JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
Nagashima Ohno & Tsunematsu JP Tower 2-7-2 Marunouchi Chiyoda-ku Tokyo 100-7036 Japan
Tel: +81 3 6889 7000 Fax: +81 3 6889 8000 Email: kenji_tosaki@noandt.com Web: www.noandt.com/en/
Recent IP Litigation Cases, Judgments and Decisions in Japan Overview Japan has frequently (almost every year) amend - ed its intellectual property (IP) laws in recent years. However, since 2023 there have been no amendments that are likely to have an impact on IP litigation in the life sciences and pharma field in Japan, and, therefore, it can be said that there have been no acts or amendments regard - ing IP laws in this field that are noteworthy and expected to influence the practice thereof in the last couple of years. There were several notable IP litigation cases, judgments and decisions in the life sciences and pharma field in Japan from late 2023 to 2024. Among them, the following cases should be noted in particular. • Vision Care and VC Cell Therapy v RIKEN et al (Petition for Compulsory Licence 2021–1). • Tokai Ika v an individual, IP High Court, Case Number: 2023 (Ne) 10040 – Procedure for Calling for Opinions from Third Parties. • Samsung Bioepis v Bayer HealthCare LLC. (Tokyo District Court Decision regarding Preliminary Injunction, 28 October 2024, Case Number: 2024 (Yo) 30029).
Overviews of the cases and some of the key points in each of the cases are provided below. Vision Care and VC Cell Therapy v RIKEN et al (Petition for Compulsory Licence 2021–1) Introduction Under the Patent Act of Japan, a compulsory licence may be awarded (ie, an involuntary non- exclusive licence granted by the government) in three situations. The first situation is when a pat - ented invention has not been worked properly in Japan for three years or more (Article 83(1) of the Patent Act). The second situation is when a person’s patented invention cannot be worked without using another person’s patented inven - tion (Articles 92(1) and (2) of the Patent Act). In these cases, one party may request discussions with the other party regarding the granting of a non-exclusive licence, and if no agreement is reached or discussions cannot be held, the party may file a petition for a compulsory licence with the Commissioner of the Japan Patent Office (JPO) (Articles 83(2) and 92(3) and (4) of the Pat - ent Act). The third situation is when the working of a patented invention is particularly necessary for the public interest (Article 93(1) of the Patent Act). In this case, a person intending to work the patented invention may request discussions with the patentee regarding the granting of a
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