to such patents.
Should judges let decide scientific experts on such highly specialized legal questions? We are convinced it is not the best solution to respond to this growing difficulty for jurists. We think this debate should not be avoided by giving the power of decisions to scientific experts, and even to judges. Legislator bodies must deal with this issue by identifying precisely what is an embryo and what is not. The public debate must spread in order to find a consensus on those ethical questions.
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1). Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
The Court made a broad interpretation of Article 6(2)(c) of Directive 98/44/EC and said that the process of development of a human being is the core of the notion of embryo. They applied this principle to fertilised but also to unfertilised ova (whose development process can be artificially stimulated).
I believe that this interpretation is a proper balance between all the parameters mentioned in the question. With this definition, human dignity and public interest are certainly ensured in accordance to Article 1 and 3 of the EU Charter of Fundamental Rights or Article 53 of the Munich Convention (see legislation). But at the same time, in order to promote research and innovation, the court mentioned an exception: “a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo”. Furthermore, the German Court “allowed the possibility to get patent if related to other methods for obtaining the same result without damaging the embryo”. For example, blastocysts are not human embryos and stem cells can be patented as long as their production does not cause the destruction of an embryo.
This means that ethical issues are respected and that, at the same time, scientists can develop other methods allowed to get patent.
2. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I believe it is important that all members of the European community have the same definition of the words that are used in this list (such as the word “embryo” or “suffering” which is something subjective). Otherwise their will be a lot of interpretations and incomprehension’s.
Of course, there are other biotechnological application that deserve protection explicitly. For example, transplantation of animal organs into human body, abortion, euthanasia, etc.
3. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
The fact that other countries don’t have such restrictions has clearly an influence on the research made about this subject. But the CJEU decided to defend human dignity before science. I believe that it is fundamental and they tried to propose other methods that can be patent, they made an exception and the fact that some inventions can’t be patent doesn’t mean that they can’t be used. Their is a nuance. It doesn’t affect biotechnological innovation in Europe
4.In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
I think that in this case the definition is clear but in other situations it could be useful to point out some other details. Furthermore, the European community should agree on a common definition.
5. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
No, I think it is normal that the national state keeps some sovereignty. But again the principle of human dignity should be a priority and it would be great that the European community agrees on a common definition.
6. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
It is fundamental that in this kind of cases, some professionals, experts, scientists give their meanings. It is the Court’s duty to take them in account. They can’t decide on (only) legal basis!
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1) Yes because the fact that is not patentable do not hinder scientific progress. It only excludes to make economic profit out of it by granting a monopoly. As far as we concerned, the patentability of human embryos does not bypass the right to human dignity.
2)Some might want to outlaw patentability of human embryo used for gestational surrogacy on the basis of morality enshrined in the ethical clause.
In our opinion, human cloning should also be banned even in the therapeutic cloning case of designer babies.
3)No because under certain conditions, scientific and therapeutic researchers is allowed. Only patentability is excluded.
4)Yes. Embryos are patentable if they never lead to human life.
5)Yes because it could lead to a forum shopping. In our opinion, the European legislator should define it.
6)Like in the Tribunal du travail in Belgium, we think that scientists from both sides should be judges for theses technical matters along with traditional judges.
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a. I believe that the article 6 (2) (c) constitute a good balance between human dignity and public interest in the sense that it constitutes a good compromise between the two. But it also think that it is a bit incomplete because it doesn’t establish enough precise exceptions, it establishs a kind of general rule but doesn’t developp the exeptions to this rule much. In my opinion it doesn’t take enough into account the different levels of public interests ..
b. In my opinion the use of dead person’s bodies should also deserve a specific protection against industrial and commercial pruposes, the directive’s list is obviously not an exhaustive one.
c. It is possible that the Brüstle judgement will a little bit slow down the stem cells researches in Europe, because in vitro stem cells are probably more expensives and hard to get that ordinary human embryos but it is not an inpassable obstacle to research. In my opinion it is only going to affect the researchs in the short term because there is surely gonna be progresses in in vitro cells’ production and because some other countries may be inspired by this EU legislation and adopt similar rules.
d. I think that the Court has well esthablished the commencement of the process of development of a human being when they said in the judgment « that fertilisation is such as to commence the process of development of a human being ». I don’t say that thereisn’t ever gonna be any questions on it but I can’t imagine any clearer response to it that Brüstle one.
e. I believe that yes, the margin of discretion left to the national courts makes the patents’ situation in europe less homgeneous but still not at a to high scale because of the case law of the CJEU that has to be taken into account by every european countries. Futhermore, a certain margin of appreciation is always necessary in order to respect countries’sovereignty, which is the key of international relations.
f. I think that if jurists cannot always be able to deal with complex scientific elements in the case of the CJEU, the jurists are supported by a certain number of experts to help them. The cases treated by the CJEU are so importants that they are studied and analysed very seriously, in this sense I’m not very worried about it.
