Research on Patent Examination Practice for Pharmaceuticals and Related Fields in ASEAN Member Statest

This report presents the results of research conducted by ERIA between 2023 and 2025. The study is based on two main components: (i) an assessment of the current patent examination guidelines and practices across ASEAN Member States (AMS); and (ii) an evaluation of the patentability of nine case examples developed by the Japan Patent Office (JPO), applying the JPO Examination Guidelines. The analysis reveals that the development and application of examination guidelines for pharmaceuticals and biotechnology vary across AMS. The research focuses on key patentability criteria, including patentable subject matter, industrial applicability, novelty, inventive step, and disclosure requirements. While the findings indicate broad convergence in examination practices across the region, notable differences remain in specific areas. The study also draws on insights from two interactive workshops involving patent examiners from all AMS. These exchanges contributed to a deeper understanding of both common approaches and divergences in practice. Overall, the project highlights the value of continued dialogue and co-operation amongst AMS intellectual property offices to strengthen consistency and advance patent examination practices in the pharmaceutical and biotechnology sectors.