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Home > Public Comments Invitation > Previous Comments > Invitation for Public Comments on the Draft Revision of Examination Guidelines for “Patent Term Extension” Brought by the Revision of the Pharmaceutical Affairs Law

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Invitation for Public Comments on the Draft Revision of Examination Guidelines for “Patent Term Extension” Brought by the Revision of the Pharmaceutical Affairs Law

October 8, 2014
Japan Patent Office
Administrative Affairs Division
Examination Standards Office

The draft revision of Examination Guidelines for “Patent Term Extension” is 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. We invite public comments as outlined below.

1. Subjects on which comments are invited

The draft revision of Examination Guidelines for “Patent Term Extension” (PDF:83KB)

2. Due date

Written comments must be received on or before Thursday, November 6, 2014.

3. Submission of comments

Please give us your name*, contact information, and occupation, and send us your comments via one of the following methods:

* If you are a corporate body or an institution, please give us the name of the body, department, and person in charge.

E-mail

pa2a10@jpo.go.jp

Please use "Written comments on the draft revision of Examination Guidelines for Patent Term Extension" as the subject line.

Facsimile

+81-3-3597-7755

To the attention of: Examination Standards Office, Administrative Affairs Div., Patent and Design Examination Depart., Japan Patent Office

Please use "Written comments on the draft revision of Examination Guidelines for Patent Term Extension" as the subject line.

Postal mail

To the attention of: Examination Standards Office, Administrative Affairs Div., Patent and Design Examination Depart., Japan Patent Office

3-4-3 Kasumigaseki, Chiyoda-ku Tokyo 100-8915, Japan

Please use "Written comments on the draft revision of Examination Guidelines for Patent Term Extension" as the subject line.

4.Notes

Please note the following.

  • The comments submitted to us will be collectively taken into consideration when we make the final decisions. It is not our intention to respond to individual comments. In principle, no replies will be offered to inquiries on hypothetical cases and comments unrelated to this revision.
  • We do not accept comments and inquiries by telephone.
  • All descriptions excepting your name and contact information may be released to the public. However, if a comment contains personal information that could make it possible to identify an individual commenter, the concerned descriptions will be concealed prior to the release of the comment to the public.
  • The personal information included with your comments, such as your name, contact information etc., will be managed appropriately, and will only be used for administrative affairs related to the invitation for public comments, such to contact you in the event that we have any questions concerning your comments.

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 will be applied to any applications to register a patent term extension filed on or after November 25, 2014.

[Last updated 8 October 2014]

Contact Us

Examination Standards Office,

Administrative Affairs Division,

Patent and Design Examination Depart,

Japan Patent Office

E-mail:pa2a10@jpo.go.jp

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