We are pleased to present the July 2025 issue (Vol. 16) of our Tech, IP and Telecoms Law Newsletter, a collection of the latest information about Japanese technology, intellectual property, and telecommunications law. We hope that you will find it useful to your business.

The Digital Administrative and Fiscal Reform Council finalized and announced its “Basic Policy on Data Utilization System” (in Japanese) on June 13, 2025. This basic policy is based on intensive discussions held over the past six months at the Data Utilization System Review Committee (in Japanese) meetings held since the end of last year. They analyze the current state of data utilization in Japan (particularly data sharing between different entities), outline measures for improving the environment for future data utilization and cross-sectoral reforms, and go further to address reforms in specific sectors such as healthcare. This policy provides a comprehensive roadmap toward creating new value through data utilization in Japanese society and promoting a virtuous cycle between data and AI.

The basic policy covers the utilization of data across a wide range of areas, from personal data to non-personal data and from private sector data to administrative data. Cross-sectoral reforms include: (1) development of a foundation for data sharing and promotion of data standardization; (2) securing incentives for data provision; and (3) establishment of a reliable digital space (ensuring data governance, data security, development of data sharing platforms, and appropriate handling of personal information). As immediate measures, the government will conduct necessary discussions on revising the Basic Act on the Advancement of Public and Private Sector Data Utilization (or enacting a new law) and aims to submit a bill to the ordinary session of the Diet in 2026. It also indicates the need to update the Act on the Protection of Personal Information in parallel.

Reforms in individual sectors will focus on key areas such as healthcare, finance, education and mobility, and efforts will be made to develop data spaces. In particular, in the healthcare field, the government will consider more effective measures, including the enactment of a special law to balance the protection of individual rights and interests with the utilization of medical data, and will summarize the results of its discussions by the end of 2025, with the aim of further refining the discussions by the summer of 2026 and submitting a bill to the 2027 ordinary session of the Diet if necessary. Additionally, in the financial sector, the government plans to outline the direction and timeline for addressing issues, including strengthening API connectivity in the credit card sector, by the end of the 2025 fiscal year.

On June 3, 2025, the Intellectual Property Strategy Headquarters published its “Intellectual Property Promotion Plan 2025” (in Japanese). This plan outlines the future direction and key initiatives of Japan’s intellectual property strategy. Amid declining international competitiveness, the plan adopts the slogan “IP Transformation” and aims to leverage Japan’s technological prowess, content creation and national brand to address societal challenges. Achieving IP Transformation requires driving the “Intellectual Creation Cycle,” which encompasses the creation, protection and utilization of intellectual property, with a focus on maximizing global marketing and revenue. The plan is structured around three main pillars: (1) strengthening competitiveness as an innovation hub; (2) utilizing advanced digital technologies like AI; and (3) capturing global market opportunities.

The plan details various key measures for each stage of intellectual property creation, protection and utilization. For instance, to combat piracy and counterfeit goods, it proposes strict border enforcement and considers necessary measures, including legal amendments, to curb intellectual property infringement. Additionally, the plan aims to support startups by addressing the shortage of intellectual property professionals through deployment and training initiatives. Specific KPIs are also set within the plan. These include aiming to rank within the top four in the Global Innovation Index (GII) by the World Intellectual Property Organization (WIPO) by 2035 (up from 13th in 2024), increasing the percentage of people who “love Japan” by 10 points by 2033, and expanding the overseas market size of Japan-originated content to 20 trillion yen by 2033.

Despite the decline in international competitiveness, Japan’s content industry continues to be a key sector for the country. To enhance soft power, it is crucial to fully utilize Japan’s intellectual capital. Collaboration between the public and private sectors is expected to drive various initiatives in line with this plan.

On June 9, 2025, Japan’s Ministry of Internal Affairs and Communications (MIC) published the “Guidance for Advertisers on Appropriate and Effective Digital Advertising” (in Japanese). This guidance addresses the risks associated with digital advertising, such as brand damage from ads appearing on undesirable platforms, wasted ad spending, and the promotion of misinformation. It was developed based on discussions within the Digital Advertising Working Group of the MIC’s “Study Group on Addressing Issues Related to Information Distribution in the Digital Space” (in Japanese). The guidance targets advertisers (including advertising personnel and management) and digital advertising service providers.

