Patent Protection for a Food Product in Considerationof the Scope of a Patent Right for a Use Invention (*)
Under the current patent and utility model examination guidelines, a newly discovered property of a publicly known
food product would not constitute any new use that could distinguish the product from other publicly known foodproducts. As far as food products are concerned, novelty as a use invention cannot be recognized. However, some people
highlighted that it is important to recognize novelty of a food product as a use invention and to give an incentive to early
developers trying to find a new property in a food product in order to promote their research and development activities.
Due to the commencement of a new labeling system for functional food products, the early developer would be unable todistinguish its product from other companies' products if they file an application (they can cite a paper written by theearly developer) and start affixing functional food labels on their products. Under these circumstances, it has been notedthat patent protection for a use of a food product has become especially important.
The purpose of this research is to conduct research on patent protection for food products in consideration of thescope of a patent right for a use invention and to provide basic data for further examination as to whether or not the
Examination Guidelines should be amended in order to recognize novelty in a food product as a use invention.

I

Introduction

1

Background and Purpose of This Research
Under the current Examination Guidelines for Patentand Utility Model in Japan, it is generally considered that,
if the invention described in a claim can be interpreted to
be an invention made based on the discovery of an
unknown property of a product and the discovery of a
new use of the product due to the property, even if the
product itself is already known, the invention described in
the claim can be regarded to have novelty as a use
invention.1 However, in the case where a product is afood product, in consideration of the common generaltechnical knowledge in the food industry, it is consideredthat the discovery of a new property of a publicly known
food product would not constitute any new use that candistinguish the product from other food products. In sum,in the case of a food product, novelty as a use invention
cannot be recognized.2
However, some people highlighted that it isimportant to recognize novelty of a food product as a use
invention and to give an incentive to early developers
trying to find a new property in a food product in order topromote their research and development activities.
Traditionally, an early developer that has discovered a
new property in a food product can distinguish its productfrom other companies' products by using the results of its
research and development activities and filing anapplication under the food for specified health use(FOSHU) system. On the other hand, due to thecommencement of a new labeling system for functional
food products,3 the early developer would be unable todistinguish its product from other companies' products ifthey file an application under this system (they can cite apaper written by the early developer) and start affixing
functional food labels on their products. Under thesecircumstances, it has been noted that patent protection fora use of a food product has become especially important.
Before determining whether it is appropriate torecognize novelty in a food product as a use invention, it
is necessary to examine the international trend as well as
the possible effects of such recognition of novelty, more
specifically, the types of inventions that would become
patentable and the scope of the patent right (whether theeffect of the patent right extends to any publicly known
food product whose use has not been clearly defined). To
conduct such examination, it is also necessary to study
the relevant systems in other countries and theimplementation practices thereof and also examine
judicial precedents, academic theories, etc. and gather
information against what types of acts of a third party apatent right for a use invention is exercisable. It is also
important to listen to the opinions of Japanese companies
and experts.
The purpose of this research is to conduct researchon patent protection for food products in consideration of
the scope of a patent right for a use invention and toprovide basic data for further examination as to whether
or not the Examination Guidelines should be amended inorder to recognize novelty in a food product as a use
invention.
2 Method of this research(1) Research on Publicly Available Information
We used books, academic papers, judicial precedents,
research reports, committee reports, databases, online(*) This is an English summary by the Institute of Intellectual Property based on the FY2015 JPO-commissioned research study report on
the issues related to the industrial property rights system.
●

