Trilateral Project 24.1-Biotechnology 185

The invention of monoclonal antibody to antigen A specified by technical means which is able to distinguish from the said publicly known monoclonal antibody has an inventive step, if the effect 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.

Therefore, the invention of the monoclonal antibody which is only specified by "class or subclass of immunoglobulin" or "produced by the deposited hybridoma" does not have an inventive step by itself.

However, the invention of the monoclonal antibody which is specified by "cross reactivity",would normally have an inventive step.