Handling of Product-by-Process Claims in
Examination Procedures (*)
In the judgments of June 5, 2015 with respect to product-by-process claims, the Supreme Court of Japan reversed
the Intellectual Property High Court’s judgments that had separated the construction of PBP claims by applying the
product identity theory for "Authentic PBP claims" and the manufacturing process limitation theory for "Unauthentic
PBP claims," and instead uniformly applied the "product identity theory" for “identification of the gist of the invention”
and “determination of technical scope of the invention.” It held that "in cases where the relevant claim falls under the
category of PBP claims (hereinafter referred to as the 'Case'), the invention will be found to comply with therequirements of clarity of inventions only if there are 'impossible or impractical circumstances (hereinafter referred to as
the 'Circumstances')’ to directly specify the product by its structure or characteristics at the time of filing theapplication." The Japan Patent Office took these judgments into consideration in revising the Examination Guidelines
and Examination Handbook and has stated its intention to enrich case examples for determination on the "Case" and"Circumstance" in the Examination Handbook. In this study, the situations of Japan and other countries (i.e., European
Patent Office, the U.K., and Germany) were grasped by conducting surveys on public information, overseas
questionnaire surveys, and considerations by experts, and thereby the basic materials were prepared to be used inconsidering specific case examples that would contribute to such determinations and whether or not to provide suchspecific case examples in the Examination Handbook.

I

Introduction

1

Background and Purpose of This Study
Following the judgments of the Supreme Court ofJapan on June 5, 2015 involving product-by-process
claim (i.e., when a claim concerning invention of a
product reciting manufacturing processes of the product;
hereinafter referred to as "PBP claim")1 , the Japan Patent
Office (JPO) initiated its “Interim Handling Proceduresfor Examinations involving PBP Claims” on July 6,2015 2 . In the Handling Procedures, "when a claim
concerning an invention of a product recites amanufacturing process of the product" (hereinafterreferred to as the "Case"), the Examiner shall determinethat the invention of that product is not clear except forthe case when the Examiner can find that the invention
involves “impossible or impractical circumstances"(hereinafter referred to as the "Circumstances").
Hereby, specific case examples that would
contribute to the determination on whether or not to fallunder "Case" or "Circumstance" are planned to be further
enriched in the Examination Handbook for Patent andUtility Model (hereinafter referred to as the "Examination
Handbook") based on future court decisions and JPO’s
appeal/trial decisions 3.
Meanwhile, information on such specific caseexamples not limited to court decisions and appeal/trial
decisions would be useful for applicants or others toconsider their responses in cases where they receive a
notice of reasons for refusal stating that the PBP claim is
not clear, or other cases. While there are no such court

decisions or appeal/trial decisions in Japan, it is necessary
to grasp the situations in other countries as well as to havethe experts consider which specific case examples areapplicable to fall under "Case" or "Circumstance", inorder to provide such specific case examples to theapplicants or others and consider whether or not toinclude them in the Examination Handbook.
The purpose of this study is, by analyzing the court
decisions and appeal/trial decisions concerning PBP
claims in foreign countries and having the experts
consider, to prepare the basic materials for considering toprovide the applicants or others with specific caseexamples that would contribute to the determination onwhether or not to fall under "Case" or "Circumstance",
and whether or not to include the specific case examples
in the Examination Handbook.
2 Methods for Conducting This Study(1) Survey of Public Information(i) Survey of Information Related to This Study
The information on systems and operations in Japan
as well as major foreign countries were surveyed,organized, and analyzed by using various publicly
available information, such as relevant literature.
(ii) Survey of Case Laws
The survey was conducted with respect to literatureand other information, including appeal/trial decisions
and court decisions, concerning PBP claims rendered by
the European Patent Office (EPO) and in the United
Kingdom (U.K.) and Germany as well as the(*) This is an English summary by the Institute of Intellectual Property based on the FY2015 JPO-commissioned research study report on theissues related to the industrial property rights system.
●

