Tokyo, 25 July 2025: ERIA successfully convened the ‘ERIA Workshop 2025: Research on Patent Examination Practices in the Pharmaceutical and Related Fields in ASEAN Member States – Phase 2’ on Friday, 25 July, at the Toshi Center Hotel in Tokyo, Japan. This event marked the final stage of a two-phase research initiative launched in early 2024 to strengthen legal certainty and enhance efficiency in pharmaceutical patent examinations across ASEAN.

The project responds to the post-pandemic surge in pharmaceutical and biotechnology innovation in Southeast Asia. Its overarching goal is to foster greater transparency and mutual understanding amongst national intellectual property (IP) offices, thereby supporting regional integration and sustainable innovation growth.

Building on Phase 1

Phase 1, held online in 2024, engaged six ASEAN Member States (AMS). This in-person Phase 2 workshop completed the coverage by focusing on Brunei Darussalam, Cambodia, Myanmar, and Viet Nam.

More than 38 participants attended, including delegates from each ASEAN IP office (with Brunei joining online), representatives from the Japan Patent Office (JPO), ASEAN Secretariat, Institute of Intellectual Property Japan (IIP Japan), Japan Pharmaceutical Manufacturers Association (JPMA), Japan External Trade Organization (JETRO), and other knowledge partners.

Opening Remarks and Session 1

The workshop opened with remarks from Mr Tatsuo Takeshige, Director of the International Policy Division at JPO, and Dr Zurina Moktar, Assistant Director and Head of the Science and Technology Division at the ASEAN Secretariat. Both speakers stressed the importance of regional cooperation to enhance legal predictability in pharmaceutical innovation.

Session 1 featured presentations by:

• Mr Takeshi Tsuru (Deputy Director, JPO), who outlined Japan’s approach to pharmaceutical and biotechnology patent examination;
• Mr Sho Nomura (Director of IP, JPMA), who shared insights on how Japanese pharmaceutical companies navigate ASEAN markets;
• Ms Fitri Astari Asril (Research Associate, ERIA), who provided an overview of ASEAN’s pharmaceutical sector and the pivotal role of patent examiners in advancing innovation and public health.

Session 2: National Practices and Comparative Analysis

Led by Mr Ryo Yamanishi, Chief Researcher at IIP Japan, Session 2 presented a comparative analysis of patent examination guidelines across the four Phase 2 countries, based on survey data and structured interviews with patent examiners.

Key findings included:

• Converging standards on patentability criteria – such as novelty, inventive step, industrial applicability, and disclosure requirements – though variations remain in interpretation and application;
• Common challenges in Cambodia and Myanmar, particularly limited human resources and technical capacity;
• A gap in Viet Nam, which has yet to designate a national depository authority for microorganisms in patent procedures.

These insights underscore the need for examiner training and greater regulatory harmonisation across AMS.

Session 3: Peer Exchange and Open Dialogue

This session enabled ASEAN IP offices to share country-specific experiences, reforms, and priorities. Highlights included:

• Indonesia’s Directorate General of Intellectual Property (DGIP) presenting recent amendments to its Patent Law, particularly on second medical use claims;
• The Intellectual Property Office of Singapore (IPOS) sharing best practices in examiner education and capacity-building.

An open discussion moderated by Professor Hiroshi Kato (Patent Attorney and Professor, Nihon University) explored differences in national practices, procedures, and the importance of robust national guidelines.

Despite diverse legal and regulatory frameworks, participants noted growing convergence on key pharmaceutical patent issues.

Closing and Way Forward

Dr Takayuki Yamanaka, Chief Operating Officer of ERIA, closed the event by highlighting the importance of research-based collaboration and continuous capacity-building. He expressed appreciation to all speakers, moderators, and participants, and encouraged sustained engagement beyond the workshop.

The workshop reaffirmed the value of technical dialogue and mutual learning across ASEAN. By connecting patent examiners, researchers, and stakeholders, the project has laid the groundwork for more coherent, transparent, and resilient IP systems.

As Southeast Asia’s pharmaceutical sector continues to grow, patent examiners will play a critical role in balancing innovation, public health, and regulatory standards. ERIA hopes the insights generated through this project will support stronger, more adaptable IP systems aligned with both regional priorities and global challenges.