제약분야의 에버그리닝(Evergreening)특허전략과 FTA 연구
A Research on the Evergreening Patent Strategy and FTA in the Pharmaceuticals Field
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초록
지식재산권은 일정한 기술을 공개함으로써 산업의 발전을 도모하는 한편, 그에 대한 상응하는 보상으로 일정기간 독점권을 부여하는 양면성이 있고, 제약산업분야는 지식재산권에 대한 중요도가 타산업에 비해 매우 높다. 에버그리닝(Evergreening) 전략은 특허에 있어서 특허의 존속기간을 연장하거나 20년 이상 특허기간을 연장하여 특허 보호기간의 더 많은 독점적 권리를 얻고자 하는 것으로 에버그리닝 전략 유형에는 염화합물, 용매화합물, 결정형, 광학이성질체, 제형 및 약물동력학적 데이터, 제법, 용도 등이 대표적이다. 에버그리닝 전략은 미국등 이미 시행되고 있는 특허허가연계등의 특수한 제도를 바탕으로 부실특허를 이용하여 시장의 지배력을 항구적으로 이용하는 부정적인 의미를 내포하고 있으나 신약개발 제약사입장에서는 신약개발과 관련하여 막대한 자금과 오랜 시간을 투자한 오리지널 의약품 개발사가 신약개발에 소요되는 투자자금을 회수하기 위한 보다 넓은 특허망 등을 활용하는 측면에서 중요한 전략수단일 것이다. 그러나 에버그리닝 전략의 부정적 이미지와 달리, 혁신적 개량기술은 공중보건의 필요성이나 시장에서 향상된 물질을 출시하기 위해 기존의 물질이나 기술을 발전시키는 것과 관련 있으므로 혁신적 개량신약은 에버그리닝 전략과 차별화되어야 할 것이다. 본 논문은 제약분야에 있어 신약개발과정과 이를 통해 에버그리닝 특허전략이 어떻게 연계되고 있는지와 이들의 이념을 살펴보고, 향후 한미FTA에서 제약분야의 주요한 제도변화인 특허허가연계가 제약산업에 어떠한 영향을 미치며, 제도변화에 쟁점이 되고 있는 사안에 대하여 전문가 및 산업계의 설문을 통해 바람직한 제도마련(안)을 제시하였다.
Abstract
Intellectual property rights have double-sidedness, as they both promote the development of industry by opening certain technologies to the public while granting exclusive rights to parties as compensation for it. In the pharmaceutical industry, the importance of intellectual property rights is higher than in other industries. The evergreening strategy aims to extend the patent duration of a patent or extend the patent period for over 20 years to acquire more exclusive rights during the patent protection period. Major types of evergreening strategies include using salts compounds, solvates, crystal forms, optical isomers, formulations and pharmacokinetic data, methods, usages, etc. Evergreening strategy has negative implications of seeking permanent market dominance by using bad patents based on special systems such as patent-linkages, etc., which have been already implemented in advanced countries such as the U.S.A. However, from the viewpoint of new drug developing pharmaceutical companies, evergreening is an important strategic method in that an original pharmacy developing company, which has invested tremendous amounts of money and time, uses a broader patent network, etc. to recover the funds invested in the development of new drugs. Meanwhile, different from the negative image of the evergreening strategy, as it relates to existing substances or the development of technology it shall be differentiated from innovatively improved new drugs for the necessity of public health, from an innovatively improved technology or a launch of improved substances. In this paper, we study the new drug development process in the pharmaceutical field and how the evergreening patent strategy is related and their ideologies. I also study how patent-linkage, a major systemic change in the pharmaceutical field of the future Korea-U.S. FTA, might affect the pharmaceutical industry, and present desirable system preparations (plans) through a survey for specialists and industry of the major points of controversy in these changes.
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