Date: 13 May 2024

Our Director, George Huang (Attorney at Law and Patent Attorney), recently shared his expertise of Taiwan patent linkage system and current litigation practice on AIPLA Chemical Practice Chronicles Spring 2024 Volume 12 Issue 1. This article analyzes court rulings from civil infringement litigations from the pharmaceutical patent linkage system and offers strategies for both brand and generic drug manufacturers. AIPLA Chemical Practice Chronicles is a Newsletter published regularly by the AIPLA Chemical Practice Committee.

The Patent Linkage System in Taiwan may incentivize generic drug manufacturers to challenge the patent rights held by brand drug producers and gain entry into the market before patent expiration. Under this system, the first generic filer of the P4 declaration enjoys a 12-month period of market exclusivity, a significant departure from previous practices. Previously, generic drug makers were relegated to a passive role, awaiting the expiration of brand patents before market entry.