1994년 무역관련 지적재산권에 관한 협정 [Agreement on Trade-Related Aspects of Intellectual Property Rights (이하‘TRIPs협정’)] 하에서의 강화된 특허보호가 세계무역기구[World Trade Organization (이하‘WTO’)] 회원국의 공중보건보호를 취하는 것을 방해하지 않는 것으로 TRIPs협정에서는 세가지 유형의 특허규정1)을 두고 있다. 그런데 문제는 이 조항들이 상당히 간략하고 애매모호하게 규정되었다는 점이다. 조약법에 관한 비엔나협약 [Vienna Convention on the Law of Treaties(이하‘VCLT’)] 제31조와 제32조에 비추어 그 의미를 해석하면 다음과 같다. TRIPs협정 제27.2조 하에서 WTO 회원국은 ‘공공질서’또는‘공서양속’에 관한 자국의 정의에 따라 특정종류의 의약품을 특허대상으로부터 일괄적으로 제외할 수 있으나, 의약품의 가격이 높다는 이유는 특허대상 제외의 정당한 사유가 되지 못한다. 또한 개인적, 학술적 그리고 실험적 용도로 이용하는 경우‘공공질서 또는 공서양속의 보호’에 위배되지 않는 발명에 대해서는 WTO 회원국은 특허대상에서 제외할 수 없다. TRIPs협정 제27.3조 (a)호 하에서 기존의 물질에 대한 새로운 치료방법, 유전자 치료방법의 특허 대상으로부터 제외여부는 WTO 회원국의 재량권에 속하는 사항이다. TRIPs협정 제27.3조 (b)호 하에서 특허신청 시 유전자원의 출처공개 조치는 특허신청 허여에 있어서 필수요건으로 요구되어서는 아니 된다. TRIPs협정 제30조에서는 허여된 권리에 대한 예외를 규정하고 있다. 특허권자의 배타적인 권리에 대한 예외조치는 TRIPs협정 제30조의 3단계 요건을 만족하여야 한다. 첫 요건인‘제한된’은“ 범위가 한정된”의 의미이다. 두 번째 요건은‘통상적인 이용에 불합리하게 저촉되지 아니’하여야 한다. ‘불합리한 저촉’에 대한 해석에 있어서 각 국가는 특허권자의 배타적인 권리보호에 대한 서로 다른 철학을 가지고 있다는 점을 염두에 두어야 한다. TRIPs협정 제30조에서의 세 번째 요건은‘제3자의 정당한 이익을 고려’한 특허권자의‘정당한 이익을 불합리하게 저해해서는 아니 된다.’는 것이다. 동 조항에서의‘특허권자의 정당한 이익’은 특허권자의‘법적인 이익’보다는 더 넓은 의미이며, ‘제3자의 정당한 이익’은 공중의 의약품에 대한 접근의 권리를 포함하는 이익이다. 강제실시에 대하여 규정한 TRIPs협정 제31조를 살펴보면 강제실시 조치를 취함에 있어서 공중보건위기와 관련되는 질병은 만성병일 수 있다. TRIPs협정 제31조는 강제실시 허여 이유에 대하여 제한하지 않는다. 강제실시 협상에 실패한 동일한 특허대상에 대하여 강제실시를 허여한다면 사용자와 특허권자사이의 서한이나 연락 등을 참조하여 사안에 따라서는 강제실시 사용예정자의 사전협상 의무는 면제될 수 있다고 본다. TRIPs협정 제31조 (h)항에서의‘승인의 경제적 가치를 고려한 적절한 보상’에 있어서 WTO 회원국의 동 조항에 대한 신축적인 이행이 가능하다. 공중의 의약품에 대한 접근을 보장하는데 있어서 상당히 중요한 조치임에도 불구하고 기존의 TRIPs협정 특허제도에서 허용되지 않는 공중보건보호 조치는 TRIPs협정 특허규정에 대한 해석이 아니라 개정작업을 통하여서만 그 정당성이 보장된다.

