5

Desirable Operations of Patent Microorganism
Depositary Institutions (*)

Where a person files a patent application for an invention pertaining to a microorganism in Japan, he/she
must deposit the microorganism in a depositary institution except when the microorganism is easily obtainable.
Thus, the Budapest Treaty imposes the obligation of secrecy on international depositary authorities (IDAs)
in order to protect the secrets of inventions of microorganisms as claimed in patent applications. On the other
hand, institutions engaging in deposit operations are required to improve the efficiency of the operations withthe aim of continuing stable operations and enhancing convenience for system users.
In addition, the operations of two patent microorganism depositary institutions in Japan are scheduled to
be integrated in fiscal 2012, and those patent microorganism depositary institutions are now required to
improve the efficiency of the operations.
Given this factor, we conducted surveys on the status of securing the fulfillment of the obligation of secrecy
at microorganism culture collections in Japan and abroad, specific methods for concurrent engagement indifferent operations and sharing of equipment, backup and safety management of deposited microorganisms,
methods of furnishing operations, etc., and examined desirable implementation of operations to run patent
microorganism depositary institutions in a stable and efficient manner.

Ⅰ Introduction
Under the Japanese patent system, where aperson files a patent application for an invention
pertaining to a microorganism, he/she must
attach to the application a copy of the certificateof acceptance issued by an IDA as provided by the
Budapest Treaty or a document proving that the
microorganism has been deposited in a domestic
depositary institution designated by theCommissioner of the Japan Patent Office (JPO),
except when the microorganism is easily
obtainable.
The Budapest Treaty imposes an obligationof secrecy on IDAs, which prohibits them fromdisclosing
informationonwhetheramicroorganism has been deposited to any person,with the aim of protecting secrets of inventions of
microorganisms as claimed in patent applications.
The Treaty provides that IDAs shall not give out
any information about deposited microorganisms
to any person with certain exceptions.
On the other hand, as long as the patent
microorganism deposit system is to enable anapplicant who intends to obtain a patent to work
the relevant invention, patent microorganism
depositary institutions are required to improvethe efficiency of their operations with the aim ofcontinuing stable operations and enhancing
convenience for system users.
In addition, the operations of two patent
microorganism depositary institutions in Japanare scheduled to be integrated after April 2012,
and those patent microorganism depositary
institutions are now required to improve theefficiency of their operations.
Given this factor, in this study, we conductedsurveys on the status of securing the fulfillmentof the obligation of secrecy, etc. at IDAs in Japanand abroad, specific methods for concurrent
engagement in different operations and sharing ofequipment, backup and safety management ofdeposited microorganisms, methods of furnishing
operations, etc., and also conducted surveys on
the status of fulfillment of the obligation of
secrecy, etc. at microorganism culture collectionsin Japan which engage in operations similar to
those of patent microorganism depositary
institutions. Thereby, we examined desirable
implementation of operations to run patent
microorganism depositary institutions in a stableand efficient manner.

Ⅱ OutlineofthePatentMicroorganism Deposit System
1

Purpose of the patent microorganism
deposit system

The patent system is a system that makes ita principle to grant a person who has created anindustrially applicable invention having novelty
and inventive step the exclusive right for the(*) This is an English translation of the summary of the FY2011 JPO-commissioned research study report on the issues
related to the industrial property rights system.
●

IIP Bulletin 2012 Vol.21

1 ●working of the invention in return for publicationof the invention. Therefore, the description, etc.
of a patent application must disclose theinvention clearly and sufficiently to the extent
that a person ordinarily skilled in the art canwork the invention.
However,formicroorganism-related
inventions, samples of relevant microorganisms
are not easily obtainable in some cases. In such acase, the invention cannot be substantively
worked and publication of the invention cannot be
sufficiently secured; therefore, the invention is
not regarded as having been disclosed.
Consequently, it is impossible to grant theexclusive right for the invention based on theprinciple of return for publication.
Given this factor, the patent microorganism
deposit system is one that enables a person
who has created a microorganism-related
invention to secure the confirmation/working of
the invention by third parties and fulfill therequirement of disclosure of the description bydepositing the microorganism pertaining to theinvention, which is hard to obtain, in a patent
microorganism depositary institution in advanceand thereby making it available for furnishing tothird parties under certain requirements.
Specifically, in Japan, Article 27-2 of theOrdinance for Enforcement of the Patent Act
provides that an applicant shall attach to an
application a document proving that the relevant
microorganism has been deposited in an IDA as
provided by the Budapest Treaty or an institution
designated by the Commissioner of the JPO,
except when the microorganism is easily
obtainable.
In addition, the Budapest Treaty also
provides that if an applicant deposits a
microorganism in any IDA, the Contracting Statesof the Treaty shall deal with the case as if the
microorganism was deposited for the purpose of
their own patent procedure and the Contracting
States shall not require compliance withrequirements different from or additional to thosewhich are provided in this Treaty and theRegulations.
2Regarding the obligation of secrecy

