자료독점권(Data Exclusivity), 사실상 특허권 존속기간의 연장인가?

Abstract

This article relates to study on data exclusivity which is described on "Free Trade Agreement between the Republic of Korea and the United States of America(here in after, refer to as 'Korea-U.S. FTA')". It is said that data exclusivity and the brand new approval-patent linkage system are typical examples of Trips-plus provisions. Korea already have been protecting the data which is submitted for approval of new drug since 1995. However, the present data exclusivity system has several problems. First, data exclusivity right is enforced in drug reexamination system which is drafted for reviewing of safety and efficacy of drug product, consequently totally different from data exclusivity system as to purpose. Second, the period of protecting is too long and the level of protecting is too high under the present Korea data exclusivity system compared with those under America or Korea-U.S. FTA data exclusivity system. Finally, in Korea, data exclusivity system is just described in Korea Food and Drug Administration Rule which is not an Act. Therefore this article suggested to revise Korean pharmaceutical affairs law reads as follows. (i) The applicant who submitted information for approval of new chemical entities are entitled to have 5 years data exclusivity from the date of marketing approval as to the safety or efficacy information submitted in support of the marketing approval, or evidence of the marketing approval. (ii) The applicant who submitted information for approval of a pharmaceutical product that includes a chemical entity that has been previously approved for marketing in another pharmaceutical product are entitled to have 3 years data exclusivity from the date of marketing approval as to the new clinical information which is essential to the approval of the pharmaceutical product and submitted in support of the marketing approval.