從比較法建構臺灣專利連結制度

Abstract

近年來，各國為因應經濟全球化，擴大貿易投資，均紛紛積極推動雙邊及複邊自由貿易協定，美國亦持續以自由貿易協定的協商手段將專利連結制度延伸到世界各國。在韓國與美國因簽訂自由貿易協定而將正式實施專利連結制度之際，臺灣不應畫地自限而消極地逃避專利連結制度的立法問題，在面臨美國強權的施壓下，臺灣究竟該如何審視專利連結制度的法理思維和政策思維，正是本文所努力的方向。 美國的專利連結制度有其耐人尋味的法理與政策思維，細部政策間環環相扣，該如何以抽絲剝繭的方式順次解開每個環節，即為本文嘗試以比較法分析各國經驗的首要目標。由於各國現有的法制和藥品生態皆不相同，結果的好壞無法直接作為採納的依據，惟可在各國中找尋與臺灣相似的部分，設定最值得臺灣學習的立法樣本，並以外國經驗作為前車之鑑，透過印證的方式思考其立法思維，以期建構出一套具有國際性又不失本土化的立法政策。

In recent years, to adapt to the globalization of economics and to expand trade and investment, countries are actively promoting bilateral and multilateral Free Trade Agreement. The United States, by way of negotiation through Free Trade Agreement, continues to promulgate the Patent Linkage System to the world. At the moment when Korea is ready to formally adopt the Patent Linkage System due to its Free Trade Agreement with the United States, Taiwan should not limit itself and evade the responsibility of the legislation of the Patent Linkage System. Under the pressure exerted by the United States, this dissertation endeavors to find a perspective through which Taiwan examines the legal and political thinking of the Patent Linkage System. Patent Linkage System has its intriguing legal and political thinking, with each policy deeply entwined with others. Therefore, the primary objective of this dissertation is to, after unraveling and clarifying each policy and its effects, compare and analyze different countries' regulations from a comparative law perspective. Due to the existing differences of legal environments and pharmaceutical markets among nations, the outcome of implementation cannot be the only factor being considered. However, by searching for situations akin to Taiwan's among different countries in the hope that a model could be set up and followed, while at the same time taking other countries’ experiences as lessons, this dissertation aims to, by way of reflecting on different legislative thought, construct an international legislative policy without compromising Taiwan’s local roots.