Medicament characterized by novel dose and usage shall be patentable.

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

1. A medicament characterized by a novel component.
2. A medicament characterized by a novel composition.
3. A medicament characterized by a novel use.

The expert committee recommends that the following category of invention become a patentable subject matter as well.

1. A medicament characterized by a novel dose (amount per administration) and a novel usage (dosage interval).

A medicament sold with indications for the dose and usage will infringe the corresponding patent. A medicament without indication will not.

The committee suggests that such a medicament characterized by novel dose and usage be considered to involve inventive steps only when it should dramatically reduce the side effect or improve patients' quality of life (QOL).

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

The expert committee recommends that each of the following category of the invention be a patentable subject matter.

1. A medicament characterized by a novel dose (amount per administration) and a novel usage (dosage interval).
2. A method of gathering data from human body in order to assist physicians provide diagnosis.

Note that this policy change is brought by rewriting of the examination manual, and hence, perhaps it will be applied to all the pending applications retrospectively. Several interested parties express concern about legal instability of the grant based on the new examination manual. Examination manual is just a internal standard of the Japanese Patent Office provided for the convenience of examiners and applicants. The court is not at all bound by the manual. They argue that such policy change for the patentable subject matter should be firmly legislated in the Patent Act.

Patentable invention with difficulties in specifying cells

Novel use of known human- or animal-derived materials, such as cells or cell-derived materials, is patentable as described before. However, it might be practically impossible to define or specify the material per se because of its complexity. Consequently, a product claim for such not-well-defined material is likely to be rejected for being unclear in Japanese practice.

When the material is not well defined, such novel use should NOT be claimed in the form of product claims, such as:
A cultured cell sheet derived from oral mucosa epithelial cells for regenerating cornea.
This claim is likely to be rejected for being unclear because the cultured cell sheet is not so well defined as to clearly outline the scope of the claim, and thus, appropriately warn the third parties.

Instead, such novel use should be claimed in the form of method of manufacturing claims, for example:
A method of manufacturing cultured cell sheet for regenerating cornea comprising a step of: treating oral mucosa epithelial cells with procedure X.
Please note that none of the oral mucosa epithelial cells, the procedure X and the cultured cell sheet has to be novel. In other words, patentability of the claim is recognized within novel use of a known product.

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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