Trilateral Project 24.1-Biotechnology 005

[1994-Revised Patent Law (applicable to applications filed 1995.7.1 - )]

1) Provisions on the detailed description of an invention

Patent Law Section 36(4)
"The detailed description of an invention shall be stated, as provided for in an ordinance of the Ministry of International Trade and Industry (Ministerial Ordinance requirement), and in such a manner sufficiently clear and complete for the invention to be carried out by a person having ordinary skill in the art to which the invention pertains (enablement requirement.)"

The "ordinance of the Ministry of International Trade and Industry" is provided for the Section 24^bis of Regulation under Patent Law as follows (Ministerial Ordinance requirement):
"Statements of the detailed description of the invention which are to be in accordance with an ordinance of the Ministry of International Trade and Industry under Section 36(4) shall state the problem to be solved by the invention and its solution, or other matters necessary for a skilled person in the art to understand the technical significance of the invention." (Section 24^bis of Regulation under Patent Law)

According to the Implementing Guidelines for 1994-Revised Section 36 of the Patent Law (hereinafter merely referred to as "Implementing Guidelines"), the practice of the enablement requirement under Patent Law Section 36(4) ("in such a .... pertains.") is as follows:
"The detailed description of the invention shall be described in such a manner that a person who has ability to use ordinary technical means for research and development (including comprehension of document, experimentation, analysis and manufacture) and to exercise ordinary creative activity in the art to which the invention pertains can carry out the claimed invention on the basis of matters described in the specification (excluding claims) and drawings taking into consideration the common general knowledge as of the filing." (Implementing Guidelines I-1-3.2)

2) Provisions concerning claims

Patent Law Section 36(6)
"The statements of the scope of claim shall comply with each of the following items:

• (i) the invention for which a patent is sought is the one described in the detailed description of the invention;
  
• (ii) the invention for which a patent is sought is clear;
  
• (iii) statements of each claim is concise;
  
• (iv) statements are as provided in an ordinance of the Ministry of International Trade and Industry."

• Item (i) - This item is satisfied if a matter corresponding to what is claimed is written in the detailed description of the invention. (Implementing Guidelines I-1-2.2.1)
• Item (ii) - When determining the clarity of the claimed invention, the examiner should consider not only statements of the claim but also descriptions in the specification (excluding claims) and drawings, taking into consideration the common general knowledge as of the filing. (Implementing Guidelines I-1-2.2.2(2))
• Item (iii) - This item does not deal with the inventive concept defined by the claim statement but deals with the conciseness of the statement itself. Also, it does not require plural claims as a whole be concise when an application contains two or more claims. Rather, it requires each claim be stated concisely. (Implementing Guidelines I-1-2.2.3)
• Item (iv) - This item is the legal requirement regarding technical rules of claim drafting. (Implementing Guidelines I-1-2.2.4)

[1987-Revised Patent Law (applicable to applications filed 1988.1.1 - 1995.6.30)]

Under the 1987-Revised Patent Law, only "indispensable constituent features of the invention for which a patent is sought" shall be set forth a claim (see old Section 36(5)(ii)).
The practice under the old Section 36(5)(ii) is as follows according to Examination Guidelines for Patent and Utility Model in Japan (published in June 1993) (hereinafter merely referred to as "Examination Guidelines")
That "the indispensable constituent features of the invention for which a patent is sought" are defined, implies that an invention for which a patent is sought is clearly identified by the features defined in a claim. Typical examples of statements violating is requirement are the following;

• 1) features defined in claims are composed of a single technical means and the technical means is expressed functionally or operationally.
  
• 2) a technical means is expressed by a process in an invention of a product. However, when there is no other appropriate expression besides the expression using a process and the product can be specified thereby, it does not violate the old Section 36(5)(ii). (Examination Guidelines I-1-3.3 )