E

SCP/9/5
ORIGINAL: English
DATE: March 17, 2003

WORLD INTELLECTUAL PROPERTY ORGANIZATION

GENEVA

STANDING COMMITTEE ON THE LAW OF PATENTS

Ninth Session
Geneva, May 12 to 16, 2003

INDUSTRIAL APPLICABILITY AND UTILITY REQUIREMENTS:

COMMONALITIES AND DIFFERENCES

Document prepared by the International Bureau

I. INTRODUCTION

1. At the eighth session of the Standing Committee on the Law of Patents (SCP), held in
Geneva from November 25 to 29, 2002, the International Bureau was mandated to prepare a
study regarding commonalties and differences between the industrial applicability and the
utility standards (see paragraphs 307 and 313 of the draft Report (document
SCP/8/9 Prov.2)). The present document contains an overview of various national/regional
laws and practices concerning the industrial applicability and utility requirements, and
attempts to identify certain characteristics of these requirements. Further, it reviews those
areas in which there is a substantial overlap of practices as well as those in which the two
requirements differ substantially. Finally, it provides some background information on the
alternative texts contained in Article 12(4) of the draft Substantive Patent Law Treaty (SPLT)
(see document SCP/9/2).

2. It is recalled that, following the decision made at the fourth session of the SCP, which
was held in Geneva from November 6 to 10, 2000, the International Bureau invited the SCP
Electronic Forum members to provide information regarding the industrial applicability and
utility requirements under their national/regional law. All the responses received at that time
are available on the SCP Electronic Forum (http://www.wipo.int/scp). Based on those
responses, the International Bureau prepared an informal paper containing information on the
application of the industrial applicability or utility requirement under national/regional
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practices. The informal paper, which is also available on the SCP Electronic Forum, was
submitted to the SCP at its fifth session, held in Geneva from May 14 to 19, 2001.

3. In order to prepare the present document, after the eighth session of the SCP, the SCP
Electronic Forum members were invited to submit further comments which might assist the
International Bureau. Those comments are also available on the SCP Electronic Forum.

II. INDUSTRIAL APPLICABILITY REQUIREMENT

National and Regional Laws and Practices

4. The patent laws of many countries and regions require that an invention be susceptible
or capable of industrial application. The responses1 received from Austria, Belgium,
Denmark, France, Germany, Portugal, Serbia and Montenegro, Spain, Sweden, the United
Kingdom and the European Patent Office (EPO) showed that, in these jurisdictions, an
invention shall be considered to be susceptible (or capable) of industrial application if it can
be made or used in any kind of industry, including agriculture. The general understanding is
that the term industry shall be interpreted in the broadest possible sense.

5. The Guidelines for Examination in the EPO,2 Part C, IV, 4.1 state that the term
industry should be understood as including any physical activity of technical character,
i.e., an activity which belongs to the useful or practical arts as distinct from the aesthetic arts;
it does not necessarily imply the use of a machine or the manufacture of an article and could
cover, e.g., a process for dispersing fog, or a process for converting energy from one form to
another. According to those Guidelines, Part C, IV, 4.4, in general, methods of testing
should be regarded as inventions susceptible of industrial application and therefore patentable,
if the test is applicable to the improvement or control of a product, apparatus or process which
is itself susceptible of industrial application. According to EPO document EUROTAB 2/99
as well as the submission from the EPO, as regards the distinction between the criterion of
technical character (see the EPO Guidelines, C-IV 1.2 (ii) and 2.2) and the criterion of
industrial applicability, an invention susceptible of industrial application does not necessarily
have a technical character. If the claimed subject matter as a whole lacks technical character,
an objection to it cannot be raised under Article 57 of the Convention on the Grant of
European Patents European Patent Convention (EPC) [industrial application], but should be
based on Article 52 EPC [patentable inventions]. As regards methods of surgery, therapy and
diagnosis under Article 52(4) EPC 1973, they will be discussed in paragraph 18.

6. The submission from the EPO states that the industrial applicability requirement might
play a decisive role in the determination of the patentability in respect of three types of
inventions: (1) those which appear to be impossible to carry out because they contravene the
laws of physics (for example, a perpetual motion machine); (2) those concerning methods
which could be considered to fall entirely within the private or personal sphere; and (3) those
involving gene sequences, for which the industrial application must be disclosed (on this
point, see paragraphs 20 to 24). In relation to the second point, the EPO Boards of Appeal

1
The responses listed or mentioned in this document include both the responses received after
the fourth session of the SCP (see paragraph 2) and the responses received after the eighth
session of the SCP (see paragraph 3).
2
See http://www.european-patent-office.org/legal/gui_lines/index.htm.
 SCP/9/5
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have held that the requirement for industrial applicability implies a commercial
exploitation, with the purpose of achieving financial gain (see Board of Appeals decisions
T204/93; T144/83). On the other hand, it was confirmed in decision T74/93 that, when a
method falls entirely within the private or personal sphere of a human being, it cannot be
considered to be susceptible of industrial application. This case focused on a contraceptive
method for women. The compound, which was new and inventive, was held to be patentable,
but the method claim was found to be lacking in industrial applicability, as the use of the
compound was a purely personal use which could only be carried out in private by the women
themselves.

