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Home > Public Comments Invitation > Previous Comments > Invitation for Public Comments on Draft Revision of Examination Guidelines for “Industrially Applicable Inventions” and Draft Revision of Examination Guidelines for “Medicinal Inventions”

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Invitation for Public Comments on Draft Revision of Examination Guidelines for “Industrially Applicable Inventions” and Draft Revision of Examination Guidelines for “Medicinal Inventions”

August 6, 2009
Examination Standards Office
Japan Patent Office

On May 29, 2009, a report "Patent Protection in Field of Advanced Medical Technologies"(Intellectual Property Strategy Headquarters)"( External link ) was issued by the Advanced Medical Patent Exploratory Committee under the Expert Study Group on Enhancement of Competitiveness through Intellectual Property, the Intellectual Property Strategy Headquarters, which was reported to the 23rd meeting of Strategic Council on Intellectual Property on June 24. The contents of the report are as follows;

  • In order to protect the medicinal inventions with new dosage and administration, as inventions of "products,"which show the effect exceeding beyond the expectation of the person skilled in the art, Examination Guidelines should be revised, (adding the concrete examples)
  • In order to newly add "the methods for gathering data from the human body for assisting the conclusive diagnosis"(mechanisms or principles of tomographic imaging by MRI or X-ray CT etc.) to patentable subject matter, Examination Guidelines should be revised, (adding the patentable and non-patentable examples)

Recommended by the report the Draft Revision of Examination Guidelines of "Part II, Chapter 1 Industrially Applicable Inventions"and the Draft Revision of Examination Guidelines of "Part VII, Chapter 3 Medicinal Inventions"are established.The outlines of the Drafts Revision of Examination Guidelines are as follows.

(1) Regarding Part II, Chapter 1 "Industrially Applicable Inventions"

  • (i) The methods for gathering data from the human body is made not considered to be "the diagnostic methods practiced on the human body,"as long as it does not contain the surgical or therapeutic steps or the steps of judging the condition of diseases etc. of human for medical purposes.
  • (ii) The examples of the inventions related to the combinations of products (combination of physical means and biochemical means, combination of tissue-derived materials and scaffolding materials, and combination of tissue-derived materials and medicine etc.) are added.
  • (iii) It is made clear that the methods for cellular differentiation and induction etc. are not "methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body,"and the examples of the inventions of related arts are added.
  • (iv) The examples of the inventions of arts related to assisting devices are added.

(2) Regarding Part VII, Chapter 3 "Medicinal Inventions"

  • (i) In medicinal inventions, the invention is novel when there is difference between the invention and the conventional medicine in medicinal use of applying to a specific disease with a specific dosage and administration.
  • (ii) The examples of the inventions characterized in the medicinal use of tissue-derived materials (cells etc.) are added.
  • (iii) The examples of the inventions characterized in the medicinal use of cells specified by manufacturing process are added.

We invite interested parties to submit written comments on Drafts Revision of the Examination Guidelines. Comments should be submitted in the following way. The submitted comments will be considered as references in the final determination.

It should be noted that the applications which will be examined after the publication of the final version of the revised Examination Guidelines will be examined based on the revised Examination Guidelines, regardless to their filing dates.

With regard to the handling of related applications, please refer to this link.

Way of submitting written comments

1. Subject on which comments are invited

  • Draft Revision of Examination Guidelines for "Industrially Applicable Inventions"
  • Draft Revision of Examination Guidelines for "Medicinal Inventions"

2. Materials

The materials are available from the links above. Please note that Japan Patent Office (JPO) is unable to respond to requests for materials to be sent by mail, e-mail or fax.

3.Due date

Written comments must be received on or before Saturday, September 5, 2009.

4.Submission of comments

Comments should be submitted to:

<E-mail>

PA2A10@jpo.go.jp

The subject should be "written comment on Drafts Revision of Examination Guidelines"

<Facsimile>

+81-3-3597-7755

The subject should be "written comment on Drafts Revision of Examination Guidelines"

<Postal mail>

Examination Standards Office, Administrative Affairs Div., First Patent Examination Depart., Japan Patent Office, 3-4-3 Kasumigaseki, Chiyoda-ku Tokyo 100-8915, Japan

The subject should be "written comment on Drafts Revision of Examination Guidelines"

* The following information must be provided:(i) your name, (ii) contact information (telephone number, facsimile number, e-mail address), (iii) occupation, and (iv) place of employment. Please note that your comments cannot be accepted through telephone.

5.Notes

  • Comments must be written in English or Japanese.
  • Format type of the written comment is not restricted..
  • Please note that JPO will not send replies to each of the comments.
  • Please note that all descriptions except your name, address, telephone / facsimile number and e-mail address may be released to the public. However, if there are descriptions which are information concerning an individual capable of identifying the individual, or which are judged to have a fear of harming the properties etc. of the individuals / legal persons etc., the concerned descriptions will be concealed prior to the release of the comment to the public.
  • The individual information such as the name, the contact address etc. contained in the written comment will be appropriately managed and will be utilized only in the work related to the present invitation of the written comment, for example, in the contact with one who submitted the comments in case that there are uncertainties.
  • This English document is unofficial translations. Only the original Japanese text of "Examination Guidelines for Patent and Utility-model"has effect, and this translation is to be used solely as reference material to aid in the understanding of the examination guidelines.

[Last updated 6 August, 2009]

Contact Us

Examination Standards Office,

Administrative Affairs Division,

Japan Patent Office,

E-mail:PA2A10@jpo.go.jp

FAX:+81-3-3597-7755

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