한국형 허가-특허 연계제도에서의 제네릭 독점권 부여 여부

Korean Approval-Patent Linkage System: To Allow or Not Generic Exclusivity

Under the Korea-US FTA, Korea has to introduce so called“ approval-patent linkage” system. Article 18.9(5) of the KORUS FTA prescribes that Korea has to establish a notice system, and an automatic stay system. The Pharmaceutical Act was already amended to introduce the notice system, under which the Korean Food & Drug Administration shall maintain patent register. Korea now studies an ideal Korean style automatic stay system. In designing an ideal automatic stay system, the first and most important question should be whether Korea may allow generic exclusivity or not. If the answer is “NO”, we do not have to study generic exclusivity relevant complex issues, such as triggering, forfeiture, delisting, authorized generic, reverse payment settlement, etc. This paper briefly studied situations in China and Canada, which already operated approval-patent linkage system several years. The two countries do NOT allow genetic exclusivity. Though, patent challenges have been reasonably active. It says that even without generic exclusivity, generic companies may still actively challenge relevant patents. Considering (1) that a company which may enjoy generic exclusivity will be normally foreign big generic companies, (2) that the complex issues regarding generic exclusivity have not been enough studied, (3) that Korea's special legal environment is much different from that of the U.S.A., especially Korea's patent invalidity trial system and the protection scope confirmation trial system, and (4) that it would be appropriate to analyze the system after its first at least two or three year operations, and to decide whether to allow generic exclusivity or not, this paper suggests that for several years of its first operations, the Korean approval-patent linkage system shall not introduce the generic exclusivity system.