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Un nouveau souffle va être apporté à l’éternel débat concernant le brevetage des cellules souches embryonnaires (CSE) humaines, puisque la Cour de justice européenne (CJUE) tient aujourd’hui-même une audience pour discuter de la définition du terme « embryon humain » et de son utilisation industrielle et commerciale.
The EU court has been asked to define 'human embryo' and outline their practical uses as spelled out in the EU's Biotechnology Directive (see 'Background'), which states that "the human body, at the various stages of its formation and development," cannot be considered a patentable invention.
Brüstle vs. Greenpeace
The request for a preliminary ECJ ruling on the matter comes from the German Federal Court of Justice, which failed to decide whether to patent a method of converting embryonic stem cells (hESC) into nerve cells, which could potentially be used to treat neurological trauma and disease and was introduced by German researcher Oliver Brüstle.
The patent was originally granted to Brüstle in 1999. But following legal action by Greenpeace, the patent was deemed to be in violation of the EU biotech directive and was partially revoked.
After a renewed appeal by the patent holder and given the incapacity of the German court to decide, a number of questions are now being referred to the ECJ for a preliminary ruling.
A request for a preliminary ruling enables national courts to ask the ECJ for its interpretation of EU law or enquire as to its validity. The ECJ's response or interpretation is binding on the national court to which it is addressed, as well as on other national courts before which problems of the same nature are raised.
Questions to be answered
The ECJ hearing on the Brüstle vs. Greenpeace case, which starts today (12 January), seeks to clarify the terminology used in the EU biotech directive and answer a series of specific questions tabled by the German court.
Firstly, the Court is asked to define 'human embryo' as well as clarify the specific wording used in the EU biotech directive, which states that "uses of human embryos for industrial or commercial purposes" are not patentable.
Brüstle argues that the ban on granting a patent should only apply to embryos that are more than 14 days old and that the EU directive should allow the patenting and use of embryonic cells before the 14 day mark.
Secondly, the ECJ is asked to be more explicit regarding the expression "uses of human embryos for industrial or commercial purposes" and to specify whether that also includes patenting for scientific research.
Greenpeace argues that a patent always has a commercial purpose and points out that research is possible without a patent, whereas patent law regulates commercial use.
The third question focuses on whether technical findings can be patented, in this case referring to the method of converting embryonic stem cells into nerve cells.
In search of clarity
The EU's biotech directive does not mention embryonic stem cells, as the technology did not exist when the directive was discussed and adopted in 1998.
However, in a resolution adopted in 2005, the European Parliament sought to address the matter.
It insisted that "the creation of human embryonic stem cells implies the destruction of human embryos and [...] therefore the patenting of procedures involving human embryonic stem cells or cells that are grown from human embryonic stem cells is a violation" of the EU directive.
The European Patent Office (EPO) has taken the provisions of the EU's biotech directive into account and transposed them into the European Patent Convention (EPC).
In 2008, the European Patent Office (EPO) decided not to patent the development of human stem cell cultures whose preparation involves the destruction of embryos.
Positions
Ahead of the ECJ hearing, cross-party MEPs including Peter Liese (European People's Party; Germany), Vittorio Prodi (Socialists & Democrats; Italy), Miroslav Mikolášik (EPP; Slovakia), Eva Lichtenberger (Greens/European Free Alliance; Austria), Carlo Casini (EPP; Italy) and Greenpeace's advisor on the case, Christop Then (executive director of Test Biotech), rallied against patenting embryonic stem cells, stressing that it is unacceptable to patent technologies that destroy human life.
The MEPs said that while opinions diverge in the European Parliament as to whether research with embryonic stem cells is ethically acceptable, "there is a broad rejection throughout all political parties" regarding the patentability of research results, as it raises "the question of commercialisation of the human body".
A recent report from the European Science Foundation (ESF) highlights "the complexity of patenting human embryonic stem cell technologies in Europe".
It notes that "while innovations based on human embryonic stem cells can fulfil standard patentability requirements, the European Patent Convention is not clear about what falls within ethical guidelines. Under the convention patents cannot be issued for uses of human embryos for industrial or commercial purposes, but the convention does not state whether purely therapeutic use of stem cells would be defined 'commercial'."
The ESF also notes that "the European Patent Office will not grant a patent if the invention relies exclusively on a method requiring the destruction of a human embryo. Yet this does not specify if 'human embryo' includes stem cells derived from a blastocyst, a very early stage embryo. Blastocysts that have lost the ability to develop into a human are a common source of stem cells for research".
