Revision of Japanese Patent Examination Guidelines Regarding Medical Activity

I. The Japanese Patent Examination Guidelines regarding medical activity were revised as of August 7th, 2003. The revised Guidelines are applied to all patent applications to be examined after August 7th, 2003, irrespective of their filing dates.

Summary of the revised Guidelines
Point 1) Methods for manufacturing medicines (such as hematological drugs, vaccines, genetically modified medicines) or medical parts (such as artificial bones, cultured epidermal sheets) utilizing material obtained from the human body are now patentable, even if such methods are performed on the presumption that the resultant manufactures will be returned to the same human body.

Point 2) Operating methods performed in a medical instrument or apparatus having no step for applying to the human body are now patentable.

II. Revised Examination Guidelines (Excerpt) (Added portions are underlined)

“Methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body” are deemed to be industrially inapplicable, and therefore unpatentable (Article 29-1 of the Patent Law).

Regarding Point 1)
Methods for treatment of samples that have been removed from the human body (e.g. blood, tissues, or hairs), or methods of gathering data by analyzing the same, are not included in “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.” However, if the methods for treatment of these samples are performed on the presumption that they will be returned to the same human body (e.g. a treatment of blood by dialysis), then such methods are considered as “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.”

Methods for manufacturing medicines (such as hematological drugs, vaccines, genetically modified medicines) or medical parts (such as artificial bones, cultured epidermal sheets) utilizing material obtained from the human body are not considered “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body,” even if such methods are performed on the presumption that the manufactures will be returned to the same human body.

Furthermore, methods for contraception or delivery are also included in “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.”

Regarding Point 2)
An instrument or apparatus for use in such methods [medical acts], or a pharmaceutical substance, is a product, and is not included in “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.” On the other hand, an operating procedure on the human body by means of such an instrument (e.g. a scalpel) or a method for treating the human body with a pharmaceutical substance is considered, “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.” Operation methods performed in a medical instrument or apparatus are not considered “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.”

III. Examples

The following examples are considered as not consisting “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body,” and are therefore patentable.

Example 1)
Title: Method for manufacturing cells for gene therapy

Claim:
A method for manufacturing cancer therapy cells, comprising:
introducing genes into W cells removed from the human body, using Z vector including DNA coding X protein and DNA coding Y protein.

Example 2)
Title: Image processing method in an X-ray CT device

Claim:
An image processing method in an X-ray CT device, comprising the steps of:
obtaining image data by performing reconfiguration processing based on dose distribution detected by X-ray detecting means;
comparing picture elements of said obtained image data with a threshold previously stored in a memory;
replacing the picture elements in a picture element area determined by the comparison to be lower than the threshold, with zero to remove noise;
and
transferring the image data clear of noise to display means.

Description:
An X-ray CT device according to the present invention can obtain excellent image data by reconfiguring based on dose distribution and removing picture elements lower than a threshold as noise. §c§c

Explanation
A method invention expressing functions of a diagnostic device is considered substantially equivalent to the diagnostic device itself as long as the recited steps are all performed in the device, and therefore such a method invention is not considered as “methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body.”
However, if a claim describes a step for detecting a signal from the human body or a step for applying to the human body, then such a claim is considered a diagnostic method on the human body or a preparative treating method and is therefore unpatentable.

IV. Patentable and unpatentable medical inventions according to the revised Guideline are listed below for your reference:

Unpatentable medical inventions:
Methods for treatment of the human body by surgery or therapy and diagnostic methods practiced on the human body (medical act), including (without limiting sense):
* Operating procedures on the human body by means of a medical instrument;
* Methods for treating the human body with a pharmaceutical substance;
* Methods for contraception or delivery;
* Methods for surgical operations and drawing blood;
* Cosmetic methods for surgical operations even if they have no therapeutic or diagnostic purpose;
* Methods of giving or injecting medicine, or giving physical treatment to a patient for cure or restraint of a disease;
* Methods of transplanting or implanting substitute organs such as artificial internal organs or artificial limbs;
* Methods of preventing a disease;
* Methods of treatment for the maintenance of physical health;
* Preparatory methods of treatment by therapy, auxiliary methods for improving treatment results, or methods for nursing associated with the treatment;
* Methods of gathering various kinds of data by measuring structures or functions of an organ in the human body for medical purposes such as detecting diseases or recognizing or judging the physical condition of the human body, or methods of judging the condition of diseases based on the data; and
* Methods of measuring the shape or size of internal organs or the conditions of the interior or exterior of the human body for medical purposes of detecting diseases or recognizing or judging the physical condition of the human body.

Patentable medical inventions:
* Medicines;
* Medical instrument or apparatus;
* Methods for treatment of samples that have been removed from the human body (e.g. blood, urine, tissues, or hairs), and methods of gathering data by analyzing the same;
* Operating methods performed in a medical instrument or apparatus having no step for applying to the human body; and
* Methods for manufacturing medicines (such as hematologic drugs, vaccines, genetically modified medicines) or medical parts (such as artificial bones, cultured epidermal sheets) utilizing material obtained from human parts (see the central large box in Figure shown below).