4The Examination and Implementation of Use Inventionsin Major Countries

Major patent offices have not conformed to each other in terms of the interpretation and implementation of
special claims relating to a use invention, as represented by product-by-use claims and use claims. Especially inJapan, a variety of claim forms are admitted in relation to use inventions of a publicly known chemicalcompound or a composition, and there are thus many problems that are peculiar to each industrial field. With
that, claim forms, requirements for patentability, judicial precedents, and the scope of the right for use
inventions were organized, and problems with the examination and implementation of use inventions wereextracted with respect to each industrial field with high needs for use inventions, through comparison with theresults of overseas research in the United States and Europe. Specifically, there are the problem of special use
claims in the pharmaceutical field, the problem of the description requirements for pharmacological mechanisms
and pharmacological data, the particularity of examination in the cosmetic field, the problem relating todescriptions limiting a product by use in the chemical fields, and the problems of claims defining a product byproperty and overlapping rights in the alloy field. Solutions to these problems were considered. Toward
international harmonization, problems were raised and proposals were given in relation to desirable ways to
examine and implement use inventions in Japan.

Ⅰ Purposes and Outline of theStudy
The purpose of this study is firstly to clarify
problems relating to the examination andimplementation of use inventions, and secondly tomake proposals for desirable ways to examine andimplement use inventions in Japan based on theconsideration of solutions to these problems.
In order to clarify problems, analysis was
conducted on the overall picture of therequirements for patentability, judicial precedents,
and the scope of the effect of a patent right inrelation to use inventions. At the same time, four
technical fields-the pharmaceutical, cosmetic/food,chemical, and alloy fields-were selected as majorindustries with high needs for use patents, andproblems in each industry were extracted.
Next, research was conducted on theexamination and implementation of use inventions
in general in the United States and Europe
respectively as well as on specific problems
extracted in each of the above-mentioned technicalfields, for the purpose of gaining an understanding of
the present situation of examination andimplementation in major foreign countries.
Solutions to these problems were consideredthroughcomparisonofexamination
andimplementation in Japan, the United States, andEurope based on the overseas research results.
Incidentally, for this study, "inventions of whichclaims contain a description relating to some sort ofuse" in a broad sense, including inventions that are
not purely use inventions, were defined as"use-related inventions."

IIP Bulletin 2004

Ⅱ Use-Related Inventions
With respect to use-related inventions,differences in relevant provisions and in handling in
examinations, appeal/trial decisions, and court
decisions among Japan, the United States, andEurope, were considered from the viewpoint of thehandling of "use inventions," novelty (including
identity), inventive step, clarity, the enablement
requirement, and the support requirements. Then,proposals were made with a view to harmonizationthat is defined as "one invention is provided withequal protection in Japan, the United States, andEurope."Specifically, the following were proposed.
(1) Product-by-process claims and product-by-use
claims shall be handled in the same way, and shallmean a product suited to the limitation. On thatbasis, "a product shall not be novel unless its
structure or composition is different from thosepublicly known." However, the pharmaceutical andcosmetic fields where process claims are notavailable shall be regarded as exceptions to this.
(2) In the United States, there are many decisionsof the lack of novelty due to inherency, for example,
the one in the Claritin Case. But this point should
be unified among Japan, the United States, andEurope.
(3) With respect to limitation by a mechanism inuse claims, a mere clarification of a mechanism shallnot create novelty. However, the pharmaceuticalfield where process claims are not available shall be
regarded as an exception to this, and limitation by amechanism that is different from well-known
mechanisms shall create novelty.

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(4) Decision standards for the inventive step of a"product" or a "composition claim" should be unified
among Japan, the United States, and Europe.
(5) For appropriate protection of inventions, clarity
test in Japan shall be made to conform to that inEurope.
(6) In Japan, the requirement of "utility (though themeaning of the word is not clear)" shall be separated
from Section 36(4) and it shall be integrated into the"industrial applicability" in the main paragraph of
Section 29. On the other hand, the requirements of"how to use" and "how to make" shall be left in
Section 36(4) to clarify provisions.
(7) The concept of "predictability" shall be
introduced into the enablement requirement inJapan to create the appropriate standards.
(8) The handling of biological data shall be unified
among Japan, the United States, and Europe.

