從比較法觀點建構台灣專利連結制度

Discuss and Establish Taiwan Patent Linkage System from Comparative Law Perspective

蕭郁溏 ； 陳鋕雄

《萬國法律》 200期 (2015/04) Pp. 92-110

摘要

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，正是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台灣相似的部分，設定最值得台灣學習的立法樣本，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。

關鍵字

學名藥 ； 簡式新藥申請 ； 專利連結

並列摘要

Constructing Taiwan's Patent Linkage System from a Comparative Law Perspective Patent Linkage System has its intriguing legal and policy thinking, with each policy deeply entwined with others. Therefore, the primary objective of this paper is to, after unraveling and clarifying each policy and its effects, compare and analyze different countries' regulation s 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 modal could be set up and followed, while at the same time taking other countries' experiences as lessons, this paper aims to, by way of reflecting on different legislative thought, construct an international legislative policy without compromising Taiwan's local roots.

並列關鍵字

Hatch-Waxman Act ； Generics ； Abbre viated New Drug Application ； Patent Linkage