JAPAN Trends and Developments Contributed by: Kenji Tosaki and Takahiro Hatori, Nagashima Ohno & Tsunematsu
non-exclusive licence, and if no agreement is reached or discussions cannot be held, the per - son may file a petition for a compulsory licence with the Minister of Economy, Trade and Indus - try. Before making a decision in response to a petition for a compulsory licence, the opinions of the Industrial Property Council, an administra - tive committee established under the Ministry of Economy, Trade and Industry, must be sought. On 13 July 2021, Vision Care Inc. and VC Cell Therapy Inc. (collectively, the “Petitioners”) filed a petition for compulsory licence to work Japa - nese Patent No 6518878 (Title of Invention: “Method for producing retinal pigment epithelial cells”) (the “Patent Right”), which is jointly owned by RIKEN, Osaka University and HEALIOS K.K. (collectively, “Counterparties”), under Article 93(2) of the Patent Act (Petition for Compulsory Licence 2021–1; the “Petition”). The Petition was handled by the Invention Practice Subcommit - tee (the “Subcommittee”), established under the Industrial Property Council. After nearly three years, the Petition was withdrawn following a settlement agreement reached by the parties on 30 May 2024 (the “Settlement Agreement”). This article introduces the course of events related to the Petition. Since the discussions before the Subcommittee are not publicly available, this article relies on the Settlement Agreement, including the attachments thereto, which the parties posted on their website. According to the “Operational Guidelines for Compulsory License System”, the following two situations, among others, are considered as situ - ations where the working of a patented invention is particularly necessary for the public interest (Article 93(1) of the Patent Act). The first is when it is particularly necessary in fields directly relat - ed to people’s living, such as the preservation of life and property of the people, and the construc -
tion of public facilities. The second is when not granting a non-exclusive licence for the patented invention hinders the sound development of the relevant industry, and as a result, substantially harms people’s living. Facts As mentioned above, the Petition was filed by the Petitioners on 13 July 2021. In response to the Petition, RIKEN stated on 4 October 2021, that it was willing to discuss this matter with the Petitioners, Osaka University and HEALIOS. Osaka University responded on 5 October 2021, that it had no opinion at that time. HEALIOS requested on 6 October 2021, that the Petition be dismissed. On 2 December 2021, the first meeting of the Subcommittee was held to deliberate on the Petition. A total of 22 meetings of the Subcom - mittee were held before the settlement was reached. During that time, the Petitioners and HEALIOS each submitted written opinions and evidence in response to requests from the Sub - committee. While the Subcommittee deliberated on the Peti - tion and made its preliminary assessment, the Subcommittee reached the preliminary view that it would be desirable for the parties to settle the case through self-initiated discussions between the parties. Based on this view, one member of the Subcommittee, a former Chief Judge of the IP High Court, took the lead and informed the Petitioners, the representative director of Vision Care, HEALIOS, and Sumitomo Pharma Co., Ltd. (Sumitomo Pharma and HEALIOS were jointly developing a treatment using retinal pigment epithelial (RPE) cells derived from allogeneic iPS cells.) (within the bounds of confidentiality) that, based on the preliminary view of the Subcom - mittee, there was a possibility that granting a
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