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a) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that the interpretation of the CJEU seeks to strike a balance between human dignity and the public interest in research and innovation, leaving in the background the economic reasons for patent protection. With regard to the balance between the first two interests, I think that, with its decision on Oliver Brüstle v. Greenpeace (C-34/10) , the Court gave great importance to ethical and moral reasons, leaving limited space for scientific research. However, the Court itself has shown that it understands the importance of research in the International Stem Cell Corporation case. I therefore believe that the balance, although not perfect, can be calibrated with the passing of time and the advancement of scientific techniques.
b) Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
The list contained at Article 6(2) of Directive 98/44/EC is to be understood as an illustrative and non-exhaustive list. It will then be up to the legal community to understand what other behaviour may be covered, also taking into account the progress and innovations of scientific research.
c) The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Yes, I share that criticism. By broadly interpreting the concept of the ‘human embryo’, the Court has not left much room for action to research and scientific innovation.
d) In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
No, I think that the concept of ‘commencement of the process of development of a human being’ established in Brüstle is a nuanced concept, which does not guarantee certainty. Moreover, considering that a certain margin of action is left to the national courts in deciding what falls within the definition of an embryo, I think that there will be no uniformity of application. Also for this reason, I believe that the Court will be called upon to give a new opinion on the subject in the coming years.
e) Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, as I said before, I believe that the lack of clarity of the concepts expressed by the Court may lead to a lack of uniformity of application and a consequent lack of harmonisation of the patent systems in the different Member States.
f) A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
I believe that, when the Court is faced with such complex scientific issues, it should take a long time to be able to understand the subject through many hearings of the highest technical experts. I do not think it would be correct to leave these decisions to scientists, as they do not have sufficient knowledge of the legal system; knowledge necessary to balance all the delicate interests at stake. I believe, however, that a greater role should be played by politics: it is politicians, as an expression of the citizens, who represent the changes in the sensitivity of society on ethical and moral issues.
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A. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
In general it does. The list given here seems reasonable, and does not constitute too much of a burden for scientific research in my opinion (except for the point about embryos, but I will discuss this topic later).
B. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
In a near future, scientists could be able to create functional human gametes in a laboratory setting, thus outside the human body. They could produce gametes useful for reproduction purpose. On the bright side, this would allow infertile men and women to finally have their own biological child. But on the other hand, this will also allow solo reproduction (i.e. having a baby only with your cells), or multiplex parenting (a baby could have 4 parents for instance) which is already way more questionable in an ethical point of view. Therefore, if this technology was to be created, I think that it could be useful to extend the list of this Article 6… (http://blog.practicalethics.ox.ac.uk/2019/01/human-in-vitro-gametogenesis-and-the-same-sex-marriage-debate/)
C. The Brьstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
I agree with this argument. Stem cells researches looked like an exciting prospect for a future medical breakthrough. Researcher in Europe will be tempted to continue their research in the US, and to leave Europe. If I am correct, stem cells research needs to use embryo cells. And i don’t really get why it is an issue. If a women was to abort, why couldn’t we use some of the cells of the embryo before? Since the research in stems cells are promising, this would be for the greater good. If we manage to ensure that this does not create a business, with women trying to abort as much as possible to sell embryo cells, I don’t really see any issue here.
D. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brьstle?
I am not quite sure, but I am not a specialist. In my understanding, this clarification only allow us to exclude embryos who do not have the potential capacity to develop into a human being from the spectrum of this disposition. I couldn’t tell if this clarification is sufficient or not.
E. Both in Brьstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
It could in theory. There are now 28 member States in the EU. Some are progressivist, others very conservatives. In countries such as Poland, Cyprus, or Ireland, abortion for instance is only legal in certain given scenarios. With this context, I don’t see a prosperous future for stem cells researchers in these countries…
F. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
It is clear that this is not an ideal solution. I think that in these highly-specialized technical matters, the CJEU could use the help of some amici curiae, who would enlighten the Court with their knowledge and advises. Their opinion would only count as an advise, and the final word would remain in the judges’ hands, but this would give more weight and relevance to the decisions taken by the CJEU.
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Human embryos at the bar: the blurring lines between law and science in patent protection.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think that the CJUE ensure a proper balance between human dignity, the public interest in research and innovation and the economic justification at the basis of patent protection because the Court makes the difference between embryos that will not have the capacity to develop into human being that can be used in science and be protected by patent law and embryos that will lead to the development of a human being that cannot be patented. Human integrity, scientific research and patent protection are three interests protected by EU law. Indeed, scientific research, inventions and innovations play a significant role in the industrial development of our society and for this reason it must be protected by patent law. Legal protection is the only way to make scientific research profitable and promote its advancement. Nonetheless, scientific research as well as patent law are submitted to the respect of the fundamental’s principles. The protection of human integrity and dignity are absolutes rights that no rules can derogate, because there is no more important that human life. Accordingly, CJUE issued that embryos cells even for scientific research cannot be patented because those cells will lead to the development of human being.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
I do not think that the list contained at article 6 (2) of the Directive is a comprehensive list. The list cover plenty of notions. CJUE plays a significant role in the interpretation of the directive by trying to support scientific advancement without offending public morality. The Court gives a wider or a tight interpretation of the notions that are listed in the directive according to the evolution of the society while respecting public order, morality, ethic and fundamental rights. Genomic editing in precise and specific fields could be added at that list, because in some circumstances it need protection. Genomic editing are technologies that allow genetic material to be added, removed, or altered at particular locations in the genome. The CRISPR-Cas9 is an illustration of editing genome that have been recently developed. This biotechnological is necessary to the prevention and treatment of human diseases but it also enable scientists to change physical traits, like eye colour. The ethical problem with CRISP-Cas9 comes when people use genome editing for traits such as athletic ability, height, increasing brain power or personality traits that are not important for health. This can lead to deviations and affect human dignity. Furthermore, genome editing will increase disparities in access to health care and it can even create classes of individuals defined by the quality of their engineered genome. Genetic test also deserves some protection and could be added at the list with some exceptions. Even though, genetic tests help to prevent cancer, people who submit to the test and that have high-risk hereditary cancer syndromes have problems with health insurance because of the information provided to the insurance. Hence, genetic tests are substantial for scientific research, prevention of cancer and treatment but it also deserve some protection because it can affect human dignity.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
I partially agree with this argument. Indeed, it definitely restricted a lot more the patentability than before but on the other hand this protection is essential because we are talking about potentials human’s life. It is a good thing that the notion of « embryo » is seen in a broad view because there must be no discrimination in this field. The stem cell is protected whether it is fertilized or not, both situations are under the notion of « embryo ». I don’t think that it is the tombstone of the research because this field won’t stop evolving because of some restrictions. It might make it more difficult but this field is so essential that scientists would always continue to search and find new elements. Believe that we cannot give patent on everything because human’s life is sacred.