IIP Bulletin 2016 Vol.25

1 ●commentaries thereof. Also, in compiling the results ofanalysis of the case laws, we received some advice froman attorney at law/patent attorney who has knowledge on
patent laws and regulations and case laws of major
foreign countries (Europe).
(2) Overseas Questionnaire Survey
We conducted the questionnaire survey with local
law firms, asking about the situations of the EPO, theU.K., and Germany by extracting question items mainly
from the points that have not been extracted in the surveyof public information.
(3) Consideration by the Committee
A committee was formed of eight members withexpert knowledge relating to this study (industry experts,
patent attorneys, and attorneys at law) and the meetings
were held three times for consideration, analysis andadvices from technical standpoints. At the committee, themethods for conducting the surveys of public informationand the overseas questionnaire survey were considered,and referring to the results of each survey, the following
points were discussed:(i) Relevance of PBP Claims* With respect to the determination concerning the"Case," what specific case examples may fall under type(1-1), (1-2), or (2) of Section 2204 or type (i) or (ii) of
Section 2205 in Part II, Chapter 2 of the Examination
Handbook or others, respectively;* Whether or not there are any specific case examples
that are particularly helpful for consideration as to be
included in the future as falling under type (2) or (ii) of
the Examination Handbook.
(ii) Allegation and Proof for Descriptions as a PBP
Claim to be Accepted* With respect to the substances of the allegation andproof of the "Circumstances," what matters be contained
for the allegation or f to be accepted, such as thecharacteristics of the art covered by the invention, level ofthe analysis technology, and the details of the workrequired to identify the invention by the structure or
characteristics* Whether or not there are any specific case examples forallegation and proof that are particularly helpful for
consideration of future inclusion to the Examination
Handbook.

II Handling of "PBP Claims" in Japan
1

OutlineIn this study, PBP claims (i.e., where claims
concerning inventions of products recite manufacturing
processes of the products) were considered. They include●

for example such a claim as "Product Y obtained bymanufacturing process X." There may be cases where allfeatures of the invention are described only by the"manufacturing process" with the starting material andthe reaction thereof, or where some feature of theinvention is described as structure or the like and partly
characterized by wording of the "manufacturing process."
With respect to the construction of PBP claims (foridentifying the gist of the invention and determination of
the technical scope of the invention), product identity
theory and manufacturing process limitation theory havebeen known since before. Under the product identity
theory, the claim is constructed as to even cover a productobtained by a different manufacturing process, if the
product is identical to the product obtained by the
manufacturing process described in the claim On theother hand, under the manufacturing process limitation
theory, the claim is literally constructed by limiting to
only cover a product obtained by the manufacturing
process described in the claims (product Y obtained bymanufacturing process X).
2

Laws, Regulations and Examination Guidelines
or the Like Concerning PBP Claims
Pursuant to Article 36, paragraph (6) of the Japanese
Patent Act, the statement of the "claims" shall "comply
with each of the following items."(i) the invention for which a patent is sought is stated in
the detailed explanation of the invention;(ii) the invention for which a patent is sought is clear;(iii) the statements for each claim is concise.
Accordingly, pursuant to Article 36, paragraph (6),item (ii), the invention for which a patent is sought must
be clear.
Meanwhile, the JPO had been considering, based on
the consideration at the first meeting (held on August 22,2014) of "the Working Group on the Patent Examination
Standards, the Patent System Subcommittee, theIntellectual Property Committee of the Industrial
Structure Council," under the policy for revising the
Examination Guidelines as "summarizing the basic ideasof the application of relevant laws such as the Patent Act"and the Examination Handbook as "including enoughcase examples, court precedents, and application
examples useful in understanding of the basic ideas of the
Examination Guidelines, in addition to summarizing
procedural matters and points to consider necessary to
perform the examination procedures." 4 On June 5, 2015,
while the consideration by the Working Group was still
continuing, the judgments of the Supreme Court of Japan
mentioned above were rendered and the "review andrevision of the Examination Guidelines concerning
product-by-process claims" became the subject of thesixth meeting (held on July 3, 2015) of the Working
Group on the Patent Examination Standards. As a result
2 ●IIP Bulletin 2016 Vol.25

