Q178 draft report.pdf - SFIR

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6 The Swedish Group believes that the reason behind this exemption is the idea that the ethical and moral principles recognised of the countries in Europe should be prevalent and supplement the standard legal examinations in patent law. The provision is only limited to inventions of such a nature that they cannot at all be used in a moral or legal way. Within the field of biotechnology, it has been emphasised that this rule should be interpreted as to protect human, animal or plant life, for example to prevent the patenting of processes whose use would offend against human dignity. * Plant or animal varieties. * Essentially biological processes for the production of plants of animals. The Swedish Group understands that the exclusion of plant and animal varieties as well as essentially biological processes for the production of plants and animals from patentability originates from the historical division between macro- and microbiology in patent law, and the development of a separate sui generis protection system for plant varieties as products of traditional breeding processes (The Plant Variety Protection System). At the time of enactment of the EPC, a distinction between macro- and microbiology was quite natural. Microbiological processes such as fermentation had been used in industry for a long time, and the knowledge of microbiological substances such as for example antibiotics was nothing new. Plants and animals were traditionally bred by crossing and selection. The Swedish Group believes that the advent of biotechnology research has changed the prerequisites for this exclusion. Biotechnology processes are from a patent law perspective regarded as technical, and thereby possible to patent, notwithstanding the fact that naturally occurring material and processes are being used. Thus, the distinction between macro- and microbiology is no longer upheld, resulting in historical exclusions with no real basis in a modern patent system. 3. What is the effect of this definition on activities concerning patent protection? 6
7 3.1 Is the scope of protection sufficient or does it lack opportunities for further protection? This includes economic aspects for the users as well as for the public in general regarding various technologies. In the opinion of the Swedish Group, the patent system is flexible enough to operate foreseeable needs for further protection, i.e., providing patents to inventions that may be developed in the future within existing or new fields of technology. The Swedish Group does not believe that the field of patentable subject matter is overly broad, provided that the patentability criteria are strictly applied and national courts interpret the claims consistently to commensurate with the disclosure and not including prior art. In Sweden, the Group believes the balance between protecting the inventor without impeding the technical development, e.g. freedom to operate, to be appropriate. 3.2 If the scope of protection is not sufficient, how does this affect the users’ policy on patenting? Does this also have an impact on research policy? As indicated supra, the Swedish Group believes the balance for patent protection with respect to patentable subject matter to be appropriate. 3.3 What are obstacles from political or social sources outside the purely legal field which play a role in research and patenting? With respect to, in particular, life sciences, the Swedish Group believes that the possibility for patent protection is necessary to foster research and development by providing return for large investments. That being said, public perceptions of patenting, specifically in the biotech field with issues such as gene patents, receive unfavorable response. Also within the research community itself, specifically from researchers conducting much of the basic research at universities and 7
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Q178 draft report.pdf - SFIR

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