IP Court Decision Digest: "Pharmaceutical Preparation" Patent Case (Reiwa 7 (Gyo-Ke) No. 10073)

WISECODE Take

This ruling by the Japan Intellectual Property High Court highlights a common misconception among many business owners: even if a technical solution effectively solves a problem, it may not necessarily possess the 'inventive step' required by patent law. In sports, merely following basic rules without demonstrating extraordinary skill or innovative strategy will not lead to victory. Similarly, if an invention simply conforms to industry norms or regulatory requirements, such as packaging a 'pharmaceutical preparation' containing 'ripasudil' to 'block light with wavelengths of 300-335nm' to ensure stability, it may be deemed an obvious solution to a 'person skilled in the art' under patent law. The Japan Intellectual Property High Court, in case 'Patent Reiwa 7 (Gyo-Ke) No. 10073', upheld the decision of lacking inventive step, ruling that such an effect was 'an effect predictable by a person skilled in the art'. For companies in the pharmaceutical, food, or any highly regulated industry, this case serves as a reminder that designs made solely to comply with market approval requirements like 'pharmaceutical approval', if merely 'naturally discoverable properties', may struggle to gain patent protection. This does not mean compliance is unimportant, but rather that patent strategies must go beyond basic compliance, seeking true innovation. Otherwise, businesses risk investing in R&D without securing market exclusivity. First, companies should conduct prior art searches early in the R&D phase and assess the 'non-obviousness' of their technology, rather than focusing solely on functionality or regulatory compliance. Second, when applying for a patent, beyond detailing the technical efficacy, it is crucial to emphasize how the solution surpasses the expectations of 'a person skilled in the art' or the limitations of existing technology. In the arena of patents, compliance is merely an entry ticket, but innovation is the key to victory. Zhidian offers patent portfolio health check services to help businesses evaluate the competitiveness of their patent assets.