歐盟生物科技發明指令 98/44/EG 的道德論辯

The Moral Arguments under the “Directive 98/44/EC on the Legal Protection of Biotechnological Inventions”

歐盟生物科技發明指令98/44/EG存有道德條款。是否應將「公序良俗」條款納入於專利法中，迭有正反意見之爭論。繼而引發歐盟生物科技專利指令第六條之「公序良俗條款」是否適當性之討論，且該條款被怪罪認為，將使得歐洲與美國、日本在生物科技的競爭上處於不利地位之重要因素。由幾個與道德相關之爭議案例，如哈佛鼠案、愛丁堡案及H2-Relaxin案等，可以得知「公序良俗條款」之價值判斷決定否授予專利，其嚴重激辯之程度。美國與歐洲的「公序良俗條款」之不同觀點，在本文也有深入之比較。我國專利法以及現行專利審查基準之二者本質上涉及到立法行為的「法律保留原則」以及「行政解釋界限」之問題發生：（一）、專利法公序良俗條款之法律明確性問題、（二）、專利審查基準之法律保留問題、（三）、專利審查基準（行政命令界限）不得增設法律所無的限制、（四）、法律授權明確性問題。本文分別針對上述問題，詳細論述之，並對我國專利法制的「公序良俗條款」，提出其修正建議。

“Directive 98/44/EC on the legal protection of biotechnological inventions」(Biopatent-Directive) is now the only statute of European Union protecting the intellectual property and legislating particularly and solely on ethical issue regarding biotechnological inventions on earth; it builds the legislative model for the protection of intellectual property on biotechnology. Therefore, it’s necessary for us to study「Directive 98/44/EC on the legal protection of biotechnological inventions”. The Meanings and Arguments of “Public Order or Morality Clause” on the of “Directive 98/44/EC on the legal protection of biotechnological inventions” not only contribute the understanding of it to our industry, government and research institution but also provides the academic circle with the international reference on interest value. Moreover, the fruition of this analysis is the important basis that we can take to directly participate in the international organization.