Patentable invention characterized by use of human- or animal-derived materials, such as cells

The following subcategories of inventions are patentable subject matter under current Japanese practice.

i) a human- or animal-derived materials such as cells or cell-derived materials.
ii) novel use of known human- or animal-derived materials such as cells or cell-derived materials.

Such novel use should be claimed in the form of product claims, for example:
A cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.

Such novel use should NOT be claimed in the form of simple method claims, for example:
Use of a cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
A method of regenerating cornea by using a cultured cell sheet derived from oral mucosa epithelial cells.

The distinction between the product claims and the method claims is, again, whether the practice of physicians and medical doctors should fall within the scope of the claim or not.

Patentable invention characterized by step of treating, for example, human cells ex vivo

The following subcategory of invention is patentable subject matter under current Japanese practice.

i) a method of manufacturing medicament or medical material for a human or animal subject comprising a step of:
treating (e.g. artificial differentiation or induction, separation, purification, diagnosis) a material (e.g. cells) obtained from the human or animal subject ex vivo.

ii) a method of manufacturing medicament or medical material for a human or animal subject comprising a step of:
treating (e.g. artificial differentiation or induction, separation, purification, diagnosis) a material (e.g. cells) obtained from another human or animal subject ex vivo.


Please note that the following subcategory of invention is NOT a patentable subject matter.

iii) a method of obtaining medicament or medical material for a human or animal subject comprising a step of:
treating (e.g. artificial differentiation or induction, separation, purification, diagnosis) a material (e.g. cells) obtained from the human or animal subject ex vivo.

iv) a method of treating (e.g. artificial differentiation or induction, separation, purification, diagnosis) a material (e.g. cells) obtained from a human or animal subject ex vivo,
wherein thus obtained medicament or medical material is ultimately returned back to the human or animal subject.


The difference between patentable and unpatentable is quite difficult to grasp if you consider the true nature of the inventions. However, intention of the Japanese government is clear. They do not want to grant patents to inventions which might interfere the practice of physicians or medical doctors. The phrase "manufacturing medicament or medical material" ensures that the medicament or medical material must be manufactured, usually in a facility other than the hospital, and provided commercially. This is not a practice of most physicians or medical doctors do.

Patentable inventions characterized by novel combination of known articles

The following subcategories of inventions are patentable subject matter under current Japanese practice.

i) a combination of physical means (e.g. magnetic devices, infrared irradiator, ultrasonic devices) and biochemical means (e.g. reagents, cells),
ii) a combination of human or animal derived materials (e.g. cells) and scafold materials,
iii) a combination of human or amimal derived meterials (e.g. cells) and reagents (e.g. growth factors), etc.

The expert committee recommends clarification of patentable subject matter by rewriting the examination manual.

The following five categories of inventions are patentable in current practice. According to the committee, however, researchers and IP managers are often unaware that such categories of inventions may be protected under current Japanese practice.

1. An invention characterized by a novel combination of known articles.
2. An invention characterized by a step of treating, for example, human cells ex vivo.
3. An invention characterized by a use of human- or aminal-derived materials, such as cells.
4. An invention with difficulties in specifying cells.
5. An invention of in the field of assist devices.

Expert commitee publishs final report on patent reform in advanced medicine and medical device field

On May 29, 2009, the expert committee published their final report on patent reform in the field of advanced medicine and medical devices. The report discusses what kind of inventions in above fields should be and should not be patented under the Japanese patent practice. The Intellectual Property Strategy Headquarters, whose chairman is Prime Minister Taro Asoh, has summoned the committee early this year. Member of the committee includes physicians or professors of medical schools, patent attorneys, lawyers, a journalist, professors of social sciences, representatives from industrial sectors such as pharmaceuticals and medical devices. Their recommendations will be implemented by early next year at the latest.

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