3Patent Examination Practices (Description Requirements)－Description Requirements in the Biotechnology Field－
The description requirements for descriptions, etc. have been gaining attention in recent years.
Given the various arguments going on concerning the description requirements, this study was
carried out by a subcommittee on the Study on Description Requirements in the Biotechnology
Field, which conducted examinations dedicated to the biotechnology field, and a subcommittee on
Study on Desirable Descriptions, which conducted examinations without limiting the technical field.
In the Study on Description Requirements in the Biotechnology Field, the relevant subcommittee
investigated and examined court judgments and Board of Appeal decisions concerning description
requirements in the biotechnology field and conducted a questionnaire survey and an interview
survey concerning such requirements. Its aim was to identify any differences between thedeterminations on the description requirements in Japan and such determinations in Europe andthe United States, in the biotechnology field, and to clarify the cause for such differences.

I

Introduction

In discussions held by the Project Teamon Protection and Utilization of Intellectual
Property in the Life Sciences, which was set
up in the Expert Panel on Management ofIntellectual Properties, Council for Scienceand Technology Policy, it was pointed out that,in the biotechnology field, determinations on
the description requirements in Japan may
be stricter than those in Europe and theUnited States. However, no specific examples
were given as to which aspects of Japanesedescription requirements were stricter thatthose in Europe and the United States, andthe actual situation is not quite clear.
Thus, this study was conducted with theaim of identifying any differences between
the determinations on the description
requirements
in
Japan
and
such
determinations in Europe and the UnitedStates, in the biotechnology field, andclarifying the cause for such differences.

II

Comparative Analysis of Cases(Boards of Appeal Decisions/Court
Judgments) in Japan, the UnitedStates and Europe

In this study, an investigation was first
conducted on guidelines, etc. concerning the●

IIP Bulletin 2008

description
requirements
inthebiotechnology field in Japan, the UnitedStates and Europe. In Japan, the ideas of thedescription
requirements
inthebiotechnology
field
are
indicatedin“Biological Inventions,” Chapter 2, Part VII
in the “Examination Guidelines for Patentand Utility Model in Japan.” In the UnitedStates, requirements, including the written
description requirement and the enablement
requirement, are explained using examples
in the biotechnology field in the “Manual of
Patent Examining Procedure” (MPEP). In
addition, the “Synopsis of Application of
Written Description Guidelines” provides
explanations using specific examples of genes
and antibodies. However, in Europe, the“Guidelines for Examination in the European
Patent Office” and other documents provide
noexplanations
dedicatedtothebiotechnology field, except explanations on
deposit of biological material. Therefore, acomparative analysis of these guidelines is
not enough to examine specific differences
between the determinations in Japan andthose in Europe and the United States, andthe causes for such differences.
Accordingly, in this study, a comparative
analysis was conducted on court judgments
in Japan and the United States and decisions
by the EPO Boards of Appeal that made18 ●determinations
onthedescription
requirements in the biotechnology field, anddeterminations made in the examinations
and boards of appeal decisions for thecorresponding applications filed with otherpatent offices, while making reference toJapanese, U.S. and European guidelines.

1Comparative
analysisofmajorJapanesecourt
judgments
anddeterminations for the corresponding
European and U.S. applications

Japanese Case 1 (2003 (Gyo-Ke) No. 220)is a case of a patent application relating to acomposition comprising a combination ofhepatitis C viral (HCV) antigens for detecting
anti-HCV antibodies. In this case, the patentin question was invalidated in a trial forpatent invalidation in Japan, due to violationof the enablement requirement. Further, inthe subsequent litigation for rescission of thetrial decision, the claim was dismissed andthe trial decision of invalidation was upheld.
However, the corresponding U.S. application
was patented after an examination, although
the patent claims slightly differed from thosefor which patent validity was disputed inJapan. As for the corresponding European
application, the portion at issue wasdetermined to satisfy the enablement
requirement, and the patent was maintained.
In this case, the determinations on theenablement requirement differed between
Japan and Europe, although the claim
statements of both applications included thesamefollowing
expression:“antigencomprising an epitope from the ... domain.”
The difference in determinations on theenablement requirement concerning theouter limit of the invention, that is, whether
it is necessary to specify all antigens
comprising an epitope or it is sufficient to beable to screen them rationally, is considered
to have derived different outcomes between
Japan and Europe.
Japanese Case 2 (1998(Gyo-Ke) No. 95)
is a case of a patent application relating tobeta subunits of the T-cell antigen receptor inmammals. In this case, the patentability of●

