Various systems related to food (labeling system for nutrition and health functions, food use inventions)

I recently attended a seminar on food use inventions co-hosted by the Japan Patent Attorneys Association and the JBA Intellectual Property Committee, where I had the opportunity to listen to some useful information about the current status of food use inventions in Japan. I would like to briefly introduce the food labeling system and, from the viewpoint of IP, the criteria for food use inventions in Japan.

1. Food labeling system

– Food for Specified Health Use

Foods for specified health uses are foods that contain health-effect ingredients (Involved Ingredients) that affect the physiological functions of the body, and that indicate that a specific health purpose can be expected from their intake (indication of health use). These are so-called “Tokuho” foods.

In order to sell a food as a Food for Specified Health Use, each food must undergo a government review of the food’s efficacy and safety and be approved. (Article 43, Paragraph 1 of the Health Promotion Law)
Due to the high hurdle to obtaining this permission, the utilization rate of this system was not high until the Food with Functional Labeling System, discussed below, was established.

– Food with Functional Labeling

The Food with Functional Labeling System, which began in 2015, is a system that allows businesses to label foods with functional claims if they notify the Commissioner of the Consumer Affairs Agency of the necessary matters, such as scientific evidence regarding the safety and functionality of the food, before marketing, based on rules established by the government.
Unlike Food for Specified Health Use (Tokuho), the government does not conduct an examination, so businesses must take responsibility for proper labeling based on scientific evidence.
Unlike “Tokuho” , this system has lowered the cost and hassle involved in the procedures and is being used more and more, especially by food-related companies, positively affecting their sales volume and sales.
On the other hand, there have been some cases that have undermined trust in the Food with Functional Labeling System based on the Food Labeling Law, and consumers need to carefully check the quality of functional food products.

2. Criteria for Food Use Inventions in Japan

– Criteria for Food Use Inventions in Japan

In Japan, the JPO’s examination criteria before the revision cited as an example the use invention “bone-strengthening yogurt to which ingredient A is added,” and stated that even if a new attribute of a known food is discovered for use as a food, it does not usually provide a new use that can be distinguished from a known food, and therefore, food use inventions were denied.
In March 2016, the JPO’s Examination Guidelines and Examination Handbook were revised in line with the introduction of the Food with Functional Labelling System in 2015. In the revised examination criteria, in the case of the following claims

1. A food composition for preventing hangover, comprising ingredient A as an active ingredient.
2. A food composition for preventing hangover as claimed in claim 1, wherein said food composition is a fermented dairy product.
3. The food composition for preventing hangover as claimed in claim 2, wherein said fermented dairy product is yogurt.

(i) when the use “for preventing hangovers” is found due to the discovery of an unknown attribute of ingredient A, namely, that it promotes the metabolism of alcohol; or
(ii) the use found by the attribute is new and different from previously known uses of the “food composition containing ingredient A”.


They determined that if the above requirements (i) and (ii) are met, the invention claimed in the claims is to be admitted, including the use limitation “for preventing hangovers” (thus, the two are certified as different inventions).

-Current Examination of Food Use Inventions in Japan

According to the explanation given at the seminar on food use inventions jointly organized by the Japan Patent Attorneys Association and the JBA Intellectual Property Committee, the current examination standards for food use inventions in Japan are the same as those for use inventions in the pharmaceutical field, where use inventions have traditionally been allowed. In the case of use inventions in pharmaceuticals,

An “invention of a thing” that is based on the discovery of an unknown attribute of a thing and seeks to provide a new pharmaceutical use for that thing will be admitted as use invention.

They say that the same criteria are applied to food use inventions.
However, I had the impression that, unless one tried to find a specific case, one would not be able to get a firsthand sense of how the JPO’s “examination standards are the same as those for use inventions in pharmaceuticals” described above would be applied.
When considering food use inventions, it will be necessary to continue to examine claims, etc., with reference to the latest examination standards, examination handbooks, and relevant judicial precedents.

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