7. The response from France indicated that the condition of industrial applicability
requires that the invention could be exploited (made or used) in the industry at large,
including commerce and agriculture. With respect to the quality of the result of the
exploitation of the invention, the Tribunal de grande instance de Paris has ruled that the law
takes into account neither the result of the usage of the invention nor the quality of such
result; an imperfect result or even a regression does not lead to a non-compliance with the
requirement of industrial applicability (PIBD, 1998, No. 659.III.398). According to the
response, this refusal of appreciating the merit of the invention distinguishes the notions of
industrial applicability and utility. Nevertheless, to be patentable, the invention should
produce a real technical result. The Tribunal de grande instance de Paris decided, in another
case, that in order for the invention being patentable, it is sufficient if the invention procures
a immediate technical result of industrial nature, even if its result is fable and imperfect, and
even if engineers consider that the invention did not have any commercial benefits or any
utility in its exploitation (PIBD 1985, No. 375.III.246).

8. The response from Denmark explained that the fundamental meaning of the industrial
application requirement was that an invention is available or existed as a practical reality.
In other words, the inventor should be able to indicate at least one practical application/utility
with respect to an invention.

9. The response from Austria noted that, although the Austrian Patent Law did not contain
any definition of the term industrial applicability, it was understood in a very broad sense
that the invention must be able to be made or used in any kind of industry, including
agriculture. According to its practice, the invention must be capable to be carried out within
professional activities, that is, the invention must be workable and reproducible. It was
explained that the invention should be able to achieve the objective claimed in order to be
workable, and that the same result should be obtained each time the invention was carried out
in order to be reproducible. According to its practice, a theoretical possibility to apply the
invention within professional activities was sufficient.

10. The theoretical possibility of manufacture or use in any industry was also mentioned in
the response from Germany. In order to comply with the industrial applicability requirement,
it is not necessary to demonstrate real manufacture or use in the industry, or to get an approval
by the Technischer berwachungsverein (technical inspection association). It indicated that
the industry within the meaning of industrial applicability was a continuing, independent,
authorized activity geared towards profit, including primary production, such as agriculture,
forestry and horticulture. It further noted that, if a process was applied exclusively by so-
called free professions, such as practicing doctors, lawyers or pharmacists, it was not
industrially applicable.
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11. The response from Portugal indicated that, as a result of the definition of industrial
applicability, inventions which lacked practical reality or were absurd or clearly going against
the laws of physical or chemical sciences were not patentable. Similarly, any kind of artisan
made products or techniques lacked industrial applicability, as each artisan product had a per
se value, which was not the case for mass-produced goods.

12. The response from Sweden explained that industrial applicability should be considered
in a broad sense, for example, commerce, forestry, public administration, gardening, hunting,
fishery and the defense. It noted, however, that an invention within the meaning of the
patent law should: (i) exhibit a technical character; (ii) yield a technical effect; and (iii) be
reproducible. Therefore, it concluded that the discussion on industrial applicability was
closely linked to the interpretation of invention under the patent law.

13. The Manual of Patent Practice issued by the Patent Office of the United Kingdom3
indicates that the term industry should be understood in its broadest sense as including any
useful and practical, as distinct from intellectual or aesthetic, activity (apart from medical
methods which are described in paragraph 16, below). It is restricted neither to tangible
material nor to purely commercial or profitable activities. Citing the views of the High Court
of Australia in NRDCs Application, [1961] RPC 134, the Manual explains that, to meet the
industrial applicability requirement, there must be something in which a new and useful
effect, be it creation or alteration, may be observed. According to the response from the
United Kingdom, perpetual motion machines are considered to be inherently without utility,
and although many are specifically intended for use in industry, they are always considered to
fail the applicability test.

14. The Brazilian Association of Intellectual Property (ABPI) explained that, according to
Article 15 of the Brazilian Industrial Property Law 9279/96, inventions and utility models
are considered to be susceptible of industrial application when they can be made or used in
any kind of industry. It concluded that the possibility of industrial application would seem
to imply that an invention must: (i) be feasible, i.e., it can be reduced to practice; (ii) have a
known utility, otherwise it would not have a practical application; and (iii) be of a technical
or technological nature, otherwise it would not relate to industry.

15. In some other countries, the definition of industrial applicability contains explicit
examples, in particular, services, clarifying the broad scope of the term industry. For
example, the response from Argentina stated that, according to Article 4 of Law No. 24,481
(T.O. 1996), industry should be understood as including agriculture, forestry, livestock
breeding, fisheries, mining, processing industries in the strict sense and services.
Nevertheless, in practice, it explained that the concept of industrial applicability included any
physical activities of a technical character. For instance, certain activities that belong to the
customs and practices of the aesthetic arts may be included in the concept of industry.
Similarly, Article 12, IV of the Law of Industrial Property of Mexico provides that inventions
can be made or used in any field of economic activities.

16. According to the response from Japan, the Japanese Patent Law provides for the
industrial applicability requirement without a statutory definition. Instead, the Examination
Guidelines4 issued by the Japan Patent Office (JPO) provide an exhaustive list of inventions

3
See http://www.patent.gov.uk/patent/reference/index.htm.
4
See http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/1312-002_e.htm.
 SCP/9/5
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which are not considered as industrially applicable. They are: (i) methods for the treatment
of the human body by surgery or therapy and diagnostic methods practiced on the human
body (see paragraph 16, below); (ii) commercially inapplicable inventions (e.g., inventions
applied only for personal use, or inventions applied only for academic or experimental
purposes); and (iii) practically inapplicable inventions (e.g., a method for preventing the
increase in ultraviolet rays associated with the destruction of the ozone layer by covering the
whole surface of the earth with an ultraviolet ray absorbing plastic film). The response from
the Republic of Korea stated that a similar list was provided for in the Examination
Guidelines of the Korean Intellectual Property Office (KIPO).

