Under the patent-market approval linkage system, whether a patent of an original drug has been infringed is taken into account as a factor in granting a market approval for a generic drug. The patent-market approval linkage system was first developed in the U.S. and subsequently adopted by other countries including Canada and Australia. Pursuant to the Korea-U.S. Free Trade Agreement, Korea also agreed to introduce and implement the system from March 15, 2015. As the patent-market approval linkage system is related to the approval of drugs, the relevant provisions are set forth in the Pharmaceutical Affairs Act (the “Act”). There has been much discussion over how the Act should be amended to introduce the system, and the proposed amendments to the Act (the “Amended Act”) were finally confirmed and passed at the Plenary Session of the National Assembly in March 3, 2015.
The Amended Act is set to take effect on March 15, 2015. The following is the overview of the key aspects of the patent-market approval linkage system.
- Introduction of Prohibition on Sale of Generic Drug
- Introduction of First Generic Exclusivity System
- Other Provisions of the Amended Act
- Scope of Applicability of the Amended Act
