Does the directive permit the patenting of life?
No. Life itself is not a material, and as such is not patentable. However, subject to specific controls and definitions, biological material and living matter such as micro-organisms, cell lines, plants and animals, are patentable under patent laws in Europe. Like with all patents, also the other patentability requirements have to be fulfilled, and this is never the case with just naturally occuring living matter. This is already there and can only be discovered, not invented. Only if something has been changed technically, the new product or living matter, and its offspring, can be patented.
The directive does not change this situation. It merely confirms and clarifies it. It is also important to mention again, that patents do not give ownership of the patented material, only the right to exclude others from commercial use of the material. This is frequently misunderstood about the patent system. A patent is only an exclusive right - to stop others practising the patented invention absent a licence. It does not give any ownership rights. One owns the intellectual property but not the patented material itself.
Controls and definitions are necessary, since patent law and wider ethical considerations must be respected. The directive does not extend patent protection for biotechnological inventions beyond the principal rules of patent law; its main role is to bring long overdue uniformity to the existing national patent rules.
This directive is not a debate over "patenting life". The real area of debate with this directive is over the precise nature and scope of the controls and definitions to be imposed. The directive confirms that man, the human body, or parts of it are not patentable. This is based not only on ethical considerations, but it also flows from the basic principles of patent law, that is to say, that only inventions may be patented, while discoveries cannot.
The reason why an element derived from humans can be patented - such as an element isolated from the body by artificial techniques, is that this may be an invention (provided the product is new, inventive and commercially applicable). For instance, the human body produces interferon naturally; the provision of the ability to produce interferon outside the body in a non-natural fashion, combined with the know-how to use this interferon as a cancer medicine, is not merely a discovery: it is a true invention, which can lead to the patenting of that interferon and the gene that codes for it.
It is important to understand the scope of the directive. Patents do not give rights to the patentee to use their invention. Judgements on how appropriate it may be to use an invention (have to) come from the legislators who impose controls on research and on the exploitation and commercialisation of its results on behalf of society. For this reason patent law as such is not really fit for ethical provisions.
The directive does not change this situation. It merely confirms and clarifies it. It is also important to mention again, that patents do not give ownership of the patented material, only the right to exclude others from commercial use of the material. This is frequently misunderstood about the patent system. A patent is only an exclusive right - to stop others practising the patented invention absent a licence. It does not give any ownership rights. One owns the intellectual property but not the patented material itself.
Controls and definitions are necessary, since patent law and wider ethical considerations must be respected. The directive does not extend patent protection for biotechnological inventions beyond the principal rules of patent law; its main role is to bring long overdue uniformity to the existing national patent rules.
This directive is not a debate over "patenting life". The real area of debate with this directive is over the precise nature and scope of the controls and definitions to be imposed. The directive confirms that man, the human body, or parts of it are not patentable. This is based not only on ethical considerations, but it also flows from the basic principles of patent law, that is to say, that only inventions may be patented, while discoveries cannot.
The reason why an element derived from humans can be patented - such as an element isolated from the body by artificial techniques, is that this may be an invention (provided the product is new, inventive and commercially applicable). For instance, the human body produces interferon naturally; the provision of the ability to produce interferon outside the body in a non-natural fashion, combined with the know-how to use this interferon as a cancer medicine, is not merely a discovery: it is a true invention, which can lead to the patenting of that interferon and the gene that codes for it.
It is important to understand the scope of the directive. Patents do not give rights to the patentee to use their invention. Judgements on how appropriate it may be to use an invention (have to) come from the legislators who impose controls on research and on the exploitation and commercialisation of its results on behalf of society. For this reason patent law as such is not really fit for ethical provisions.
