Local view for "http://purl.org/linkedpolitics/eu/plenary/2005-10-25-Speech-2-282"
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"en.20051025.22.2-282"2
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".
Mr President, I understand Members’ concerns that the biotechnology directive should be applied correctly. This is important, not just for all those in industry who use patents to support the introduction of new products and processes, but also those who benefit from the availability of the results of research and development. These could be researchers, industrial competitors, patients and medical staff and those who administer health systems.
The term ‘therapeutic cloning’ covers a wide range of different possibilities. Research may be permitted in some Member States and not in others. For the Commission, the use of human pluripotent stem cells to cure diseases is not necessarily excluded from patentability. In light of those arguments, a modification of the directive does not, at this stage, seem appropriate.
In conclusion, I would like to recall that biotechnology has enormous potential for good, particularly in medical fields, and patent protection is of great importance to key industrial sectors, which invest heavily in research and development costs. We are working in the context of a global economy, which means our industry and researchers are competing with those in the United States and growing markets such as Asia. Indeed, according to recent reports Chinese companies filed more biotechnology patents in Europe in certain sectors last year than European companies did. As I have said, I understand the concerns that some Members have raised and I shall listen with interest to the debate.
Biotechnology covers a wide range of powerful and sometimes controversial technologies. They can make a vital contribution to the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. Biotechnology also creates new opportunities and prospects for developing life-saving drugs and treating diseases. It offers enormous potential for massively improving the quality of life of many citizens. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up.
Directive 98/44/EC establishes well-balanced principles for the protection of biotechnological inventions through patents. It also takes into account the ethical aspects of this sensitive subject, as well as the legitimate desire of industry and others to establish a clear and effective scope for patent protection in this area of technology.
Let me recall that the purpose of the directive is to establish the legal framework for granting patents, which covers the results of research. It does not in any way replace regulations that govern research in particular areas, including certain ethical rules such as those on human integrity.
The Commission will continue to follow the application of the directive in practice very carefully, with due regard to ethical, moral and cultural considerations, and will not fail to inform the European Parliament, as it has so far done, in the framework of the evaluation reports envisaged in the directive.
In terms of the particular areas identified by Parliament in the motion for a resolution, I make the following remarks. On purpose-bound protection, the issue is whether patents on gene sequences – DNA sequences – should be allowed according to the classical model of patent claim whereby a first inventor can claim an invention that covers possible future uses of that sequence. Or should the patent be restricted so that only the specific use disclosed in the patent application can be claimed, which is purpose-bound protection?
On examination of the technical provisions of the directive, it can be seen that none of these articles explicitly addresses the concept of a restricted scope of protection relating to the specific use identified for the gene sequence concerned. That might be seen as arguing for the usual broad scope of protection rather than a restricted one, since that has always been the traditional approach in patent law.
On the other hand, it might be thought that the Community legislator had intended at least to raise the possibility of a limited scope of protection, covering only the specific industrial application identified in the patent as far as this particular type of invention is concerned. That restrictive interpretation should not be incompatible with the directive.
The Commission will now, in consultation with those involved, consider the consequences of allowing both interpretations of the directive and the best way to achieve a correct application of the directive on human cloning. The directive is clear for the Commission as regards the issue of patentability of reproductive cloning involving the creation of new human beings, which is clearly excluded under Article 6 of the directive."@en1
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