Ⅲ Judicial Precedents Relating to
Use-Related Inventions in Japan
According to judicial precedents in Japan, theexistence of use inventions (or use-related
inventions) has been recognized, though "useinvention" is considered to be a scholarly term. A
generally accepted interpretation is that a use
invention is "an invention that focuses attention on
one property of a product and is to be used solely fora particular use based on the property, which has notbeen known in the past."
Regarding such use-related inventions, thisreport introduced relevant judicial precedents inrelation to novelty, inventive step, and thedescription requirements for a specification,
respectively. As for novelty, according to judicial
precedents, even if a product is well-known or
publicly known, it may be deemed to be patentable
if its use involves novelty. In this report,
consideration was also given to judicial precedents
that ruled that incomplete inventions should not be
deemed to have the effect of eliminating later
applications. In addition, after introducing judicial
precedents relating to the determination of theinventive step of use inventions, deliberation was
conducted on a judicial precedent that found thatthe description of pharmacological test data isrequired for a medical use invention from theviewpoint of both the description requirements fora detailed description of the invention and those forthe scope of claims, as a judicial precedence
relating to the description requirements for a
specification.

Ⅳ Scope of the Effect of a Patent
Right for a Use-Related Invention
The basic idea of the scope of the effect of apatent right for a use-related invention was
confirmed, and consideration was given on scholarly
ideas and interpretations in judicial precedents. As
for the interpretation of the scope of the effect of apatent right for a use-related invention, past
discussions are considerably limited both in theories
and judicial precedents. In the present
circumstances, all of them, including specificproblem-raising and theoretical analysis, do not go
beyond ambiguous, fragmentary discussions.
Discussions through the following two stages
are required in the process of delimiting the scopeof the effect on the premise of a patent right for a
use-related invention.
(i) Determining the correspondence of the claimsof a patent right for a use-related invention to thecategories of inventions under the Patent Law(ii) Interpreting each claim of a use-related
invention
It can be said that problems to be discussed
exist in both stages. Needless to say, theories thatshould be applied in each stage can be said to be
based on the framework of the Patent Law ingeneral. However, since the details of how toreflect the particularity of use-related inventions
have not yet been sufficiently worked out, amethod for delimiting the scope of the effect of apatent right for a use-related invention still
remains unclear. That is, it can be concluded thatthe greatest challenge is the point of how to clarify
the interpretation standards for the stage ofcategory classification and claim interpretation for
inventions. In particular, the clarification of theinterpretation standard of "how to interpretmatters relating to use described in the claims of a
use-related invention" and the provision of thelegal grounds thereof are considered to be thelargest challenges.
More generally, this means that further
detailed review should be conducted on the point of
whether there is some sort of gap between thehandling(examination
standards
and
implementation) of claim descriptions of a
use-related invention at the stage of granting of aright and the idea of the claim interpretation of a
use-related invention at the stage of exercise of theright or whether there is room for such a gap. On
the condition that the possibility for such a gap
arises, it should be brought into view to makepossible appropriate adjustments to the handling at
the stage of granting of the right (specifically, in theform of alterations in examination standards andimplementation).

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Ⅴ Problems and Solutions Relating
to Use-Related Inventions in EachTechnical Field
A.