17. The response from the Republic of Moldova stated that, according to Article 7 of the
Patent Law of its country, an invention shall be considered as susceptible of industrial
application if it could be used in industry, agriculture or any other field of activity. In
practice, it noted that an invention should be considered as susceptible of industrial
application if the following information resulted cumulatively from the description of the
invention: (i) the subject matter of the invention can be used at least in one field; (ii) the
problem and its solution; (iii) the invention is disclosed in a way that a person skilled in the
art could make the invention without being engaged in an inventive activity; and (iv) the
invention can be reproduced with the same characteristics and effects as many times as
necessary. A similar practice is also found in the response from Romania. According to
Article 4, paragraph 1 of the Patent Law of the Russian Federation, an invention shall be
deemed industrially applicable if it can be used in industry, agriculture, public health and
other sectors of the economy. The response from the Russian Federation clarified that, when
determining whether an invention could be used in a certain sector of the economy, the
following points were examined in accordance with the Regulations: (i) whether the
application as filed contains the principal objective of the claimed subject matter; (ii) whether
the application as filed defines means and ways to achieve this objective as specified in the
claims; (iii) whether it is actually possible to achieve the objective as specified by the
applicant when carrying out any of the claimed invention.

18. In addition to the above, many countries indicated that methods for the treatment of
the human or animal body by surgery or therapy, and diagnostic methods practiced on the
human or animal body should not be regarded as inventions which are susceptible of
industrial application. For the purpose of this document, however, it may not be necessary to
discuss this issue in detail, since in some other countries, such methods for the treatment of
the human or animal body are excluded from patentability without any reference to industrial
applicability. Such an exception is then rooted in grounds of public policy. It should be
noted that, according to Article 27.3(a) of the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS Agreement), Members of the World Trade Organization
(WTO) may exclude from patentability diagnostic, therapeutic and surgical methods for the
treatment of humans or animals without any reference to the industrial applicability
requirement. Against this backdrop, Article 52(4) of the European Patent Convention was
amended by the Act Revising the Convention on the Grant of European Patents of
November 29, 2000, so that methods for the treatment of the human or animal body are one of
the categories of inventions in respect of which European patents are not granted, without any
reference to industrial applicability. In Japan, the issue as to inventions relating to medical
methods is now under consideration by the Medical Methods Working Group of the Industrial
Structure Council.

19. The responses show that, apart from inventions regarding methods of treatment of the
human or animal body, decisions based on the lack of industrial application are, in general,
 SCP/9/5
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very rare. Many responses pointed out that this follows from the fact that the concept of
industrial applicability was applied very broadly and that other grounds for refusal, such as
the enabling disclosure requirement and the requirements concerning patentable subject
matter, were more often imposed to refuse an application. As regards the enabling disclosure
requirement, if a claimed invention fails to demonstrate its practical application, it is probable
that the disclosure of the claimed invention in the application would fail to enable a person
skilled in the art to carry out the claimed invention. With respect to patentable subject matter,
aesthetic creations, for example, may be considered as not being applicable in industry, while,
at the same time, they may not be regarded as creations falling under the definition of
inventions under the patent law.

Industrial Applicability and Biotechnological Inventions

20. In recent years, the requirement of industrial applicability has gained significant
importance for the determination of the patentability of inventions in the field of
biotechnology, more specifically, of inventions concerning, for example, a sequence or a
partial sequence of a gene. In general, in order to comply with the industrial applicability
requirement, an applicant has to indicate the ways by which the claimed invention satisfies the
possibility of industrial application in the description unless it is clear to a person skilled in
the art from the nature of the claimed invention. In relation to sequences and partial
sequences of genes, this general requirement is given a specific form in many countries.
According to Article 5.3 of the Directive 98/44 of the European Parliament and of the Council
on the legal protection of biotechnological inventions,5 the industrial application of a
sequence or a partial sequence of a gene must be disclosed in the patent application.
Recital 23 of the Directive provides that a mere nucleic acid sequence without indication of a
function does not contain any technical information and is therefore not a patentable
invention. Recital 24 of the Directive specifies that, in order to comply with the industrial
applicability requirement, in the cases where a sequence or partial sequence of a gene is used
to produce a protein or a part of a protein, it is necessary to specify which protein or part of
the protein is produced and what function this protein or part of this protein performs.
Rule 23b(1) of the Implementing Regulations to the EPC provides that the above Directive
should be used as a supplementary means of interpretation. Further, Rule 23e(3) of those
Implementing Regulations and the Guidelines for Examination in the EPO, Part C, IV, 4.6
provide a requirement and explanations similar to the above Directive. The submission from
the EPO, however, noted that, arguably, Rule 23e(3) EPC did not really focus on the contents
of the concept of industrial applicability, but rather addressed the issue of enabling disclosure.
It further noted that this issue could be dealt with under different provisions of the EPC; if the
function of a gene sequence is not disclosed, arguably, it is a discovery and not an invention,
running afoul of Article 52(2)(a) EPC. Moreover, the absence of such a disclosure could also
give rise to an objection under Article 56 EPC, since without such use or function there would
be no technical effect which could provide the basis for an inventive step.