I don’t think so. According to the CJEU, « Any human ovum after fertilisation must be considered falling under the legal definition of embryo », and so cannot be the subject of a patent. The goal here is to frame in a broad way the patentability of stem cell. I thing that more regulations are not a bad thing for Europe but it still need to be reasonable and in accordance with the other countries.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
The definition of “human embryos” has been difficult to apprehend over years. To make this notion understandable, we studied 2 important judgments: the Brüstle judgment and the International Stem Cell Corporation Case. According to me, the term of “human embryos” is better defined in the first judgment (Brüstle judgment). Indeed, the CJEU stated that “any human ovum after fertilisation must be considered falling under the legal definition of embryo, because “that fertilisation is such as to commence the process of development of a human being”. In this case, we went further with the notion of unfertilised ova, whose development process can be artificially stimulated. In the International Stem Cell Corporation Case, the Court has not sufficiently clarified the meaning of “commencement of the process of development of a human being”. This case only underlined the fact that “the stem cells obtained from parthenogenetically-activated ovocytes are not able to develop into a human being”. Not clear enough! That’s why the UK Court intervened and asked to the CJEU to clarify the meaning of “commencement” of the process of development of a human being.
e. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, of course it can, especially when the Court says that the “national court has to verify, in light of scientific developments, whether a stem cell obtained from embryos at the blastocyst stage are able to commence the development process”. But all states are not equally advanced in the scientific field. Therefore, two states could draw different conclusions out of the same fact and it would be legally accepted because it’s authorized by the CJEU. So, it can indeed jeopardise European harmonization of patents and maybe lead to dangerous consequences. If a country A declares that a certain biological material falls under the definition of embryo, then it’s protected by patent law. But if country B declares that it does not, then searchers might tend to go working in the country B because they could experience more.
Leaving a margin of appreciation is something good and sometimes necessary, but we have to be careful to what we leave to the states so that it won’t create discrimination among the EU members.
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
I think judges ‘knowledge is first and foremost legal. It’s normal that they are not specialized in science, it’s not their job. Therefore, I think that no, a court of jurists cannot adequately decide legal questions dealing with complex scientific concepts. One solution could be to have experts in the court that could help judges understand scientific issues that are very technical. The idea would not for the expert to give its opinion on the case, but rather to explain the technical matters of the case to the judges so that they can make an informed decision.
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1) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
No, I find article 6 (2) to be overly cautious about Human dignity. Innovation is being heavily restricted by this directive. Fertilized or unfertilized human ovum won’t be used in scientific research anymore, since the potential breakthroughs it could yield cannot be patented. Without an economic incentive, the field of stem cells study will be abandoned in favor of more profitable projects. The only exception concerns inventions that have therapeutic or diagnostic purposes. As for the economic basis of patent protection, it is also being put aside for the same reason. If inventions can be created, but not patented, anyone pursuing the study of stem cells won’t be able to earn any profit from it. This directive essentially neutralizes the economic function of the patent. In the end, the CJEU preserved human dignity and public morality at the cost of innovation and intellectual property rights.
2) Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
The list at article 6 (2) includes the most important issues concerning the risks of biotechnology. However, I do not believe it is complete, there will certainly be new inventions that might threaten human dignity in the future. If inventions related to non-fertilized ovum can be protected from patenting, then so should the ones that are using human spermatozoa. The aim of the CJEU is to prevent the manipulation of human and animal DNA, to accomplish this objective, human embryos from both male and female should be protected.
3) The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Yes. By preventing the patentability of inventions on human embryos, the CJEU probably dissuaded many investors or scientists from innovating in the field. If there is no patent, then the opportunity for profit will be meager, maybe even non-existent. And without any economic incentive, nobody will want to waste their money by doing research in a field that isn’t profitable anymore. However, the CJEU did not prohibit patentability for therapeutic or diagnostic purposes. Stem cells research would still exist in Europe and it would be oriented toward medical innovations. Europe will probably be left behind in terms of scientific innovations compared to the US, nevertheless, new inventions in the medical field will still be made.
