Heisei 20 (Gyo-Ke) 10366 [Gastritis Treatment Agent] <Iimura>
Updated: 1 hour ago
Article information
Type: Case note
Classification: Patents
Topics: Inventive step, Motivation and teaching away
First published on this site: 2023-12-30
Case number: Heisei 20 (Gyo-Ke) 10366
Display and classification checked: 2026-11-14
Heisei 20 (Gyo-Ke) 10366 [Gastritis Treatment Agent] <Iimura>
* Criteria for assessing inventive step of second-medical-use inventions
* Proof through post-filing literature and opinion letters counteracting a teaching away!!
⇒ Inventive step denied
‘... Post-filing literature and opinion letters ... also contain the view that ... ; throughout the period before and after filing, there was no established view that gastric ulcers and gastritis differ in their pathology and mechanisms of onset ... .’
(Extract from the court's reasoning)
[Claim] A therapeutic agent for gastritis caused by reflux of bile acids into the stomach, comprising ... as an active ingredient
For an invention concerning use of a substance, it goes without saying that whether a newly discovered property (use) could readily have been conceived by a person skilled in the art should be determined on the basis of publicly known technology and common general technical knowledge in the invention's field. In this case, where efficacy as a ‘gastric-ulcer treatment agent’ was known before filing, whether a person skilled in the art could readily conceive the technical idea that it also has efficacy as a ‘gastritis treatment agent’ should be determined by comprehensively considering (1) whether gastric ulcers and gastritis differ in pathology and mechanisms of onset; (2) whether gastric-ulcer and gastritis treatment agents differ in mechanisms of action; (3) comparison and examination of other drugs effective for both gastric ulcers and gastritis; and (4) whether factors discourage applying the compound to gastritis treatment, etc. ...
At the time of filing ... acute gastric mucosal lesions appear to have begun being identified as a cause of acute gastritis, but attacks on normal mucosa through gastric-juice irritation were also identified for gastric ulcers. It cannot be found that their pathologies or mechanisms of onset were recognized as clearly distinct. Post-filing literature and opinion letters show changes in gastritis classification after the discovery of H. pylori, but regarding the relationship between gastric ulcers and gastritis, some take the view that gastric ulcers are advanced gastritis (Otsu 8), while others, such as the plaintiff's opinion letter, take the view that they differ in their mechanisms of onset (Ko 52). It should therefore be said that, throughout the period before and after filing, there was no established view that gastric ulcers and gastritis differ in pathology and mechanisms of onset. Accordingly, it is difficult to find that, at the filing date, persons skilled in the art recognized gastric ulcers and gastritis as different in pathology and mechanisms of onset and their therapeutic agents as different in mechanisms of action.
Originally published: 2023-12-30
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Update history
The first publication date and update dates are recorded separately. Display maintenance does not mean that the legal analysis was re-verified.
2026-11-14: Display and classification maintenance (article information, issue tags, language/SEO links, related articles, and consultation path added).
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