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Home > Public Comments Invitation > Feedback > Revision of the Examination Guidelines for “Patent Term Extension”

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Revision of the Examination Guidelines for “Patent Term Extension”

January 6, 2015
Japan Patent Office
Administrative Affairs Division
Examination Standards Office

The draft revision of Examination Guidelines for “Patent Term Extension” was prepared based on the discussions at the 2nd meeting (October 3, 2014) 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 October 8, 2014 to November 6, 2014 and finalized the revision of the Examination Guidelines for “Patent Term Extension” on November 25, 2014.
The Revised Examination Guidelines are applied to any applications to register a patent term extension filed on or after November 25, 2014.

The Revised Examination Guidelines for “Patent Term Extension” (PDF:252KB)

Reference Information about Draft Revision of Examination Guidelines on Patent Term Extension

1. Rename of Pharmaceutical Affairs Law and an Addition of the dispositions designated by Cabinet Order

The “Law for Partial Amendment to Pharmaceutical Affairs Law and Other Legislation” will rename “Pharmaceutical Affairs Law” to “the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics”. “Pharmaceutical Affairs Law” written in the Examination Guidelines will be replaced in line with the said rename.
An approval of regenerative medicine products will be added as the dispositions designated by Cabinet Order, and an approval of in vitro diagnostics will be defined in different provisions from those of pharmaceuticals by the new law. For concise description, “a drug product, an in vitro diagnostic, and a regenerative medicine product” will be defined as a “DRUG PRODUCT” in the Examination Guidelines.

2. Matters to be stated in an application form

In principle, in the case of making application for an in vitro diagnostic and a regenerative medicine product, the 2 items in the application form, i.e. “the product that was the subject of the disposition” and “use” under the section of “the details of the disposition designated by the Cabinet Order under Article 67(2)” , should be written as follows.

  • ”The product that was the subject of the disposition”
    In the case of an in vitro diagnostic, the name (product name, etc.) and component involved in reaction system specified in the approval certificate must be written in.
    In the case of a regenerative medicine product, the name (product name, etc.) and component cell or transgene specified in the approval certificate must be written in.
  • ”Use”
    In the case of in an in vitro diagnostic, purpose of use specified for it in the approval certificate must be written in.
    In the case of a regenerative medicine product, indications or performance specified for it in the approval certificate must be written in.

3. Date of implementation

The revised Examination Guidelines are applied to any applications to register a patent term extension filed on or after November 25, 2014.

[Last updated 6 January 2015]

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Examination Standards Office

Administrative Affairs Division

Japan Patent Office

E-mail:PA2A10@jpo.go.jp

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