論我國醫藥品專利強制授權法制的發展

從20世紀初到今日，產業技術發展日新月異，其法令政策亦隨局勢變更而有所增減，與人類切身的醫學領域更是如此，我國歷年專利法修訂過程中，對於醫藥品專利之相關規定，曾引起不少討論與爭議，特別是強制授權部分。然而，臺灣專利法已於2011年11月29日完成修法，為歷年修法幅度最大一次，在強制授權部分亦有很大變革，我國政府分別從杜哈宣言、TRIPs協定、巴黎公約等方面從中參考，新增為協助無製藥能力或製藥能力不足的國家取得所需之專利藥品法條，使其適用至本國法律，以人道角度解決人民之公共衛生危機。因此我們有必要對強制授權相關法制之演變，分別針對怠於實施或未適當實施、國家緊急危難或其他緊急情況、以合理之商業條件在相當期間內仍不能協議授權、增進公益之非營利實施、再發明專利之實施、人道醫藥品專利之強制授權事由，做一次統整性之整理。敝人嘗試將我國醫藥品專利強制授權之修法歷史，包含繼受國外法部份，以及受國際組織規範改變國內法之影響，作理論與實務議題探討；為深入了解專利法之強制授權演變發展，將從立法院會議記錄、智慧局機關所針對專利強制授權制度舉辦的公聽會或諮詢會議資料，以及期刊、研討會論文之中，將法條之立法理由與修正目的，尋找行政機關人員、學者專家、專利權人等各界意見，並以坊間學者專家的書籍理論為輔，並以克流感強制授權案件進行分析，亦討論國際組織，如WTO、WIPO，及相關國際規範，包括巴黎公約、與貿易有關智慧財產權協定對國內法之影響，嘗試將醫藥品專利強制授權制度作深入的研究。本文最後將對公眾健康之公益與專利權私益利弊作其分析，試著從繁雜的專利制度中，找出橫平雙方利益的方法。

關鍵字

強制授權；特許實施；專利修正案；醫藥品專利；醫藥品強制授權；健康權； TRIPs協定； TRIPs協定與公共健康宣言；杜哈部長會議

並列摘要

From the early 20th century, the development of industrial technology has impacted societal laws and policies, increasing or decreasing in their impact in tandem with the situation. Especially in the field of medicine, the process of revision for patent laws has changed greatly over the years. The relevant provisions of patent pharmaceuticals have caused a lot of discussion and controversy, particularly the compulsory licensing section. Taiwan's Patent Laws were completed on November 29th, 2011. To amend the laws for making amendments over the years, there have been large parts of the compulsory licensing that has changed respectively from the aspects found in the Doha Declaration on the government, and the TRIPs Agreement. It referred to the Paris Convention and other sources to assist non-national pharmaceuticals lacking the ability to obtain the necessary pharmaceutical patent medicine statutes that apply to national laws. When looking at the health crisis from a humanitarian point of view, we need to focus on the evolution of the relevant legal authority. For example, in the compulsory licensing cases of failure to work or not appropriated implementation, a national emergency or other circumstances of extreme urgency, the proposed user has made efforts to obtain authorization, the public non-commercial use, authorization for the second patent and humane medical Drug Product. This research attempted to find compulsory licensing of patented pharmaceuticals to amend the law of history, including the following parts by foreign laws, as well as by the impact of changes in international organizational norms of domestic law. This study has further attempted to gain an understanding of the evolution of compulsory licensing of patent laws, Information came from Legislative Advisory Council meetings that the Intelligence Bureau held for the patent compulsory licensing system, as well as from journals, conference papers, the legist statute with amendments aim to find executive officer, scholars and experts, the patentees and other sectors’ opinions and theories from the literature, as well as that supplemented by scholars and experts opinions. Moreover, we looked at the case of compulsory licensing for Tamiflu, and also at international organizations such as the WTO, WIPO, and relevant international norms, including the Paris Convention, and the impact of trade agreements on intellectual property rights of domestic law, in order to do an in-depth report on pharmaceutical patent compulsory licensing systems. Finally, we analyze public health care patents, both public and privates ones, to assess the advantages and disadvantages, and to attempt to simplify the situation, as well as to identify the important aspects.

並列關鍵字

Compulsory License ； Medical Drug Product Patent ； Medical Drug Product Patent for Compulsory License ； Health Care ； Trade-Related Aspects of Intellectual Property Rights ； Doha Declaration on the TRIPs Agreement and Public Health ； Doha Ministerial Conference

參考文獻

洪千雯（2006）。〈以WTO規範為基礎探討TRIPS協定關於國家緊急情況的認定機制-從我國克流感專利強制授權案出發〉，《臺灣國際法季刊》，第4第1期，頁159-207。（Chien-Wen Hung [2006]. Probing into the Regulation Regarding the National Emergency of the TRIPS Agreement under the WTO Framework-With Special Referece to the Compulsory Licensing of “Tamiflu” in Taiwan. Taiwan International Law Quarterly, 4[1], 159-207.）

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論我國醫藥品專利強制授權法制的發展

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