Update: A Second Court Decision addressing Patent Linkage and Unfair Competition

Introduction

As reported in NO&T IP Law Update No.8, on October 28, 2024, the Tokyo District Court issued a decision in a case involving a biosimilar manufacturer seeking a preliminary injunction against a patent holder (Samsung Bioepis Co. Ltd. v. Bayer HealthCare LLC.

(Case Number: 2024 (Yo) 30029), hereinafter referred to as the “Bayer Case”). This decision is notable in that it addressed, for the first time, whether a statement concerning a potential infringement made by a patent holder to the Ministry of Health, Labour and Welfare (the “MHLW”), under the patent linkage system^[1] may constitute “unfair competition” as defined in the Unfair Competition Prevention Act (the “UCPA”).

Following the Bayer Case decision, this same issue was addressed in another Tokyo District Court decision, issued on December 16, 2024, in a preliminary injunction case brought by the same biosimilar manufacturer (i.e., Samsung Bioepis Co., Ltd.; hereinafter referred to as the “Claimant”) against a pharmaceutical product patent holder (i.e., Regeneron Pharmaceuticals, Inc.; hereinafter referred to as “Regeneron”) (Case Number: 2024 (Yo) 30028, hereinafter referred to as the “Regeneron Case”). What is noteworthy about the Regeneron Case decision is that the court dismissed the preliminary injunction application upon consideration of different criteria from those considered in the Bayer Case.

In this newsletter, we provide an overview of the Tokyo District Court’s ruling in the Regeneron Case and provide our summary commentary in relation to this decision.

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[Authors]

^[1] For information regarding the patent linkage system in Japan, please refer to our NO&T IP Law Update No.8, “Recent Court Decision on (i) Scope of Medicinal Use Invention and (ii) Patent Linkage” (February, 2025).