Trilateral Project 24.1-Biotechnology 131

For an invention to be patentable, it must be industrially applicable. A "product can be used" is interpreted as meaning that a product can be used in an industrially applicable way. This should be shown in the detailed description of the invention. Thus, the way of industrial application of the product shall be explicitly described in the detailed description of the invention except where it could be understood by a person skilled in the art without such a explicit description when taking into account the overall descriptions of the specification (excluding claims), drawings and common general knowledge as of the filing. (Implementing Guidelines I-1-3.2.1(2) )

Furthermore, if "a person skilled in the art" who is supposed to have ordinary skill cannot understand how to carry out the invention on the basis of teachings in the specification (excluding claims) and drawings taking into consideration the common general knowledge as of the filing, then, such a detailed description of invention should be deemed insufficient for enabling such a person to carry out the invention. (For example, if a large amount of trials and errors or complicated experimentation are needed to find a way of carrying out the invention beyond the reasonable extent that can be expected from a person skilled in the art who is supposed to have ordinary skill, such a description should not be deemed sufficient.) (Implementing Guidelines I-1-3.2 (Note 2) )

In addition, according to the "Examination Guidelines for Patent and Utility Model in Japan" (published in June 1993), an invention concerning a gene, vector, recombinant vector, transformant or fused cell whose utility is not described in a patent specification or cannot be inferred, does not satisfy the requirement set forth in the first sentence in Patent Law Section 29(1). (Examination Guidelines VIII-2-4.3.1)