“Can a brand‑name drug company’s provision of patent‑infringement related information on biosimilars to the PMDA ever constitute unfair competition?”, by Yasuhiro Sato (The Invention 2026 No.3)

Yasuhiro Sato wrote an article published in The Invention 2026 No.3.   Yasu’s article, “Can a brand‑name drug company’s provision of patent‑infringement related information on biosimilars to the PMDA ever constitute unfair competition?”, discusses a recent IP High Court decision in Japan. In this case, the court held that even if a brand‑name drug company provides the regulatory authority (the PMDA) with information alleging patent infringement in relation to a pending biosimilar application, such conduct does not give rise to liability under the Unfair Competition Prevention Act.  This decision has significant implications for Japan’s patent‑linkage system for generic drug and biosimilar applications and is attracting close attention for its impact on future practice.