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Q178 draft report.pdf - SFIR

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The Swedish Group believes that the reason behind this exemption is<br />

the idea that the ethical and moral principles recognised of the<br />

countries in Europe should be prevalent and supplement the standard<br />

legal examinations in patent law. The provision is only limited to<br />

inventions of such a nature that they cannot at all be used in a moral or<br />

legal way. Within the field of biotechnology, it has been emphasised<br />

that this rule should be interpreted as to protect human, animal or plant<br />

life, for example to prevent the patenting of processes whose use<br />

would offend against human dignity.<br />

* Plant or animal varieties.<br />

* Essentially biological processes for the production of plants of<br />

animals.<br />

The Swedish Group understands that the exclusion of plant and animal<br />

varieties as well as essentially biological processes for the production<br />

of plants and animals from patentability originates from the historical<br />

division between macro- and microbiology in patent law, and the<br />

development of a separate sui generis protection system for plant<br />

varieties as products of traditional breeding processes (The Plant<br />

Variety Protection System). At the time of enactment of the EPC, a<br />

distinction between macro- and microbiology was quite natural.<br />

Microbiological processes such as fermentation had been used in<br />

industry for a long time, and the knowledge of microbiological<br />

substances such as for example antibiotics was nothing new. Plants<br />

and animals were traditionally bred by crossing and selection.<br />

The Swedish Group believes that the advent of biotechnology research<br />

has changed the prerequisites for this exclusion. Biotechnology<br />

processes are from a patent law perspective regarded as technical,<br />

and thereby possible to patent, notwithstanding the fact that naturally<br />

occurring material and processes are being used. Thus, the distinction<br />

between macro- and microbiology is no longer upheld, resulting in<br />

historical exclusions with no real basis in a modern patent system.<br />

3. What is the effect of this definition on activities concerning<br />

patent protection?<br />

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