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1 ●information, etc. to collect information about the systems
in Japan and other countries and the implementation
practices thereof, and examined and analyzed thecollected information.
We also examined and analyzed the judgments
handed down in infringement lawsuits over the effect of apatent right for a use invention and compiled the resultsof our analysis on the judgments with the support of
attorneys.
(2) Domestic Questionnaire Survey
We conducted a domestic questionnaire survey on
135 Japanese food-related companies in order tounderstand their actual business practices and needs inconnection with use inventions of functional foodproducts.
(3) Domestic Interview Survey
In order to deepen the knowledge obtained in our
research on publicly available information, we conducted
an interview survey on eight experts and ten persons
selected from the respondents of the questionnaire survey
and analyzed the survey results.
(4) Overseas Questionnaire Survey
We prepared questions mostly about matters about
which we were unable to collect information in our
research on publicly available information, and sent
questionnaires to law firms in the U.S., the U.K.,
Germany, China, South Korea, and Taiwan.
(5) Discussions at the Committee
We established a five-person research committee
consisting of one specialist, one corporate IP expert, twoattorneys, and one patent attorney in order to obtainadvice based on their examination and analysis from anexpert perspective. The committee held a discussion threetimes about the methods of conducting research on
publicly available information, a domestic questionnaire
survey, domestic interview survey, and overseas
questionnaire survey and, based on the survey results,
examined, among other things, the scope of the effect of apatent right for a use invention of a food product and thestyles of claim based on which novelty can berecognized.

II Use Inventions in Japan
A use invention is defined as an invention madebased on (i) discovering an unknown property of a
product and (ii) finding out that the product is suitable fora novel use because of the property (Part III, Chapter 2,
Section 4, 3.1.2 of the Examination Guidelines for Patentand Utility Model in Japan).
●If a claim contains a certain phrase such as "for use
in ..." (the limitation of use) in order to specify a productby referring to a use of the product, the examiner shouldtake into consideration the description and drawings aswell as the common general knowledge available at thetime of application filing and interpret what the limitationof use means as a claimed element presented in the claim.
Based on that interpretation, the claimed invention will beidentified.
In the case of any invention embodied in a foodproduct, even if a new property is discovered in a publicly
known food product, it usually cannot be considered toconstitute a new use that can distinguish the product fromother publicly known food products (Part III, Chapter 2,
Section 4, 3.1.2 (2) Example 2 of the Examination
Guidelines for Patent and Utility Model in Japan).
Chapter 3 (Medicinal Inventions) of Annex B of thecurrent Examination Handbook for Patent and Utility
Model in Japan was newly established as Chapter 3 ofPart VII "Examination Guidelines for the Specified
Technical Fields" of the Examination Guidelines forPatent and Utility Model in Japan. In November 2004, areport titled "Patent Protection in Field of Advanced
Medical Technologies" was submitted to the Advanced
Medical Patent Exploratory Committee of the Intellectual
Property Strategy Headquarters. The report examined thetechnologies related to the "method of generating new
medicinal potency or effects applicable to the
manufacturing and sale of a medicine" and sought thepossibility of expanding the scope of product patent
protection as far as possible in consideration of the issues
related to the effect of a patent right with reference to thecases where a medicine is patented and cases in otherfields and proposed amendments to the Examination
Guidelines, etc.

III Functional Food Labeling System
1

Functional Food
There have been two types of labeled food products
in Japan, namely, food for specified health use (FOSHU),
which shows the compatibility of the food with thenational standards, and food with nutrient function claims(FNFC), which shows governmental permission for the
specific food. Since the amendment to the Food Labeling
Act on April 1, 2015, a new system was introduced,
which allows food manufacturers to label their foodproducts on their own responsibility, in addition to the
FOSHU system and the FNFC system.
2

Necessity of Patent Protection for
Functional Food Products
Under the new system of functional food labeling, it
is possible for late-comer companies, etc. to easily andinexpensively label their functional food products by
2 ●IIP Bulletin 2016 Vol.25

citing a paper, etc. written by the early developer thatmade substantial research and development investments.
There is a risk that the new system will discourage early
developers from conducting research and development
activities and making development investments. It has
been noted that Japan should emulate Western countries
and amend the current Examination Guidelines for Patentand Utility Model in Japan in such way that a new
function discovered in a food product can be recognizedas "new use," which is subject to patentability
evaluation.4
According to the results of the research on
documents such as unexamined patent application
publications and examined patent application publications
issued from January 2009 to December 2013, food claims(claims related to food products) are lower than effective
agent claims (claims related to effective agents) andmedicine claims (claims related to medicines) in terms of
the rate of patent grant.5

