Case No. 2025 (Gyo-ke) 10051
Updated: 1 hour ago
Article information
Categories: Patents
Topics: Inventive step / Design choices / Numerical limitations and parameters
Published on this website: 2026-09-29
Case No. 2025 (Gyo-ke) 10051
[Pharmaceutical product] (Koa v. Toa)
(Presiding Judge Masuda)
*Inventive step denied
Using a container made of polyolefin resin (PE, PP) for ripasudil eye drops is a design matter based on well-known technology and is readily conceivable.
Regarding "0.4 g as the free form per 100 mL of the aqueous composition"
(Translation of the quoted judgment)
"The concentration of the active ingredient in eye drops is a design matter set by a person skilled in the art within a range in which the desired effect can be expected. In preparing an ophthalmic solution premised on application to humans, designing the concentration of the active ingredient by reference to doses in rabbits and monkeys is a technical matter self-evident to a person skilled in the art.
Thus, it is natural for a person skilled in the art who encounters the finding in Exhibit Ko 2 that K-115 lowers intraocular pressure in a dose-dependent manner to seek to design a concentration expected to lower intraocular pressure in humans, based on the rabbit and monkey doses shown in Exhibit Ko 2, expecting improvement in the intraocular-pressure-lowering effect in humans … and it is recognized that this could readily have been reached."
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