Japan: Problem of Japan’s patent linkage system comes to the surface by a set of IP High Court decisions

The"patent linkage system" is in general a system wherein market approval of generic drugs is linked with the status of the originator drug's patents for the purpose of early resolution of patent disputes and ensuring the stable and consistant supply of generic drugs. Japan has not statutorily adopetd the patent linkage system, but the system is said to have been adopted in the Ministry of Health, Labor and Welfare (MHLW)'s notification level, under which marketing approval shall not be granted for a generic drig while the originator's patent covering the active ingredient is existing. Read more