TRIPS협정상 의약품 특허의 강제실시에 대한 최근 동향

Compulsory licensing is an authorization of government for a third party to produce the patented product or process without the consent of the patent owner. The WTO Member countries have a right of compulsory licensing with some conditions under the TRIPS agreement. It is usually related with pharmaceuticals but it could also apply to patents in any field. The TRIPS agreement introduced some kind of flexibilities to allow the WTO Member countries to adopt measures to protect public health and nutrition. These flexibilities have been supported and clarified by the Doha Declaration on the TRIPS Agreement and Public Health. In addition, the Decision of 30 August 2003 on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health decided on the waives of article 31(f),(h) of the TRIPS Agreement which had been legal obstacles in enjoying the right of compulsory licensing. The examples of the countries who implemented compulsory licensing such as Brazil, Thailand, Malaysia, Taiwan expose some practical problems in enforcing compulsory licensing. Those practical problems need to be considered in deciding on whether to practice a right of compulsory licensing because compulsory licensing is not a panacea. For the moment, the matter of finding a balance between the protection of intellectual property rights and public health policy is up to the WTO Member countries who consider compulsory licensing.