The guidance outlines recommended initiatives for advertisers, categorized into three key areas:

1. System Establishment and Goal Setting: This includes establishing an internal system, defining advertising objectives and key performance indicators, and ensuring information disclosure.
2. Specific Initiatives: This covers actions during the contract negotiation phase, engaging with quality certification bodies, implementing technical countermeasures, utilizing ad platform functionalities, and carefully selecting ad placements.
3. Delivery Status Confirmation: This emphasizes continuous performance monitoring and making improvements as needed.
    

The appendix (in Japanese) to the guidance provides practical and actionable content, including a flowchart for system development, examples of procedures and focus points for confirming delivery status, and methods for information disclosure.

It is worth noting that prior to this guidance, on June 21, 2024, the MIC had already requested (in Japanese) major social networking service providers to implement pre-screening for impersonation-style “fake ads” and to remove such ads post-publication. The MIC is actively and continuously addressing various issues surrounding digital advertising, and its future actions will be closely watched.

On March 19, 2025, the Special Division of the Intellectual Property High Court (IPHC) delivered a decision recognizing patent infringement concerning the production of pharmaceuticals at an aesthetic clinic (Case No. 10040 (Ne) of 2023) (in Japanese). In this case, party X (the plaintiff and appellant), who holds a patent right for the invention of a “breast augmentation composition” containing three components (autologous plasma, basic fibroblast growth factor (b-FGF), and a fat emulsion), filed a claim for damages against party Y (the defendant and appellee), a physician, alleging that the production of pharmaceuticals for use in “blood breast augmentation” at party Y’s aesthetic clinic infringed the patent. The Tokyo District Court (in Japanese) in the first instance dismissed party X’s claim.

The IPHC’s main points of contention were:

• Issue A – Whether there are grounds for invalidation due to a violation of the patent requirements for industrial applicability (Article 29, Paragraph 1 of the Patent Act) because it essentially patents a “medical procedure,” despite being patented as a “product invention” for a composition.
• Issue B – Whether party Y’s act of drawing blood from the patient and manufacturing the composition for breast augmentation fall outside the scope of patent infringement liability under Article 69, Paragraph 3 of the Patent Act, which excludes acts of dispensing based on a physician’s prescription from the effects of patent rights.

Regarding Issue A, the Japan Patent Office’s application practice (examination guidelines for patents and utility models) states that methods for surgery, treatment or diagnosis of humans (“medical procedures”) do not meet the patent requirements for industrial applicability. The court’s decision points out that “acts of manufacturing pharmaceuticals, etc. using materials taken from humans are not necessarily performed by physicians alone,” and that the development of these technologies “is significantly contributed to by research and development in the pharmaceutical and other industries, and they can be used for maintaining and restoring human life and health, thus recognizing the necessity of patent protection to promote technological development.” Therefore, the court held that there was no violation of the patent requirements for industrial applicability.

Regarding Issue B, Article 69, Paragraph 3 of the Patent Act stipulates that a “patent right for a medical invention (medicine meaning a product used in the diagnosis, therapy, treatment or prevention of a human disease…) that is to be manufactured by two or more medicines being mixed together” is excluded from the effects of patent rights. The court determined that the composition related to the invention, as described in the specifications and other documents, is used for breast augmentation, primarily for aesthetic purposes, and cannot be recognized as “used in the diagnosis, therapy, treatment or prevention of a human disease,” thus ruling that Article 69, Paragraph 3 of the Patent Act does not apply.

There are few judicial precedents that have interpreted Article 69, Paragraph 3 of the Patent Act, making the decision presented in this case a valuable reference for future practice. Furthermore, the handling of medical procedures under the Patent Act has been subject to ongoing examination with the advancement of technology, and further discussions based on this decision are anticipated.

