Introduction to the New Regulatory Initiative

Japan’s Ministry of Health, Labour and Welfare (MHLW) recently presented a proposal for improving the operation of the “Patent Linkage System” – a system that ensures generic and biosimilar drugs do not infringe on the patents of the original innovator drugs before they receive approval. The new proposal – presented at the Pharmaceutical Affairs and Food Sanitation Council’s subcommittee on Pharmaceutical and Medical Device Systems – is aimed at streamlining the approval process for generics and biosimilars.

Clarification of Patent Definitions and Scope

The Ministry aims to clarify the definitions and scope of substance and use patents, which must be considered during the approval process. This move is intended to prevent discrepancies between innovators and generic/biosimilar drug companies that often lead to litigation. Such legal disputes can threaten the stable supply of generic and biosimilar drugs in Japan, a concern raised by industry stakeholders during a subcommittee hearing in May.

Proposal for Expert Consultation System

Given the complexities of patent law and the absence of a system for expert consultation, the MHLW acknowledges the difficulty in determining the extent of patent rights and whether a generic or biosimilar drug infringes upon them. To address this, the Ministry has proposed establishing a task force team to discuss the processes consulting patent infringement and the criteria for approving generics and biosimilars. This taskforce team would also explore mechanisms to incorporate expert opinions into the decision-making process, aiming to implement a formal system where third-party experts provide opinions on potential patent conflicts.

Potential Impact on Drug Approvals

By establishing a more transparent framework and involving independent experts, the MHLW hopes to streamline the approval process for generics and biosimilars, minimize the risk of legal disputes, and ensure a more stable supply of affordable medicines in Japan. This initiative might also affect the strategies and timelines for overseas pharmaceutical companies entering the Japanese market.

The Ministry’s efforts to refine the Patent Linkage System reflect a broader commitment to balancing patent protection with the need for affordable medicines, making Japan an increasingly attractive market for global pharmaceutical companies.

Entering Japan’s Life Sciences Market

To ensure success in today’s global life sciences industry, companies must recognize and be prepared for a dynamic regulatory landscape. Guided by decades of regulatory and clinical experience, ELIQUENT Japan partners with innovators to develop a synchronized, global go-to-market approach that unlocks the full potential of the Japanese market.

ELIQUENT’s premier team of globally-minded, bilingual experts have the specialized skills to assist innovators across therapeutic areas, modalities, and markets. Clients turn to ELIQUENT for our deep command of Japan’s regulatory requirements, and our unrivaled ability to partner and communicate with Japan’s local constituencies. This unique blend of strategic guidance and technical skill aligns with your goals to unlock regulatory success. 

Learn more about ELIQUENT Japan’s capabilities.