Patent microorganism depositary institutions
handle information concerning unpublishedpatent applications for microorganisms, etc. in
the course of implementing deposit operations,etc. Therefore, imposed upon them is theobligation of secrecy, which requires maintenance●of secrecy concerning deposited microorganisms,
under the Budapest Treaty.
In addition, the Regulations based on said
Treaty provide that depositary institutions shallnot give out any information about deposited
microorganisms to any person. Moreover, theWorld Intellectual Property Organization (WIPO)
has formulated guidelines for the purpose ofproviding systematic information on theprocedures and requirements for depositors andthose who receive furnishing and giving practicaladvice to depositors and those who furnish
microorganisms.
However, the Budapest Treaty, theRegulations and the guidelines do not mention at
all the specific implementation, etc. for promoting
the improvement of the efficiency of operations
in compliance with said obligation though they
provide for the content of the obligation of
secrecy imposed on IDAs and exceptions thereto.
On the other hand, Japanese domestic laws
and regulations do not include any special
provision on the specific implementation ofprovisions on the obligation of secrecy though
they include such provisions.
3Regarding the furnishing system

The Budapest Treaty defines "depositary
institution" as an "institution which provides forthe receipt, acceptance and storage of
microorganisms and the furnishing of samples
thereof." The Treaty provides for the obligation of
IDAs to furnish samples of deposited
microorganisms under certain requirements.
The Regulations under the Budapest Treaty
provide that IDAs shall furnish samples of
microorganisms using a prompt and appropriate
method. In addition, the Regulations also provide
for the requirements for furnishing to anindustrial property office, a depositor or a person
who has obtained approval from a depositor, and aperson who has been qualified under laws andregulations, respectively. The Regulations
provide that one of the conditions for furnishing
to a person who has been qualified under laws
and regulations shall be certification by anindustrial property office that the person has theright to receive furnishing.
Furthermore, the WIPO guidelines describe
each country's requirements concerning whether
a person who has requested furnishing has been
qualified under laws and regulations.
In terms of Japanese domestic laws andregulations, Article 27-3 of the Order for
2 ●IIP Bulletin 2012 Vol.21

Enforcement of the Patent Act provides for therequirements for furnishing samples of patent
microorganisms and stipulates that the purpose offurnishing a microorganism shall be limited toexperiment or research on an invention
pertaining to the microorganism and that aperson who has received the furnishing of a
microorganism shall not have the furnishedmicroorganisms be used by any third party.
Moreover, specific requirements which a person
who requests furnishing should fulfill are also
provided in a public notice.
4

Identification of the problems

As mentioned above, the Budapest Treaty
imposes certain obligation of secrecy on IDAs.
However, the related regulations and guidelines
do not clearly stipulate the specific scope anddegree of implementation of the obligation of
secrecy which are required to secure thefulfillment of the obligation under the Treaty. The
same goes for Japanese domestic laws andregulations. In addition, specific implementationin each country is also unclear with regard torestrictions on use, etc. at the time of furnishingof samples.
For
thisreason,whereapatentmicroorganism depositary institution belongs to
the same organization to which an institution
engaging in similar operations such as culturecollection belongs, there are unclear points, forexample, as follows: to what degree concurrent
engagement in different operations and sharing ofequipment are permitted, whether facilities
should be independent, and what degree of
security management is required in terms of theacceptance and storage of microorganisms andfurnishing of samples thereof. This becomes aproblem in promoting the improvement of theefficiency of operations while fulfilling theobligation of secrecy.
If maintenance of secrecy is excessively
thorough, it is supposed that it will affect thesetting of fees for deposit and furnishing due toan increase in the operating budget, etc., which
will lead to deterioration in safety management
and other services due to increase in costs. This
will cause concern about hindrance to stable
implementation of operations and also result in
impairing convenience for system users.