4) In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilized ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
The explanation given by the Court makes it very clear that the prohibition of patents applies to cells that have the capacity to develop into human beings. However, the judgement does not explicitly mention what is meant by the “development of a human being”. It is not explained whether the prohibition applies to cells that will form a fetus, or cells that may be used to replicate human body parts. Worse still, the Court leaves the appreciation of the inherent capacity of cells to develop into human beings to the National Courts. Instead of giving a definitive explanation, the CJEU lets the other states of the European Union deal with this issue.
5) Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardize the European harmonization of patents?
Yes, by leaving a margin of appreciation to the member states, the harmonization of patents across the Union will be disturbed. If each national Court is free to determine what constitutes the development of a cell to a human being, patentability might be allowed or forbidden depending on the country.
6) provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly specialized technical matters?
Jurists alone may not be able to give a satisfactory solution to the current problems without any scientific knowledge. Since these issues on cells can be very complex, I believe it would be better for the Court to consult or summon a specialist in the field. The same way some cases require a person specialized in a certain field to establish concrete facts, the CJEU should also call upon scientists or specialists in stem cell research. This would allow jurists to give a sound judgement based upon the current scientific knowledge.
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The CJEU decision on Oliver Brüstle vs Greenpeace (C-34/10) – prepared by Rossana Ducato, post-doc researcher at UCLouvain and USL-B
1) In today’s world, we all understand how science and technology has helped and is still helping us. It saved millions of people, all around the world and it’s still doing. In order to use the wide sense of article Article 6(2)(c) of Directive 98/44/EC for the therapeutic or diagnostic purposes aimed at treating the human embryo, we believe that no limit should be given. The public interest and research and innovation first aim, is and should be to help and save lives. If the uses are for that, then we should give them the full access. It becomes tricky when we talk about the human dignity, cause in fact, where is the limit to consider what an “embryo” or a “commencement “is ?.Everyone has their own thinking, wether being influenced by science or by their religion. If the Court believes that, at the state of the art, the discussed stem cells cannot develop to term and, therefore, they do not have the inherent capacity of developing into a human being, we believe that human dignity is given less protection compared to the others, since every country can decide, some will totally ignore the human dignity to give innovation more power.
2) The list will have to be more exhaustive, new developments are already taking place (nucleotide polymorphisms, bioinformatics) that are not provided by the very general terms of the directive.
3) yes, but we believe that a certain precision should be given.
4) Exactly, that’s the biggest problem! Everyone will have their way to “rule” in such a sensitive concept. The question of embryo is important since it also concerns abortion. So automatically the way countries are gonna define those words, will have an impact on other things that are extremely sensitive and important. We cannot let countries, taking the power on this question cause for exemple: a country like Poland will not accept any access for innovation , because of their believes.
5) No it cannot, todays generation and the is different. We cannot let people that doesn’t have any knowledge about an issues take action on that. We should give their place to scientist that actually have worked on that, human right activist,.. We should give more places to those who know the issues and knows how it works. We actually should not have permanent people, every issues should have their own debate with people that are in the issues, that are living the problem or are working on it.
Lara Van Assche & Shimona Anoop
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a. The article 6 (2) (c) excludes from patentability “human embryo”. The cell to be excluded from patent must be able to develop itself into a human being. An another hypothesis of exclusion from patent refers to a cell in which the process of science (production of an another cell) would damage the human embryo.
The CJEU gives an exception: a patent can be granted if the invention covers uses for therapeutic or diagnostic purposes aimed at treating the human embryo.
Therefore, we can see that in the field of scientific research, researchers still have the possibility to patent biological invention as long as they respect the CJEU’s criteria. We can’t consider that human dignity weights too high compared to other interest such as the economic interest. According to me, there is a proper balance. Nowadays, we cannot be constraint to immobilism ! We must go forward in the light of the therapeutic or diagnostic purposes notwithstanding the conservative background of human dignity. The CJEU protects efficiently the human dignity following the criteria of exclusion.
b. The list is not comprehensive due to the evolution in the field of scientific invention. The §1st : when commercial exploitation would be contrary to ordre public or morality, the patent would be denied. By principle, ordre public or morality evole !! We tend to recognize a larger part in science. On the other hand, biotechnological application (invention) appears faster than the move in social norms. That’s why EU must keep the list face to reality, and create new type of exclusion from patent. Simply, the criteria’s changed from Brüstle judgement to the International Stem Cell action, this shows how the appreciation of opportunity of patent is moving and how the list is required to evolve.
c. I do agree with this argument. it is sure that the Brüstle judgement slowed down researches in the domain of activity of embryo which can develop into human being because the potential invention could not be patent. For the large medecine companies no benefit would be allow to them whereas scientists in US could easily find companies to finance their researches. This lighter legal framework is more propitious to invention.
