제약분야의 특허분쟁사례를 통한 LCM과 에버그리닝의 이론과 논고
A theory and study on the LCM(Life cycle management) and evergreening according to the cases of patent litigation in the Korean pharmaceutical industry
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제약분야의 특허전략은 이해관계자의 입장에 따라 LCM 또는 에버그리닝으로해석하고 있다. 오리지널 의약품 제약사는 특허전략을 기술 혁신의 노력인 LCM이라고 주장하는 반면 제네릭 의약품 제약사와 보건 당국은 오리지널 제약사의 특허전략은 값이 저렴한제네릭 의약품의 접근성을 낮추어 항구적인 시장 지배의 목적인 에버그리닝이라고 주장하고있다. 본 연구는 한국에서 거대시장을 형성하고 있는 오리지널 의약품의 특허출원과 특허분쟁사례를 통해 LCM과 에버그리닝을 어떻게 개념화하고 논의되어야 하는지 제시하였다. 본 사례 연구 결과 LCM은 신약개발의 새로운 기술 응용을 바탕으로 연구의 성과물을 특허전략과 연계하였다. 반면, 에버그리닝은 의약품 허가 장벽을 높이기 위한 방법중의 하나로특허권을 활용된 것으로 판단된다. 본 연구결과를 바탕으로 이해에 따라 일방의 주장이 아닌LCM과 에버그리닝의 개념화를 통해 차별화된 시각으로 논의를 이끌고자 한다.
Abstract
To the analysis and discussion whether to conceptualization between the basis and LCM(Life cycle management) of patentability decisions and evergreening through research on patent application strategies and litigation cases. The Stakeholders have said that the LCM and evergreening strategies are an innovative effort to develop new pharmaceuticals, while others say that it is an effort to block generic pharmaceuticals from entering the market and permanently dominate the market by generic pharmaceuticals manufacturers or health economic perspectives. To achieve the goal of research, to discuss for conceptualization LCM and Evergreening strategies through patent application strategies for 14 pharmaceuticals for APIs and case studies for litigations. As a results, the LCM is getting patent rights for the results of research at the initial R&D stage and as such this shall be regarded as part of an effort for technology innovation. However, Evergreening is granting patent rights for the results by making high permission barrier to prevent the market entry of generic pharmaceuticals in the late development period during the pharmaceuticals development process or after their launch. This may lead to the problem of getting weak in health economic aspects and consumer welfare aspects by lowering the market accessibility of cheap generic pharmaceuticals.
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