21. Specific guidelines for the determination of industrial applicability in the

biotechnological field are also found in the Examination Guidelines for Inventions in Specific
Fields (Biological Inventions) issued by the JPO and in the Examination Guidelines for
Biological Inventions issued by the KIPO. They state that inventions relating to a gene, a
vector, a recombinant vector, a transformant, a fused cell, a recombinant protein or a

5
See http://www.europa.eu.int/cgi-bin/eur-lex/udl.pl?REQUEST=Seek-
Deliver&COLLECTION=lif&SERVICE=all&LANGUAGE=en&DOCID=398L0044.
 SCP/9/5
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monoclonal antibody, whose utility is not described or not inferred based on the specification,
do not meet the industrial applicability requirement.

22. The Patent Office of the United Kingdom (UK) issued, in September 2002,
Examination Guidelines for Patent Applications relating to Biotechnological Inventions6 and,
in particular, the practice concerning the industrial applicability requirement in respect of
sequences or partial sequences of genes. The Guidelines explain that the determination of
industrial applicability with respect to sequenced or partially sequenced genes was not easy,
because the industrial application of genes or protein sequences was not apparent from the
invention itself. On the other hand, the use of short DNA sequences or ESTs as probes is well
known. Thus the question arises what needs to be shown to demonstrate industrial
applicability. Referring to the Utility Examination Guidelines and the Guidance on the
Application of the Utility Guidelines issued by the United States Patent and Trademark Office
(USPTO), the said UK Examination Guidelines further state that, although the Guidelines
issued by the USPTO did not have direct effect in the UK, the requirement in the United
States of America that a specific, substantial and credible utility must be disclosed, was
arguably the sort of disclosure, relating to industrial applicability, which the UK Office would
expect to be contained in a UK application. The Guidelines, however, further noted that, in
the absence of a judgement from the UK courts or of a decision from the EPO, there could be
no certainty that such an approach would be upheld in the UK if challenged.

23. In this context, reference is made to the Decision of the Opposition Division of the
European Patent Office dated June 20, 2001, ICOS Corporation/Seven transmembrance
recepter (EP-B-0630405), OJEPO 2002, 293.7 In this case, the Opposition Division decided
that, as potential uses of the invention are disclosed in the specification which however are
based on a proposed function of the V28 protein as a receptor which is not sufficiently
disclosed in the specification, the potential uses disclosed in the application are speculative,
i.e., are not specific, substantial and credible and as such are not considered industrial
applications.

24. As described in paragraph 20, in general, in order to comply with the industrial
applicability requirement, an applicant has to indicate the ways the claimed invention satisfies
the possibility of industrial application unless it is clear to a person skilled in the art from the
nature of the claimed invention. The Guidelines for Examination in the EPO, Part C, II, 4.12
regarding EPC Rule 27(1)(f) provide that the description should indicate explicitly the way in
which the invention is capable of exploitation in industry, if it is not obvious from the
description or from the nature of the invention. It further states that the expression capable
of exploitation in industry means the same as susceptible of industrial application.

Main Characteristics of Industrial Applicability

25. As described above, national and regional laws and practices concerning the industrial
applicability requirement vary significantly. At one end of the spectrum, the requirement of
industrial applicability is met as long as the claimed invention can be made in industry
without taking into account the use of the invention. This view is, for example, found in one
of the commentaries to Article 57 of the European Patent Convention, according to which the
requirement of industrial applicability is complied with, if the product invention can be either

6
See http://www.patent.gov.uk/patent/reference/index.htm.
7
See http://www.european-patent-office.org/epo/pubs/oj_index_e.htm.
 SCP/9/5
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made in industry or used in industry. Therefore, as long as the invention can be made in
industry, the requirement of industrial applicability is met even if it could be used only in a
non-industrial environment, such as use in the private sphere (for example, games and
sporting goods). 8

26. At the other end of the spectrum, the usefulness of the claimed invention is fully
taken into consideration for the determination of industrial applicability. Bearing these
differences in mind, it may be possible, however, to extract certain characteristics which form
the core concepts of this requirement. Since this requirement is defined as being susceptible
of (or capable of) industrial application, the following analysis will focus on two aspects of
this requirement, namely, industrial and application.

27. Firstly, an invention shall be applicable in industry. All the responses emphasized the
broad scope of the term industry. From the explanations given in respect of the
national/regional practices, the following characteristics may be commonly found in the
various practices.

28. The first characteristic is that an invention must be applicable in any non-mental activity
that belongs to the useful or practical arts. A similar explanation is also found in the PCT
International Preliminary Examination Guidelines, IV-4. 19, according to which industry
includes any physical activity of a technical character, that is, an activity which belongs to the
useful or practical arts as distinct from the aesthetic arts. The invention shall be applicable in
the non-mental activity in the sense that the activity is not a mental or spiritual act, but rather
an act in the real world. In accordance with the words useful or practical arts, activities that
belong to aesthetic or intellectual arts are not considered as susceptible of industrial
application. In view of the illustrative examples of industry which are provided for in
national/regional legislation and practice, it could be said that the business setting in which
the invention is applied, such as the manufacturing sector, the agricultural sector, the service
sector, the trading sector, etc., is not relevant in this context. Rather, it is the nature of the
activity in connection with the exploitation of the invention which is at stake.