of the consideration, the JPO published the "Interim
Handling
Proceduresfor
Examinations
andAppeals/Trials Involving Product-by-Process Claims" on
July 6, 2015 based on the judgments of the Supreme
Court5.
Subsequently, based on the considerations by theWorking Group on the Patent Examination Standards, on
September 16, 2015, the JPO released the thoroughly
revised "Examination Guidelines for Patent and Utility
Model," 6 as well as the thoroughly revised"Examination Handbook for Patent and Utility Model"(hereinafter simply referred to as the "Examination
Handbook")on the same date7 . Operations under theserevised "Examination Guidelines for Patent and Utility
Model" and "Examination Handbook" are applied to theexaminations on or after October 1, 2015.
In this revised "Examination Guidelines for Patentand Utility Models," the parts concerning PBP claims
were moved to Part II, Chapter 2, Section 3, 4.3.1 andPart III, Chapter 2, Section 4, 5., and changes have been
made to the parts that would be affected by the judgmentsof the Supreme Court mentioned above.
In addition, the contents of the abovementioned"Interim Handling Procedures for Examinations andAppeals/Trials Involving Product-by-Process Claims"
have been reflected in Sections 2203 through 2205 in the
Examination Handbook.
This study began amidst the above-mentioned
developments. At the committee formed for this study,
the contents stated in the Examination Handbook wereconsidered, and based on the results of the consideration
described in Chapter V below, the JPO published on its
webpages "Reference examples of arguments andverification presented by applicants involving 'impossible
or impractical circumstances' concerning product-by-process
claims" 8 on November 25, 2015 and "Addition of
examples not considered to be product-by-process claims"9
on January 27, 2016, respectively.
The JPO plans to further consider the handlingprocedures for PBP claims, including further enrichmentof case examples where the "Circumstances" may befound and case examples that would not be considered tobe PBP claims and to revise the Examination Handbook
by the beginning of April 2016 based on the results of theconsideration.
2 Court Decisions Related to PBP Claims(1) Previous Court Decisions
As overall tendency of previous court decisions
before the judgments of the Supreme Court, decisions
generally tended to basically stand on the product identity
theory in identifying the gist of the invention. In
determining the technical scope, many decisions also
stood on the product identity theory or the manufacturing
process limitation theory if there were special●

