Revision of Examination Guidelines for "Industrially Applicable Inventions"and Revision of Examination Guidelines for "Medicinal Inventions"

October 23, 2009
Japan Patent Office

On May 29, 2009, a report "Patent Protection in Field of Advanced Medical Technologies"(Intellectual Property Strategy Headquarters)" 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"were published on August 6, and we invited interested parties to submit written comments on them. Considering the submitted public comments, these guidelines are revised as follows.

These revised guidelines will be applied to the applications that are examined on and after November 1, 2009.

In addition, while the examination of the related applications have been now postponed (with regard to the handling of these applications, please refer to this link.), JPO will initiate the examination on November 1, 2009.

Revised Examination Guidelines for "Industrially Applicable Inventions"<PDF 242KB>

Revised Examination Guidelines for "Medicinal Inventions"<PDF 139KB>

(Reference) The outlines of the Revised Examination Guidelines:

(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 "methods of diagnosis of humans,"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 of inducing differentiation of cells etc. are not "methods of surgery, therapy or diagnosis of humans,"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.

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[Last updated 23 Oct 2009]