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IIP Bulletin 2012 Vol.21

Ⅲ Outline of Patent Microorganism
Depositary Institutions in Japan
1

International
PatentOrganism
Depositary (IPOD) of the National
Institute of Advanced Industrial Scienceand Technology (AIST)For full-time staff members, the obligation of
secrecy is provided in the employment
regulations of the AIST. Full-time staff members
are given explanations on the content of theobligation when they are employed as staff
members, and training is provided to them on aregular basis to confirm the matters to becomplied with. In addition, for contract staff
members, the obligation is provided in theemployment regulations for contract staff
members. Contract staff members are obliged tosubmit a written pledge after hearing
explanations of the obligation of secrecy at thetime of their employment, and training isprovided to them on a regular basis to confirm
the matters to be complied with in the samemanner as full-time staff members.
No staff member has imposed upon them theobligation of secrecy specialized in patent
microorganism deposit operations, and generalprovisions on the obligation of secrecy which
apply to the AIST also apply to staff members. In
addition, as no microorganism culture collection
is established in the AIST, there is neither
concurrent engagement in different operations
nor sharing of equipment.
Deposited microorganisms are stored in an
independent building within the AIST, and a key
card is used for entrance into and exit from thefacility as a security measure. Moreover, the IT
system for patent microorganism deposit
operations is isolated from outside, and datachange tracking is automatically recorded.
Furthermore, measures such as storing backups
on another hard disk are taken.
Regarding the securing of safety, there arebiosafety level (BSL) classification regulations bywhich the IPOD checks the pathogenicity, etc.
based on the names, etc. of deposited
microorganisms. In addition, the backup is stored
in the same building.
When furnishing a sample of a deposited
microorganism, the IPOD requires a person who
has requested furnishing to submit a "certificate
of consent concerning the request for furnishing"and prohibits such person from using a furnishedmicroorganism for purposes other than the
3 ●intended purposes.
Incidentally, the IPOD neither provides aservice to identify the classification of adeposited microorganism nor take measures toreduce or exempt fees. Moreover, the procedure
is available only in the Japanese language, and the
IPOD does not accept deposits in foreign
languages in principle.
2

PatentMicroorganisms
Depositary(NPMD) of the National Institute ofTechnology and Evaluation (NITE)

For full-time staff members, the obligation of
secrecy is provided in the employment
regulations of the NITE. Full-time staff members
implement operations based on the operation
manual of the NPMD. However, they do not have
imposed upon them the obligation of secrecy
specialized in patent microorganism deposit
operations, and the general provisions on the
obligation of secrecy which apply to the NITE asa whole also apply to them.
Though a microorganism culture collection(NBRC) is established within the same building,
its office and laboratories are separated fromthose of the NPMD in units of rooms and noequipment is shared between the NBRC and the
NPMD. In addition, independency is ensured
through management of entrance into and exitfrom the facilities by using passwords and ID
cards. Furthermore, the IT system for patent
microorganism deposit operations is a system
isolated from outside.
For the securing of safety, the NPMD has
biosafety level (BSL) classification regulations,and confirms the safety of cultures by questioning
depositors about unclear points after checking
documents submitted by the depositors at thetime of deposit. In addition, the backup is stored
in a separate place within the NPMD, and somesamples are stored in a geographically distantplace.
When furnishing a sample of a deposited
microorganism, the NPMD has a person who hasrequestedfurnishingsubmita"written
acceptance concerning use of the microorganism"
and prohibits such person from using a furnishedmicroorganism for purposes other than theintended purposes.
Incidentally, the NPMD neither provides aservice to identify the classification of adeposited microorganism nor takes measures toreduce or exempt fees. Moreover, the procedure
is available only in the Japanese language, and the●

NPMD does not accept deposits in foreign
languages in principle.
3

Framework in Fiscal 2012 and Thereafter

In the "Basic Policy on the Review of Affairs
and Operations of Incorporated Administrative
Agencies (decided by the Cabinet on December 7,2010)," it was decided to integrate the IPOD and
the NPMD and to take necessary measures in theorder of precedence in fiscal 2011 and thereafter.
The Ministry of Economy, Trade andIndustry, etc. has just announced that the NITE
will succeed to the IPOD's patent microorganism
deposit operations in April 2012 with the aim ofintegrating
patentmicroorganism
deposit
operations.