IIP Bulletin 2016 Vol.25

circumstances while some decisions applied the
manufacturing process limitation theory or applied the
product identity theory if there were special
circumstances.
(2) Developments of the Cases Led to the
Judgments of the Supreme Court on June 5,2015
In case (i) Judgment of the Tokyo District Court ofMarch 31, 2000, Case No. H19(2007) (Wa) 35324, theplaintiff, the patentee of the patent 3737801 "pravastatin
sodium substantially free of pravastatin lactone andepipravastatin, and compositions containing the same"
alleged that the defendant's specific medicine infringes
the plaintiff's patent right and sought injunction of the
manufacture and sale of such medicine as well as thedisposal of such medicine in stock.
The court held that the "technical scope of thepatented invention should be constructed by limiting to
the product manufactured by the manufacturing processdescribed in the claim 1 of the patent in dispute."
Furthermore, in case (ii) Judgment of the Tokyo
District Court of July 28, 2001, Case No. H20(2000)(Wa) 16895, the plaintiff claimed for injunction against
the import and sale of the defendant's relevant medicine
as well as the disposal of such medicine in stock.
However, unlike in case (i) mentioned above,
construction of PBP claims was not particularly disputed
and the court dismissed the claim for lack of inventive
steps, holding that "the patent in dispute should beinvalidated in the course of an appeal/trial for patent
invalidation."
Meanwhile, the defendant in case (i) mentioned
above filed a request for an appeal/trial for patent
invalidation with respect to the patent right mentioned
above and the plaintiff in case (i) mentioned above
defended against this by filing a request for correction.
The JPO, allowing the correction, rendered an appeal/trial
decision to dismiss the request for an appeal/trial forpatent invalidation in case (iii) appeal/trial decision ofAugust 25, 1999, request for an appeal/trial for patent
invalidation No. 2008-800055.
In case (iv) Judgment of the First Division of theIntellectual Property High Court of January 27, 2012,
Case No. H21(2009) (Gyo-Ke) 10284, case to seek
rescission of the appeal/trial decision (iii) mentioned
above, the court, classifying PBP claims into authentic
PBP claims "in which a product is specified by means ofa process to manufacture the product because there arecircumstances where it is impossible or difficult to
directly specify the product by means of the structure orfeature of the product at the time of filing an application",and unauthentic PBP claims for which "it cannot be said
that there are circumstances where it is impossible ordifficult to directly specify the product subject to the3 ●invention by means of the structure or feature of the
product at the time of filing an application," held that thiscase was the latter and there was no error in the
conclusion of the appeal/trial decision that could not
decide the claim invalid, and thereby dismissed therequest.
While case (iv) mentioned above was pending, incase (v) Judgment of the Grand Panel of the Intellectual
Property High Court of January 27, 2012, Case No.
H22(2010) (Ne) 10043, as the appeal for case (i)mentioned above, where the appellant (patentee),claiming the same as in the first instance, sought
rescission of the judgment of the prior instance , as withthe case (iv) mentioned above, the court classified PBP
claims into authentic PBP claims and unauthentic PBP
claims, and thereby rendered a decision to dismiss theappeal on the same date as case (iv) mentioned above toseek rescission of the appeal/trial decision.
Later, in case (vi) Judgment of the First Division of
the Intellectual Property High Court of August 9, 2012,
Case No. H23(2011) (Ne) 10057, as the appeal for case(ii) mentioned above, the court dismissed the appeal on
the grounds that no "Circumstances" could be found andthat "the gist of the invention is recognized as being
limited to products manufactured through the
manufacturing process as stated in the claim."(3) Judgments of the Supreme Court
In the final appeal case (i) Judgment of the Second
Petty Bench of the Supreme Court of June 5, 2015; Case
No. H24(2012) (Ju) 1204, for case (v) mentioned above,and the final appeal case (ii) Judgment of the Second
Petty Bench of the Supreme Court on June 5, 2015, Case
No. H24 (2012) (Ju) 2658, for case (vi) mentioned above,
respectively, (Presiding judge: CHIBA Katsumi; Judges:
ONUKI
Yoshinobu,
ONIMARU
Kaoru
and
YAMAMOTO Tsuneyuki), the summary of the judgment
was stated as follows:
1. Even in the case of what is generally referred to asa "product-by-process claim," that is, when a claim of apatent for an invention of a product recites the
manufacturing process of the product, the technical scopeof the patented invention should be determined as
referring to products that have the same structure,
characteristics, etc. as those of the product manufacturedby the manufacturing process.
2. In the case of what is generally referred to as a"product-by-process claim," that is, when a claim of apatent for an invention of a product recites the
manufacturing process of the product, the recitation of theclaim should be held to meet the requirement that "theinvention is clear" as prescribed in Article 36, paragraph(6), item (ii) of the Patent Act, only if there arecircumstances where it was impossible or utterly
impractical to directly define the product subject to the●invention by means of its structure or characteristics at
the time of the filing of the application.
In the judgment of the Supreme Court for case (ii,the phrase "the technical scope of the patented invention
should be determined…" shall be read as "the gist of theinvention should be identified…."
In each of these judgments, there were a concurring
opinion by Judge CHIBA and an opinion by Judge
YAMAMOTO.
However, since the appellant of the final appeals
stated its intention to waive its claim at the Intellectual
Property High Court to which the appeal was remanded,
the action was closed.