the application in question was denied inJapan on the basis of violation of theenablement requirement in a trial against
the examiner’s decision of refusal, and thistrial decision was upheld in the subsequent
litigation for rescission of the trial decision.
As for the corresponding U.S. application, thefirst Office Action was notified in theexamination phase, but the applicant
submitted a notice of appeal and declarations
by experts. After subsequent interviews, theenablement requirement was found to besatisfied. Also for the corresponding
European application, an opposition was filed
after the decision to grant a European patent,
and the patent was revoked due to lack ofnovelty and other grounds, but theenablement requirement was determined tobe satisfied. In this case, Japan, the UnitedStates and Europe all determined that “it isdoubtfulwhetherallfragmentsarebiologically active” at least once for the claim
statement, “at least eight amino acids,” buttheir final determinations were divided.
Japanese Case 3 (1997 (Gyo-Ke) No. 249)
is a case of a patent application relating to
the mammalian granulocyte-macrophagecolony-stimulating factor (GM-CSF). The
description contained only working examples
of mouse GM-CSF, and claimed a mammalian
GM-CSF gene. In Japan, the patentability of
the application was denied for claims relating
to DNA encoding mammalian GM-CSF, whichwere limited by the sequence, in a trial
against the examiner’s decision of refusal due
to violation of the enablement requirement.
In the subsequent litigation for rescission of
the trial decision, the applicant submitted aJapanese translation of the declarations thatwere submitted in the United States, but thetrial decision was upheld. With regard to thecorresponding U.S. application, the first
Office Action was issued in relation toviolation of the description requirements.
However, after amendments and submissionof declarations by experts, the patent was
finally granted for claims relating to DNA
encoding mammalian GM-CSF without
sequence limitations. In the case of thecorresponding European application, the19 ●IIP Bulletin 2008

patent was granted for claims relating to
DNA encoding mammalian GM-CSF withsequence limitations.
Japanese Case 4 (1998(Gyo-Ke) No. 393)
is a case of a patent application relating to
peptides with natriuretic activity. The
description at the time of the filing had
contained statements on identification ofhuman BNP and other matters, but its
natriuretic activity had not been confirmed.
In Japan, the applicant indicated in the
opposition proceedings that a specific peptide
included in the claimed peptides actually has
natriuretic activity, and contended that thedescription of a later application filed by athird person at around the same time also
contains statements to the effect that said
specific peptide has natriuretic activity, but
the patent was revoked on the basis that theinvention was incomplete. This decision on
opposition was upheld in subsequent court
proceedings. However, the corresponding U.S.
application was determined to satisfy theenablement requirement after interviews
with the examiner and submission ofdeclarations by experts, and was patented.
The corresponding European application was
also patented with no reasons for refusal as
to violation of the description requirements.
In this case, although there was thedifference that the incompleteness of theinvention was the point at issue in Japan andthe enablement requirement was the point at
issue in the United States, differences were
found between Japan and the United Statesin whether or not experiment results anddeclarations by experts submitted after thefiling were adopted.
Japanese Case 5 (2005 (Gyo-Ke) No.
10712) is a case of a patent application
relating to a CDR-grafted antibody. In Japan,
the patentability of the application was
denied in a trial against the examiner’s
decision of refusal due to violation of theenablement requirement, and this trial
decision was upheld in the subsequent
litigation for rescission of the trial decision.
With regard to the corresponding U.S.
application, although the first Office Action
was issued in relation to violation of the●

IIP Bulletin 2008

enablement requirement, the application waspatented after a counterargument. The
corresponding European application faced
opposition on the basis of violation of theenablement requirement, etc., and the patent
was revoked due to the addition of new
matter without a determination on theenablement requirement. One cause for thedifferent outcomes derived in Japan and theUnited States is that, in Japan, a detailed
study was made as to the presence or absenceof any deficiency in the theoretical orexperimental support of the claimed
invention by working examples.
In this manner, although the five
Japanese cases examined in this study
cannot be compared easily due to differencesin the levels of appeal, it was found that thedeterminations in Japan tended to be stricter
than the determinations in Europe and theUnited States.

