Life Sciences and Pharma IP Litigation 2025

JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu

non-exclusive licence would be awarded in part. The relevant parties were then encouraged to engage in discussions to seek a settlement. As a result of further discussions, the relevant parties (including the Petitioners and the Coun - terparties) reached the Settlement Agreement on 30 May 2024. Under the Settlement Agreement, the Counterparties covenant not to exercise the Patent Right against a certain range of acts in which the Respondents are involved, on the condition that the term of the no-assertion of the Patent Right will remain in effect from the conclusion of the Settlement Agreement until the expiration of the Patent Right, and the number of cases shall be limited to 30 cases in principle. Comments This case is significant because it was the first reported case where a compulsory licence was sought based on the particular necessity for the public interest. It is also significant because the key member of the Subcommittee suggested that a compulsory licence might be awarded in part after considering the arguments and evi - dence submitted by the parties. Tokai Ika v an individual, IP High Court, Case Number: 2023 (Ne) 10040 – Procedure for Calling for Opinions from Third Parties Background The Patent Act of Japan provides that, in a lawsuit regarding infringement of patent rights or utility model rights (only in the first instance and the appellate instance), if the court finds it necessary upon the petition of a party, and after hearing the opinions of the other party, the court may call for the submission of written opinions from the general public regarding the application of the Patent Act to the case and other mat - ters, setting a reasonable and specified period for submission (Article 105-2-11 of the Patent

Act). This procedure (“Procedure for Calling for Opinions from Third Parties”) was established by the amendment to the Patent Act in 2021. Among the written opinions submitted by third parties, the court can only use those submitted as evidence by a party as a basis for its judg - ment, and the general public may have access only to those submitted as evidence. The Procedure for Calling for Opinions from Third Parties was carried out for the first time in 2022 in the appellate instance of Dwango v FC2 et al (IP High Court, Case Number: 2022 (Ne) 10046). The second Procedure for Calling for Opinions from Third Parties was carried out by the IP High Court in 2024. This article briefly introduces this second one. Facts The Plaintiff (Tokai Ika K.K.) owns the patent right entitled “Composition for Promoting Increase in Subcutaneous Tissue and Subcutaneous Adi - pose Tissue” (Japanese Patent No 5186050) (the “Patent Right”). The patented invention at issue is the invention claimed in Claim 4, which is a dependent claim to Claim 1. Claims 1 and 4 read as follows. Claim 1: A composition for promoting an increase in subcutaneous tissue, characterised in that it comprises autologous plasma, basic fibroblast growth factor (b-FGF), and fat emulsion. Claim 4: A composition for breast augmenta - tion, comprising a composition for promoting increase in subcutaneous tissue according to any of Claims 1 to 3 used for breast augmenta - tion. The Defendant is a physician who operates a plastic surgery clinic (the “Clinic”). At the Clin - ic, the Defendant provided breast augmenta -

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