Please use this identifier to cite or link to this item: http://hdl.handle.net/11455/21080
標題: A Review of Article Seventy Six of Patent Law of Taiwan
我國專利法第七十六條立法論上之檢討
作者: 陳憶華
Chen, I-Hua
關鍵字: 強制授權;compulsory licensing;政府使用;醫藥品;與貿易有關之智慧財產權協定;修改與貿易有關之智慧財產權協定議定書;專利濫用;公眾健康;補償金;克流感;產業發展;Government Use;medicine;TRIPs;Protocol Amending the TRIPs Agreement;abuse of patent right;public health;compensation;Tamiflu;development of industry
出版社: 科技法律研究所
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摘要: 
As a member of the WTO, Taiwan's patent system needs to observe TRIPs and the protocols related to the WTO. Nevertheless, both the “Koninklijke Philip CD-R”and“Tamiflu” cases reveal that compulsory licensing of the patent system in Taiwan does not fulfill the principle of TRIPs in the area of patent protection. In CD-R case, the reasons that Taiwan Intellectual Property Office(TIPO) granted a compulsory license to applicant, Gigastorage Crop., not only caused nationwide criticism, but has brought about EU Trade Barrier Regulation investigations. The purpose of this paper is to find a way in which the compulsory licensing system of the Patent Act of Taiwan can come into agreement with TRIPs. In reviewing TRIPs Article 31 and the patent protocols of the WTO, and surveying the legislation of patent use by member governments of the WTO and their internal patent laws, it was found that developed countries that have long histories of patent systems have both incorporated “Government Use” and “Compulsory Licensing” systems in their legislations.
According to TRIPs and the Paris Convention for the Protection of Industrial Property, the implementation of compulsory licensing is only applicable in cases to counterbalance patent abuse when exploration of patent rights in these cases would lead to unfair competition or damaging to social order. Due to the fact that compulsory licensing is related to the rights of private property involving the concept of civil law, it is not appropriate to leave the administrative bureau such as TIPO to make the final decision. This thesis suggests that the government should consider having the courts decide whether or not compulsory licensing cases should be put on trial for approval. This would restrain patent abuse and keep compulsory licensing fair and balanced. While researching answers to “The Protocol Amending the TRIPs Agreement of the WTO”, it became evident that the Taiwan Intellectual Property Office amended the Draft of the Patent Act Article 76-1 and 76-2. In order to present a workable suggestion for compulsory licensing, review of law-making as well as policy suggestions were made to amend the Draft and suggest amending the relevant articles so as to bring future policy concerning pharmaceuticals for use in national emergency situations in line with the WTO protocols.
The design of the legislation for “Government Use” and compulsory licensing enables the government to reconsider the following issues: the balance between the public interest and individual property rights, the scale of compensation, the definition of emergency, the need for medical support in national emergencies, and use for military and national defense purposes. Furthermore, export of generic pharmaceuticals produced under compulsory licensing for humanitarian ends and the impact on the local industry in Taiwan with respect to new drug access and the possible deferment of foreign investment are critical considerations to be addressed.
After finding the existing problems and flaws in the Patent Act and the Draft, this paper makes some recommendations regarding “Government Use” and compulsory licensing, with the desire to present an equitable patent system.

我國為WTO之會員,專利制度需遵守TRIPs與相關WTO協定,惟我國兩例強制授權案「飛利浦CD-R案」與「克流感案」,接續突顯我國強制授權制度無法落實TRIPs對專利權保護之精神,不僅引發國際批評,更使我國面臨歐盟之貿易障礙調查。為檢視我國專利強制授權是否符合TRIPs之規定,本文藉由分析TRIPs article 31、WTO相關協定與參酌部份WTO會員內國之專利制度後,發現專利制度歷史較悠久之國家,於專利法中皆有政府使用與強制授權兩種制度存在,以強制授權解釋TRIPs article 31為較狹隘之概念,亦發現我國專利法疏於規範國際公約對於強制授權之使用與限制規定。
於政府使用部份,本文認為政府為公共利益使用私人發明之目的,為國家徵用之概念,與一般強制授權作為糾正專利濫用之目的不同,於參照各國立法例後,提出增訂政府使用條款之建議。此外根據TRIPs、巴黎公約之解釋,可知強制授權之使用僅限於糾正專利濫用之情形。由於強制授權涉及政府對人民財產權之拘束,應參酌大陸法系國家之規定,建議由法院與公平交易委員會作為強制授權之審理與核准機關,以限縮行政機關之裁量權,維護強制授權之公正性。此外,適逢智慧財產局因應修改與貿易有關之智慧財產權協定議定書提出專利法草案,為求整合本文脈絡,亦對我國作為進口國之問題,與智慧財產局所提出之專利法修法草案第76條之1與76條進行評析。
政府使用與強制授權制度之立法設計與實施,涉及之層面甚廣,規範涉及政府對公共利益維護之義務、人民財產權之保障與補償金給付、緊急情況之國民用藥需求、為軍事與國防安全目使用私人專利權、為人道援助之目的強制授權出口醫藥品,更間接影響我國產業之發展、人民獲得新藥之途徑與外資投資研發之意願。在釐清並整合我國制度之現存問題,並評估各種可能之影響後,本文對政府使用、強制授權與修正草案提出修正建議,以期作為日後修法之參考。
URI: http://hdl.handle.net/11455/21080
Appears in Collections:法律學系

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