Method for carrying out operation, medical treatment or diagnosis with respect to human

December 5, 2003
Patent Attorney
Ichiro Kaneko

1. Abstract
Examination standards for methods for surgery, therapy, or diagnosis practiced on the human body were revised. In consequence, a method for manufacturing a medical product or the like (e.g. a cultured skin sheet, an artificial bone) by use of a collection extracted from a human body as a raw material, which had been conventionally out of the scope of patent granting, was newly included within the scope of the patent based on the presumption that the collection is supposed to be returned to the same body for the therapy. The revised examination standard applies to applications filed after Aug 7, 2003.

2. Concrete example of invention newly included within the scope of the patent under the revision to the examination standards

Invention included within the scope of the patent

(Title of the invention)
A method for manufacturing a cell for gene therapy

(Claim)
A method for manufacturing a cell for cancer treatment, comprising:
introducing a gene into W cell taken out from a human body with Z vector including DNA encoding X protein and DNA encoding Y protein.


(Excerpt from Detailed description of the invention)
It was made clear that the recombinant cell drug for the cancer treatment obtained by the manufacturing method shrinks cancer by inhibiting new blood vessel growth peculiar to the cancer and stimulating immunity. Although a cell acquired from a relative of a donor may be used, in view of compatibility, it is most desirable to use the cell of the donor his/her own.

(Explanation)
A method for manufacturing medical products such as the gene recombinant cell drug or the like by use of a cell extracted from a human body as a raw material does not fall within “methods for surgery, therapy or diagnosis practiced on the human body”, even if the method includes the use of a collection extracted from the donor his/herself as described in Detailed description of the invention.

Invention not included within the scope of the patent

(Title of the invention)
A method of gene therapy

(Claim)
A method for shrinking cancer comprising:
injecting Z vector including DNA encoding X protein and DNA encoding Y protein into a human being.

(Excerpt from Detailed description of the invention)
It was made clear that injection of the gene recombinant vector into the human being shrinks cancer by inhibiting new blood vessel growth peculiar to the cancer and stimulating immunity.

(Explanation)
The method including the injection of the gene recombinant vector is nothing less than “the method for therapy of the human body “.

3. Comparative table showing the handling of inventions relating to medical practice for each country

	Japan	U.S.A	Europe
Method for surgery, therapy, or diagnosis practiced on the human body	N.G	O.K	N.G
Method for manufacturing a cell for gene therapy (autogenous)	N.GO.K (revised)	O.K	O.K
Medical equipment	O.K	O.K	O.K
Rule on reserved effect for doctor’s practice	Not ruled	ruled	not ruled
Method for surgery of an animal	O.K	O.K	N.G

4. Background of the revision of the patent examination standard

(1) Circumstances of patent granting to inventions relating to medical practice
These days, regenerative medical techniques and gene therapy related techniques have been progressing rapidly. New technologies such as a culture method for skin, a treatment method for a cell, and the like have been developed. In addition, products of biologic origin are likely to be produced by people who are not doctors. It is anticipated that there will be a lot of cases in which these processed/treated products of biologic origin are given manufacturing approval from the authorities as medical products or medical equipment. Along with the change of the circumstances, there are strong demands for granting the patent to medical related inventions involved in process, therapy, or manufacturing of the products of biologic origin. As a result, it is required to clarify the handling of the inventions in the patent law.

(2) Handling of treating methods for regenerative medical techniques (before the revision)
Before the revision of the examination standard, a method for manufacturing a medical product or medical equipment (e.g. a cultured skin sheet) by use a collection from a human body (e.g. a cell) as a raw material was judged whether it was included within the scope of patent granting by the following criterion: whether the medical equipment or the like manufactured by the method was transplanted into another human body (allotransplanting) or returned to the same body (autologous transplanting). In the case where the medical equipment was returned to the same body (autologous transplanting), the method was considered “ a method for treating a sample extracted from a human body on the presumption that the sample is supposed be returned to the same body for therapy” (e.g. a method for artificial dialysis). Therefore, the method fell within “methods for surgery, therapy, diagnosis practiced on the human body”. As a result, the method was excluded from the scope of the patent granting.
However, in the current status, companies, apart from medical fields, start to manufacture the medical product or the medical equipment (e.g. a cultured skin sheet) by use of the collection extracted from the human body (e.g. a cell) as the raw material. Therefore, at least the method must be industrially applicable, regardless the method transplants the medical equipment or the like into another person (allotransplanting) or returns the medical equipment or the like to the same body (autologous transplanting). Therefore, it requires the implementation of turning the method into business by granting the patent.

(3) Revision of examination standards for a method for surgery, therapy, or diagnosis practiced on a human body
As described above, a method for manufacturing medical products (e.g. a cultured skin sheet, an artificial bone) by use of a collection extracted from a human body as a raw material, which had been conventionally out of the scope of patent granting, was newly included within the scope of the patent based on the presumption that the collection is supposed to be returned to the same body.