REGULATORY
Japan Begins Overhaul of Patent Linkage Framework with First Notification
Japan’s Ministry of Health, Labor and Welfare (MHLW) has taken the first step in a planned revamp of its patent linkage system, which determines whether generic and biosimilar applications conflict with existing patents. The effort began on October 8, when…
To read the full story
Related Article
- Japan Launches Pilot Expert Committee System for Patent Linkage Reviews, Aims to Reduce IP Feuds
November 17, 2025
- Japan Launches Study on Legal Framework for Patent Linkage System
October 9, 2025
- PhRMA Questions Utility of Proposed Expert Committee for Patent Linkage
May 8, 2025
- MHLW to Revise Patent Linkage Scheme in FY2025, Create Expert Committee
April 16, 2025
- MHLW Mulls System to Seek Expert Input for Patent Linkage
July 29, 2024
REGULATORY
- Japan Panel Seeks Easing of Rules on Radiopharma Research Samples
June 16, 2026
- LDP Team Reviews Draft Industry Cluster Plans for Radiopharma, Blood Products
June 16, 2026
- DPP Calls for End to Off-Year Drug Price Cuts, Chuikyo Reform
June 15, 2026
- Pharma Wages Multi-Front Lobbying amid Push for Leaner Honebuto
June 12, 2026
- Many Approved AGs Remain Unlisted Despite Final Pre-Reform Opportunity
June 12, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





