論美國專利連結制度於我國實行之妥適性

Patent Linkage in Generic Pharmaceutical Marketing approval- the Propriety of Adopting Such Measure in Taiwan

陳蔚奇(Wei-Chi Chen)

指導教授 ： 倪貴榮 ； 王立達

國立交通大學/管理學院/科技法律研究所/碩士(2010年)

https://doi.org/10.6842/NCTU.2010.00194

摘要

美國作為世界上最具影響力之國家，其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作為核心架構。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，最後透過實證研究之方法，訪談國內實務界、製藥界之人士，了解我國學名藥產業以及國外藥廠對於此一議題之立場以及支持或反對理由，希望本文能對於探討美國專利連結引進我國妥當與否之相關議題作出具體貢獻。

關鍵字

學名藥 ； 專利連結 ； 原廠藥

並列摘要

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. Besides, in order to get fresher and more substantial suggestions concerning whether or not to establish such measure in Taiwan, the author also interviewed several attorneys, representatives of local Pharmaceutical industry and Big Pharma, and tried to analyze if the patent Linkage is suitable for our industrial environment. Even if Taiwanese government finally chooses to adopt patent linkage, these injurious side measures should not be introduced altogether.

並列關鍵字

Generic drugs ； Brand-name drugs ； Hatch-Waxman Act ； Patent linkage

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