29. Because of the nature of the word industry, certain inventions, however, are not
considered as susceptible of industrial application in many countries, even if they are
applicable in a non-mental activity that belongs to the useful or practical arts. The first
category of these inventions are inventions which could be applied only in the private and
personal sphere for ones own needs. Examples of such inventions include a method for the
local application of a contraceptive composition (EPO), a method of smoking (JPO) and a
method of fixing a ski shoe to a ski (Intellectual Property Office of Switzerland). The second
category of these inventions are inventions which could be applied only in association with a
particular person. This concept is connected to the reproducible feature of the word
industry. For example, although a certain product could be made or used in a non-mental
activity that belongs to the useful or practical arts, the essential value of that product may be
derived from specific personal skills associated with a person concerned, and therefore, each
of these products has its per se value. Such a product may not be considered as susceptible of

8
Europisches Patentbereinkommen, Mnchner Gemeinschaftskommentar, Article 57, IV.D. It
may be argued that, as regards these examples, the games or sporting goods could be sold to
others, and therefore, could be used in an industrial environment, bearing in mind the broad
scope of the term industry.
9
See http://www.wipo.int/pct/en/access/legal_text.htm.
 SCP/9/5
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industrial application. Although the draft SPLT does not cover matters concerning the rights
conferred by patents, it should be noted that, in many countries, exploitation of a patented
invention for private purposes is not considered as infringing the exclusive rights conferred by
the patent. Therefore, in those countries, if a patent is granted to an invention which could be
usable only for private purposes, such a patent would probably not be enforceable anyway.

30. The second aspect of industrial applicability is that the invention shall be capable of
application in industry. By definition, this means that an invention which has no
application in industry is not an invention susceptible of industrial application. One of the
typical examples of such inventions is an invention alleged to operate in a manner clearly
contrary to the laws of nature, for example, a perpetual motion machine.

31. As described above, since the notion of industry in the context of industrial
applicability can be characterized by the nature of the activity that belongs to the useful or
practical arts, it could be said that, if an invention can be made or used in connection with an
activity that belongs to the useful or practical arts, such an invention shall be considered as
susceptible of industrial application. In this case, industrial applicability means that the
claimed invention can be made or used in any kind of industry in the sense that it must have
a useful or practical application. It is not sufficient that the claimed invention can be simply
made or used. Such a view is, in particular, found in a comment by the English Court of
Appeal in Chiron Corp v Murex Diagnostics Ltd and other [1996] RPC 535.10

32. This aspect of practical applicability is found in many of the responses from
national/regional Offices that require industrial application. In other words, an invention
should have practical or useful purposes and should produce a real result. A speculative use is
not sufficient. This aspect is highlighted, in particular, in the field of biotechnological
inventions. For example, with respect to an invention concerning a gene sequence that
produces a protein, not only which protein is produced, but also the function or utility of the
protein should be disclosed in order to meet the requirement of industrial applicability. In this
case, a decisive question raised is not whether a gene sequence concerned can be isolated (i.e.,
an invention can be made or used in the field of biotechnology), but whether that gene
sequence has a practical or useful application. It may also be noted, however, that this
approach does not appear to be applied to the same extent to all categories of inventions.

33. If a claimed invention fails to demonstrate its practical application, in many cases, the
disclosure in the application as filed will also fail to enable a person skilled in the art to carry
out the claimed invention (enabling disclosure requirement). Although this requirement,
according to which the claimed invention shall be disclosed in the application in an enabling
manner, is a separate requirement from the industrial applicability requirement in many
national/regional laws, in some countries, the industrial applicability requirement also
contains aspects of the enabling disclosure requirement. Similarly, many of the inventions
which do not fall under the definition of the term invention in the context of patent law or
which are not considered patentable subject matter would not comply with the requirement of
industrial applicability.

10
It stated that industry does not exist to make or use that which is useless for any known
purpose and that IP rights should be confined to that which has some useful purpose.
 SCP/9/5
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III. UTILITY REQUIREMENT

National Laws and Practices

34. The patent laws of another group of countries do not provide an industrial
applicability requirement, but require utility. The law of the United States of America
requires that a patentable invention be a new and useful process, machine, manufacture, or
composition of matter, or a new and useful improvement thereof.

35. The Guidelines for Examination of Applications for Compliance with the Utility
Requirement11, issued by the USPTO, provide that an invention has a well-established utility
if: (i) a person of ordinary skill in the art would immediately appreciate why the invention is
useful, and (ii) the utility is specific, substantial and credible. If the applicant has asserted that
the claimed invention is useful for any particular practical purpose (i.e., it has a specific and
substantial utility) and the assertion would be considered credible by a person of ordinary
skill in the art, the utility requirement is met.

36. The definitions of the terms specific and substantial utility are given as follows:

Specific utility The specific utility contrasts with a general utility that would be
applicable to the broad class of the invention. For example, a claim to a polynucleotide
whose use is disclosed simply as a gene probe would not be considered to be specific in the
absence of a disclosure of a specific DNA target. Similarly, a general statement of diagnostic
utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a
disclosure of what condition can be diagnosed.

Substantial utility Utilities that require or constitute carrying out further research to
identify or reasonably confirm a real world context of use are not substantial utilities. The
examples of situations that do not define substantial utility are:

(i) basic research such as a studying the properties of the claimed product itself or the
mechanisms in which the material is involved;

(ii) a method of treating an unspecified disease or condition;

(iii) a method of assaying for or identifying a material that itself has no specific and/or
substantial utility;

(iv) a method of making a material that itself has no specific, substantial and credible
utility;

(v) a claim to an intermediate product for use in making a final product that has no
specific, substantial and credible utility.

So-called throw away utilities do not meet the tests for a specific or substantial utility. For
example, using transgenic mice as snake food is a utility that is neither specific (all mice

11
Manual of Patent Examination Procedure (MPEP), 2107
(see http://www.uspto.gov/web/offices/pac/mpep/mpep.htm)
 SCP/9/5
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could function as snake food) nor substantial (using a mouse costing tens of thousands of
dollars to produce as snake food is not a real world context of use).

