Differences between a simple method and a method of producing a product

An abbreviated translation of Art.2(3) of Patent Act is as follows:

“Working” of an invention in this Act means the following acts:
(i)          in the case of an invention of a product, making, using, selling, leasing, exporting, importing, or offering for sale or lease thereof;
(ii)         in the case of an invention of a process, the use thereof; and
(iii)        in the case of an invention of a process for producing a product, in addition to the action as provided in item (ii), acts of using, selling, leasing, exporting, importing, or offering for sale or lease the product produced by the process.

It is characteristic of Japanese Patent Act that an invention of a (simple) process and an invention of a process for producing a product are explicitly distinguished from each other.  As you can see, an invention of a process for producing a product can enjoy a higher degree of protection.

A famous case concerning this issue is the Supreme Court decision of 16 July 1999 (H10 (O) No.604). This case involves a patent for an assay for physiologically active substance. This assay is used for the quality control of pharmaceuticals. The defendant used this patented assay during the manufacture of their product, but outside Japan territory. Therefore, the use of the assay by the defendant did not infringe the Japanese patent of the patentee. The patentee still tried to enforce the patent against the imported pharmaceutical products. They argued that their assay method is essentially a method of producing pharmaceuticals because the assay is indispensable for the method of producing pharmaceuticals. The Tokyo High Court agreed and found infringement.

However, the Supreme Court disagreed. The Court said that the Patent Act explicitly distinguishes a (simple) process from a process of producing a product, and provides different protection to them. Whether an invention is a (simple) process or a process of producing a product should primarily be determined by the description of the claims. The patentee’s assay is clearly a (simple) process.

It is not surprising that nowadays an invention which is essentially a simple process is often drafted in a claim of a process for producing a product as follows:

A process of producing a medicament, comprising
(i).....
(ii) detecting the presence of substance X, and
(iii)..........

This type of claims can be allowed. But, we do not know yet how this type of claim should be interpreted in an infringement suit.

Recent decision of Intellectual Property High Court of 10 May 2010 (2009(Gyo-ke)No.10170) also involves the issue of simple vs. produce methods.

A very simplified representation of the claim at issue is as follows.

A process for manufacturing a pharmaceutical composition for the treatment of condition X, comprising the steps of:
- screening a compound for the treatment of condition X; and
- preparing a medicament.

In this case, the method of screening a compound for the treatment of condition X was patentable. Moreover, the step of preparing a medicament is considered to be a routine procedure for a person skilled in the art.

The IP High Court held that the specification does not meet the requirement of enablement. The court’s reasoning is as follows.

From the description of the application itself, a person skilled in the art should be able to identify the active ingredient of the pharmaceutical composition, which is a product to be produced by the method, as the chemical compounds per se. In other words, a person skilled in the art should be able to know from the description of the application whether a composition comprising a compound of certain structure falls within the scope of the patent claims or not. The number or availability of candidate compounds, the time required for screening, and whether the process is routine or not is irrelevant in this case.