Regarding the examination of an invention of a food product with a limitation of use, there was a significant change in the Examination Guidelines for Patent and Utility Model (hereinafter, "JPO Guidelines") and the Examination Handbook for Patent and Utility Model (hereinafter, "Examination HB") in Japan in 2016. The revision, published on March 23 and took effect on April 1, 2016, has opened a path to recognize patentability of a claim directed to the invention of novel use of a known food ("food use invention"; hereinafter, "FUI").
The established practice in the Japan Patent Office (JPO) prior to the revision was to deny patentability of an invention of a food product with a limitation of use due to lack of novelty or inventive step. For example, when "a yogurt comprising A as a component" was known, novelty or inventive step of "a yogurt for use in strengthening bones comprising A as a component" was not recognized, because "a yogurt for use in strengthening bones" was still used as a yogurt and did not provide any new use of the known yogurt.
On the other hand, the Japanese regulatory systems permit the food industries to use certain expressions to claim functional aspects of food products. For example, the Food Sanitation Act permits labeling of food products with "nutrient function claims" when the food conforms to the criteria set forth by the national regulatory authority or with "specified health use" when a special permit is issued by the national regulatory authority. Besides, the regulatory control on the labeling of food products has also been changed by the amended Food Labeling Act which took effect on April 1, 2015, to introduce the new system known as "food with function claims", which generally allows the food industries to label functions on their own responsibilities. Encouraged by these developments in the Japanese regulatory systems, the voices of the food industries became stronger, demanding more appropriate protection of FUIs by patent rights.
The 2016 revision of the JPO Guidelines and Examination HB on FUIs was a dramatic shift from the conventional practice to more practical ones, increasing chances to obtain protection of the food products as used, i.e., as labeled on the market, by claiming FUIs. The JPO Guidelines have inserted the following example as patentable claims for FUIs:
[Claim 1] A food composition for use in preventing a hangover containing an ingredient A as an active ingredient.
[Claim 2] A food composition for use in preventing a hangover according to claim 1, wherein the food composition is a fermented milk product.
[Claim 3] A food composition for use in preventing a hangover according to claim 2, wherein the fermented milk product is yogurt.
Since 2016, the JPO recognizes the limitations of use as exemplified above as allowable elements of invention as a basic rule, when reviewing novelty and inventive step of the claimed food product (composition).
Having said that, the JPO Guidelines and Examination HB also provide exceptions to the basic rule. When the claimed subject matter is directed to a compound, microorganism, animal or plant, even if it is specified with a limitation of use (e.g., "Compound Z for use in ..." or "a banana for use in ..."), the limitation of use is not considered in the determination of novelty or inventive step of the subject matter. In addition, in the case where the claimed subject matter is expressed as "a food for use in X ...", when the claimed food is considered to encompass a plant or animal itself based on the descriptions in the specification, novelty or inventive step of the food may be denied in view of the existing food without the limitation of the use.
The revision of JPO Guidelines and Examination HB has enabled us to obtain protection of FUIs, i.e., food products as labeled on the market, but sales of food products generally take place with the involvement of wide variety of sellers in different levels and diversified distribution channels and marketing methods. Some food products may be offered on the market without explicit indication of their use (efficacy) and their use is only advertised on the company's website or TV commercials. It may be a common method of marketing for food products, but may present some problems in obtaining patents claiming FUIs, making it difficult to exercise the patent rights against infringers who market the food products without explicit indication of patented FUIs. There arises the issue of interpretation of the scope of protection of a patent claiming a FUI.
An example of Japanese court decisions helpful in dealing with such issue can be an IP High Court decision in 2006 (Case No. H17(ne)10125; so-called "Cilostazol Case"). The decision says, "even if the sales takes place with no indications of the patented use or no labeling of said use on the product, if the court can determine that the product was sold to be used for said use based on specific circumstances under which the product was sold, it is possible to determine that there was the act of working the patented use". In view of the IP High Court decision, in the case where "a food product comprising component A as an active ingredient" is patented, when Food Company X markets the food product without a functional labeling of said use (efficacy) and advertises or promotes said use (efficacy) of the food product on the company's website or TV commercials, Food Company X's acts can establish infringement of the patent from the specific circumstances under which the food product is sold.
The scope of the Cilostazol Case can also be applied to the case where there are multiple actors in the infringing act of selling a food product without an explicit indication of patented use, for example, the case where Food Company X sells to Wholesaler Y "a food product comprising component A as an active ingredient" (patented product) without a functional labeling of said use (efficacy) and Wholesaler Y distributes it to Retailer Z (e.g., supermarket), and then Retailer Z provides the functional labeling of said use (efficacy) at the retailing site for sales promotion of the product. In determining that the product was sold to be used for said use between the multiple actors, another IP High Court decision in 2011 (Case No. H22(ne)10091; so-called "Heavy Metal Fixative Case") applied the following tests: a) whether all of the companies involved in the sales of the product at issue undertake business of selling the product for the use at issue (piperazine-based fixative for use in fixing heavy metals in fly ash) or business associated with said business, and b) whether any of these companies was selling the product as a product to be used for a use other than the use at issue during the period that the product was sold. The Court considered affirmative results of these two tests as specific circumstances that allowed to recognize that the product was manufactured and sold as that to be used for the patented use.
Finally, the scope of these two decisions should also be applicable to the case where Food Company X puts "a food product comprising component A as an active ingredient" on the market with no functional labeling associated with the patented use (efficacy) and consumers buy the product with the expectation of exerting the efficacy at issue. In this case, too, if the Court is able to determine that there are specific circumstances that allow to recognize that the product was manufactured and sold as that to be used for the use at issue, Company X's act of putting the product on the market should establish infringement. To this end, specifically, the patentee will need to provide evidence that allows the Court to determine that there were specific circumstances that the consumers bought the food product only for the patented use. The alleged infringer, on the other hand, will need to provide evidence that the product was used for a use other than the patented use during the period that the product was sold. The Court's determination would be in the balance.
The 2016 revision of the JPO Guidelines and Examination HB opened a path to obtain patents claiming FUIs as discussed above, but there still remains uncertainty in exercising the patent rights on the actual acts of infringers due to the common practice surrounding the use of food products as discussed above. We will stay keen on the development of this issue.