論醫藥品專利權之保護與限制 —以法律經濟分析為中心

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Please use this identifier to cite or link to this item: https://irlib.pccu.edu.tw/handle/987654321/52670

Title:	論醫藥品專利權之保護與限制 —以法律經濟分析為中心 Research on the Protection and Restriction of Pharmaceutical Patents - Focused on Economic Analysis of Law
Authors:	簡陳由
Contributors:	法律學系
Keywords:	醫藥品專利權專利藥學名藥 TRIPS協定法律經濟分析 pharmaceutical patent branded drugs generic drug TRIPS agreement economic analysis of Law
Date:	2022
Issue Date:	2023-07-06 09:47:28 (UTC+8)
Abstract:	醫藥品專利權屬智慧財產權，在製藥產業，向來存在二項利益衝突，其一是專利藥與學名藥之間的產業競爭衝突；其二是醫藥品專利權保護與公共健康之間的私益與公益衝突，亦即醫藥品專利權保護與限制之間的法律衝突，此一衝突伴隨國際經濟貿易之發展日漸增多且趨於複雜。本研究旨在以法律經濟分析為研究取向，討論醫藥品專利權制度存在原因、對製藥產業與公共健康的影響，研擬如何達成醫藥品專利權保護與限制之間的調和與平衡。所採用之研究方法為法律經濟分析法、比較研究法、文獻分析法。研究發現：一、醫藥品專利權保護(專利權延長、資料專屬保護、專利連結)的經濟分析，對於達成保障專利藥廠私益與維護公共利益間，均具有正面之助益。二、醫藥品專利權限制(強制授權、研究及試驗免責、真品平行輸入)的經濟分析，其中成本效益分析即需在公益與私益之間達成平衡點。三、應建構最有利於本國的醫藥品專利權保護制度。依據研究結論提出研究建議：醫藥品專利權擁有現行法專利延長、資料專屬保護及專利連結制度，讓專利藥品價格因專利藥廠受醫藥品專利權保護制度而居高不下，卻為不爭的事實。本文對此提出改善措施，為平穩專利藥價，避免專利藥廠在藥品專利延長期間以高價壟斷藥品市場，造成專利藥廠獲取極高利潤，則用藥民眾負擔極高成本之失衡現象，必要時政府應採取相當程度介入管控之措施，除對專利藥廠於專利延長期間增加稅收外，更應對專利藥廠於藥品專利延長期間內有適度之監督機制，以防止專利藥廠藉由醫藥品專利延長期間之保護而破壞市場交易機制，造成用藥民眾負擔極高購藥費用，導致用藥民眾負擔高額的交易成本，終致藥品交易市場失控的場面。 Pharmaceutical patents are a kind of intellectual property right. The purpose of this study is to take economic analysis of Law as the research orientation, to discuss the reasons for the existence of the pharmaceutical patents , its impact on the pharmaceutical industry and public health, to develop how to achieve a reconciliation and balance between the protection and restriction of pharmaceutical patents. The research methods are economic analysis of Law, comparative research and literature analysis. The research findings: 1. The economic analysis of pharmaceutical patents protection (patent term extension, data exclusivity, patent linkage) is of positive help in achieving the protection of the private interests of patented pharmaceutical companies and the maintenance of public interests. 2. Economic analysis of pharmaceutical patents restrictions (compulsory license, exemption of research and experimentation, the parallel importation of genuine goods), and cost-benefit analysis that requires a balance between public and private interests. 3. It is necessary to construct a pharmaceutical patents protection system that is most beneficial to our country. Based on the research conclusions, a research suggestion is put forward: the patent rights of pharmaceuticals have the patent extension of the current law, the exclusive protection of data, and the patent linkage system. It is an indisputable fact that the price of patented drugs remains high because patented pharmaceutical companies are protected by the system of patent rights of pharmaceuticals. This paper proposes improvement measures to stabilize the price of patented drugs and avoid the monopoly of patented pharmaceutical companies at high prices during the period of drug patent extension. The government should take measures to intervene in control to a certain extent. In addition to increasing taxes on patented pharmaceutical companies during the patent extension period, they should also have an appropriate supervision mechanism for patented pharmaceutical companies during the drug patent extension period, so as to prevent patented pharmaceutical companies from exploiting drug patents. The extended period of protection destroys the market transaction mechanism, causing the drug users to bear extremely high drug purchase costs, resulting in high transaction costs for the drug users, and eventually leading to a situation where the drug trading market is out of control.
Appears in Collections:	[Department of Law & Graduate Institute of Law ] thesis

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