Trilateral Project 24.1-Biotechnology 107

Since monoclonal antibodies are generally obtained from cells producing these monoclonal antibodies, a concrete description needs to be provided so that a person skilled in the art can produce or obtain these cells. Moreover, "deposition" of cells producing these monoclonal antibodies is, in principle, required because it is not generally repeatable to obtain a hybridoma producing these specific monoclonal antibodies.

However, "deposition" of them is not required in case that monoclonal antibodies or a hybridoma producing such monoclonal antibodies can be easily obtained by a person skilled in the art, described below as 1) and 2).

1) In case that repeatability of obtaining the hybridoma producing the monoclonal antibodies is certain.

"Deposition" of such a hybridoma is not required if the hybridoma can be reproduced with a certain repeatability on the basis of i) such descriptions as working examples that a certain type of hybridoma producing the monoclonal antibody has been obtained several times or several types of such hybridomas have been obtained simultaneously, or ii) a certificate on the result of experiment submitted by the applicant that such hybridomas can be obtained without undue experimentation on the basis of the concrete description in the detailed description of the invention.

2) In case that the claimed invention is not related to monoclonal antibodies having specific properties but simply related to "monoclonal antibodies corresponding to antigen A".

Where antigen A clearly possesses immunogenecity, "deposition" is not generally required, because it is likely that several types of monoclonal antibodies corresponding to antigen A can be obtained without undue experimentation if not considering the conditions for specific cross-reactivity, etc.

"Deposition" is not required, provided that there is concrete disclosure, such as working examples, which show that the protein having certain immunogenecity can be obtained without undue experimentation, and that "monoclonal antibodies to antigen A" can be made by a person skilled in the art without undue experimentation, by using common method for producing monoclonal antibodies.