IV Scope of the Effect of a Patent
Right for a Use Invention
It is necessary to examine whether the effect of apatent right granted for a use invention would extend to a
publicly known product whose use has not been clearly
defined. This is the reason why this research was
conducted.
The following is a summary of the results of ourresearch on judicial precedents, our questionnaire survey
and interview survey, from the perspective of the effect ofa patent right for a use invention.
- The effect of a patent right for a use invention would notextend to a publicly known product whose use has notbeen clearly defined. Whether the effect would extend tosuch product or not should be determined after examining
whether the product has the use in question.
- If a suspected infringer fails to sufficiently allege andprove that the publicly known products that the suspected
infringer handles do not have such use in question, theeffect of the patent right could extend to those products.
However, this is the issue of the sufficiency of theprovided allegation and proof that needs to be examinedon a case-by-case basis.
- If novelty is found in a food product as a use invention,
the effect of a patent right should be examined in thesame manner as we examined any other types of use
inventions and no particular precautions are necessary
just because it is related to a food product.
- According to the survey results, 73% of the responding
companies said that, if novelty is found in a food productas a use invention, the effect of a patent right would
extend to any act of manufacturing and selling a foodproduct carrying a functionality label. 21% of the
responding companies said that the effect of a patent right●

IIP Bulletin 2016 Vol.25

would extend to an act of manufacturing and selling a
product that does not carry a functionality label, if thefunctional component in question is added to or increasedin the product without any advertisement, etc. It is
predicted that even fewer people would consider that, if
novelty in a food product is recognized as a use invention,
the effect of the patent right in question would extend toan act of manufacturing and selling a publicly known
food product that does not carry any label about the use of
the product.
- Although a use of a product does not directly affectinfringement judgment, the judgment handed down in a
lawsuit to seek rescission of a JPO decision to the effectthat a use should be taken into consideration when
determining whether or not a product invention is
identical to another product invention has revealed that a
court clearly recognizes a use separately from otherfactors.6

V Styles of Claim Based on Which
Novelty Should Be Recognized
The questionnaire survey and interview survey on
the issue of whether novelty should be recognized in afunctional food product as a use invention has shown that
there are users' needs for patent protection for a functional
food product as a use invention. The respondents to thequestionnaire survey and interview survey presented
examples of the appropriate styles of patent claims
including the claims that end with certain words such as"XXX agent," "composition," "food composition," and"food" as well as the claims containing certain phrases
such as "containing an active ingredient" and "labeledas." In the interview survey, the respondents madevarious comments.
Based on the results of the aforementioned research,
the research committee made a discussion regarding thefollowing styles of claim.
Style 1:
Style 2:
Style 3:
Style 4:
Style 5:Banana for XXX
Yogurt for XXX containing Ingredient P as anactive ingredient
Food composition for XXX containing
Ingredient P as an active ingredientComposition for XXX containing Ingredient P
as an active ingredient
XXX agent containing Ingredient P as anactive ingredient

The opinions of the committee members are listed
below.