Problem in the Pharmaceutical Field (I)Impact of Special Use Claims on the
Medical and Pharmaceutical Industries
and the Possibility of Solution of the
ProblemResearch and study were conducted on theactual conditions of special use claims in thepharmaceutical field. The examples of special claims
that are affecting the industry of this field werecollected, and their origins were analyzed. In cases
where an application was transferred to the national
phase in Japan claiming the priority of acorresponding European application or U.S.
application, there are divergences between claims inJapan and those in Europe or the United States.
Comparing these claims with the description of theessence of the invention in the specification ofJapanese application or patent, claims in Japan were
not considered to sufficiently cover the essence of
the invention unlike claims in Europe or the UnitedStates. If these cases are divided into categories,
there is a common tendency that claims aredifferent from the essence of the invention whenrelating to a treatment method or a therapeutic use.
In such cases, registration was made by productclaims or process claims that are not relating totreatment. In addition, in many cases involving
claims for treatment, a reason for refusal as stated in
the main paragraph of Section 29 of the Patent Law
was found in the examination process. Due to theseresults, it was considered that separately fromconventionally known special use claims that are
based on the wording in claims, there are special
use claims that occur to avoid process claims
relating to treatment in the pharmaceutical field. It
was thought that the use of process claims in thepharmaceutical field should be considered as asolution to these special use claims.
B.

Problem in the Pharmaceutical Field (II)First of all, comparative consideration was
conducted on the question of how two inventions
that are specified by a pharmacological mechanism
called "R-receptor antagonism," that is, "R-receptor
antagonist composed of compound X" and"therapeutic agent for disease Y composed of
R-receptor antagonistic compound," are examined inJapan, the United States, and Europe. For theformer claim, novelty may be denied in the UnitedStates, as the event "R-receptor antagonism" that
occurs in vivo is considered to be inherent incompound X. In Europe, since the word "R-receptor
antagonist" contains unspecified number ofpathologic conditions and diseases to be alleviated,
it is considered unclear. The latter claim is

IIP Bulletin 2004

considered unclear both in the United States and inEurope on the ground that it does not structurally
limit the compound at all. Contrary to this, theExamination Guidelines in Japan do not indicate
how to describe the names of diseases andpathologic conditions in the claims of a medical use
invention. It is appropriate not to recognize an
invention as one for medical use unless it is clearlystated that the invention is used for a particulardisease that specifically appears as a humanpathologic condition. For the latter claim, it isconsidered difficult to maintain clarity also in Japan.
However, the collection of examples includes someexamples that confuse this understanding. It is
desirable to allow claiming an invention as acompound with "R-receptor antagonistic" action
without specifying any specific compound only when
the invention cannot be appropriately specified byexpressions other than such, and not to make any
exceptions.
Next, through comparative consideration on
the question of whether it is allowed to submit
pharmacological data to recover from the violation of
the disclosure requirement in Japan, the UnitedStates, and Europe, it was confirmed that such
submission is widely allowed in the United States
while it is relatively difficult in Europe. However,
how far such submission is allowed in Japan cannot
be ascertained even by referring to the Examination
Guidelines. Technical matters necessary for thedescription of the invention differ depending on thetype of invention. For medical use inventions, "howto use" should be considered not as the enablement
requirement but as the description requirement, andthe submission of pharmacological data to coverdeficiency in description of "how to use" should not
be allowed. On the other hand, submitting test
methods or data to recover from the violation of theenablement requirement should be allowed since itwill help third parties consider the invention
through comparison.
Due to the revision of Section 36 of the Patent
Law in 1995 and the publication of the
Implementing Guidelines, the freedom of claim
description increased, and the unified Examination
Guidelines across all industries were established.
However, because of this, decision standards inexamination rather became difficult to understand in
the field of medical use inventions. In order tosecure the high validity and predictability of
examination results, it is desired that the standards
are reasonable and clear as well as easy tounderstand. In addition, in examination, priority
should be given to the protection of clear scoperather than the protection of broad and ambiguous
scope.