On May 30, 2025, the Autonomous Driving Working Group, established by the Ministry of Land, Infrastructure, Transport and Tourism, released its “Interim Report on the Autonomous Driving Working Group” (in Japanese). This interim report primarily consolidates the results of discussions aimed at the societal implementation of autonomous taxis, which were highlighted as a key policy in the “Mobility Roadmap 2024” published in June 2024.

Within the working group, the institutional framework for promoting the societal implementation of autonomous vehicles was examined, focusing on “regulatory relaxation tailored to business models” and “three perspectives based on the Autonomous Driving SWG¹ Report” as key issues. For the former, the following were identified as issues for consideration: (a) clarification of the management outsourcing operation; (b) required operation management for specific autonomous driving; and (c) regulation of platforms involved in taxi dispatch. For the latter, the following were considered: (d) ensuring safety through the specification of certification standards; (e) prevention of recurrence through investigation of accident causes; and (f) compensation in the event of damage. The interim report details the current status, challenges, organized insights and future responses for each of these issues. It was recognized that advancing specific initiatives, such as necessary institutional development and the establishment of response systems, in line with the report’s direction, is important. Furthermore, it was suggested that consideration should also be given to promoting the societal implementation of Level 4 autonomous vehicles in automotive transport businesses beyond taxis, and eventually realizing Level 5 autonomous vehicles.

Additionally, on June 13, 2025, the Mobility Working Group, established by the Digital Agency, published the “Mobility Roadmap 2025” (in Japanese). The roadmap takes into account the current situation where initiatives for the societal implementation of autonomous driving remain in the demonstration phase, and a clear outlook for full-scale commercialization has yet to be established. It revisits the policies compiled in the 2024 version by incorporating new considerations from the perspective of redesigning mobility services to better integrate supply and demand, reduce the burden of initial capital investment, and address other aspects of appropriate business structures. The roadmap outlines the direction for future measures. The policies based on it are expected to undergo progress evaluation in the fiscal year 2025, with new challenges to be identified and clarified, leading to further revisions in the “Mobility Roadmap 2026.”

We will continue to closely monitor the trends in institutional development from the demonstration to implementation stages of autonomous driving, as well as the trends in legal systems based on these developments.

On July 1, 2025, the National Cybersecurity Office (NCO) was established as a reorganization of the Cabinet Secretariat’s National center of Incident readiness and Strategy for Cybersecurity (NISC).

On July 10, the NCO invited public comments on a draft standardized reporting format to be used for reporting to relevant government agencies in cases of DDoS attacks and ransomware incidents (in Japanese) (the solicitation period ends August 9).

When cybersecurity incidents such as cyberattacks occur, affected organizations are required to report them to the relevant authorities in accordance with existing systems. For example, this includes the obligation to report personal data breaches to the Personal Information Protection Commission (PPC) under Article 26 of the Act on the Protection of Personal Information, the obligation to report incidents to the competent ministry under relevant industry laws, and the need to report to and consult with the police as victims of cybercrime. Furthermore, under the law to prevent damage caused by unauthorized acts against important computers (Active Cyber Defense Act), which was enacted on May 16, 2025 (for an overview, please refer to Vol. 15 of this newsletter (May 2025)), essential infrastructure providers will be subject to new reporting obligations for security incidents.

In response to this situation, the Cyber Security Strategy Headquarters meeting held on May 29, 2025, identified the urgent need to reduce the burden on organizations affected by incidents by standardizing reporting formats and implementing necessary institutional reforms to centralize reporting destinations. As part of the meeting materials, the “Standardization of Incident Reporting Formats” (in Japanese) was published based on these considerations.

The specific timeline is divided into two major phases. In the first phase, starting October 1, 2025, the standardized reporting format for DDoS attack and ransomware incidents (excluding latent cyberattacks) will be implemented. In the second phase, in conjunction with the enforcement of reporting obligations under the Cyber Response Capability Enhancement Act (by November 23, 2026), the reporting system will be improved and reporting channels consolidated.