1. Summary of the Judgment (Court Case No.10093 (Gyo-ke) 2022 = Court Case No.10094 (Gyo-ke) 2022)
“Regarding competition of this invention with PCSK9, the specified matters of the invention which are ‘competing with reference antibodies’ are not limited to antibodies that bind to the same or overlapping positions as the reference antibodies, as alleged by the defendant, but also include antibodies that compete with PCSK9 in a manner that causes steric hindrance in the binding of PCSK9 to LDLR protein. Therefore, such antibodies are required to be supported as binding-neutralizing antibodies. Despite the foregoing, unlike the case of antibodies that bind to the same or overlapping positions to which the reference antibodies bind, there is no description in the specification of the mechanism by which antibodies that compete in the manner of binding to positions which then causes steric hindrance in the binding of PCSK9 to LDLR protein neutralize the binding …, there is nothing in the description to suggest that these are at least sterically interfering antibodies. In this case, it must be said that the detailed description of the invention in the specification does not disclose anything about the binding-neutralizing activity of an antibody that competes with a reference antibody in a manner that cause steric hindrance in the binding of PCSK9 to the LDLR protein. Therefore, from this point of view, the invention does not satisfy the support requirement.
The defendant argues that even if there is an antibody that competes with … 21B12 antibody (the reference antibody) but cannot neutralize the binding of PCSK9 to LDLR protein, such an antibody is excluded from the technical scope of this invention 1 in terms of the wording, and therefore this is not a reason for the invention to violate the support requirements. However, … if there is an antibody that competes with 21B12 antibody, the technical significance of this invention should be that it is identified as having functional characteristics as a binding neutralizing antibody between PCSK9 and LDLR protein by the same mechanism as that of 21B12 antibody. Therefore, it is clear that if antibodies that compete with 21B12 antibody include those that do not have binding neutralization, that assumption of their technical significance is invalidated (in a case such as this case, if it is interpreted that it is sufficient to exclude no binding-neutrality in terms of wording, it would also be permissible to specify very broadly where the antibody binds to PCSK9 – e.g., to most of PCSK9 – which would allow the patent claims to be broad without justification; therefore, the interpretation is not reasonable).
In a separate case for revocation of the trial decision concerning this invention, the allegation by Sanofi regarding violation of the support requirement was dismissed. However, it is also possible to understand that this is due to the natural assumption that an antibody competing with 21B12 antibody would bind to the same position on PCSK9 as 21B12 antibody and have the same function as 21B12 antibody, in light of the circumstances of the allegations and proof at the time. In contrast, in this case, despite the fact that the aforementioned premise has been called into question by new claims based on new evidence, such as the statements of Dr. [A] and Dr. [B], structural analysis by Professor [F]’s expert opinion, etc. …, and related documentary evidence concerning an “EGFa mimic antibody” …, etc., there is no decision criteria to support the aforementioned premise. Therefore, this should be a reasonable basis for the difference between the conclusion of the separate judgment and the judgment in this case.”
2. Some Considerations
As for the logic that was accepted in the previous final decision that the support requirement is satisfied by reciting a particular effect in the claim, the court in this case did not approve the logic, finding that “if it is interpreted that it is sufficient to exclude in terms of wording any antibody that has no binding-neutrality, it would also be permissible to specify very broadly the locations where the antibody binds to PCSK9, such as to most of PCSK9, thus allowing the patent claims to be broad without justification; therefore, the interpretation is not reasonable”.
Writer: Hideki TAKAISHI
Supervising editor: Kazuhiko YOSHIDA
Hideki TAKAISHI
Attorney at Law & Patent Attorney
Nakamura & Partners
Room No. 616, Shin-Tokyo Building,
3-3-1 Marunouchi, Chiyoda-ku,
Tokyo 100-8355, JAPAN