2

Comparative analysis of major U.S.
court judgments and determinations
for the corresponding Japanese andEuropean applications

U.S. Case 1 (Monsanto Co. v. Scruggs) isa case of a patent application relating to achimeric gene, which is expressed in plant
cells. In the United States, Monsanto, thepatentee,sued
Scruggsforpatentinfringement, and Scruggs asserted thedefense of patent invalidity based on
violationofthewrittendescription
requirement
andtheenablement
requirement. The Court of Appeals for theFederal Circuit (CAFC) determined that,
although no specific DNA sequence wasdisclosed in the description, the written
description requirement and the enablement
requirement were satisfied because thesequencesof
CaMV
promoters
werewell-known at the time of the filing and the
CaMV strains could be acquired from theAmerican Type Culture Collection. The
corresponding applications in Japan andEurope were both determined to satisfy thedescription requirements, as in the UnitedStates.
20 ●U.S. Case 2 (Capon v. Eshhar) is a case ofa patent application relating to a chimeric
receptor in which a cytoplasmic domain and atransmembrane domain are joined to adifferent kind of extracellular ligand-binding
domain. The Board of Patent Appeals andInterferences (BPAI) of the United States
Patent and Trademark Office (USPTO)
determined that neither the Capon patent
nor the Eshhar application satisfied thewritten description requirement. However,
the CAFC remanded the case, holding thatthe BPAI did not determine the statements inthe description and the known science at thetime of the filing. On the other hand, thecorresponding Japanese application waspatented without being subjected to any
notice of reasons for refusal concerning
violation of the description requirements.
The corresponding European application was
opposed on the basis of lacking sufficiency of
disclosure, etc., but it was determined thatthe disclosure was sufficient, and thisdecision by the Opposition Division was
upheld by the Board of Appeal.
U.S. Case 3 (University of Rochester v.
G.D. Searle & Co. Inc.) is a case of a patentapplication relating to a method forselectively inhibiting PGHS-2 (COX-2)
activity in a human host, comprisingadministering a non-steroidal compound that
selectively inhibits activity of the PGHS-2
gene
product.
Whilethedescription
contained statements on the method of
evaluating the PGHS-2 activity, it containedno specific statements on the non-steroidal
compound that selectively inhibits PGHS-2
activity. In the United States, the Universityof Rochester sued G.D. Searle & Co. Inc. and
Pfizer, Inc. for patent infringement, but the
CAFC determined that the patent wasinvalid due to violation of the written
description requirement, since the patent did
not provide any guidance for obtaining thecompounds that can be used to carry out theclaimed methods (compounds that selectively
inhibit PGHS-2 activity) and there was no
pre-existing awareness in the art of any suchcompound. In Japan and Europe as well, nopatent was granted for a method for●selectively inhibiting PGHS-2 activity in ahuman host, comprising administering a
non-steroidal compound that selectively
inhibits activity of the PGHS-2 gene product.
In this manner, although the three U.S.
cases examined in this study cannot becompared easily due to differences in thelevels of appeal, it was found that thedeterminations by the U.S. CAFC concerning
the description requirements were similar tothe determinations in Japan and Europe.

3

Comparative analysis of major EPO
Board of Appeal decisions anddeterminations for the corresponding
Japanese and U.S. applications

European Case 1 (T 0973/03) is a case ofa patent application relating to a composition
used as a therapeutic agent against chronicviral hepatic diseases. The composition
relating to the invention comprised a
combination of a polypeptide sequence
havingoneormore
antigenicTcell-activating epitopes and a carrier capableof presenting the epitope sequence(s) boundto each other by covalent or hydrophobic
bonding, and the description only contained
working examples concerning hepatitis B
virus (HBV). In Europe, a decision to grant apatent was made for the application, without
being restricted to hepatitis B. However, in
opposition proceedings, it was determinedthat the invention was enabled only forhepatitis B, and this decision on opposition
was upheld by the Board of Appeal. With
regard to the corresponding Japaneseapplication, a patent was granted for claims
as limited to treatment of hepatitis B, after atrial against the examiner’s decision ofrefusal. The corresponding U.S. application
was also patented after the claims became
limited to treatment of hepatitis B. The
determinations in Japan, the United Statesand Europe coincided in that they all foundthe invention to be patentable as long as it
was limited to treatment of hepatitis B, butthey differed as to the extent to which the“antigenic T cell-activating epitopes” and“carrier” needed to be specified in the patent
21 ●IIP Bulletin 2008

