Revision of the Examination Guidelines for Patent and Utility Model

March 23, 2016
Japan Patent Office
Administrative Affairs Division
Examination Standards Office

The draft revision of Examination Guidelines was prepared based on the discussions at the 7th to the 9th meetings of the Working Group on the Patent Examination Standards supervised by the Patent System Subcommittee under the Intellectual Property Committee of the Industrial Structure Council.

The Japan Patent Office invited the public to submit comments on it from February 10, 2016 to March 10, 2016 and finalize the revision of the Examination Guidelines.

The Examination Guidelines related to the Patent Law Treaty will apply to patent applications filed on and after April 1, 2016. Other guidelines will be effective on and after April 1, 2016, regardless of filing dates.

• Use Invention of Foods
  “Part III Chapter 2 Section 4 Claims Including Specific Expressions” (PDF:147KB)
• Examination Guidelines related to the Patent Law Treaty
  “Part VI Chapter 4 Reference filing” (PDF:78KB)
  “Part VII Chapter 1 Overview of Foreign Language Written Application System” (PDF:105KB)
  
• Extension of Patent Term
  “Part IX Extension of Patent Term” (PDF:187KB)

Overview of the revision of Examination Guidelines

(i) Overview of the revision of Examination Guidelines for Patent and Utility Model in Japan related to the use invention for foods.

• (1) If there is the limitation of use in a claimed invention of foods, the examiner recognizes that the limitation of use has the meaning of specifying the claimed invention.
• (2) However, in cases where the invention is animals or plants, even if there is the limitation of use in a claimed invention, the examiner interprets such animals and plants as the animals and plants themselves without limitation of use because such a limitation of use only indicates the utility of animals and plants.

(ii) Overview of the revision of Examination Guidelines for Patent and Utility Model in Japan associated with a legislative amendment of the Patent Act, etc. for　accession, etc to Patent Law Treaty

• (1) New chapter of “Reference Filing” has been established and describes the overview of the system, the requirements and effects for reference filing, the determination on the substantive requirements (whether or not matters stated in the description or drawing(s) of a reference filing remain within matters stated in the claims, description or drawing(s) of an earlier patent application) and the procedure of the examination on the substantive requirements.
• (2) The precedent of “the addition of a new matter” is applied for the determination on the substantive requirements described above.
• (3) Others: the formal modifications associated with the enforcement of the Patent Act revised on 2015, etc.

(iii) Overview of the revision of Examination Guidelines for Patent and Utility Model in Japan related to an application for registration of extension of patent term

• (1) The interpretation of whether or not the disposition designated by Cabinet Order has been necessary to obtain for the working of the patented invention where both the present disposition and the prior disposition have been made.
  When an act of manufacturing and distribution of drug products or an act of manufacturing and import of agricultural chemicals subject to both the present disposition and the prior disposition falls under an act of working of the patented invention pertaining to an application for registration of extension, it is considered as follows:
  It is not deemed that the present disposition has been necessary to obtain for the working of the patented invention pertaining to the application for registration of extension, when manufacturing and distribution of drug products or manufacturing and import of agricultural chemicals subject to the prior disposition are found to include those subject to the present disposition as a result of comparing the two dispositions with respect to the examination matters related directly to substantial identity as drug products or agricultural chemicals in the light of the type and subject of the patented invention pertaining to the application for registration of extension.
• (1-1) Interpretation of “Examination matters related directly to substantial identity” in each patented invention
  There are examples of cases where the disposition designated by Cabinet Order is “an approval of manufacturing and distribution of pharmaceutical products”, “an approval of manufacturing and distribution of in vitro diagnostics”, “an approval of manufacturing and distribution of regeneration medicine etc.” or “a registration of agricultural chemicals” and the patented invention is “an invention of product”, “an invention of manufacturing process” or “an invention of drug formulation”. This disposition follows to the judgment of the Supreme Court.
• (1-2) Definition of Inclusion
  When the prior disposition and the present disposition are partially overlapped or they are completely overlapped, it is also regarded as one of the aspects of inclusion.
• (2) Information which should be included in a request of the application
  When the difference between the present disposition and the prior disposition needs to be clarified, the applicant can state “dosage and administration” in a column of “use” of “the details of disposition designated by Cabinet Order under the Article 67(2)” as the information which should be included in the application.

[Last updated 23 March 2016]

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Examination Standards Office Administrative Affairs Division Japan Patent Office E-mail:PA2A10@jpo.go.jp