This article examines the drug patent-approval linkage system in South Korea and its implications. The system prohibits the sale of generic drugs which would infringe the patents of brand-name pharmaceutical companies who have developed the original drugs, by alerting the original patent holders and by withholding marketing approval. This has the object of protecting the rights of the patent holders.

The article considers the background to the patent-approval linkage system, including the FTA agreement entered into with the US and the patent dispute resolution system in South Korea. The article also discusses the way in which the patent-approval linkage system is being implemented. In particular, it examines the notice system that has been put in place to alert patent holders that an application for approval of a generic drug based on their patent is being made, and the expected marketing prevention system which will stop these generic drugs from being marketed while in the approval stage.

This article is part of the Practical Law multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.