IP High Court, Reiwa 6 (Gyo-Ke) 10073 [Therapeutic agent inducing cytotoxicity] <Judge Masuda>
更新日:3 日前
Article information
Article type: Case note
Category: Patents
Topics: Inventive step
First published on this website: October 6, 2026
Case information: Reiwa 6 (Gyo-Ke) 10073 [Therapeutic agent inducing cytotoxicity] <Judge Masuda>
Display/classification checked: October 6, 2026
IP High Court, Reiwa 6 (Gyo-Ke) 10073 [Therapeutic agent inducing cytotoxicity] <Judge Masuda>
≈ Reiwa 6 (Gyo-Ke) 10074
* Even if a particular mutation was common general technical knowledge, it cannot necessarily be said to have been disclosed in the cited reference.
⇒ Nevertheless, inventive step denied.
(Judgment, translated)
Regarding Difference 3 (whether aspartic acid at position 265 of the Fc region is mutated to alanine), paragraph [0744] of Exhibit Ko 10 merely states that “certain other Fc regions” may be used where it is desirable to eliminate or reduce effector function. It does not clarify specifically what those “certain other Fc regions” are. Thus, even if the D265A mutation in the Fc region was well-known technology or common general technical knowledge as one means of reducing Fcγ receptor binding affinity and effector function, it cannot go so far as to be said that the specific D265A mutation is described, or is equivalent to being described, as one of those “certain other Fc regions.”
⇒ Nevertheless, in the bispecific antibody of the Ko 10 invention, which does not require effector function, introducing the D265A mutation into the Fc region on the basis of that common general technical knowledge would have been readily conceivable to a person skilled in the art.
⇒ Inventive step denied.
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