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C. Problems of Use Inventions in the
Cosmetic/Food Fields and Consideration
ThereofIn the cosmetic/food fields, there are many
inventions created based on the discovery of a new
function of a publicly known natural material. Suchinventions are often described in product claims(agent claims) limited by use due to the problem ofnovelty arising if they are treated as inventions of
product and the problem of industrial applicability
arising if they are treated as inventions of process.
Looking at recent examples of patent claims in thefield in question, patents have been granted basedon claims limited by use at various levels, from thespecific effect that can recall the final product to an
action mechanism of expression of an active
substance. However, the examination standards forsuch use inventions, especially the decision
standards for identity when comparing two or moreuses, cannot be said to be clear in Japan. In addition,
there is room for discussion on the validity of a formof expression called "agent claim."
In this overseas research, answer was received
from both Europe and the United States that for thesame active substance, novelty may be recognizedin the second cosmetic use (whitening) even if thefirst cosmetic use (moisturizing) is publicly known.
In particular, it was made clear that in the UnitedStates, the identity of the means and timing of
application of an active substance has nothing to dowith the determination of novelty and does notserve as a ground for refusal based on the inherency
doctrine, with respect to a use invention that isexpressed by a process claim. On the other hand, it
was indicated that limitation by use based on action
mechanism (inhibition of enzyme Z) would be
refused due to inherency in the publicly known finaluse (treatment of disease Y). When considering two
requirements for inherency (unexpressed claimed
elements (i) necessarily exist in the prior art and (ii)are recognizable for persons skilled in the art) withreference to corresponding European practice, it canbe said to be sufficiently realistic to adopt theserequirements as decision standards in Japan. Here,"recognition" by persons skilled in the art should bemade a requirement in principle both in determining
the fulfillment of the requirements for patentability
and in interpreting the technical scope after
registration. However, it is possible to adopt thehandling in which "recognition" requirement shall,
exceptionally, not be applied to limitation by use
based on action mechanism.
If the essence of a use invention exists in aprocess element, i.e. using an active substance thatbrings about a particular effect with the intent toachieve the effect, it is appropriate to directly
express the process element by a process claim, and
it is desirable to recognize that an invention ofprocess for nonmedical treatment is industriallyapplicable (as with the practice in Europe). In
addition, it is considered desirable to further unify
the forms of expression even though the current
practice of agent claims is maintained at the
moment.
D.

Consideration Regarding the Protectionof Use-Related Inventions in the Chemical
Field
In the chemical field, there are considerable
claim descriptions that refer to the use of a chemical
substance relating to an invention. However, there
are not so many applications for "use patent" in astrict sense. Thus, it seems that no very serious
problems have occurred in practice even under thecurrent Examination Guidelines relating to use
inventions in Japan. If the Japanese Examination
Guidelines are revised in the future to those closer
to the practice in Europe and the United States fromthe viewpoint of international harmonization, it isdesirable to ensure the freedom of claim description
and to give consideration so as to keep room for theobtainment of rights for use inventions in the formof product claim.
E.

Problems in the Alloy Field
The wording "property or/and use" is still
described in many claims of applications in the alloy
field for which the past Examination Guidelines byindustry provided that "the property or/and use of
the alloy must be expressed in the scope of claims."
Despite the fact that the wording described as
matters specifying the invention plays an importantrole when determining the technical scope of theinvention, the wording "property or/and use" maysometimes be interpreted several ways with respect
to inventions in the alloy field, which were
examined according to the current Examination
Guidelines and granted patents. However, since
there is no means of reasonably confirming how theexaminer has understood the wording, gaps are easy
to occur among the applicant's intent, theexaminer's determination, and the third party's
interpretation, which makes it significantly difficult
to determine the scope of the right in the present
circumstances.
In this report, the meaning of the descriptionsof "property" and "use" as matters specifying theinvention in the alloy field was verified on the basisof the Examination Guidelines, appeal/trial decisions,and judicial precedents in the past, and problems
with determining the scope of the right by applying
the current Examination Guidelines were indicated.
In addition, a method of solving these problems by
the same standards as for other fields was examinedin consideration of the particularity of inventions in
the alloy field.

