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.