Ⅳ Statusof
OperationsofMicroorganism Culture Collectionsin Japan1

Outline of the survey

We conducted a questionnaire survey about
the outline of the institution, regulations on the
obligation of secrecy and the status of
implementation thereof, the status of sharing of
personnel (full-time engagement in one kind ofoperation/concurrent engagement in different
kinds of operations), facilities, etc. with otherdepartments,
regulations
ondeposited
microorganisms and the management system
therefor, and furnishing and other operations,targeting22
institutions
engaging
inmicroorganism culture collection operations inJapan (all institutions which belong to the Japan
Society for Culture Collections (JSCC), except
the IPOD).
The breakdown of 15 institutions whichanswered the questionnaire is: 10 universities,
four research institutes, and one administrative
organ. We conducted an additional interview
survey targeting nine out of those 15 institutions.
2

Survey results

Differently from patent microorganism
depositary institutions, microorganism culturecollections do not have imposed upon them theobligation of secrecy with binding power, which isbased on a treaty, domestic law or regulation, etc.
Therefore, there are no provisions and manuals
on the obligation of secrecy of the unified content
or level. In reality, microorganism culture
4 ●IIP Bulletin 2012 Vol.21

collections apply the general provisions of theirparent institutions, such as universities andincorporated administrative agencies, as they are.
However,asmicroorganism
culturecollections also engage in operations in which
they handle cultures which have not been
disclosed to outside, they take certain measuresfor physical or mechanical resources, such as
storage facilities for microorganisms and IT
systems for operations, from the perspective of
maintaining secrecy. On the other hand, regarding
personnel resources (full-time engagement in one
kind of operation/concurrent engagement indifferent kinds of operations), personnel
resources are divided depending on the volume ofoperations from the perspective of efficient
allocation of personnel.
Moreover,themainoperationsofmicroorganism culture collections are thecollection, preservation, and provision of
microorganisms; therefore, most collections havean established backup system.
Regarding furnishing, microorganism culturecollections do not have imposed upon them therequirements for furnishing based on a treaty,
domestic law or regulation, etc., differently frompatent microorganism depositary institutions.
Therefore,
they
furnishsamplesofmicroorganisms without especially limiting
purposes except when there is a safety problem,
such as pathogenicity, and when a person who hasrequested collection of a culture does not desire
furnishing.
Incidentally,
microorganism
culturecollections give certain considerations withregard to measures to reduce or exempt fees andacceptance of applications in foreign languages.

Ⅴ Statusof
OperationsofOverseas Patent Microorganism
Depositary Institutions
1

Outline of the survey

In order to study the actual conditions of theimplementation of operations of overseas patent
microorganism depositary institutions, we
conducted an interview survey on the outline of
the institution, regulations on the obligation of
secrecy and the status of implementation thereof,
the status of sharing of personnel (full-timeengagement in one kind of operation/concurrent
engagement in different kinds of operations),
facilities,
etc.
with
other
departments,
regulations on deposited microorganisms and the●

IIP Bulletin 2012 Vol.21

management system therefor, and furnishing andother operations, targeting nine major IDAs in
the United States, the United Kingdom, France,
Germany, China, and South Korea.
2