claims. The Japanese patent claims specifiedanarrowerscopeofantigenicTcell-activating epitopes than that in the U.S.
and European patent claims, and contained
more detailed limitations concerning thecarrier than those in the U.S. and European
patent claims.
European Case 2 (T 0446/99) is a case ofa patent application relating to a neutralized
polypeptide that can be used as vaccine
ingredient against pertussis toxin. Although
the description did not contain statementsthat the biological activity of the polypeptide
as a vaccine has been confirmed, it contained
working examples concerning the ability tobind to a toxin-neutralizing antibody and its
ADP-ribosyltransferase activity, which serves
as a marker of toxic activity. In Europe, anappeal was filed with the Board of Appeal
against a decision by the Opposition Division
to maintain the patent, but the Board of
Appeal also determined that the enablement
requirement was satisfied, based on thestatementinthedescription.
The
corresponding Japanese application also
faced a trial for patent invalidation, but wasdetermined to satisfy the enablement
requirement.
The
corresponding
U.S.
application was subjected to an Office Action
concerning the enablement requirement, etc.,
but after making amendments to add claim
limitations and making responses, theapplication was determined to satisfy theenablement requirement and was patented.
In this case, the amino acid which substitutes
the “arginine at the ninth position from the
N-terminus” in the claim statement was not
limited in Japan and the United States, but
in Europe, it was limited to lysine, the sameas that indicated in the working example.
In this manner, in the two European
cases examined in this study, the scope of thepatent claims in Japan was narrower thanthat in Europe for European Case 1, but thescope of patent claims in Japan was broader
than that in Europe for European Case 2.
Therefore, the determinations in Europe
were not found to be consistently looser thanthe determinations in Japan.

III

●

22 ●

IIP Bulletin 2008

Description
Requirements
inJapan, the United States andEurope from the User Point of View

In this study, a questionnaire survey andinterview survey were conducted to collectuser opinions, given that there is theabove-mentioned indication that, in thebiotechnology field, determinations on thedescription requirements in Japan may bestricter than those in Europe and the UnitedStates.

1

Questionnaire survey

A questionnaire survey of domestic users
was conducted on the following two topics foreach technical field (physics, mechanical,
chemical,biotechnology,
electric,
andinformation and communications), targeting
regular member companies of the JapanIntellectual Property Association (JIPA):(i) Differences between determinations on thedescription requirements in Japan and thosein Europe and the United States for eachtechnical field; and(ii) Applicants’ views on determinations on
the description requirements in Japan foreach technical field.
The results of the questionnaire survey
showed that, in the biotechnology field,
determinations
ontheenablement
requirement and the support requirement inJapan tend to be stricter than those inEurope and the United States. However, thesame tendency was observed for othertechnical fields as well, and it could not be
concluded that the biotechnology field is the
only field in which the determinations inJapan are stricter than those in Europe andthe United States.
In addition, determinations on clarity inthe biotechnology field in Japan were also
stricter than those in Europe and the UnitedStates, similar to those in other technicalfields. On the other hand, it was found that,in the biotechnology field, a higher
percentage
ofapplicants
found
the
determination on clarity in Japan to beslightly looser than those in the United

States, compared to the other technicalfields.
With regard to determinations on thedescription
requirements
inthebiotechnology field in Japan, about 40% of
the applicants responded that they found thedeterminations to be “problematic” or “rather
problematic,” indicating that the percentage
of applicants who found the determinations
to be reasonable is lower compare to theother fields. The reasons for finding thedeterminations to be problematic weremainly attributed to the determinations on
the description requirements in Japan being
strict, but there were a few applicants who
found the determinations on the description
requirements in Japan to be problematic due
to being loose.

2Interview survey

An interview survey of applicants(companies, universities and public research
institutes) and patent attorneys was
conducted with the aim of collecting detailed
information concerning differences between
determinations
ofthedescription
requirements in the biotechnology field inJapan and those in Europe and the UnitedStates.
As a result of the interview survey, themajor opinion on the determination of thedescription
requirements
inthebiotechnology field in Japan, the UnitedStatesandEuropewasthat
thedeterminations in Japan were stricter thanthose in Europe and the United States,
similar to the results of the questionnaire
survey. However, some responded that, in thepatentexaminations
inJapan,“thedeterminations are less varied between
examiners” and “examiners point out
violations of the description requirements indetail and in an easy-to-understand manner.”
With regard to certified experiment results,
there was an opinion that “in Japan, certified
experiment results, etc. submitted after thefiling are less likely to be adopted as thebasis for satisfaction of the description
requirements, compared to Europe and the●United States.”
As for views on determinations of thedescription
requirements
inthebiotechnology field in Japan, among company
applicants,
36%
found
that
the
“determinations in Japan are reasonable”
and 32% thought that the “determinations inJapan should be looser.” On the other hand,among university and public research
institute applicants, 50% thought that the“determinations in Japan should be looser”
and none of the applicants found that the“determinations in Japan are reasonable.”
As the points to note by applicants andpatent attorneys in the biotechnology field,
many respondents mentioned basic mattersfor satisfying the description requirements,
such as “including plenty of working
examples in the description at the time of thefiling” and “sufficiently stating the specificmodes of the invention in the description.”