37. In order to comply with the utility requirement, the assertion of utility should be
credible. The assertion of utility is considered credible if the assertion is believable to a
person skilled in the art based on the totality of evidence and reasoning provided.12 The
assertion is credible unless the logic underlying the assertion is seriously flawed, or the facts
upon which the assertion is based are inconsistent with the logic underlying the assertion. A
credible utility is assessed from the standpoint of whether a person skilled in the art would
accept that the claimed invention is currently available for such use. For example, nucleic
acids could be used as probes, chromosome markers or forensic or diagnostic markers.
Therefore, the credibility of such an assertion would not be questioned, although such a use
might fail the specific and substantial tests. Situations where an invention is found to be
inoperative, and therefore lacking utility, seem to be very rare. Examples of such cases
include: an invention asserted to change the taste of food using a magnetic field, a flying
machine operating on flapping or flutter function and a method of controlling the aging
process.

38. Case law in the United States of America determining whether an applicant identifies
any specific utility for the claimed invention or not has been developed, in particular, in the
field of chemistry and pharmacology. For example, indicating that the compound may be
useful in treating unspecified disorders, or that the compound has useful biological properties,
would not be sufficient to define a specific utility for the compound. Further, although many
research tools, such as nucleotide sequencing techniques, have a specific utility, if an
invention is useful only in a research setting, it does not address whether the specific
invention is in fact useful as required under the patent law.

39. MPEP 2107.1, IV. provides detailed explanations about the relationship between
35 U.S.C. 101 and 35 U.S.C. 112, first paragraph. Where a claimed invention does not have
utility, in many cases, the specification could not enable a person skilled in the art to use that
invention. Consequently, in those cases, the disclosure of the claimed invention does not
comply with the requirement under 35 U.S.C. 112, first paragraph. The fact that an applicant
has disclosed a specific utility for an invention and provided a credible basis supporting that
specific utility does not provide a basis for concluding that the claims comply with all the
requirements of 35 U.S.C. 112, first paragraph.

40. Under the law of Canada, the term invention means any new and useful art, process,
machine, manufacture or composition of matter, or any new and useful improvement in any
art, process, machine, manufacture or composition of matter. Utility means having industrial
or commercial value in a manner that benefits the public.13 For example, a perpetual motion
machine that serves no useful purpose does not comply with the utility requirement.
Similarly, a device that only suits the convenience of a specific manufacturer, for example, by
impressing a trademark on a product or holes to fit another of the patentees products, has no
utility.

12
Revised Interim Utility Guidelines Training Materials issued by the USPTO
(see http://www.uspto.gov/web/patents/guides.htm).
13
Patents: A Canadian Compendium of Law and Practice, George Francis Takach, 1993, page 34.
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41. A finding that the alleged invention is not useful may be expressed in a way that the
invention will not work, either in the sense that it will not operate at all or, more broadly, that
it will not do what the specification promised it would do (false promise).14 It is sufficient
if the specification correctly and fully describes the invention and its operation or use as
contemplated by the inventor, so that a person skilled in the art may be able to use the
invention as successfully as the inventor himself. Further, if a genus claimed is not proved by
a person attacking the patent in suit to include inoperable species, if the claim includes so
many species that not all could have been tested and found by the inventor to have the
promised utility, the claim is invalid, absent a possible showing by the patentee that the entire
claim could be soundly predicted to have the requisite utility (sound prediction).

42. Control in the sense that a claimed invention results from the control of the inventor
or of those practicing the invention, and does not merely result from the application of the
laws of nature, may be a factor in the analysis of whether an invention is useful.15 The
Patent Act of Canada, however, does not require that all characteristics of the claimed
invention be under the inventors control in order that the invention be useful and patentable.
Similarly, reproducibility of an invention may be considered insofar as it relates to the
question of utility, but the reproducibility of all characteristics of an embodiment of the
invention is not a prerequisite to a finding that an invention is present. 16

43. The law of Australia provides that a claimed invention shall be a manner of
manufacture within the meaning of Section 6 of the Statute of Monopolies and be useful.
The Australian Office notes that certain aspects of the manner of manufacture requirement
and useful requirement under its law considerably overlap with the industrial applicability
requirement. What constitutes a manner of manufacture is determined by case law and
traditional principles, including the exclusion of fine arts and mere ideas or discoveries. The
courts have pronounced on a number of occasion that a process, to fall within the limits of
patentability, must be one that offers some advantage which is material, in the sense that
the process belongs to a useful art as distinct from a fine art that its value to the country
is in the field of economic endeavor.17

44. The following examples relate to inventions which are not considered a manner of
manufacture:

(i) claims to microorganisms per se without any practical application;

(ii) an improved plan for a subterranean utility distribution scheme (the issuance of
instructions to a gang of workmen to dig evacuations and lay conduits as indicated on a plan
of a site cannot of itself constitute any development in a useful art);

(iii) a method for operating a jet aircraft to reduce noise over built up area
(considered not patentable because it represented operating instructions for a known aircraft
and because it was mischievous to the state or generally inconvenient by adding demands on
pilots).

