{"id":48002,"date":"2025-04-28T12:46:29","date_gmt":"2025-04-28T12:46:29","guid":{"rendered":"https:\/\/my.legal500.com\/developments\/?post_type=legal_developments&#038;p=48002"},"modified":"2025-04-28T12:49:46","modified_gmt":"2025-04-28T12:49:46","slug":"update-a-second-court-decision-addressing-patent-linkage-and-unfair-competition","status":"publish","type":"legal_developments","link":"https:\/\/my.legal500.com\/developments\/thought-leadership\/update-a-second-court-decision-addressing-patent-linkage-and-unfair-competition\/","title":{"rendered":"Update: A Second Court Decision addressing Patent Linkage and Unfair Competition"},"content":{"rendered":"<h2><strong>Introduction<\/strong><\/h2>\n<p><strong>As reported in <a href=\"https:\/\/www.noandt.com\/en\/publications\/publication20250212-1\/\">NO&amp;T IP Law Update No.8<\/a>, 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 (<em>Samsung Bioepis Co. Ltd. v. Bayer HealthCare LLC<\/em>.<\/strong><\/p>\n<p><!--more--><\/p>\n<p>(Case Number: 2024 (Yo) 30029), hereinafter referred to as the \u201c<strong>Bayer Case<\/strong>\u201d). 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 \u201c<strong>MHLW<\/strong>\u201d), under the patent linkage system<a href=\"#_ftn1\" name=\"_ftnref1\"><sup>[1]<\/sup><\/a> may constitute \u201cunfair competition\u201d as defined in the Unfair Competition Prevention Act (the \u201c<strong>UCPA<\/strong>\u201d).<\/p>\n<p>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 \u201c<strong>Claimant<\/strong>\u201d) against a pharmaceutical product patent holder (i.e., Regeneron Pharmaceuticals, Inc.; hereinafter referred to as \u201c<strong>Regeneron<\/strong>\u201d) (Case Number: 2024 (Yo) 30028, hereinafter referred to as the \u201c<strong>Regeneron Case<\/strong>\u201d). 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.<\/p>\n<p>In this newsletter, we provide an overview of the Tokyo District Court\u2019s ruling in the Regeneron Case and provide our summary commentary in relation to this decision.<\/p>\n<p>View original article <a href=\"https:\/\/www.noandt.com\/en\/publications\/publication20250408-1\/\">here<\/a>.<\/p>\n<p>[Authors]<\/p>\n<table>\n<tbody>\n<tr>\n<td width=\"643\"><strong>Kenji Tosaki <\/strong>(Partner)<\/td>\n<\/tr>\n<tr>\n<td width=\"643\"><strong>Nozomi Kato<\/strong><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><a href=\"#_ftnref1\" name=\"_ftn1\"><sup>[1]<\/sup><\/a> For information regarding the patent linkage system in Japan, please refer to our NO&amp;T IP Law Update No.8, \u201c<a href=\"https:\/\/www.noandt.com\/en\/publications\/publication20250212-1\/\">Recent Court Decision on (i) Scope of Medicinal Use Invention and (ii) Patent Linkage<\/a>\u201d (February, 2025).<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-48002","legal_developments","type-legal_developments","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/my.legal500.com\/developments\/wp-json\/wp\/v2\/legal_developments\/48002","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.legal500.com\/developments\/wp-json\/wp\/v2\/legal_developments"}],"about":[{"href":"https:\/\/my.legal500.com\/developments\/wp-json\/wp\/v2\/types\/legal_developments"}],"wp:attachment":[{"href":"https:\/\/my.legal500.com\/developments\/wp-json\/wp\/v2\/media?parent=48002"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}