論TRIPS協定下醫療程序發明之專利適格性

根據「世界貿易組織」（World Trade Organization，簡稱WTO）中「與貿易有關之智慧財產權協定」（Agreement on Trade-Related Aspects of Intellectual Property Rights，簡稱TRIPS協定）第27條第3項第(a)款規定，關於「醫療人類或動物之診斷、治療及手術方法」，「會員國得將該發明之可專利性予以排除」。因此，若一項發明涉及「醫療人類或動物之診斷、治療及手術方法」，亦即「醫療程序」，WTO會員國得選擇是否排除其「專利適格性」。至於藥品、醫療器材、醫療儀器等醫療領域有形的物品發明，以及其他技術領域無形的方法發明，協定並未容許排除專利適格性。然而，隨著醫療領域中科技進展、創新型態演進、產業結構轉變，當初制定此款規定所基於之依據如今仍否存在，值得思考。從而，本論文所欲探討之議題為，此款規定獨獨排除醫療發明中方法發明之專利適格性，是否過於僵化，而有修改之必要。若然，又該如何調整，搭配何種平衡措施，始能兼顧醫療科技之蓬勃發展，與健康需求之滿足。

關鍵字

世界貿易組織；與貿易有關之智慧財產權協定；醫療程序；醫療方法；專利適格性；醫療創新；可近性

並列摘要

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provides inventors incentives so as to promote invention and innovation. Such protection does not extend to all fields of technology, however. Rather, according to Article 27.3(a) of the TRIPS, medical procedure innovation may be excluded from patent eligibility, while medical product innovation and method innovation of other technology fields not. There are certain policy considerations behind this exception indeed, but in light of the trend of new developments in medical technology, one can’t help to wonder if there are better solutions for this multi-faceted issue. Hence this study endeavors to observe the trend of medical procedure innovation, explore its potential implication for TRIPS Article 27.3(a) and evaluate the impact of medical procedure patent on public health, medical industry and other related public interest. The result of this study suggests that under current TRIPS regime of patent rights, which allows excluding patent-eiligibility of medical procedures, the trend of medical technology development will be, and is being, manipulated towards a direction not favorable to public health, which calls for a modification in the TRIPS regime of patent rights.