14
Canadian Patent Act Annotated, Robert H. Barrigar, 1999, 2:160.
15
Canadian Patent Act Annotated, Robert H. Barrigar, 1999, 2:175.
16
Canadian Patent Act Annotated, Robert H. Barrigar, 1999, 2:175.
17
National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252,
IBM v Commissioner of Patents (1991) 22 IPR 417.
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45. The concept of manner of manufacture also includes a threshold inventiveness

requirement that would exclude an invention consisting of merely a new use of an old
substance, involved old integers without a working interrelationship producing a new or
improved result or was otherwise obvious on the face of the specification. Examples of these
principles include a container with its contents with a set of written directions (it does not
constitute a manner of manufacture unless the package itself is novel) and rocket projectors of
known design manufactured from reinforced synthetic resinous plastic material (it is merely
the use of a known material in the manufacture of known articles for the purpose of which its
known properties make that material suitable).

46. On the other hand, the requirement that an invention be useful is closely associated
with questions of false suggestion and misrepresentation, and it does not include any
judgement as to the social benefit or the value or morality of the invention. The essential
principle is that the invention should allow the addressee to achieve the effects or results
promised by the patentee. Therefore, it is sufficient if the invention can be used and offers the
public a useful choice. Lack of utility is a ground for revocation of the patent, but not a
ground for objection during examination or in opposition proceedings. It nevertheless may be
addressed to some extent in examination and opposition proceedings when considering
sufficiency, fair basis and clarity of the description and claims.

47. The following inventions are considered not to meet the requirement that an invention
be useful under the law of Australia:

(i) An invention related to control circuits for gas discharge lamps. The
specification indicated that the invention would reduce heat generation in the ballast.
However the evidence was that some circuits falling within the scope of the claims failed to
work and caused lamp failure because of excessive heat generation. Consequently the
promise of the invention was not fulfilled.

(ii) The promise of a cheese for permanent keeping was not fulfilled by the
sterilization process claimed.

48. According to the response from New Zealand, Section 41(1)(g) of the New Zealand
Patents Act 1953 states that a patent may be revoked on the grounds that the claimed
invention is not useful.

Main Characteristics of Utility

49. As in the case of the industrial applicability requirement, practices in the countries
which require utility (or usefulness) vary. As a general rule, however, certain characteristics
commonly applicable to the utility requirement can be identified.

50. Firstly, inoperative inventions or, more broadly, inventions which do not work in a way
they promised to do, do not comply with the utility requirement. In other words, claimed
inventions which are clearly not operative, or which could not be soundly predicted to have
the requisite utility, do not meet the utility requirement.

51. The second common concept is that, even if any use of a claimed invention is asserted,
the utility requirement would not be met where such use is too general, absurd or non-realistic
in view of the gist of the claimed invention. Under the practice of the United States of
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America, this concept seems to be covered by the expression specific and substantial utility.
The same concept expressed in more general terms is also found in the responses from
Australia and Canada. In connection with the explanation of the term manner of
manufacture, the submission from Australia addressed the point that a claimed invention
should offer some material advantage in the sense that it belonged to a useful art and that its
value to the country was in the field of economic endeavor. The submission from Canada
indicated that utility meant having industrial or commercial value in a manner that benefited
the public and that the control of the inventor and the reproducibility of the claimed invention
might be considered in respect of utility. Both submissions suggested that the claimed
invention with the asserted utility should offer concrete benefits to the public.

52. As in the case of the industrial applicability requirement, the utility requirement also
relates to other patentability requirements, in particular, requirements concerning the
disclosure of the claimed invention. Since the required utility could not be a speculative one,
it is also related to a principle that the scope of the claims is commensurate with the invention
as disclosed. Under national practices, this aspect is found, in particular, in relation to
expressions such as credible utility, sound prediction and false suggestion.

IV. COMMONALITIES AND DIFFERENCES BETWEEN THE INDUSTRIAL

APPLICABILITY AND THE UTILITY REQUIREMENTS

53. The scope of the term industrial applicability differs from one country to another, and
so does the term utility. Considerable overlaps, however, exist between these two
requirements.

Commonalities

54. Focusing on the general common characteristics of the two requirements, an invention
that is inoperative, for example, an invention which is clearly non-operable in view of well-
established laws of nature, would not comply with both the industrial applicability and utility
requirements. This type of invention is considered either having no application in industry or
not being useful for any purpose, because it doesnt work.

55. In respect of an invention that is operable, the same invention may not always meet both
the industrial applicability requirement and the utility requirement. However, at least in part,
both requirements seem to address a similar issue. Generally speaking, an invention which is
not useful in a substantial or concrete way, for example, its asserted use is too general, too
absurd, not realistic or speculative, does not comply with the utility requirement. On the other
hand, the practice applied to, in particular, biotechnological inventions, and a comment by the
English Court of Appeal in Chiron Corp v Murex Diagnostics Ltd and other [1996] RPC 535,
show that the practical and useful application of the claimed invention is not foreign to the
question of industrial applicability. Although it is not possible to draw any general
conclusion in view of the differences which exist among the countries that require industrial
applicability, at least certain inventions that can be made or used in any kind of industry, but
cannot show any practical or useful application, could be refused on the grounds of both the
industrial applicability requirement and the utility requirement. However, the extent of
utility or usefulness required may require to be further examined by the SCP members if
the need for a general rule in this respect was felt.
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Differences

56. One of the differences between the industrial applicability requirement and the utility
requirement is that claimed inventions which could apply solely in the private or personal
sphere for ones own needs, or which could be applied solely in association with a particular
person, would not meet the industrial applicability requirement, even if the term industry is
interpreted in the broadest sense. Although not many examples of inventions falling under
this category were suggested by the SCP members, it may be further explored how the
patentability of these inventions is assessed in those countries which apply the utility
requirement. At least in the submissions from Australia and Canada, with respect to a
manner of manufacture and utility, respectively, a commercial value in connection with
benefits to the public was mentioned (see paragraphs 40 and 43). It may be noted that at least
some of the countries applying utility, although they grant patents for inventions applicable
only for private use, provide some safeguards for limited uses of the invention, such as the
de minimis doctrine.

