In order to prevent abuse and delays in the approval process for generic drugs, Japan should establish clear guidelines on patent linkage and explore alternative dispute resolution mechanisms, which would foster competition, reduce drug prices, and ensure access to affordable medicines for the public.

Patent linkage is a crucial mechanism that ensures that the approval of a pharmaceutical product is in accordance with patent rights. However, in Japan, there are numerous issues surrounding this mechanism. One major problem is the lack of clear guidelines, which opens up the opportunity for patent holders to abuse their rights and for the Ministry of Health, Labour and Welfare (MHLW) to make inappropriate approval decisions without the authority to determine patent infringement. Consequently, patent litigation increases, leading to delays in the approval process for generic drugs and confusion in the market due to injunctions. These challenges hinder fair competition, hinder the timely market entry of generic drugs, and have a negative impact on public health. To mitigate these problems, Japan should establish clear and transparent guidelines on patent linkage and explore alternative dispute resolution mechanisms. By implementing these measures, Japan can foster competition, reduce drug prices, and enhance access to affordable medicines for its citizens.

The high level of awareness of the issue was evident in the 501 responses received from 76 persons interested in Japan's patent linkage system.

See https://www.tokkyoteki.com/2023/09/patent-linkage.html