Mr. Young Sun Cho and Ms. Hyunsuk Jin, attorneys at Yoon & Yang LLC have contributed an article titled “Overview and implications of the drug patent-approval linkage system in South Korean Regulation” at Practical Law (Multijurisdictional Guide) Life Sciences 2014-15. This article discusses the background and status of implementation of the drug patent-approval linkage system in South Korea.
The Korean government has implemented the drug patent-approval linkage system following the execution of the free trade agreement (FTA) with the United States, under which the Korean government is obligated to gradually implement the notice system and marketing prevention system. However, because the Korean government has discretion over enacting the specific methods of implementation for the notice system and marketing prevention system, it would be important to understand the difference between the drug patent-approval linkage system in Korea and the system under the US Hatch-Waxman Act, which is the benchmark system of the Korean system.
The notice system has been implemented as of March 15, 2012 and the marketing prevention system is expected to be implemented on March 15, 2015. With respect to the notice system, the article discusses in detail the criteria and procedure for registration in the drug patent list (Green List), method and scope of notice, etc. In addition, with respect to the marketing prevention system, the article introduces the overall plan for implementing the marketing prevention system based on the information revealed through the hearing held by the Ministry of Food and Drug Safety (MFDS) on November 29, 2013 and other issues currently discussed within the healthcare industry.
For your information, the MFDS announced on March 19, 2014 that the “Detailed Operational Guide for the Drug Patentapproval Linkage System” should be amended and implemented in order to improve the registration system in the Green List and the notice system. Such amendment has been carried forward in order to complement the shortcomings revealed during the operation of the registration system in the Green List and to promote its effectiveness and the applicant’s convenience. Major areas of amendment include the specification of the information submitted in connection with application for the registration, disclosure of the fact that an application has been filed for registration, prenotification of the result of the review, and expansion of the scope of registered information, etc.
In addition, the MFDS made a pre-announcement of legislation of a bill for partial amendment of the Pharmaceutical Affairs Act on March 21, 2014, of which the main features are introduction of systems such as the marketing prevention of generic drugs, and approval of exclusive marketing right of the first generic applicant under the drug patent-approval linkage system. Furthermore, the Drug Approval and Patent Adjudication Committee will be established under the MFDS and it will review claims for appeal on the disposition under the drug patent-approval linkage system. For your information, the public opinions on the pre-announced bill are collected until May 20, 2014.