By: The Irish Times
Source: http://www.irishtimes.com
A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.
Background
Oliver Brüstle is the holder of a patent, filed on December 19th, 1997, which concerns isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases.
According to the information supplied by Mr Brüstle, clinical applications for the procedure already exist, particularly for patients suffering from Parkinson’s disease.
On the application of Greenpeace eV, the Federal Patent Court in Germany ruled that Mr Brüstle’s patent was invalid insofar as it covered processes for obtaining precursor cells from human embryonic stem cells.
Mr Brüstle appealed and the Federal Court of Justice in Germany decided to refer questions to the European Court of Justice.
These concerned the interpretation of, in particular, the concept of “human embryo” which is not defined in directive 98/44/EC on the legal protection of biotechnological inventions.
The question was whether the exclusion from patentability of the human embryo covers all stages of life from fertilisation of the ovum or whether other conditions must be met, for example that a certain stage of development be reached.
Decision
The court pointed out that it was not called upon to deal with questions of a medical or ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the directive.
The context and aim of the directive showed that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could be affected. It followed that the concept of “human embryo” must be understood in a wide sense, it said.
The court therefore considered that any human ovum must, as soon as fertilised, be regarded as a “human embryo” if that fertilisation was such as to start the process of development of a human being.
A non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis must also be classified as a “human embryo”, the court said.
In relation to the stem cells obtained from a human embryo at the blastocyst stage, which are involved in the invention introduced by Mr Brüstle’s patent, the court found that it was for the referring court to ascertain, in the light of scientific developments, whether they were capable of commencing the process of development of a human being and, therefore, were included within the concept of “human embryo”.
The court also examined whether the concept of “uses of human embryos for industrial or commercial purposes”, which is not patentable under the directive, also covered the use of human embryos for purposes of scientific research.
The court noted that the grant of a patent for an invention implies, in principle, its industrial or commercial application.
The use of human embryos for purposes of scientific research which was the subject matter of a patent application, could not be distinguished from industrial and commercial use and therefore could not be patented.
However, this did not mean the exclusion of patents used for therapeutic or diagnostic purposes applied to the human embryo itself and which were useful to it, for example to correct a malformation and improve the chances of life.
The court held that an invention was excluded from patentability where the implementation of the process required either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process did not refer to the use of human embryos.
Source: http://www.irishtimes.com/newspaper/ireland/2011/1031/1224306801891.html
Source: http://www.irishtimes.com
A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented. The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable.
Background
Oliver Brüstle is the holder of a patent, filed on December 19th, 1997, which concerns isolated and purified neural precursor cells produced from human embryonic stem cells used to treat neurological diseases.
According to the information supplied by Mr Brüstle, clinical applications for the procedure already exist, particularly for patients suffering from Parkinson’s disease.
On the application of Greenpeace eV, the Federal Patent Court in Germany ruled that Mr Brüstle’s patent was invalid insofar as it covered processes for obtaining precursor cells from human embryonic stem cells.
Mr Brüstle appealed and the Federal Court of Justice in Germany decided to refer questions to the European Court of Justice.
These concerned the interpretation of, in particular, the concept of “human embryo” which is not defined in directive 98/44/EC on the legal protection of biotechnological inventions.
The question was whether the exclusion from patentability of the human embryo covers all stages of life from fertilisation of the ovum or whether other conditions must be met, for example that a certain stage of development be reached.
Decision
The court pointed out that it was not called upon to deal with questions of a medical or ethical nature, but must restrict itself to a legal interpretation of the relevant provisions of the directive.
The context and aim of the directive showed that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could be affected. It followed that the concept of “human embryo” must be understood in a wide sense, it said.
The court therefore considered that any human ovum must, as soon as fertilised, be regarded as a “human embryo” if that fertilisation was such as to start the process of development of a human being.
A non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis must also be classified as a “human embryo”, the court said.
In relation to the stem cells obtained from a human embryo at the blastocyst stage, which are involved in the invention introduced by Mr Brüstle’s patent, the court found that it was for the referring court to ascertain, in the light of scientific developments, whether they were capable of commencing the process of development of a human being and, therefore, were included within the concept of “human embryo”.
The court also examined whether the concept of “uses of human embryos for industrial or commercial purposes”, which is not patentable under the directive, also covered the use of human embryos for purposes of scientific research.
The court noted that the grant of a patent for an invention implies, in principle, its industrial or commercial application.
The use of human embryos for purposes of scientific research which was the subject matter of a patent application, could not be distinguished from industrial and commercial use and therefore could not be patented.
However, this did not mean the exclusion of patents used for therapeutic or diagnostic purposes applied to the human embryo itself and which were useful to it, for example to correct a malformation and improve the chances of life.
The court held that an invention was excluded from patentability where the implementation of the process required either the prior destruction of human embryos or their prior use as base material, even if, in the patent application, the description of that process did not refer to the use of human embryos.
Source: http://www.irishtimes.com/newspaper/ireland/2011/1031/1224306801891.html
