Trilateral Project 24.1-Biotechnology 182

Even if the antigen A' used for the production of a monoclonal antibody to antigen A' is novel, when a monoclonal antibody to antigen A which is so closely similar to antigen A' as to be very likely to have the same epitopes as those of antigen A' is publicly known, it is very likely that such two monoclonal antibodies are the same. Therefore, in such a case, novelty cannot be present(see 2.2(6)).

However, the invention Y' of a specific monoclonal antibody to antigen A' would have inventive step, when there is some difference between the specific monoclonal antibody and that of prior art with respect to, for example, affinity to antigen A', cross reaction to other antigens which are different from A or A', and when the effect based on this difference is either qualitatively different from that of prior art or a qualitatively homogeneous but quantitatively superior, which cannot be expected by a person skilled in the art on the basis of the state of the art as of the filing.

In addition, there is no difference in the above judgement even if antigen A' is a modified protein of antigen A.