| 關 鍵 詞： |
學名藥；專利連結；藥品專利；上市審查 |
| 中文摘要： |
作為世界上最具影響力之國家，美國不斷透過貿易協商與制裁之手段，希望延伸其制度理念至他國，藉以降低貿易障礙並保護本土產業。近年來該國亟欲引介「專利連結」制度進入台灣，即為一顯例。所謂專利連結制度，係指學名藥上市審查或政府之藥品定價與保險給付決定，與其是否侵害原廠藥品專利連結在一起。本文擬針對此一主題，探討美國專利連結制度所包含的多重複雜環節，依其至今實際施行狀況，是否具有充分的正當化基礎，可以解決現實問題並導引國內產業蓬勃發展。本文擬透過文獻研究，就美國專利連結之制度結構與配套措施，進行通盤檢討並評估其立法缺陷，同時援引世界貿易組織與美國實務案例加以印證，藉以釐清專利連結制度之真正核心要素，並且指出美國現制下包含過多保護原廠專利之週邊措施，所造成的可觀負面影響。
|
| 英文關鍵詞： |
ageneric drugs；brand-name drugs；Hatch-Waxman Act；pharmaceutical patents；marketing approvaln |
| 英文摘要： |
As one of the most powerful countries in the world, the United States has been constantly promoting its legislations to countries around the world through trade negotiation and threat to sanction, for the purposes of abating trade barriers and pursuing its own interest. In recent years, for instance, the United States has been trying zealously to introduce the “patent linkage” system into Taiwan. “Patent linkage” means that the marketing approval of generic drugs or the payment of medical insurance are “linked” to the judgment of whether the generics infringe a valid patent held by a brand-name pharmaceutical company on the same type of drugs or not. Focusing on this issue, the authors firstly makes further discussion into the complexity of the patent linkage system in order to examine whether the system is fully justifiable, and try to evaluate whether it in reality resolves the problems it was set to settle and facilitates the development of domestic pharmaceutical industry. Secondly, this article evaluates thoroughly the pros and cons of the existing patent linkage system in the U.S. by means of literature review and case study. The authors find that most of the negative effects that the system now brings about result from its pro-brandname measures, which not only stifle generics competition and accessibility in the pharmaceutical market but also are not essential for the system to fulfill its mandate. Even if Taiwanese government finally chooses to adopt patent linkage, these injurious side measures should not be introduced altogether.
|
| 目 次： |
壹、緒言：台美經貿協商重要議題
貳、美國專利連結制度之起源、發展與現況分析
一、 1984 年立法前美國製藥業亟欲解決問題
二、 1984 年 HWA 法案之內容
三、 HWA 立法後運作狀況與問題
四、 2003 年 HWA 之修正以及仍待解決之問題
參、從實際案例看現行美國專利連結制度之缺陷
一、 GlaxoSmithKline v. Apotex (Paxil®)
二、 Pfizer, Inc. v. Ranbaxy Laboratories, Limited 案(Lipitor®)
三、 US. v. Bristol-Myers Squibb Co. (antitrust/BuSpar®)
四、 In re Ciprofloxacin Hydrochloride Antitrust Litigation (Cipro®)
肆、回歸專利連結之存立基礎與核心制度需求
一、專利連結制度之建制目的
二、專利連結之真正核心要素－通知
三、學名藥是否侵害專利並未涉及藥政機關職掌任務
四、擴張之專利連結是否給予專利權人過度保護？
伍、美國現行制度設計治絲益棼
一、 FDA 是否審查橘皮書登載專利陷入兩難
二、 30 個月停審期間欠缺正當性基礎
三、 180 天市場獨家銷售權造成錯誤誘因
陸、結論與本土建議
|
| 相關法條： |
 |
| 相關判解： |
|
| 相關函釋： |
|
| 相關論著： |
|