The CJEU approach negatively affect biotechnological innovation in Europe due to the need to respect the restriction and the lack of freedom in the light of an economics outcome. Of course researches can be made but the reward (patent) would not be possible !!
d. The Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle. Indeed, the Court said that stem cells which have the inherent capacity of developing into a human being are excluded from the patent framework. According to me, we can clearly understand the application field of the EU regulations whether the cell can develop itself into a future human being. The Court has envisaged the hypothesis of an unfertilized human ovum. Therefore the Court has used examples.
e. The CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo, I think that the situation cannot jeopardise the European harmonisation of patents as such. Indeed, the CJEU as already said has clearly stated the criteria’s whether the patent is or not possible. Therefore, the power of decision comes to the states to apply and follow the guideline given by the EU legal framework. States should have the approximate same appreciation in the matter of patentability of biotech inventions. The EU already regulate the matter, let the states apply and decide the national cases.
f. A Court composed by jurists, can’t adequately decide legal questions dealing with complex scientific concepts. I propose that a group composed by experts from different countries are asked to summit a rapport on the subject saying what they find doable and reasonable. An another solution more autonomous could be a treaty in order to put the states as such into the negociation and come up with a decision (treaty). We can use a similar instrument to the “convention collective de travail” in the EU law. Of course, judges don’t know the technical and underground aspect of biotech invention and patent relate to it.
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a) I believe that the CJUE tried to reach a balance. Blocking all patent would for sure limit (if not kill) science from further progresses. Indeed, being able to patent ensures scientists an economic reward, encouraging them to invest in scientific research in the field of biotechnology. But at the same time, the directive and its interpretation by the CJEU does not allow to patent everything! For moral reasons and in order to preserve human dignity, stem cells that have the inherent capacity to turn into human beings cannot be patent. It seems to me that a certain balance is reached here.
b) The directive mentions the impossibility to patent “processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes”. I believe that the modifying of the genetic identity of the animal should be better protected. Don’t the animals deserve a protection similar to ours? At least no matter if the animal is suffering or not, if the process of modification of its genetic identity has no benefit to man or animal, patentability should not be allowed.
c)For sure, the Brüstle decision restrains stem cells researches in Europe and not elsewhere. So, in that field, Europeans would be disadvantaged. But, at the time the CJUE simply wanted to protect human dignity over economic and scientific advantages. So, I do not agree with the argument: what comes first is human dignity as a fundamental right. This comes before the competitiveness of the European biotechnical industry.
d) No, I believe that the CJUE still fails to provide general guidelines and more precise classifications of cells that would allow a harmonization of the stem cells patentability. The CJUE should have been clearer and should have established herself at what point does an organism develop into a human being.
e) Yes. First, because of the lack of general guidelines defining when an organism develops into a human being, leaving a big margin of interpretation to member states is a threat to a harmonious interpretation. Indeed, the CJEU provides that it is the role of national courts to determine whether the “inherency test” is conclusive or not. Different state may arrive to different conclusions! Let’s note that national courts can also decide to prohibit the patentability of stem cells on the basis of art. 6 (1) and its reference to public order. At the end of the day, art. 6 can thus be applied differently according to different national interpretations. The CJEU thus fails to pave the way to a harmonious interpretation of article 6 (1 and 2) of the Biotech Directive.
f) I believe that sometimes judges do not have the technical education required to understand cases that are very specific. We could argue that the CJEU was based on wrong information’s and did not quite understand the issue in the Brüstle case. Indeed, a few years later in the Stem Cell Corporation case, the Court changed its interpretation completely! In the first case the CJEU decided that “unfertilized human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being”. On the contrary, in the second decision, the CJEU ruled that “an unfertilized human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, that ovum does not, in itself, have the inherent capacity of developing into a human being”. A solution to address this knowledge gap would be to force judges to consult experts on very technical issues and to force them to follow the opinions submitted by experts in those technical fields.
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Cantalupi Giulia
1. Article 6 of Directive 98/44/EC is the so-called ethical clause. The second paragraph establishes a list of inventions that cannot be patentable; among them, letter (c) states that human embryos used for industrial or commercial purposes proposes are excluded. The ECJ first underlines that its role is neither of a medical nor of ethical nature but must be restricted to a legal interpretation of the relevant provisions of the Directive (§30). The context and the aim of this Directive is to exclude patentability in any situation where respect for human dignity could be affected: that is why the notion of ‘human embryo’ must be understood in a wide sense (§34). The Court held that stem cells obtained from a human embryo at the blastocyst stage (as in Brüstle’s patent) should be included within the concept of ‘human embryo’, as established in Article 6(2)(c) (§37). It is obvious that the Court’s ratio legis follows the Directive main objective which is to protect human dignity: yet I do not think that this interpretation provides a good balance between human dignity and public innovation/research. The problem is that with this decision, the ECJ not only stepped over the line separating the interpretation from the creation of law (in providing a definition of ‘human embryo’) but it raises serious issues about future research into the domain of regenerative medicine. Since the Court has chosen not to confine its analysis to the patent context (by giving a broad definition of the notion of ‘human embryo’) this decision could seriously stifle the biomedical domain in favor of human dignity. The overly generic ECJ’s interpretation was not confirmed by the German Court which ruled that despite the fact that blastocyst can potentially commence the process of development, actually they are ‘functionally dead’. Therefore, they are not human embryos (“functionally dead”) so that stem cells can be patented (as long as their production does not cause the destruction of an embryo). From an economic standpoint, this ruling has brought some problems in the commercial exploitation of stem cell inventions in the pharmaceutical industry. In fact, as the inventor has to transfer the right to commerce the new technology only by assignment or licensing because without an exclusive right, the production of new medicines will turn out into a huge economic risk for pharmaceutical industries.