Overlaps with other requirements

57. First, both requirements are closely related to, in particular, the enabling disclosure
requirement, the definition of invention in the context of patent law, and the exclusions
from patentable subject matter. In practice, many of the inventions which do not comply with
the industrial applicability or utility requirements do not comply with these other
requirements either. In the context of the draft SPLT, the enabling disclosure requirement is
provided for in draft Article 10 and draft Rule 10, the texts of which are, in general, agreed by
the SCP. This means that the practices of the Offices could be harmonized to the extent that
the enabling disclosure requirement and the industrial applicability/utility requirement
overlap. The patentability of those inventions which fall within the scope of the overlapping
area would be refused in any Contracting Party, on the grounds of, at least, non-compliance
with the enabling disclosure requirement. On the other hand, the definition of invention
under the patent law and patentable subject matter vary significantly among national and
regional laws. As it was suggested at earlier sessions of the SCP, unlike the enabling
disclosure requirement, it would be difficult to reach full agreement on these matters in the
SCP. One of the key issues relevant to this matter could be the technical character of the
claimed invention. In view of the fact that the term industry is construed in the broadest
sense in many of the countries which require industrial applicability, it may be envisaged to
separate the technical character of an invention from the industrial applicability/utility
requirement, as suggested in paragraph 147 of the Practice Guidelines under the SPLT in
document SCP/8/4.

58. As a general conclusion, an invention that is inoperative, for example, an invention

which is clearly non-operable in view of well-established laws of nature, is not patentable on
the grounds of both the industrial applicability requirement and the utility requirement. Under
certain circumstances, an invention not having the requisite utility may be refused on the
grounds of non-compliance with the industrial applicability requirement, where the invention
could be made or used in any kind of industry, but could not show any practical or useful
application. A clear difference exists between the industrial applicability requirement and the
utility requirement as to inventions which could be solely used in the private and personal
sphere, although the utility requirement applied in certain countries takes into account the
public benefit of the invention.
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V. ALTERNATIVES IN DRAFT ARTICLE 12(4) OF THE SPLT

59. As regards the industrial applicability and utility requirements, three alternative texts are
proposed in draft Article 12(4) of the SPLT (see document SCP/9/2). Although a Contracting
Party may use either the term industrial applicability or the term utility under the
applicable law, the provision is intended to provide a single definition that could be expressed
in either terms. The texts of the three alternatives are reproduced below:

[Alternative A]

A claimed invention shall be industrially applicable (useful). It shall be considered

industrially applicable (useful) if it can be made or used for exploitation in any field of
[commercial][economic]activity.

[Alternative B]

A claimed invention shall be industrially applicable (useful). It shall be considered

industrially applicable (useful) if it can be made or used for exploitation in any kind of
industry. Industry shall be understood in its broadest sense, as in the Paris Convention.

[Alternative C]

A claimed invention shall be industrially applicable (useful). It shall be considered

industrially applicable (useful) if it has a specific, substantial and credible utility.

60. According to Alternative A, the words for exploitation in any field of

[commercial][economic] activity imply that the claimed invention has a practical or useful
application, rather than that it could simply be made without any use, or could be simply used
in a non-reasonable manner. The general rule as to what constitutes an invention with
practical or useful application (or alternatively, what constitutes an invention without
practical or useful application) may be provided in the Practice Guidelines, if the SCP
Members agreed that further elaboration is necessary. The expression
[commercial][economic] activity attempts to capture the broad scope of the term industry
that appears in many national and regional laws. Further, this expression is intended to
exclude inventions that could be applied solely in connection with the personal and private
sphere. In practice, according to the broad scope of the term industry in Alternative B, the
term any kind of industry in Alternative B and the expression any field of
[commercial][economic] activity may not be substantially different. Alternative A, however,
aims at using an explicit term that covers the activities which could fall within the scope of
industry in its broadest sense.

61. Alternative B reflects the standard wording of the industrial applicability requirement
that appears in many national and regional laws. In addition to the question concerning the
scope of the term industry, the provision could be interpreted in a strict sense so that, for
example, an invention concerning an isolated partial gene sequence may be considered as
complying with the requirement under Alternative B, although no function of, or utility for,
such a sequence is disclosed, apart from the general understanding that the sequence could be
used as a probe.

62. The wording of Alternative C is modeled after the practice of the utility requirement, in
particular, in the United States of America. In addition to the question as to the extent to
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which utility of the claimed invention should be required, Alternative C could be interpreted
in a way that an invention that could be applied only in connection with personal needs or
personal skills would be considered to comply with the industrial applicability/utility
requirement as long as that invention has the required utility.

63. One possible way which may be explored by the SCP could be to first identify, based on
this document, the commonalities between the two requirements. These elements, together
with other requirements which overlap with industrial applicability/utility, may form the basis
to attempt to elaborate a common requirement. The next step could be to identify and attempt
to solve the existing differences. Finally, it may be noted that any terms chosen in respect of
a new requirement would need to be clearly circumscribed, for example, in the Practice
Guidelines. In any event, it should be ensured that such wording, if it had already been used
in some jurisdictions, would not result in the importation of the case law and practices used in
such jurisdiction in relation to that wording.

64. The SCP is invited to note the contents of

this document.

[End of document]