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의약품 허가-특허 연계제도의 등재의약품에 대한특허 도전에 관한 연구

Research on the Patent Challenges under the Patent Linkage System in Korea

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초록

본 연구에서는 한국 허가-특허 연계제도의 등재의약품에 대한 특허 도전에 있어서 등재의약품이 특허 도전을 받을 위험에 등재특허의 특성이 미치는 영향에 대해 분석하였다. 등재특허의 피인용, 특허패밀리, 청구항, 출원인, 발명자, 기술분류 수 측면에서 특성을 파악하였고, 등재특허 출원일의 등재의약품의 허가일 이후 여부를 통해 오리지널 제약사의 에버그리닝 전략과의 연관성을 파악하였다. 분석 결과, 의약품의 다양한 특성을 통제한 후에도 피인용, 특허패밀리, 출원인, 기술분류 수 측면에서의 특허 특성 차이와 오리지널 제약사의 에버그리닝 전략과의 연관성이 등재의약품이 특허 도전을 받을 위험에 유의한 영향을 주는 것으로 나타났다. 이와 같은 결과는 제네릭 제약사들이 특허 도전에 있어서 의약품의 특성뿐만 아니라, 등재특허의 특성을 고려하여 도전 대상을 전략적으로 선정하고 있음을 보여준다.

Abstract

In this study, we analyzed the impact of patents’ characteristics on the risk of patent challenge under the Korean patent linkage system. The characteristics of patents were identified in terms of the number of citations, patent families, claims, applicants, inventors, and technical classifications, and the relevance to the original pharmaceutical company's evergreening strategy was identified through whether the patent application date was after the approval date of the listed drug. It is found that differences in patent characteristics in terms of the number of citations, patent families, applicants, and technical classifications and the relevance to evergreening strategy are significant for the risk of a drug being challenged, even after controlling for various characteristics of drugs. These results show that generic pharmaceutical companies strategically select challenge targets by considering not only the characteristics of the drug but also the characteristics of the patents.

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