Show less2. I think that the list contained in Article 6(2) of Directive 98/44/EC is a comprehensive one; even if it is very short, all four listed processes are unambiguous. Once again, since those processes are not fully described they are amenable to a broad interpretation by Member States. This can lead, as we have seen in Oliver Brüstel v. Greenpeace, national courts asking for clarification of the notion in order to give a preliminary ruling. I do not foresee any other biotechnological application affecting human dignity that could deserve protection explicitly.
3. I do believe that that decision of the CJEU negatively affected biotechnological innovation in Europe. In USA (and Asia) morality exclusions on patents is more liberally applied or barely exist. Both USA and Japan foresee morality exclusion on patents, but Europe seems to stand alone in its strict application of the morality-based exclusion on human ES cells. The USA addressed the morality of stem cell use by strict legislation on public funding rather than on restricting patentability. This is one of the main reasons why restrictions on stem cell patents in Europe may be a concern for the pharmaceutical industry which prefers collaboration with academic partners in the USA where private scientific innovation is better protected.
4. International Stem Cell contested the refusal of the UK Intellectual Property Office to register for a patent related to non-fertilized human ova. This time the case was different since stem cells obtained from parthenogenesis-activated oocytes are not able to develop into a human being. The CJEU was thus asked to clarify the meaning of ‘commencement’. The Court held that the stem cells in question cannot fully develop, and therefore, they do not have the inherent capacity of developing into a human being. I do not think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being”. In this case the Court is only referring to these specific cells, it does not give a broad definition of ‘commencement’ as it was done for the notion of ‘human embryo’ in Brüstle.
5. The margin of discretion left to national courts in determining whether a biological material falls under the definition of embryo given by the CJEU in these two decisions could stifle the European harmonization of patents. This is because each domestic court will be able to give various nuances of the notion, creating differences in the legal protection of biotechnological inventions. As a consequence, such differences could create barriers to trade and hence hamper the proper functioning of the internal market.
6. I believe that a Court composed by only jurists cannot be able to decide adequately on complex cases, specifically those involving important questions in the scientific field. For example, in many circumstances, it turns out most of the lawyers working on biotechnological patent cases were formerly engineers or highly- specialized people quite able to understand the technicalities of the case. This could be also applicable to courts. Especially the European Court (at least the President), whose aim is to give clear answers on the interpretation of EU law, should be assisted /supported by a body of highly specialized staff.
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Question a) Yes, we think the interpretation of the court is correct. Indeed, even if it is important to have innovation in the scientific world to cure several diseases, the notion of human dignity is, according to us, more important. Stem cells taken from embryos shouldn’t be something put up in the market nor a basis for having a patent. Therefore, the interpretation of Article 6(2)(c) of Directive 98/44/EC done by the CJEU does ensure a proper balance between all the different interests at stake in the case.
Question b) Yes, we think the list is comprehensive and already offers a large scope of protection. According to us, there isn’t any other biotechnological application affecting human dignity that could deserve protection explicitly.
Question c) It seems to be a problem for the development of biotechnological innvoation in Europe if Europeans cannot use the way of research forbidden by the Brüstle Judgment
Nevertheless, this ban is based on morality grounds. It’s why the European decision can be understandable because the Court held on the basis of the article 6 of the Directive 98/44/CE which a political choice of the EU.
Question d) The legal definition of embryo given in Brüstle is that « any human ovum after fertilisation must be considered falling under the legal definition of embryo, because “that fertilisation is such as to commence the process of development of a human being” (§35 Brüstle judgment). ».
As we can see, the wording of the Court in the Brüstle judgment is very general and not very precise. It’s why I think the Court clarified as it can the the meaning of this wording.
Question e) Yes it could. Indeed if countries start to define differently the notion of « embryo » then, patents could contain embryos for certain countries and not contain embryos for other countries. Consequently, people could work on something which is illegal for some countries and isn’t for others within the EU. If people doesn’t agree on what is protected by the patent, depending on inclusivity of the country’s opinion, third partie could exploit a part of the invention without even knowing that he’s doing it illegally.
Question f) Currently, a lot of ethical questions try to find a judiciary answer as scientific and political field aren’t able to do so, unanimously and undeniably. If at least, the all scientific community agree on what is an embryo and what isn’t, then maybe, with the experts’ help, juges will be able to answer this question. Nevertheless, as laws are adopted by MPs who are representing the people, each country will have its opinion on the question and consequently judges too. The analyze can be easily transferred to the UE. If judges were to be forced to have a panel of experts which would be representatives of the dominant points of view on these technical matters, judges might be in a better position to answer those kind of questions.
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Answers to Questions About Embryos and all those stuffs :
Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
I think The article 6(2) of the Directive as interpreted by the CJEU ensure a proper balance because it is enough precise by saying and precising that the use of human embryos “for industrial or commercial purposes” is unpatentable. In that way, that ensure the respect of what can be called “Ordre Public”, by forbidding any kind of economic exclusivity on any part that comes from human body, this going with the CJEU Consideration going deeper, stating that even an ovum is not fertilized, it can be considered as embryo when it is stimulated by parthenogenesis because it has a creative aptitude. Globally, those things are also protected at the national level by the National Law.
Moreover, this provision find its legitness in the way that even patenting embryos is illegal, it protects public researches and innovation, what can be seen with the precision quoted before, because the purposes of those researches are not industrial or commercial application but progress, science and human knowledge.
Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
This list, contained at Article 6(2) of the Directive, can be considered as comprehensive, considering that it protects that is europeanly seen as necessary for public order and health protection, like cloning or modifying the germ line genetic identity of human beings, what we consider as basic deontology in Europe.