3 ●(1) Definition of the Appropriate Style of Claim
Based on Which Novelty Should be
Recognized- Since it is difficult to differentiate "composition" from"active agent," a political decision must be made as towhich one should be appropriate.
-Before discussing the appropriate styles of claim, apolitical decision must be made to determine what should
be protected.
- Novelty should not be recognized in natural foods due
to negative consequences. Since a non-natural foodproduct such as yogurt could be regarded to fall under aconcept lower than "composition," it would be impossible
to distinguish between Style 2 and Style 3 to make a
distinction between a style of claim based on whichnovelty can be recognized and a style of claim based on
which novelty cannot be recognized. Such distinction
should be made between Style 1 and Style 2.
- In principle, satisfaction or dissatisfaction of the novelty
requirement should be determined based on theinterpretation of the invention as a technical thought.
Therefore, the style of claim should not be used as asingle factor to officially determine whether the claim isappropriate or not.
(2) Style 1- This style should not be permitted in principle because
it is essential to indicate the active ingredient.
(3) Style 2- This style can be considered to be appropriate as afood-related claim.
(4) Styles 3 and 4- In the case of a food product whose configuration
cannot be specified (e.g., health drink, tea), it may bereasonable to recognize novelty in the form of a foodcomposition and determine the satisfaction ordissatisfaction of the description requirement inaccordance with the guidelines that are similar to thosefor medical products.
- This style seems to be the most appropriate interms of the scope of a food-related claim.
(5) Style 5- It is not necessary for the JPO to specify that the JPO
would accept a claim if it contains a phrase "XXX agent."
It would be more reasonable to check the generalmeaning of such phrase (in a comprehensive dictionary
such as Kojien) and examine the content of thedescription, and then determine whether novelty or an
inventive step can be recognized or not.
- If the phrase "XXX agent" is used in a food-related
claim, it would cause difficulty in distinguishing it frommedical use invention and could cause confusion.
●

VI Others (Determination of theSatisfaction or Dissatisfaction of
the Inventive Step Requirement andthe Description Requirement)
Under the current Examination Guidelines for Patentand Utility Model in Japan, a use invention having
novelty will be considered to involve no inventive step if
any person ordinarily skilled in the art could easily
conceive of the use based on the already known productproperty, structure, etc. 7 In the case of a medical
invention, the applicant is usually required to present
more than one major working example unless any person
ordinarily skilled in the art could manufacture or obtain achemical compound, etc. based on the common generaltechnical knowledge as of the time of the application
filing and could use the chemical compound, etc. for a
medical use. In order to prove the medical use, theapplicant is usually required to present the results of apharmacological test as a working example.8
In the questionnaire survey and the interview survey,
many respondents said that the JPO should makeappropriate determinations on the satisfaction ordissatisfaction of the inventive step requirement and thedescription requirement. It is important to makeappropriate determinations from the perspective of not
only novelty but also the inventive step requirement andthe description requirement.
The opinions given by committee members are as
follows.
- If it is simply a matter of evaluating a good thing as agood thing as is the case with a medical invention, it
might be a good idea to recognize novelty and make anappropriate determination from the perspective of an
inventive step.
- If a new function is accidentally discovered in acommon food product, the grounds for denying theexistence of an inventive step would be important.
- In the case of a claim that yogurt is effective against
cancer, it would be possible to make an appropriate
determination from the perspective of the description
requirement.

VII Use Invention in Various Countries
and Regions
1

U.S.
In the U.S., in the case of an invention of a new useof a publicly known product or composition, novelty
would not be recognized if the invention is described in a
product claim (MPEP2112 I). A use claim would not be
acceptable either. (MPEP2173.05 (q)). The invention
would be found patentable only if it is described in a
4 ●IIP Bulletin 2016 Vol.25

"process of use" claim (Section 100 (b) of 35 U.S. Code,MPEP2112.02, MPEP2103 IIIA). The holder of a process
patent for a use invention of a food product could allege
that a third party's act of manufacturing and selling a foodproduct constitutes induced infringement (Section 271 (b)of 35 U.S. Code) or contributory infringement (Section
271 (c) of 35 U.S. Code). On the other hand, it has been
noted that recent judgments handed down by theSupreme Court have exhibited stricter application of thecriteria for proving the occurrence of induced
infringement.
2

EPO
If a new use of a publicly known food product that isclaimed as an invention is regarded as a medical use (thefirst or second medical use), the EPO would carry out theexamination practices for a medical use invention andrecognize novelty as an invention described in a productclaim with limited uses (Article 53 (c) and Article 54 (4)and (5) of the EPC). The description requirements
applicable to the medical field would be applied to thiscase. If the food product has a non-medical use, a process
claim or a use claim will be permitted to describe theinvention (Part G, Chapter VI, 7.2 of the Guidelines for
Examination).
3

