IP High Court, Reiwa 2 (Gyo-Ke) No. 10094 — Agent for suppressing recurrence of reflux esophagitis (Judge Mori)
Updated: 4 days ago
Article information
Article type: Case note
Category: Patents
Topics: Inventive step
First published on this site: 2026-10-10
Display/classification checked: 2026-10-10
IP High Court, Reiwa 2 (Gyo-Ke) No. 10094 — Agent for suppressing recurrence of reflux esophagitis (Judge Mori)
*Common general knowledge at the priority date: completion of a phase II clinical trial led to denial of inventive step.
Phase I clinical trial: safety trial
Phase II clinical trial: efficacy trial with a small number of participants
Phase III clinical trial: efficacy trial with a large number of participants
<Difference>
Invention 1 is an “agent for suppressing recurrence of proton-pump-inhibitor-resistant reflux esophagitis,” containing “rabeprazole sodium” as its active ingredient and administered “for maintenance therapy.” By contrast, Invention Ko 1 is “rabeprazole sodium (E3810) used in a phase III clinical trial to examine efficacy and safety” “in maintenance therapy for patients with PPI-resistant reflux esophagitis.”
(Excerpts from the judgment, translated; portions omitted)
[...] In light of common general knowledge concerning safety, the tolerability of long-term administration of 20 mg of rabeprazole sodium once daily in maintenance therapy was clear to a person skilled in the art at the priority date. [...] Considering also that no safety difference was thought to exist between twice-daily and once-daily administration, [...] no circumstance indicating an obstacle from the perspective of clinical safety to administration of “10 mg per dose twice daily” for “four weeks or more” is apparent. [...] A person skilled in the art could readily have conceived of using the rabeprazole sodium of Invention Ko 1 as a recurrence-suppressing agent administered during maintenance therapy for patients with PPI-resistant reflux esophagitis, thereby adopting the matters specifying Invention 1 relating to Difference 1. [...]
The plaintiff relies on the 2017 judgment (Heisei 28 (Gyo-Ke) No. 10107). However, that judgment addressed “novelty,” not “inventive step,” and plainly concerned a different case.
Original article (2025-08-14):
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This history records actual publication, display, and classification changes made on this site.
2026-10-10: First published the LinkedIn original on this site and set the classification, article information, and consultation link.
2026-10-10: Aligned the translation link, canonical URL and hreflang with the verified public URLs.
2026-10-10: Updated related-article links. The original article text was not changed.
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