It may be important to say that this point of view is different in North America, where the notion “deontology” is more flexible, where the acceptance is broader, that’s why we often receive mails containing offers poposing us to practice some genetic tests so we can find our genetic lineage, in reality, our genetic informations are after sell by those companies to advertising one.
in the future, when will arrive “Human enhancement” like bionic organs, that will make humanity progress, the research on that will have to be controlled so we cannot create people like what we see in Dystopian Movies.
The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
As said in the previous question, the notion of “deontology” is broader and more restrictive in Europe than in the US for example. In facts in terms of industrial and economic application, having a strict deontology as what we have is protective of the human body, but that strictness can be a drawback in terms of scientific progress and innovation. The scientist that are working on the human functioning science are really restricted in Europe in terms of researches and experiences what can slow down the progress. That’s what happened for stem cells and that’s the reason why Europe falls behind in terms of scientific discovery comparing to other Countries or Region.
In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
No, the Court’s decision in Brüstle did not clearly address the question of whether the term “human embryo” includes organisms likely to trigger a human being’s development process regardless of whether that process could be completed. According to Comptroller General, there is also uncertainty as to whether the Court relied on arguments reflecting an inaccurate understanding of the technical framework as it exists to date.
Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
This binding aspect of one of the essential provisions of the text of the directive seems to me to argue in favour of the more uniform interpretation possible of the concept of human embryo within the Union, rather than imposing a strict definition. I do not see how such a categorical ban, which applies to all Member States, could exist on the basis of concepts which are not common. If we do not let a certain freedom to definit a such important term to Member States, they will probably transpose anything. Therefore, it is our view that the concept of human embryo must find a community meaning.
A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
In my opinion, a single college of judges and jurists is not able to legislate on this issue alone. If the legal body is recognized as wanting to pacify and regulate laws on biology and ethics in order to protect individuals, it cannot impose laws on a subject as scientific as this one, without any medical basis or knowledge of biology. I think that long philosophical debates are necessary in order to find a common and European vision that is closest to all. I am therefore in favour of a collegial body of jurists, sociologists and scientific experts to avoid such questions.
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IGNACZUK Sara, DEVROEDE Hortense
Show less1) Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection?
This does not seem to be the case. Of course the CJEU needs to take into consideration certain moral values when deciding a case, which in this instance is human dignity. In many of its decisions, the Court puts a lot of efforts in underlying that the EU is a community build on common values and not merely a common economic market. But, in this case, it did that in a wrong fashion. If the Court’s decision has some burdensome effects on the public interest in research and innovation, this should be at least based on a more solid explanation. In fact, the CJEU relied on the notion of human dignity without indicating its meaning or purpose in relation to scientific and commercial issues. It presupposed that it was something given. It also failed in considering any other values that might be relevant for such a legal question. It tried to find a balance between the defense of human dignity and the support for innovations in the scientific field by prohibiting patents when the research involves the use of human embryos possessing the ‘inherent capacity’ to become a human being. However, without explaining in what sense human dignity is incompatible with the granting of patents in the case where the scientific process involves the use of human embryos, the balance seems to be odd. And this is even more alarming in the sense that such a decision may have burdensome effects on further development and commercialisation of cellular therapies research in the EU. The question here is not that the CJEU ruling is illegitimate, in fact it might be rightful, but it is not sufficiently motivated to justify such a blow on the progress of science.
2) Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
This list does not seem to be exhaustive. In fact, if its aim is to list biotechnological applications that are undermining human dignity, there are many others, and maybe even more important items than the simple use of human embryos possessing the ‘inherent capacity’ to become a human being for purposes of scientific research, that should be included in the enumeration. We might of course think about the technique of animal cloning, but also about the use of biological techniques to improve peoples’ skills, performances or strength (for example in the sportive field), or about the DNA surgeries used to create tailor-made children.
3) The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
Yes, it did, but probably less than we might expect. In fact, there is an inherent commercial feature to patents, which means that depriving inventors of property rights over their findings might have the effect of cutting off their wings and retain them from continuing their researches. A possible solution for them would probably consist in focussing in researches that do not involve embryos possessing the ‘inherent capacity’ to become a human being. But, even if this does not happen, there are maybe other ways of preventing a complete slowing down on the brakes. Here it is up to the EU Member States to intervene. Even if the CJEU rejects patents for scientific innovations which imply the use of human embryos, Member States that still find an interest in supporting unpatentable researches might do that through for example inventive taxes or by providing a strong legal protection for such innovations.
4) In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
Not really, and this is a possible reason behind the CJEU’s deferral to national courts of the task of deciding when a given use of parthenotes meets the conditions of the inherency test. And it entitled national courts with the conduct of this test without giving them any guidelines. The reason for that seems to be the fact that this is a question of inherently factual issues. In such a case, the answer must be given on the basis of the state of the scientific acquaintance at the time the ruling is delivered by the concerned domestic court.
5) Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Yes, it does. And this can be illustrated through some actual examples that show that there are very dissimilar hESC regulatory regimes in the EU Member-States. For instance, Germany prohibits researches involving human embryos as well as the importation of stem cell lines from other countries. The U.K. and Sweden on the contrary allow such researches and even provides for comprehensive regulatory frameworks for that purpose. Other nations like Austria or Italy forbid such researches in their countries but allow importations of stem cell lines from abroad.
