생명공학적 발명의 보호와 한계 - 유럽연합의 생명공학지침(Directive 98/44/EC)을 중심으로 -

Directive 98/44/EC was adopted after a long and constructive debate lasting about ten years in both the Council and the European Parliament. During those negotiations, it emerged as a fact that biotechnological inventions are a sector in full expansion: new techniques of great promise for cures and foodstuffs are becoming established very rapidly, and the European legislator considered it essential not to hamper their development. However, their was a need to establish a sound legal framework which allowed European businesses to develop and market the products and processes deriving from genetic engineering. The Directive distinguishes between plant and animals which are patentable and plant and animals varieties which are not(Art. 4). The reason for this differentiation lies in the means of achieving the product concerned: a plant or animal variety is generally obtained by essentially biological processes(sexual reproduction observable in nature), while transgenic plants and animals are obtained through non-biological processes forming part of genetic engineering. The human body, at the various stages of its formation and development, is not patentable, as it involves a simple discovery. The same applies to the simple decoding of one of its elements. This exclusion also covers the discovery of a sequence or partial sequence of a gene. However, an element isolated from the human body, including a sequence or partial sequence of a gene, by techniques of identification, purification, characterisation and multiplication, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. This type of invention, which is eligible for patent protection, must nevertheless fulfil the classic conditions for patentability, i.e. novelty, inventive step and industrial application.