U.K.
In the U.K., if a new use of a food product claimed
as an invention can be regarded as a medical use, the UK
IPO would carry out the same examination practices as
those of the EPO and patent it as an invention describedin a product claim with a specified use (Section 4A (2)and (3) of the Patent Act). Since a medical use inventionof a food product will be protected as a product, thepatentee can allege that a third party's act ofmanufacturing or selling a patented functional foodproduct constitutes direct infringement. On the other hand,in connection with the restrictions imposed by the EU
food labeling law, it has been noted that there is an issue
with regard to protection for a food product that does notcarry a medical function label.
4

Germany
In Germany, a use invention of a food product canbe patented as an invention described in a product claim
with limited uses in the same manner as the EPO would
treat such invention (Section 2a (1) 2, Section 3 (3) and(4)). In the case of an invention for a medical use and asecond non-medical use, an invention would be
patentable if it is described in a use claim.
When a patent is granted for a use invention of afood product, in the case of a medical use invention,patent protection would be provided for a product withlimited uses. In this case, the patentee can allege that athird party's act of manufacturing and selling the patented●

IIP Bulletin 2016 Vol.25

functional food product constitutes direct infringement. In
the case of a second non-medical use invention, patent
protection would be provided by considering theinvention as a process invention. Therefore, the patentee
can allege that such third party's act constitutes indirect
infringement.
5

China
In China, novelty cannot be recognized for a use
invention of a publicly known food product if aninvention is described in a product claim. Even if theinvention is described in a process claim, a patent rightwould not be granted as long as the invention is related to
medical diagnosis or treatment. In the case of a medical
use invention of a substance, the invention could be
patented if it is described in a Swiss-type claim (e.g.,"manufacture of a medicament for treating a disease")(Article 25, 1 (3) of the Patent Law, Part II, Chapter 10,
4.5.2 of the Guidelines For Patent Examination). The
patentee can allege that a third party's act ofmanufacturing a food product by use of the invention
described in the manufacturing process claim constitutes
direct infringement. In the case of an invention for a
non-medical use, it is permissible to describe theinvention in a widely used process claim. However, due
to the lack of the provision concerning indirect
infringement, the patentee needs to allege that a third
party's act constitutes joint infringement under Article 130of the General Principles of the Civil Law of the People's
Republic of China.
6South Korea
In South Korea, if a use invention of a food productis described in a claim concerning a health-related
functional food product or food composition, thelimitation imposed on uses can be considered toconstitute a constituent feature (Part IX, Chapter 3, 2.2.(1)of the Patent Examination Guidelines). If the use inquestion is novel, novelty can be recognized as a foodproduct. An invention described in a process claim cannot
be considered to be an industrially applicable invention
and cannot be considered to be patentable, if the claimed
process can be regarded as a medical act.
The effect of a patent right for a use invention of afood product extends to any product with limited uses.
7

TaiwanIn Taiwan, in the case of a use invention of apublicly known food product, novelty cannot berecognized if the invention is described in a product claim.
Even if it is described in a process claim, a patent rightwould not be granted as long as the invention is related todiagnosis of a human or animal disease or a process of
medical treatment or surgical operation. In the case of a
medical use invention of a substance, the invention could
5 ●be patented only if the invention is described in a
Swiss-type claim (e.g., "Use of Chemical Compound P in
the manufacturing process of Medicament X for treating
Disease X") (Article 24(2) of the Patent Act, Part II,
Chapter 1, 2.5.5 of the Patent Examination Guidelines).
The patentee can allege that a third party's act ofmanufacturing a product by use of the invention
described in the manufacturing process claim constitutes
direct infringement. However, due to the lack of aprovision concerning indirect infringement, it is difficult
to provide patent protection for an invention described in
an ordinary process claim or use claim.