Source : http://cilj.co.uk/2016/04/22/2999/.
6) A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If yes, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
According to me, it is not necessary true that CJEU’s jurists do not have the required knowledge to deal with scientific issues. If there is a problem, for me it lays elsewhere. The major issue is that cases involving complex scientific concepts need deeper examination and probably even very individualized review, which is obviously not possible in the case of an overworked CJEU that has to deal quickly and with very limited means with hundreds of cases each year. An evident solution would consist in providing the Court with external assistance that would help it to correctly understand complex scientific concepts. The idea is to establish an effective collaboration between the judiciary and scientists that would alleviate the CJEU’s work, enable faster decision making and provide for a more sophisticated and suitable reasoning to the issues at stake.
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Human embryos at the bar: the blurring lines between law and science in patent protection
Questions for discussion
In Europe, human embryos are excluded from patentability on morality grounds.
a. Do you think that Article 6(2)(c) of Directive 98/44/EC, as interpreted by the CJEU, ensure a proper balance between human dignity, the public interest in research and innovation, and the economic justification at the basis of patent protection ?
For me, the ethical clause is not clear enough. The invention considered unpatentable are those that are contrary to ordre public or morality, but what’s actually « ordre and morality » ? The interpretation of these terms can differ from country to country, from person to another and so on. However, an invention can be patended if th invention covers uses for therapeutic or diagnostic purposes aimed at treatint the human embryo. As a result, the balance between all this stay for me very unclear and very tight.
b. Do you think that the list contained at Article 6(2) of Directive 98/44/EC is a comprehensive list? Do you foreseen any other biotechnological application affecting human dignity that could deserve protection explicitly?
Of course for me, that list is comprehensive but is can be still understood and interpreted very largely. It’s important to understand the meaning of each terms to know if we agree or not. Each terms can be questionned and viewed in different ways. In addition to that the list might surely be longer with all the technology advences that we did. I cannot guve any exemple of what can be added to the list but I’m sure there are some missing points.
c. The Brüstle judgement raised several criticisms. One recurring comment was that the decision would have been the tombstone of stem cells research in Europe, while, in other Countries, notably the US, there are not such restrictions. Do you agree with this argument? Did the CJEU approach negatively affect biotechnological innovation in Europe?
The CJEU approach is not to be seen negatively but rather to protect the human dignity.
d. In International Stem Cell, the CJEU formulated the “inherency test” to exclude a non-fertilised ovum stimulated by parthenogenesis from the definition of embryo. Do you think that the Court has sufficiently clarified the meaning of “commencement of the process of development of a human being” established in Brüstle?
The court said that « an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis did have the capacity to develop into a human being ». It only defined what can be develop into a human beaing and not the precise moment of the commencement. We do not know from which moment we can call the phase as commencement. So the term is actually not defined at all.
Show lesse. Both in Brüstle and International Stem Cell, the CJEU leaves a certain margin of discretion to national courts in determining whether a biological material falls under the definition of embryo. Do you think that situation can jeopardise the European harmonisation of patents?
Well, yes it can jeopardise the European harmonisation of patents if every countries have a different interpretation. However, on the one side, for such question, national courts, since they have their own national values that enforce their national identity, and their own priority, it’s normal to let them choose the defintion of embryo which falls under their values. On the other hand, it became more difficult to judge if two countries have different interpretations ; who’s gonna win the case ? Which interpretation is gonna be superior ?
f. A provocative question: do you think that the CJEU, a Court composed by jurists, can adequately decide legal questions dealing with complex scientific concepts? If not, do you foreseen any creative solution to address the knowledge gap that judges may suffer when they have to handle highly-specialised technical matters?
Of course not. The jurists cannot adequately decide legal questions dealing with scientific concepts. On this kind of case, they should call a group of expert that will give them advices based on their knowledge. Moreover, a group of civilians should also have to share their point of view on the specific matter since it concern public order and morality. And then, based on the different opinion of the population and the expert (+ based also on a legal basis) the jurists have to decide.
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a. The directive does not provide a definition of human embryos but the Court held that the Directive is meant to protect human dignity and that’s why the notion of human embryos must be understood in a wide sense. Following the Court, the organism that starts the process of development into a human being is the notion of human embryo.
b. At first appearance, the list seems to be exhaustive. That’s why they decide to make a specific list. If that list was not complete, they would not have made it.
c. According to us, this argument isn’t a really good argument. The CJUE approach affects biotechnological innovation in Europe like the UK Court and the German Court. Indeed, the German Court confirmed the unpatentability of neural precursors cells entailing the destruction of a human embryo. However, it allowed the possibility to get patent if related to other methods for obtaining the same result without damaging the embryo. Interestingly, in applying the CJEU definition of human embryo, the German Court found that, despite blastocyst can potentially commence the process of development described by the CJEU.
d. The Court hasn’t sufficiently developed and clarified the meaning. Indeed, the stem sells cannot develop to term and, therefore, they do not have the inherent capacity of developing into a human being.
e. Yes, if every european State could decide of what biological material falls under the definition of embryo, it can jeopardise the patent of an embryo.
f. No, we think that judges should be accompanied by scientists to conduct their thinking and speak with full knowledge of the facts.
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