III Results of the Surveys of PublicInformation
1

Survey of Information Related to This Study
With respect to the "Case" and "Circumstances," thecontents discussed with respect to the types, etc. of PBP
claims as well as those discussed in relation to the"Circumstances" by the authors were checked in theliterature that were relatively easy to acquire among thereference materials listed in the part of reference in thereport, and then extracted and listed them in the form ofcitation or summary.
In many of them, case examples of actual
applications or court decisions are discussed.
2 Results of the Survey of Case Laws
(1) Methods for Survey of Case Laws
The EPO provides a database on its appeal decisions,and when a search was conducted on the term
"product-by-process" as a keyword, approximately 84
cases appear as of February 29, 2016. Meanwhile, in theofficial case law book issued by the EPO, "Case law of
the boards of appeal of the European Patent Office,"major appeal decisions are introduced from various
standpoints in Part II, Chapter A, 7 "Product-by-process
claims." Therefore, the appeal decisions listed in the caselaw book or other decisions were analyzed, referring to
the answers obtained in the overseas questionnaire
survey.
In the U.K., decisions of the Intellectual Property
Office are provided in its database "Results of past patentdecisions," while court decisions are provided in the"BAILII Databases." However, no results were obtained
from the search conducted on the keyword"product-by-process," and thus the judicial precedents
mentioned in papers were analyzed, referring to theanswers obtained in the overseas questionnaire survey.
In Germany, the database is provided for each court,
such as the Federal Supreme Court and Federal Patent
Court as well as the district courts and high courts of eachstate, and the court decisions in or after 2000 may be
4 ●IIP Bulletin 2016 Vol.25

searched. There are also various other databases.
However, when the judgments by the Federal Supreme
Court of Germany in or after 2000 were searched by the
keyword "product-by-process," only four cases show, andwhen a search was conducted using the keywords"product-by-process" and the German words
corresponding to the "Circumstances," no results could beobtained. Thus, the judicial precedents mentioned in
papers, etc. concerning PBP claims were analyzed,
referring to the answers obtained in the overseas
questionnaire survey.
(2) Results of the Analysis of Case Laws
(i) Appeal Decision of the EPO
Among the appeal decisions by the EPO, T 150/82 is
one of the established appeal decisions concerning PBP
claims. In this appeal decision, it was held that "Claims
for products defined in terms of processes for their
preparation (known as "product-by-process claims") areadmissible only if the products themselves fulfill therequirements for patentability and there is no otherinformation available in the application which could
enable the applicant to define the product satisfactorily byreference to its composition, structure, or some othertestable parameter." (Also, the appeal decision T 0320/87
with the same effect.)
However, in other appeal decisions concerning PBP
claims, there were found many cases where PBP claims
were allowed to clarify the difference between theinvention in question and prior art in determining thenovelty or inventive steps of the invention, while PBP
claims were found to be in violation of the requirementsof clarity for reasons such that "there is no otherinformation available in the application that could enable
the applicant to sufficiently define the product byreference to its composition, structure or some othertestable parameter" in relation to the determination on therequirements of clarity.
(ii) Court Decisions in the U.K.
One of the most important court decisions is the
judgment for the final appeal case ofKirin-Amgen Inc
and others v. Hoechst Marion Roussel Limited and others,[2004] UKHL 46. In this judgment, the court, applying
the laws of the EPO in determining the novelty of a PBP
claim, held that "impossible or impracticalcircumstances" are "only if the product is different but thedifference cannot in practice be satisfactorily defined byreference to its composition etc."
In the judgment of the Patents Court for the case
Hospira UK Limited v Genentech Inc., the court held that
"The EPO's approach to overt product by process claims
today is settled. They will be permitted (and only
permitted) if there is no other way of defining the productopen to the patentee," while stating that PBP claims to●

