Event Information

Time：January 9, 2015 (Friday)

Place：GIS Taipei Tech Convention Center

The seminar on the patent-linkage system and regulations of generics in Korea was organized by the TGPA with the assistance from the TRPMA. Prof. Jae-Hyuan Lee from the College of Pharmacy of the Sungkyunkwan University was invited to give a speech, introducing the patent-linkage system and the generic pricing mechanism in Korea. His insightful knowledge is a valuable reference for the Taiwanese authority for the preparation of the trade talk with the US government on the patent-linkage system and related regulations.

The key points of the patent-linkage system in Korea are:

1. The original manufacturer has to file the patent listing application (PLA) within 30 days from the receiving of the marketing approval from the Ministry of Food and Drug Safety (MFDS).

2.The MFDS will check the patent information and publish it in the Green List for the public’s on-line access.

3.Generic manufacturers have to inform the original manufacturer within 7 days from their filing of drug applications.

1. In situations where the original manufacturer opposes the applications, it can file a lawsuit against the generic manufacturers in 45 days and submit the “generic-stay” request to the MFDS. The “generic-stay” can be valid for as long as 12 months. (During the “generic-stay” period, the MFDS may issue marketing approvals, but sales and the application of drug prices are forbidden.)

5.The first approved generic will be granted with 12-month generic exclusivity, with 2-month extension if it applies for NHI prices.

6.The price of original drug will be reduced by 30% when its generic is available on the market, and be reduced to the same price as generic drugs after one year of the launch of generics.

Prof. Jae-Hyuan Lee from the College of Pharmacy of the Sungkyunkwan University was briefing the audience on the patent-linkage system and generic pricing mechanism in Korea.