醫藥衍生物發明之可專利性研究：以已知物質衍生物和活性代謝物為中心

Abstract

近年來藥廠透過延續性專利，以達實質增長專利期間的「長青樹專利」問題，逐漸受到國際重視。由於醫藥產品涉及生命、健康的特殊屬性，使此議題於公平正義外亦負有公共衛生的疑慮。而專利藥廠不當利用專利策略實質延長獨占期間之問題，亦已在我國浮現。本文擬以「已知物質衍生物」及「活性代謝物」為中心，透過對於美國、歐洲、印度等國相關實務判決和理論學說的檢視及討論，探討對於醫藥衍生發明給予專利保護的妥當性，並且建立可專利性之合理判斷標準。作者發現對於不同型態的已知物質衍生物，可專利性的判斷標準必須分別加以細緻化，以便篩檢出各類型之中並未帶來實質技術進步者。並應適度對體外合成、純化態之活性代謝物授予專利。如此除可避免醫藥產業集中心力研發雖有些微改變但是缺乏實質進步的次要技術創新，亦可達到專利制度鼓勵研發之目標。於改善長青樹專利問題外，更能促進專利制度設立意旨之實現。

In recently years, pharmaceutical companies attempt to substantially lengthen the patent life of their brand name drugs through obtaining "secondary patents", and in turn generate the issue of "evergreen patents". In addition to technological innovation and industrial development, pharmaceutical products and patents are closely related to human life and health. That fact further compounds the problem, and evergreen patents in this field have thus aroused intense criticism worldwide. It is noteworthy that the same type of problems has arisen in Taiwan as well. This article critically assesses the patentability of derived composition inventions in the medical and pharmaceutical fields, especially that of the derivations of a known substance and active metabolites. Through careful examination of laws, cases, and theoretical discussions in the U.S., Europe, and India, the authors divide those derivations of various degree of innovation into different categories, and respectively propose an adequate standard of patentability. The authors also suggest that patents of purified active metabolites should be obtained adequately. Under the proposal, this article hopes to respond reasonably to the issue of evergreen patents and realize the aim of the paten laws.