IIP Bulletin 2016 Vol.25

which "Circumstances" is applied in a limited extent.
(iii) Court Decisions in Germany
In Germany, there are few cases where decisions
were made with respect to the "impossible or impracticalcircumstances." The judicial precedent that is cited themost is Beschluss v. 06.07.1971, Az.: X ZB 9/70
“Trioxan” wherein the court held that "product claims
wherein the chemical material is characterized by the
manufacturing process (so-called PBP claims) is
admissible, if the structural formula of the chemicalmaterial is not known or the chemical material cannot be
identified by the characteristics which may be confirmedwith certainty" and explained "impossible or impracticalcircumstances" by stating that "in cases where thecomplete and exact clarification of the macromolecular
substance is impossible at the time of filing, or in practiceunreasonable expense is required in relation to economic
exploitation, because, for example, in individual case, it isuncertain whether or not the specific structure has aconsiderable
influenceonthecontemplatedcharacteristics of the claimed polymer , if the applicant iscapable of clearly identifying it in another way,
macromolecular substance is not excluded from thepatent protection;" and "it would not be allowed toignore the subject matter for which protection is sought inconsidering the requirement of 'clear identifiability' of theinvention. If the macromolecular substance is not yet able
to be described at that time with accuracy that is available,
for instance, in the field of low-molecular chemistry, only
such degree of accuracy can be required that appears asaffordable in accordance with the given circumstances bytaking into consideration the practical demands and therequirements mentioned above."

IV Handling of Product-by-Process
Claims in each Country and Region
This chapter provides the answers obtained from thelocal agent for the overseas questionnaire survey.
1

Claims that would be Determined as PBP
ClaimsWith respect to (1) determination in examination ofwhether or not the relevant claim is a PBP claim and (2) aproduct claim that would not be considered as a PBP
claim, at the EPO and in the U.K. and Germany, productclaims expressed by the phrase "obtainable by…" and"obtained by…" are considered as PBP claims. Yet, it ismentioned that at least before the EPO, claims using
simple definition such as "coated," "connected,""provided," disposed," arranged," or "neutralized" would
be unlikely considered as PBP claims unless unusual
process steps are included, and if it is immediately clear
to the Examiner which characteristics of the product are
5 ●suggested, objection specific to PBP claims would
normally not be raised.
With respect to (3) product claims including
wordings that represent the structure and those
representing the process ("hybrid claims"), it was
answered that they would be considered as PBP claims inall jurisdiction.
With respect to (4) PBP claims in the mechanical,
electric/electronics, and chemical fields, various examples
were presented.
With respect to (5) handling of applications
containing a product claim and a PBP claim, it was
answered for all jurisdiction that there were no specificcase examples, but if such both types of claims exist at
the same time in a single application, no "Circumstances"would exist, and thus PBP claim would not be allowed,
however, if the PBP claim can be better distinguishedfrom prior art, the PBP claim may be allowed.
With respect to (6) handling of a product claim
dependent on an independent process claim, it was
answered that it is rather extremely general situation andthus it is allowed.
With respect to (7) prior art search for PBP claims, it
was answered that at least at the EPO and in Germany, asearch shall be conducted based on not only thecharacteristics of the product/structure but alsocharacteristics of process, and if the process step do not
clearly bring an additional characteristic to the product,
namely, if the Examiner believes that the process may bereplaced by a different process without affecting the
product itself, lack of novelty objection shall be raised,
and the burden to show the novelty by a new process
shall be shifted to the applicant.
With respect to (8) the situation where the PBP
claim does not fulfill the description requirements as wellas the responses to be made in such situation, at the EPO
and in Germany, there were no description requirements.
Moreover, in Germany, there are no conditions
corresponding to the clarity requirements under Article 84of the European Patent Convention (EPC), and thus
objection may not be raised based on violation of therequirements of clarity. Instead, the application may beobjected for insufficient description under Article 34 of
the German Patent Act. At the EPO, if the process definedin the claim is not to produce the product with thecharacteristics of the product indicated in the claim,
objection may be raised for insufficiency. If thedescription of the process is (overly) equivocal but theprocess seems to be prima facie decisive to define theclaimed subject matter and to distinguish from prior art,
either clarity requirement objection or prima facie novelty
objection would be raised. Meanwhile, it was answeredthat in the U.K., PBP claims would be handled in thesame manner as other claims.
With respect to (9) the situation where the PBP●

