Tokyo District Court, 2024 (Yo) 30028 — Age-Related Macular Degeneration (Kokubu, Civil Division 29)
(Issued around the same time as Tokyo District Court, 2024 (Yo) 30029 (Nakashima, Civil Division 40).) ⇒ Without deciding whether there was patent infringement, the court, in light of the circumstances, began with “negation of unlawfulness as a lawful act.” It adopted a framework


Tokyo District Court, 2024 (Yo) 30029 — Age-Related Macular Degeneration (Nakashima, Civil Division 40)
★ Application for a provisional injunction based on violation of the Unfair Competition Prevention Act: a case denying patent infringement by finding that the medical-use invention was not worked under an “exclusively” standard and that, on the patentee’s argument that a certain
![[Article / Patents] Cases and challenges in patent protection for biopharmaceuticals (Biotechnology and Life Sciences Committee, Patent, December 2025)](https://static.wixstatic.com/media/324a18_cf7da5b8b6a24d4288bdcfb41718dc88~mv2.png/v1/fill/w_332,h_250,fp_0.50_0.50,q_35,blur_30,enc_avif,quality_auto/324a18_cf7da5b8b6a24d4288bdcfb41718dc88~mv2.webp)
![[Article / Patents] Cases and challenges in patent protection for biopharmaceuticals (Biotechnology and Life Sciences Committee, Patent, December 2025)](https://static.wixstatic.com/media/324a18_cf7da5b8b6a24d4288bdcfb41718dc88~mv2.png/v1/fill/w_319,h_240,fp_0.50_0.50,q_95,enc_avif,quality_auto/324a18_cf7da5b8b6a24d4288bdcfb41718dc88~mv2.webp)
[Article / Patents] Cases and challenges in patent protection for biopharmaceuticals (Biotechnology and Life Sciences Committee, Patent, December 2025)
1. De facto patent linkage in Japan Under the practice based on the Ministry of Health, Labour and Welfare's “two division directors' notification,” biosimilars (BS) are, in principle, not approved while patents exist on the originator product's active ingredient or use. 2. Re-examination period
![Tokyo District Court, 2012 (Wa) 12351 [Rice Cake]](https://static.wixstatic.com/media/324a18_1e68d290faf1421383ef0182da9fd77b~mv2.png/v1/fill/w_225,h_125,fp_0.50_0.50,lg_1,q_35,blur_30,enc_avif,quality_auto/324a18_1e68d290faf1421383ef0182da9fd77b~mv2.webp)
![Tokyo District Court, 2012 (Wa) 12351 [Rice Cake]](https://static.wixstatic.com/media/324a18_1e68d290faf1421383ef0182da9fd77b~mv2.png/v1/fill/w_38,h_21,fp_0.50_0.50,q_95,enc_avif,quality_auto/324a18_1e68d290faf1421383ef0182da9fd77b~mv2.webp)