Kējì Fǎxué Pínglùn (Jun 2004)
從TRIPS 協定與公眾健康爭議論專利強制授權之功能與侷限 Functions and Restraints of Compulsory Licensing: Perspective from TRIPS Agreement and Public Health
Abstract
對於專利強制授權(compulsory licensing)制度之實際功能,以往研究文獻大致有兩種看法,其一是認為強制授權制度雖被巴黎公約與TRIPS 協定所承認,並為世界各國普遍採行,但是強制授權之實際案例在各國均甚罕見,此一制度的實際功能如何,值得懷疑。其二則認為各國強制授權實際案例雖不甚多,但是強制授權制度之存在本身,即已提供國內廠商進行授權談判時之有力籌碼,其功能不可忽視。這兩種看法雖然各有所本,但是都未能提出可資驗證的直接論據。而隨著致命的愛滋病在開發中國家迅速蔓延,以及911 事件後恐怖份子對美國的炭疽熱攻擊,在TRIPS 協定之下,各國政府可否以強制授權迫使各大藥廠大幅降價,讓廣大民眾得以使用專利藥品,以資有效維護公眾健康與人民生命安全,一時之間成為國際智慧財產法上熱門爭議問題。本文試圖從此項爭議之事實發展與相關論述中,分析強制授權之制度功能與實際侷限,以拓展對該制度研究之廣度與深度。 In the academia there are generally two positions about the practical function of patent compulsory licensing. In light of very few cases of compulsory licensing seen in the world, even though it is acknowledged both by the Paris Convention and the TRIPS Agreement, some commentators are skeptical of its function in the real life. In contrast, the other side holds that even if the real cases of compulsory licensing are scarce, the very existence of this regime can nonetheless afford a useful leverage for domestic industries in the licensing negotiation with foreign patent owners. Though both sides have their factual bases, they still fail to put forth convincing evidences and concrete reasoning for their positions. However, the wide spread of HIV/AIDS these years in Africa and Anthrax attack in the U.S. after September 11 have recently drawn people’s attention to this issue. It has been hotly discussed and debated that whether the national governments, under the TRIPS Agreement, can exert the rule of compulsory licensing to force multinational pharmaceutical corporations to cut back their drug prices, so as to make certain drugs, which are essential for public health, accessible to the general public. This new development provides an excellent opportunity to review the functions and limitations of the compulsory licensing regime. This article will make use of the real situations and arguments emerging in HIV/AIDS and Anthrax cases to analyze this issue more thoroughly, and thereby to formulate and argue for some specific findings on the topic.