A REVISION FOR THE JAPANESE PATENT EXAMINATION GUIDELINES OF "METHODS OF SURGERY, THERAPY OR DIAGNOSTIC OF HUMANS."

December 5, 2003

HARAKENZO World Patent & Trademark Patent Law Firm
Patent Attorney Ichiro KANEKO

1.SUMMARY

The Japanese patent examination guidelines of "methods of surgery, therapy or diagnostic of humans." have been recently revised to define that "manufacturing methods for medicines or medical equipment made from human parts (e.g.cultured epidermal sheets and artificial bones) with the purpose of returning it to the same person ” are within the scope of patent granting.

The revised Japanese patent examination guidelines have been applied to the examination procedure after August 7 ,2003.

2. A SPECIFIC EXAMPLE OF AN INVENTION THAT IS PATENTABLE UNDER THE REVISED EXAMINATION GUIDELINES

〔Patentable under revised Examination Guidelines〕

(Title of the Invention)

A Manufacturing Method of a Cell for Gene Therapy

(Claims)

A manufacturing method of a cell for cancer treatment, comprising:

introducing DNA coding for a protein X and DNA coding for a protein Y, via a vector Z, into a cell W extracted from a human body.

(Excerpt from the Detailed Description of the Invention)

The recombinant-cell drug for cancer treatment obtained by the manufacturing method was found to be effective in suppressing vascularization, which is a characteristic of cancer tissue, and in reducing cancer by the stimulation of the immune system.

The cell may be obtained from a donor of the same lineage, but the cell of the patient himself is most preferable in view of compatibility.

[Discussion]

Methods of manufacturing medicines such as a recombinant-cell drug using a human-derived cell as a raw material do NOT fall under the “methods of surgery, therapy or diagnostic of humans,” even though the cell is derived from the patient himself, as described in the Detailed Description of the Invention.

〔Unpatentable even under revised Examination Guidelines〕

(Title of the Invention)

A Gene Therapy Method

(Claims)

A method for reducing cancer, comprising:

injecting DNA coding for a protein X and DNA coding for a protein Y, via a vector Z, into a human body.

(Excerpt from the Detailed Description of the Invention)

Injecting the recombinant vector into a human body was found to be effective in suppressing vascularization, which is a characteristic of cancer tissue, and in reducing cancer by the stimulation of the immune system.

[Discussion]

The method in which a recombinant vector is injected into a human body is merely “a method of treating human.”

3. A COMPARATIVE TABLE CONCERNING PATENT GRANTING FOR INVENTIONS IN MEDICAL SERVICES IN JAPAN(JP), UNITED STATES OF AMERICA (US) AND EUROPEAN PATENT CONVENTION(EPC).

	JP	US	EPC
Diagnostic, therapeutic and surgical methods for the treatment of humans.	No	Yes	No
Methods to process parts extracted from a human body with the assumption that the extracted part is to be returned to the same person for therapy.	No→Yes （revised）	Yes	Yes
Medical equipments.	Yes	Yes	Yes
Execution limit provision on patent rights for medical activity by physicians	No	Yes	No
Diagnostic, therapeutic and surgical methods for the treatment of animals.	Yes	Yes	No

4. BACKGROUND OF THE REVISION FOR THE GUIDELINES

(1) Current application of medical inventions to the Patent Law

In the field of regenerative medicine and gene therapy, which has made significant progress in recent years, new technology such as methods of cultivating skin and processing cells have been created. There is a tendency for the manufacture, etc. of products derived from biotechnology to be conducted by those other than physicians, and applications for manufacturing approval by the authorities are expected to increase for processed or treated products derived from biotechnology as medicines or medical equipment. Under such changing circumstances, in order to clarify how to handle new technology under the Patent Law for the purpose of further promotion of inventions employing such technical developments.

(2) Application of processing methods of regenerative medicine (before revision of the Japanese patent examination guidelines).

In regard to the methods of manufacturing medicines or medical equipment (e.g. cultured epidermal sheets) from material extracted from a human body (e.g. cells), criteria for granting a patent differs for those in which the manufactured medical equipment is transplanted in another (allograft) and for those in which it is transplanted in the same body (autograft). The basis for this is that the latter (autograft) applies to the“method to process the parts extracted from a human body with the assumption that the extracted part is to be returned to the same person for therapy” and so cannot be granted a patent.

However, in view of the current situation that these actions are conducted within industries away from medical institutions as described above, at least this technology/methods may be interpreted as being industrially applicable, whether allograft or autograft. Therefore patents should be granted for methods of processing used for regenerative medicine for the purpose of promoting investment for research and development in the field of regenerative medicine and gene therapy, which has made significant progress in recent years .

(3) Revision of the Japanese patent examination guidelines of "methods of surgery, therapy or diagnostic of humans."

Based on the above discussions the Japanese patent examination guidelines of "methods of surgery, therapy or diagnostic of humans" have been recently revised to define that "manufacturing methods for medicines or medical equipment made from human parts (e.g.cultured epidermal sheets and artificial bones) with the purpose of returning it to the same person ” are within the scope of patent granting