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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

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Invitation for Public Comments on the Draft Revision of Examination Guidelines for Patent Term Extension

November 2, 2011
Japan Patent Office
Administrative Affairs Division
Examination Standards Office

The draft revision of Examination Guidelines for “Patent Term Extension” is prepared based on the result of discussions on how to revise the Examination Guidelines for “Patent Term Extension” at the 6th meeting (August 19, 2011) and the 7th meeting (October 24, 2011) of the Working Group on the Patent Term Extension System supervised by the Patent System Subcommittee under the Intellectual Property Policy 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:111KB)

2. Due date

Written comments must be received on or before Thursday, December 1, 2011.

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 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., First Patent 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., First Patent 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. Basic principle of the draft revision of Examination Guidelines

The Examination Guidelines will be revised so that the interpretation of the phrase “obtaining the disposition designated by Cabinet Order was necessary for the working of the patented invention” in Article 67-3(1)(ⅰ) meets the following requirements:

  • The interpretation is consistent with the Supreme Court judgments (2009(Gyo-Hi)No. 324-326); and
  • The interpretation provides consistent explanations to any case, including cases where the product that is the subject of the prior disposition does not fall within the technical scope of the patented invention, which is the case of the Supreme Court judgments.

2. Important points of the draft revision of Examination Guidelines

(1)When making a judgment about the reasons for refusal specified in Article 67-3(1)(ⅰ), the examiner shall interpret the definition of “the working of the patented invention” as follows and judge whether “obtaining the disposition designated by Cabinet Order was necessary.”

The phrase “the working of the patented invention” should not be interpreted as an act of manufacturing and marketing or otherwise handling the drug product per se that was the subject of the disposition. Nor should it be interpreted as an act of manufacturing, importing, or otherwise handling the agricultural chemical per se that was the subject of the disposition. Instead, it should be interpreted as an act of manufacturing and marketing or otherwise handling such drug product or as an act of manufacturing, importing, or otherwise handling such agricultural chemical that is defined by the "matters falling under the matters to define the invention" of the drug product or the agricultural chemical. The "matters falling under the matters to define the invention" means all matters specified in the approval certificate for the drug product or the registration card, etc. for the agricultural chemical that fall under the matters to define the invention of the patented invention.

Where the matters to define a patented invention do not include the matters falling under the use, it is appropriate to interpret “the working of the patented invention” as an act of manufacturing and marketing or otherwise handling such drug product or as an act of manufacturing, importing, or otherwise handling such agricultural chemical that is defined by the “matters falling under the matters to define the invention and the use” of the drug product or the agricultural chemical. The “matters falling under the matters to define the invention and the use” means all matters specified in the approval certificate for the drug product or the registration card, etc. for the agricultural chemical that fall under the matters to define the invention of the patented invention and that fall under the use.

(2) In the case specified in (ⅰ) or (ⅱ) below, it is not deemed that “obtaining the disposition designated by Cabinet Order was necessary for the working of the patented invention” and the examiner would issue a notice of reasons for refusal under Article 67-3(1)(ⅰ).

  • (ⅰ) Where an act of manufacturing and marketing the drug product or an act of manufacturing and importing the agricultural chemical that was the subject of the disposition concerned does not constitute an act of working the patented invention concerning the application for registration of extension
  • (ⅱ) Where such part of the patented invention concerning the application for registration of extension that is defined by the “matters falling under the matters to define the invention” (where the matters to define a patented invention do not include the matters falling under the use, “matters falling under the matters to define the invention and the use”) of the drug product or agricultural chemical that was the subject of the disposition concerned has been able to be worked by a prior disposition

[Last updated 2 November 2011]

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