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Ⅵ Overseas Research Report
In the United States, use inventions are treatedas processes (process claims), and claims limiting apublicly known substance by use (product-by-use
claims) are examined as pure product claims, andare not deemed to involve novelty in theexamination practice. In Europe, except in thepharmaceutical field, a discovery of a novel use of apublicly known product is not considered to givenovelty to the product itself. Article 54(5) of theEuropean Patent Convention is a special rule thatallows product claims relating to the first medical
use of a publicly known substance or composition.
The discovery of the second medical use is deemed
to involve novelty in Swiss-type claims (Article 54
is planned to be revised to protect the second
medical use in the same way as the first medicaluse). Regarding use inventions in fields other thanthe medical field, both process claims and use claims
are accepted in general.
Japan adopts the examination practice that
permits claiming a publicly known product as a
product limited by use, and there are thus various
forms of claims, such as agent claims, process
claims, and use claims. In the case whereinternational harmonization is aimed at in the future,
Japan, the United States, and Europe have tocompromise with one another, and it is considerednecessary to review in the future the decision
standards for novelty for "2) a product that is to be
used solely for the purpose" in the current
Examination Guidelines. The following is a list of
possible revisions of the Examination Guidelines.
(1) Accept only process claims for use inventions
relating to a publicly known product, regardless of
the industrial field, as with the United States (thisseems to be impossible in the present
circumstances).
(2) Permit claims in the form of limiting a productby use only in the medical field as an exception andaccept only process claims for other fields, as with
Europe (it is questionable whether such an
exception is possible).
(3) Adopt the implementation that permits, as in
the past, claims in the form of "pharmaceuticalproduct for...," "cosmetic for ...," and "agent for ...," ofwhich the term itself contains the meaning of use
but deems claims that end with "compound,""composition," "resin," "alloy," or "material" to mean
only raw materials and thus does not recognize
them as claims limiting by use (definitions of terms
are necessary).
(4) Accept only process claims and Swiss-type
claims (an idea that avoids making an exception as
mentioned in idea (2) and defining terms as
mentioned in idea (3)).
(5) Adopt conventional implementation, andeliminate varieties in implementation and

IIP Bulletin 2004

interpretation among technical fields by making
clear standards for "a product that is to be usedsolely for the purpose" (product-by-use claims aretransmitted from Japan as claims based on a newconcept).

Ⅶ Conclusion
The overseas research results revealed anew
differences in handling claims limiting a product byuse between the United States/Europe and Japan. In
Japan, there are individual examination standards
and examination practice with respect to eachtechnical field, including pharmaceutical, cosmetic,chemical, and alloy fields, and different examinationand implementation are carried out. This
constitutes a main cause of the recognition thatexamination and implementation in Japan are
unclear and vary depending on the industrial field.
Numerous discussions seem to be still necessary in
the future before a reasonable conclusion is drawn.
Next, there are considerable divergences
between the United States/Europe and Japan inrelation to the basic concept and implementation ofuse inventions (and use-related inventions). The
main differences are in terms of (1) industrial
applicability, (2) the description requirements, (3)the enablement requirement, and (4) examination,
implementation, and interpretation of the right for
products and processes limited by use, property, orfunction. It is considered necessary to conduct
further concentrated considerations from theviewpoint of international harmonization and better
protection with a view to legal revision in the future.
Setting aside the future direction of the
Examination Guidelines and the revisions of
relevant laws, this report pointed out various
problems with examination and implementation ineach of the pharmaceutical, cosmetic, chemical, andalloy fields, which are deep problems at present, andproposed a variety of solutions to them. It isconsidered necessary to develop these proposals
into the revision of the Examination Guidelines in
the future.
Although this research report left many
problems, it delved into problems in promoting
improvements in examination and implementation,and thus will serve as an informative source of
information for further considerations in the future.

● 28 ●(Senior researcher: Toshihiko Asano)

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