Trilateral Project 24.1-Biotechnology 104

A working example concerning a monoclonal antibody is not necessary if the protein can be obtained without undue experimentation (for example, there is a concrete description in a working example concerning the protein), and if the monoclonal antibody corresponding to the protein can be obtained without undue experimentation by a person skilled in the art by using a common method to prepare a monoclonal antibody. However, with regard to a specific monoclonal antibody having uncommon properties, a working example is necessary in general, because it is generally difficult for a person skilled in the art to obtain this specific monoclonal antibody without undue experimentation.

For example, when it is clear from such facts as a disclosure of polyclonal antibody to the protein that a protein possesses immunogenecity, the claimed invention meets the enablement requirement, without a working example of producing the monoclonal antibody. A decision about the immunogenecity is as follows with respect to items (a) - (c).

• (a) Immunogenecity cannot be recognized by the mere description of molecular weight.
  
• (b) A monoclonal antibody for diagnostic agent is usually produced by a non-human animal such as a mouse. Thus, immunogenecity to the animal cannot be recognized by the mere description that the protein is not originating in human being.
  
• (c) If an antibody corresponding to very similar protein to the claimed protein has been already obtained, it is very likely that the protein relating to the claimed invention possesses immunogenecity, though it depends on the extent of similarity.