Trilateral Project 24.1-Biotechnology 164

If antigen A' is novel, a monoclonal antibody to the novel antigen A' generally has novelty in both cases a and b. However, novelty could be denied if it can be established that the claimed monoclonal antibody is likely to be "identical" to the monoclonal antibody described in a prior art document or a prior application.

Also, even when antigen A' is novel, if antigen A having high a probability to possess the same epitope as that of A' (such as antigen A' being artificially modified from antigen A) is described in a prior art document or a prior application, there seems to be a high probability that both monoclonal antibodies (A and A') are identical. So in this case, novelty could be usually denied.