More than a decade after coming into effect, the Agreement on Trade-Related Aspects ofIntellectual Property Rights (“TRIPS Agreement”) remains a controversial but forceful legacy ofthe Uruguay Round Trade Agreements. But the ambiguous patent provisions which are potentiallysubject to diverging interpretations limit WTO Member’s ability to reach expansive proprietaryinterests concerning the protection of public health under TRIPs Agreement parachute. Thisreflects the absence of consensus among GATT Contracting Parties during the Uruguay Round.And the failure of reaching a consensus in detail is now putting pressure on the WTO Members’sovereignty to promote accessibility of medicines of public. The WTO dispute settlement process arguably should have been the forum for resolving thepernicious debates about the interpretation of patent provisions of TRIPs Agreement in relation tothe protection of public health. To this end, WTO panels and Appellate Body have applied theVienna Convention on the Law of Treaties (“VCLT”) to the interpretation of covered agreementsof WTO. This article starts by briefly introducing problems which are raised in the accessibility ofmedicines of public. The conclusion of the TRIPs Agreement in 1994 represented drastic changesin international patent system in two respects. First, TRIPs Agreement is subject to the bindingWTO dispute settlement. Second, the WTO Members have to implement minimum standard whichis required by TRIPs Agreement. As a result some WTO Members can not afford the high pricesof the patented drugs and the measures they taken for the protection of public health are alleged tobe violated the patent provisions from other WTO Members. The answer to that issue can not besolved without reviewing the interpretation rules of VCLT Article 31 and 32. Part III examines the meaning of Article 31 and 32 of VCLT. I discuss the application of theVCLT Article 31 and 32 in GATT/WTO jurisprudence which can be instructive to panels and theAppellate Body’s interpretation of patent provisions. According to the research mentioned abovethis chapter also presents the interpretation model which is specifically related to patent provisions. From Part IV to Part VI, I present the substantive interpretation of patent provisions in light ofthe protection of public health. Part IV examines the exclusions to patentability provisions. This Part is divided in three parts.The first part focuses on the Article 27.2 of TRIPs Agreement which deals with possible exclusion from the patentability to ‘protect human life or health’. The measures taken under this Article haveto satisfy four conditions. First, non-patentability can only be established if the ‘commercialexploitation of the invention is prevented’. Second, the purpose is to ‘protect ordre public ormorality’. Third, the measure is ‘necessary’. Finally, Domestic legal prohibition unrelated to ordrepublic or morality would not be of sufficient entity to exclude patent protection altogether. I analyzethe meaning of the four conditions and the relationship among them separately. The second partdeals with Article 27.3(a). The Article 27.3(a) provides exclusions with regard to therapeutic andsurgical methods. This provision is analyzed that non-patentability of methods would not affect thepatentability of equipments and substances. The third part covers the Article 27.3(b). The Article27.3(b) is the single provision in the whole TRIPs Agreement which is subject to an early revision.I introduce the main arguments concerning this provision among WTO Members. In addition to thisthe legitimacy of measures which was taken by some WTO members in order to protect geneticresources and share interests of the exploitation for plant-derived drugs is analyzed under theTRIPs patent regime. In Part V, the article examines the exception provision to the rights conferred. WTO Membersneed to comply with three conditions in order to take measures under the Article 30 of TRIPsAgreement. The first condition to be met is that the exception must be ‘limited’. The secondcondition is that the exception should not ‘unreasonably conflict with the normal exploitation’of thepatent. The third one is that the exception does ‘not unreasonably prejudice the legitimate interestsof the patent owner’and ‘takes account of the legitimate interests of third parties.’I review andinterpret the ordinary meaning of these three conditions. The interpretation is combined with theanalysis of panel’s decision in Canada-Pharmaceutical Patent Case. I conclude that the panel in thatcase failed to recognize the legitimate interests of third parties and interpreted the Article 30 for theprotection of IP rights holders’perspective. I also briefly review the relationship between the non-discrimination clause of the Article 27.1 and Article 30. I conclude that Article 30 is not an“absolute”exception provision and the measures taken under that provision should also observethe non-discrimination requirement of Article 27.1. Part VI analyzes the legal requirements involved Article 31. Article 31 is one of the mostcontroversial provisions among WTO Members concerning its importance to the pharmaceuticalcompanies’interests and promotion of the accessibility of public to medicines. The compulsorylicense could be used as a means for reducing some of the adverse costs of the patent system, butthat measure should be taken in accordance with the process and conditions listed under the TRIPsAgreement. I review three of the most controversial conditions and process of Article 31- grantingof compulsory license measures in case of insufficient work of patent, national emergency andpublic non-commercial use. The analysis include the interpretation of the terminology used in thisarticle and focus on the policy options which WTO Members can have under this Article. Finally Part VII applies the legal analysis developed in previous Parts and makes a conclusionthat the further amendment work will be needed in order to ensure sufficient public options for theWTO members to take public health protection measures under the patent regime of TRIPsAgreement. I make specific recommendations for the amendments in four aspects.

Ⅰ. 서론
Ⅱ. 해석문제의 등장배경
Ⅲ. 해석방법에 대한 고찰
IV. 특허대상 제외규정
Ⅴ. 허여된 권리에 대한 예외규정
VI. 강제실시 규정
VII. 결론

• 李華(중국변호사) | 이화