It would be necessary for each patent office to takethe results of this research into consideration and makeappropriate determinations as to whether or not a use
invention of a food product satisfies the inventive steprequirement and the description requirement as well as
the novelty requirement.
Further examination needs to be made based on the
results of this research in consideration of the systemusers' needs.
(Senior Researcher: Junichi TAIRA,
Senior Researcher: Taijiro TAKASE)

8

1

Results of Overseas Surveys
In all of the countries in which we conducted asurvey, the effect of a patent right for a use invention of afood product extends to any product or process withlimited uses, although the claim style permitted in eachcountry is different. The EPO, the U.K., Germany, andSouth Korea provide patent protection for food productswith limited uses. China and Taiwan provide patent
protection for the manufacturing processes of foodproducts with limited uses. The U.S. provides patent
protection for the methods of improving health throughspecific food intake.

IX Conclusion
This research has revealed that patent system users
strongly wish that patent offices could recognize noveltyof a use invention of a food product based on the use.
The effect of a patent right for a use invention
should not unconditionally extend to publicly known
products without any use limitation. It will be necessary
to examine whether the product in question is designed
for the use in question and determine whether the effectof the patent right would extend to it or not. If a suspected
infringer fails to sufficiently allege and prove that the
product is not designed for such use, the effect of thepatent right would extend to the publicly known producthandled by the suspected infringer. However, this is theissue of the sufficiency of the provided allegation andproof that needs to be examined on a case-by-case basis.
The examples of appropriate styles of claim for a use
invention of a food product would include the claims thatend with certain words such as "XXX agent,""composition," "food composition," and "food" as well as
the claims containing certain phrases such as "containing
an active ingredient" and "labeled as." In the interview
survey, we received various comments from therespondents. Many companies made a comparison
between Japan and other countries in terms of patentexamination practices and commented that it would benecessary to provide appropriate patent protection for ause invention described in a certain style of claim.
●

Part III, Chapter 2, Section 4, 3.1.2 of the Examination
Guidelines for Patent and Utility Model in Japan
2 Part III, Chapter 2, Section 4, 3.1.2 (2) Example 2 of the
Examination Guidelines for Patent and Utility Model in Japan
3 Consumer Affairs Agency, Government of Japan, "Kinousei
hyouji ni kansuru jouhou" (Information on Functional Food
Labeling) (http://www.caa.go.jp/foods/index23.html) [Last dateof access: October 6, 2015]
4 "Kinousei shokuhin no youto hatsumeito shiteno shinkisei
handanni tsuite" (Novelty judgment for a use invention of afunctional food products), Examination Standards Office,
Coordination Division, JPO[http://www.kantei.go.jp/jp/singi/tiiki/kokusentoc_wg/hearing_s/150327shiryou08-02.pdf] [Last date of access: October 13, 2015]
5 First meeting of the Bio-Life Science Committee in FY2013(Naomi Yoshida, Izumi Uchiyama, Noriko Tsujimoto, Yu Morita,
Shota Yamanaka), "Baio kanren iyaku hatsumei no shinsa unyo
tou ni tsuiteno chousa kenkyu" (Research on the examination
system and the implementation thereof, etc. for bio-related andmedical inventions), Patent, vol. 67, no. 13, at 4 to 24 (November
2014)
6 Judgment of Intellectual Property High Court dated Novemb
er 29, 2006, 2006 (Gyo-Ke) 10227 [http://www.courts.go.jp/a
pp/files/hanrei_jp/865/033865_hanrei.pdf ] [Last date of access: November 6, 2015]
7 Part III, Chapter 2, Section 4, 3.2.3 (Note) of the Examination
Guidelines for Patent and Utility Model in Japan
8 Annex B, Chapter 3, 1.1.1 of the Examination Handbook for
Patent and Utility Model in Japan

6 ●IIP Bulletin 2016 Vol.25