Linkage System Between Pharmaceutical Patent and Generic Market Approval Finalized

摘要

After numerous changes and modifications, the revised Korean Pharmaceutical Affairs Act ("KPAA") has finally entered into effect as of March 15, 2015, thereby to fully put in operation the patent approval linkage system introduced following the ratification of the Korea-U.S. Free Trade Agreement. Specifically, the revised KPAA further refines the requirements regarding the patent listing on the so-called "Green List" and the notification obligation of a generic drug manufacturer, which have already been in place since 2012, and newly provides the requirements and procedures for the blocking of the marketing of a generic drug, a first generic applicant's exclusivity, and the reporting of a settlement agreement.