한-미 바이오의약품 허가특허연계제도 비교 분석 및 연구

Korea introduced its drug patent linkage system in 2015 as part of the implementation of the Korea–U.S. Free Trade Agreement (KOR-US FTA), and the current framework applies to both small-molecule drugs and biologics. However, as (i) the global market share of biologics has increased rapidly compared to that of small-molecule drugs and (ii) Korean companies have strengthened their competitiveness in the global biosimilar market, concerns have grown that the existing patent linkage system — which was designed primarily with small-molecule drugs in mind — does not reflect the regulatory and economic characteristics of biologics. This article first outlines the structure of Korea’s patent linkage system and data protection system and then compares these systems with (i) the U.S. framework governing small-molecule drugs under the Hatch–Waxman Act and (ii) that governing biologics under the Biologics Price Competition and Innovation Act (BPCIA) and the Biological Product Patent Transparency Act (BPPT). The comparison focuses on the following elements: (i) mechanisms of patent information disclosure (Green List, Orange Book, Purple Book, and the patent dance), (ii) automatic/non-automatic stays of sales or approval, (iii) the scope and duration of data and market exclusivity for originator drugs and biologics, and (iv) first-marketing exclusivity for generics and biosimilars. The analysis demonstrates that Korea grants biologics and biosimilars the same data/market exclusivity periods and first-marketing exclusivity periods as those provided to small-molecule drugs and generics, despite higher development costs, longer timelines, and greater regulatory uncertainties associated with biologics. In light of the foregoing, the article presents the following proposals: (i) extending the duration of data/market exclusivity for biologics relative to small-molecule drugs; (ii) extending the first-marketing exclusivity period for biosimilars compared to generic drugs, in order to better reflect the development burden of the biosimilars; and (iii) maintaining Korea’s list-based patent information system rather than adopting the U.S. patent dance, while operating the patent linkage regime under a single “biosimilar” category rather than having separate standards for biosimilars and interchangeable biosimilars as in the United States. Through these proposals, this article seeks to develop a more balanced incentive structure that promotes both innovation in originator biologics and timely market entry of biosimilars.