claim does not fulfill the requirements for novelty or
inventive steps as well as the responses to be made insuch situation, it was answered that in all jurisdiction, if
the product itself does not fulfill the requirements,
objection may be raised.
With respect to (10) the response to resolve
objections for PBP claims, it was answered for all
jurisdiction that the following responses are available:* To submit comparative experimental data or othertechnical arguments that show that the subject matter of
the PBP claim is actually novel, namely, different from aprior art product manufactured by a different process;* To delete the PBP claim (if other types of claims areremaining);* To rewrite the PBP claim into a process claim;* To maintain the product claim while rewriting thewordings specified as a process into wordings
representing the structure (in most cases, this is difficult at
the EPO due to its strict standard for added
subject-matters);* To describe the process in the claim in more details but
based on the application as filed in order to resolve lackof clarity or prima facie novelty.
2Allegation and Proof for the Description as
PBP Claims to be Found as Clear
With respect to (1) cases where the PBP claim
would be found to be in violation of the requirements ofpatentability due to reasons such that "impossible or
impractical circumstances" do not exist or other and (2)the specific requirements of clarity for PBP claims, at the
EPO and in the U.K., it is an established case law thatPBP claims would be allowed only if the product cannot
be defined in other way (such as the composition,
structure or other structural or physical parameter)
together with the information available in the application
text. However, in Germany, there is no such clarity
requirement as mentioned above.
With respect to (3) allegation and proof that the"impossible or impractical circumstances" exist, at the
EPO and in the U.K., PBP claims are generally formallyallowed if it is evaluated based on the disclosure of theapplication as initially filed that the product cannot be
defined by a structural/physical parameter and further
data is not available to define the product itself based on
the descriptions. Moreover, in the U.K., it was suggested
as appropriate to indicate that there is no analysis
technique available to accurately decide the structure of
the product or that the product is a complicated mixtureof compounds that are difficult to clarify. However, it was
answered that in Germany, there seems to be no case laws
where the details of "impossible circumstances" were
specifically explained.

6 ●IIP Bulletin 2016 Vol.25

V Consideration by the Committee
1

Determination on the "Cases where the
Manufacturing Process of the Product isRecited in the Claims for the Invention of a
Product"
At the committee formed for this study,
consideration was made by using a draft of the material"Addition of examples not considered to be
product-by-process claims" later published by the JPO on
January 27, 2016. Various opinions were presented by thecommittee members among which the major ones were:
the judgments of the Supreme Court should bethoroughly understood and the coverage of the rulings in
the judgments should not be expanded too much; thejudgments of the Supreme Court were based on thepremise that when the manufacturing process is recited, itwould be generally unclear how the structure is, and thus
claims in which the structure is clear would not fall under
PBP claims; determinations must be made not only by theexpressions in the claims but also by taking into
consideration the intention of the applicant that can beread from the claims in whole, the description of thespecification as well as the common technical knowledge,
etc.; and guidelines for increasing the examples that
does not fall under the "Case," and enrichment of specificexamples.
2

Allegation and Proof of "Impossible or
Impractical Circumstances"
Considerations were made at the committee byusing a draft of the material "Reference examples ofarguments and verification presented by applicants
involving 'impossible or impractical circumstances'
concerning product-by-process claims" later published by
the JPO on November 25, 2015. Various opinions were
presented by the committee members among which the
major ones were: the extent that "there is no reasonable
doubt" as stated in Section 2205 of the Examination
Handbook should be clarified; and since polymers may
fall under the "Case," it is questionable whether or notpolymers should be published as one of the examples of
PBP claims where the "Circumstances" exist.

