IP High Court, 2018 (Ne) 10043 [Antibodies and Antibody Derivatives of Factor IX/Factor IXa] <Mori>
Updated: 2 days ago
Article information
Article type: Case note
Category: Patents
Topics: —
First published on this website: 2026-11-01
Display and classification checked: November 2, 2026
Originally published on Ameblo: 2024-08-07 (Japan time). Full English translation.
IP High Court, 2018 (Ne) 10043 [Antibodies and Antibody Derivatives of Factor IX/Factor IXa] <Mori>
*The limitations were held not satisfied even though some products fell within the invention's numerical range.
Functional claim
⇒ Invention defined by a numerical range
⇒ The reasons included that “it is considered difficult to ensure identity between a biosimilar … and the original drug.”
(Excerpt from the court's reasoning)
Considering …the description in the specification as well as …the wording of the claims for each invention, it is found that a person skilled in the art would understand that, among the several evaluation methods, when a chromogenic assay (FVIII assay) is performed, antibodies or derivatives falling within the inventions are those showing a measured-value-to-background ratio of at least 3 (ratio to the negative control). It is therefore appropriate to find that “increases procoagulant activity” means that, when a chromogenic assay is performed, the ratio to the negative control exceeds 3. …
Taking into account also the fact that, generally for biologics, their complex molecular structures and distinctive manufacturing processes make it difficult to ensure identity between biosimilars (follow-on biologics: products similar to an already approved original biologic by demonstrating similarity in quality characteristics, efficacy, and safety through direct or head-to-head comparison) and original drugs, even if some values exceed 3, the above experimental results, in which values are below 3 in many cases, do not permit a finding that the appellee's product falls within the technical scope of the inventions.
Translator’s notes (editorial)
The source quote uses both “at least 3” and “exceeds 3”; both thresholds are preserved.
Update history
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November 1, 2026: First published on this website.
November 2, 2026: Added article information, classification, topics, language navigation, related articles where the same case was confirmed, consultation guidance, and SEO. The original text and first-published date were preserved.
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