IV Handling of Certified Experiment
Results, etc. with Regard to
Description Requirements
When a reason for refusal has notified
that the application is in violation of thedescription requirements in an examinationof a patent application, applicants often
counter by submitting certified experimentresults relating to experiments that were notstated in the description, etc. at the time of
the filing. In this regard, it was pointed out
in the interview survey conducted in thisstudy that, in the biotechnology field inJapan, when a reason for refusal has been
notified to the effect that the application is inviolationofdescription
requirements,
particularly in respect to portions other than
the working examples that are included in
the claimed inventions, certified experimentresultsarehardlyadoptedinthecounterargument to such notice.
Thus, this chapter first reviews theenablement requirement and the support
requirement in the biotechnology field inJapan, and then reviews the handling ofcertified experiment results with regard to
violation of the enablement requirement or
23 ●IIP Bulletin 2008

the support requirement in Japaneseexamination guidelines and court judgments.
Based on these, considerations are made on
the cases where it would be appropriate to
adopt certified experiment results as thebasis for counterargument when violation of
the enablement requirement or the support
requirement has been given as a reason forrefusal.
Comparing the enablement requirement
and the support requirement, the two arealike in that a claimed invention may include
portions other than the working examples
that are stated in the description, as long as
such inclusion is permissible based on thestatements in the description, etc. and thecommon general technical knowledge at thetime of the filing. However, the two differ inthat the former prohibits a claimed invention
that includes portions that may not beworked based on the statements in thedescription, etc. and the common generaltechnical knowledge at the time of the filing,
and the latter prohibits a claimed invention
that includes portions exceeding the scope ofstatements that allow a person of ordinary
skill in the art to recognize, based on thestatements in the description, etc. and thecommon general technical knowledge at thetime of the filing, that the task of theinvention may be solved.
However, when the task of the invention
is to provide a product that has a specificfunction, the “portions that may be worked
based on the statements in the description,etc. and the common general technicalknowledge at the time of the filing” in theformer and “scope of statements that allow aperson of ordinary skill in the art to recognize,
based on the statements in the description,etc. and the common general technicalknowledge at the time of the filing, that thetask of the invention may be solved” in thelatter would coincide.
In such cases, it would not run contrary
to the statements in the examination
guidelines or holdings in court judgments toadopt certified experiment results that havebeen
submitted
as
the
basis
of
counterargument against violation of the●

IIP Bulletin 2008

enablement requirement or the support
requirement in respect to portions other than
the working examples that are included in
the claimed inventions and that relate toresults of experiments conducted based on
the statements in the description, etc. andthe common general technical knowledge at
the time of the filing.
Therefore, it would be appropriate, bothfor the case of the enablement requirement
and the support requirement, to adopt
certified experiment results that have been
submitted as the basis of counterargument
againstviolationoftheenablement
requirement or the support requirement inrespect to portions other than the working
examples that are included in the claimed
inventions, if they relate to results ofexperiments conducted based on thestatements in the description, etc. and thecommon general technical knowledge at thetime of the filing.

V

Summary

In order to keep the right ofbiotechnology-related inventions within acertain appropriate scope, while providingthem full protection under patent law, thedescription requirements will continue to beimportant in the future. This is because,
while such patentability requirements asnovelty and an inventive step indicate theattitude of patent law on how to deal withoverallinventions,thedescription
requirements, such as the enablement
requirement and the support requirement,
are intended for granting a patent for thescope which the inventor possesses andkeeping the right based on the statements ofthe claims within an appropriate scope
supported by the disclosure in thedescription.
This study found basic commonalities inpractices and operations in Japan, the UnitedStates and Europe, but at the same time, italso found some cases where outcomesdiffered between them. Although a conclusion
should not be derived easily without making
detailed considerations of the invention
24 ●background, technical contents, and thecommongeneraltechnical
knowledge
relating to each case, such differences foundin this study are expected to provide
important suggestions for future studies.
Granting of right of the appropriate
scope is extremely important for thedevelopment of industry. By accumulating
studies on the significance and function of
the description requirements in the future, itwould become possible to grant a right of thescope suitable for inventions relating tovarious biotechnology achievements.
（Researcher: Hiroko KAWARAI）●

25 ●IIP Bulletin 2008