VI Conclusion
As pointed out at the committee for this study aswell as the literature obtained by the surveys of public
information, it would be necessary to determine thecoverage of the ruling in the judgments of the Supreme
Court by taking into consideration the reasoning such that"when a claim of a patent for an invention of a productrecites the manufacturing process of the product, it isgenerally unclear what structure or characteristics of the
product are represented by the manufacturing process●

IIP Bulletin 2016 Vol.25[…]." For example, the following opinions presented by
the committee members should be sufficiently taken into
consideration in examining whether or not the claim that
recites the manufacturing process is clear and further
deciding to what claims the rulings in the judgments of
the Supreme Court are applicable: claims with expression
like a process at the first glance but clearly indicating thestate of the product should not be regarded as PBP claimsin the first place; determinations must be made by taking
into consideration not only the expression in part of theclaim but also the intention of the applicant that can beread from the claim in whole, the description of thespecification and the common technical knowledge; andthe judgments of the Supreme Court are based on thepremise that if the manufacturing process is recited, thestructure would generally be unclear, and thus claims inwhich the structure is clear would not fall under PBP
claims.
Meanwhile, reviewing the situations of the EPO, theU.K. and Germany that were surveyed by this study, withrespect to claim construction they are agreed in the
product identity theory which was also applied in the
judgments of the Supreme Court of Japan (though there isa case in the U.K. case laws where the manufacturing
process imitation theory was applied in deciding
infringement). However, with respect to "Circumstances,"it was not usual there to determine on the clarity
requirements for PBP claims in such a manner as ruled by
the Supreme Court of Japan, but, in many cases, the court
first determined the novelty and inventive steps whereby
it was examined whether or not there are circumstances
under which the claim cannot be expressed by thecomposition, structure, or other testable parameter, but
only by the manufacturing process in distinguishing fromprior art. That is, "Circumstances" had a different
meaning.
It is expected that further consideration will be madefor the planned revision of the Examination Handbook inlight of the results of this survey.
Moreover, since there are no court decisions atpresent that were rendered based on the rulings presented
in the judgments of the Supreme Court, attention should
continuously be paid to how such rulings would beapplied to future litigations.
Finally, a better direction should be sought to enable
the PBP claims to meet the purpose of the Patent Act andto be used in a manner preferable for applicants and third
parties while looking closely to the future reactions of theapplicants and operations of the JPO.
(Chief Researcher: Takeyuki IWAI)

1

7 ●Judgment of the Second Petty of the Supreme Court of Ju
ne 5, 2015; Case No. H24(2012) (Ju) 1204 and 2658
http://www.courts.go.jp/app/hanrei_en/detail?id=1365

2

3

4

5

6

7

8

9

http://www.courts.go.jp/app/hanrei_en/detail?id=1364
JPO, "Interim Handling Procedures for Examinations and A
ppeals/Trials Involving Product-by-Process Claims"
Material 1 "Review and Revision of the Examination Guidelines Concerning Product-by-Process Claims" at the 6th meeting of the Working Group on the Patent Examination St
andards, the Patent System Subcommittee, the Intellectual P
roperty Committee of the Industrial Council
Summary of the minutes of the first meeting of the Working Group on the Patent Examination Standards, the Patent
System Subcommittee, the Intellectual Property Committeeof the Industrial Council (August 25, 2014);
URL: http://www.jpo.go.jp/shiryou/toushi/shingikai/new_shinsa
kijyun01_gijiyoushi.htm (only in Japanese)
JPO, "Interim Handling Procedures for Examinations and Appe
als/Trials Involving Product-by-process claims," July 6, 2015;
URL:http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/product_proce
ss_C150706_e.htm
JPO, "Examination Guidelines for Patent and Utility Model"
URL: https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/files_guideli
nes_e/all_e.pdf
JPO, "Examination Handbook for Patent and Utility Model"
URL:https://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/files_handboo
k_sinsa_e/all_e.pdf"Reference examples of arguments and verification presented by applicants involving 'impossible or impracticable circu
mstances' concerning product-by-process claims," publishedby the JPO on its website on November 25, 2015;
URL:http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/pdf/product_pr
ocess_C151125_e/pbpc_sankourei_e.pdf"Addition of examples not considered to be product-by-proc
ess claims," published by the JPO on its website on Januar
y 27, 2016);
URL:http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/pdf/product_pr
ocess_C160127_e/pbpc_higaitou_e.pdf●

8 ●IIP Bulletin 2016 Vol.25