Pharmaceutical data protection | 弁護士・高石秀樹の特許チャンネル

[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, 2013 (Wa) 33070 [Agricultural-Produce Sorting Apparatus] <Hasegawa>

[Article] Supplementing Unfair-Competition Protection Through Civil Code Tort Law (Patent Supplement, 2023; Professor Tatsuhiro Ueno)

[Unfair Competition Prevention Act / Trade Secrets] Tokyo District Court, 2014 (Wa) 1397, the Shoe Last case

[U.S. Patents] November 6, 2023, CAFC <ACTELION v. MYLAN> — Interpretation of Numerical Limitations and Rounding

[Design / Estoppel] Intellectual Property High Court, 2021 (Gyo-Ke) 10067 <Honda>

[Article] The Relationship Between ‘Confusion’ and ‘Business Interests’ Under Article 2(1)(i) of the Unfair Competition Prevention Act (Professor Hisayoshi Yokoyama)

[Article] Judicial Decisions on Infringement Warnings and Notification of False Facts Under the Unfair Competition Prevention Act (Patent Supplement, 2023; Professor Toshiya Kaneko)

Tokyo District Court, 2012 (Wa) 12351 [Rice Cake]

Intellectual Property High Court, 2021 (Ne) 10088 and 2022 (Ne) 10014 [Information Communication Unit]

[Trademark / Contract] Osaka District Court, 1996 (Wa) 6700 — Abuse of the right to terminate

Patent Case Law and Intellectual Property Practice Blog