The EU court has been asked to define 'human embryo' and outline their practical uses as spelled out in the EU's Biotechnology Directive (see 'Background'), which states that "the human body, at the various stages of its formation and development," cannot be considered a patentable invention.
Brüstle vs. Greenpeace
The request for a preliminary ECJ ruling on the matter comes from the German Federal Court of Justice, which failed to decide whether to patent a method of converting embryonic stem cells (hESC) into nerve cells, which could potentially be used to treat neurological trauma and disease and was introduced by German researcher Oliver Brüstle.
The patent was originally granted to Brüstle in 1999. But following legal action by Greenpeace, the patent was deemed to be in violation of the EU biotech directive and was partially revoked.
After a renewed appeal by the patent holder and given the incapacity of the German court to decide, a number of questions are now being referred to the ECJ for a preliminary ruling.
A request for a preliminary ruling enables national courts to ask the ECJ for its interpretation of EU law or enquire as to its validity. The ECJ's response or interpretation is binding on the national court to which it is addressed, as well as on other national courts before which problems of the same nature are raised.
Questions to be answered
The ECJ hearing on the Brüstle vs. Greenpeace case, which starts today (12 January), seeks to clarify the terminology used in the EU biotech directive and answer a series of specific questions tabled by the German court.
Firstly, the Court is asked to define 'human embryo' as well as clarify the specific wording used in the EU biotech directive, which states that "uses of human embryos for industrial or commercial purposes" are not patentable.
Brüstle argues that the ban on granting a patent should only apply to embryos that are more than 14 days old and that the EU directive should allow the patenting and use of embryonic cells before the 14 day mark.
Secondly, the ECJ is asked to be more explicit regarding the expression "uses of human embryos for industrial or commercial purposes" and to specify whether that also includes patenting for scientific research.
Greenpeace argues that a patent always has a commercial purpose and points out that research is possible without a patent, whereas patent law regulates commercial use.
The third question focuses on whether technical findings can be patented, in this case referring to the method of converting embryonic stem cells into nerve cells.
In search of clarity
The EU's biotech directive does not mention embryonic stem cells, as the technology did not exist when the directive was discussed and adopted in 1998.
However, in a resolution adopted in 2005, the European Parliament sought to address the matter.
It insisted that "the creation of human embryonic stem cells implies the destruction of human embryos and [...] therefore the patenting of procedures involving human embryonic stem cells or cells that are grown from human embryonic stem cells is a violation" of the EU directive.
The European Patent Office (EPO) has taken the provisions of the EU's biotech directive into account and transposed them into the European Patent Convention (EPC).
In 2008, the European Patent Office (EPO) decided not to patent the development of human stem cell cultures whose preparation involves the destruction of embryos.
Positions
Ahead of the ECJ hearing, cross-party MEPs including Peter Liese (European People's Party; Germany), Vittorio Prodi (Socialists & Democrats; Italy), Miroslav Mikolášik (EPP; Slovakia), Eva Lichtenberger (Greens/European Free Alliance; Austria), Carlo Casini (EPP; Italy) and Greenpeace's advisor on the case, Christop Then (executive director of Test Biotech), rallied against patenting embryonic stem cells, stressing that it is unacceptable to patent technologies that destroy human life.
The MEPs said that while opinions diverge in the European Parliament as to whether research with embryonic stem cells is ethically acceptable, "there is a broad rejection throughout all political parties" regarding the patentability of research results, as it raises "the question of commercialisation of the human body".
A recent report from the European Science Foundation (ESF) highlights "the complexity of patenting human embryonic stem cell technologies in Europe".
It notes that "while innovations based on human embryonic stem cells can fulfil standard patentability requirements, the European Patent Convention is not clear about what falls within ethical guidelines. Under the convention patents cannot be issued for uses of human embryos for industrial or commercial purposes, but the convention does not state whether purely therapeutic use of stem cells would be defined 'commercial'."
The ESF also notes that "the European Patent Office will not grant a patent if the invention relies exclusively on a method requiring the destruction of a human embryo. Yet this does not specify if 'human embryo' includes stem cells derived from a blastocyst, a very early stage embryo. Blastocysts that have lost the ability to develop into a human are a common source of stem cells for research".
euractiv
