• HOME
  • Announcements
  • Obtaining IP Rights
  • JPO Activities
  • Statistics ⁄ References
  • About JPO
  • FAQs

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

Main content starts here.

Revision of the Examination Guidelines for "Patent Term Extension"

February 14, 2012
Japan Patent Office
Administrative Affairs Division
Examination Standards Office

The draft revision of the Examination Guidelines for "Patent Term Extension" was 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.

The Japan Patent Office invited the public to submit comments on it from November 2, 2011 to December 1, 2011 and finalized the revision of the Examination Guidelines for "Patent Term Extension" on December 28, 2011.

The Revised Examination Guidelines are applied to the applications that are examined on and after December 28, 2011.

The Revised Examination Guidelines for "Patent Term Extension" (PDF:68KB)

Reference Information about the Revised Examination Guidelines on Patent Term Extension

1. Basic principle of the revision of the Examination Guidelines

The Examination Guidelines were 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 Revised 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 that was the subject of the disposition. The "matters falling under the matters to define the invention" means all matters specified in the approval certificate or the registration card, etc. that fall under the matters to define the invention of the patented invention.

If the patented invention does not include any matters specifying 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 that was the subject of the disposition. The "matters falling under the matters to define the invention and the use" means all matters specified in the approval certificate or the registration card, etc. 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 or 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 14 February 2012]

Contact Us

Examination Standards Office

Administrative Affairs Division

Japan Patent Office

E-mail : PA2A10@jpo.go.jp 

download Adobe Reader

Some of the publications on this site are in PDF format. To view them, you will need to have Adobe Acrobat Reader. Please click the graphic link to download Acrobat Reader.