Survey results

Institutions to which major IDAs in othercountries belong concurrently engage in patent
microorganism deposit operations and culturecollection operations. In terms of the form oforganization, these institutions are roughly
divided into (a) those mainly consisting of an IDA
and a culture collection and (b) those which havea parent institution in which an institution
engaging in culture collection and otheroperations is established. In either case, few
institutions formulate regulations on the
obligation of secrecy unique to patent
microorganism deposit operations. In reality,
fulfillment of the requirements for the obligationof secrecy required in the Budapest Treaty andthe Regulations is secured by regulations on the
obligation of secrecy which are shared with theculture collection or the parent institution.
In addition, regarding staff members, theinstitutions are divided into (a) those in whichpatent microorganism deposit operations are
implemented only by full-time staff members, (b)those in which full-time staff members play amajor role but experts support operations (=staff members concurrently engaging in different
operations are allocated) depending on thespecies, etc. of deposited microorganisms, and (c)those in which all staff members concurrently
engage in different operations. However, few
institutions adopt the form of (a), and many
institutions actually allocate staff members
concurrently engaging in different operations
depending on microbial species and the volume ofoperations.
Many institutions concurrently engaging inpatent microorganism deposit operations andculture collection operations store patent
microorganisms and other microorganisms in thesame building, and they are roughly divided into(a) those which manage patent microorganisms
and other microorganisms in independent storage
facilities (refrigerator, freezer, etc.) respectively
and (b) those which manage them using
independent storage containers, etc. while using
the same storage facility. In addition, regarding
the IT system, the institutions are roughly
divided into (a) those which use a stand-alone IT
system and independent database for patent
5 ●microorganism deposit operations and (b) thosewhich use the same IT system as the one used
for other operations and limits access with theuse of a password, etc.
Regarding the securing of safety, major IDAs
in other countries set BSL classification based on
the guidelines, etc. set by an internationalorganization or the government of their own
country. Many IDAs allocate necessary experts
according to the BSL classification. Moreover, theIDAs manage the microorganisms of BSL 1 or 2
using facilities for the microorganisms of BSL 2.
Furthermore, when furnishing a sample of a
microorganism of BSL 2 or higher, IDAs decideon the propriety of sending the sample of the
microorganism in consideration of whether the
person who has requested furnishing has thenecessary facilities and has obtained allnecessary permissions. In sending a sample of a
microorganism, IDAs use a special preservation
container in many cases.
In addition, all IDAs subject to the interview
survey make backups of deposited cultures, andthey are roughly divided into those which store
the backups in a physically distant place andthose which store them on the same premises orin the same building.
Regarding restrictions on furnishing, laws
and regulations or agreements, etc. often impose
certain restrictions in relation to the purposes
and acts of use of furnished cultures in othercountries in the same manner as in Japan. No
regulations imposing criminal punishment wereidentified. There was an opinion that filing acomplaint against a person who has requested
furnishing and has committed a violation as well
as related authorities through a civil means is oneof the remedies.
Hardly any IDAs introduce measures toreduce or exempt fees as a measure to enhance
convenience for system users. On the other hand,regarding acceptance of applications in foreign
languages, all of the institutions subject to thesurvey actually accept deposits, etc. in English
where the official language is a language otherthan English.

operations, it is considered necessary to examine
the fact that patent microorganism depositary
institutions in Japan also conduct patent
microorganism deposit operations concurrently
with operations of other departments, such as
culture collection. In doing so, one of the possible
rational methods is to establish an operationalframework while giving consideration to thevolume and specialty of operations and backup
personnel, etc. and taking into account theeffective utilization of personal resources acrossmultiple departments with respect to individual
operations.
In addition, it is necessary to pay proper
attention, including adoption of measures to havestaff members clearly recognize divisions ofoperations in which they concurrently engage, inorder to prevent the occurrence of situations
such as confusion of the obligations under theTreaty (including the obligation of secrecy) andother operational obligations. Moreover, taking
into account the importance of the obligation of
secrecy in patent microorganism deposit
operations, it is considered necessary to examine
not only the development of agreements or
regulations but also the development of a basic
manual specialized in said operations and specificguidelines as well as enrichment of training forstaff members.
On the other hand, sharing of buildings,
facilities, etc. should also be examined at patent
microorganism depositary institutions in Japan
from the perspective of improving the efficiency
of operations. In doing so, it is considered
important to ensure separation at the container
level at the very least to the extent that safety
can be secured according to the BSL level and to
take measures to prevent the occurrence of
operational human errors.
Moreover, with regard to information
management, including the IT system, one of thepossible methods is to formulate and thoroughly
implement a code of conduct concerning
information management in reference tooperations, etc. at other institutions which arerequired to maintain secrecy of information.

Ⅵ Desirable Operations of Patent
Microorganism
Depositary
Institutions in Japan

2

1

Maintenanceof
secrecyandimprovement of efficiency of operations
In order to improve the efficiency of●

Implementation of operations for stableand efficient running

It is ideally desirable to store the backup of adeposited culture in a physically distant place.
However, it is considered that geographicalisolation is not necessarily required from theperspective of the efficiency of operations at
6 ●IIP Bulletin 2012 Vol.21

depositary institutions, taking into account that adepositor has the right to redeposit a
microorganism if the microorganism is lost.
However, it is also necessary to promote theenrichmentofnecessaryfacilities
in
consideration of circumstances of natural
disasters which occur in Japan and expenses for
preparing against them. Moreover, one of thepossible methods is to store the backup in
separate places within the same premise or thesame building through effective use of existing
facilities.
Regarding the handling of high BSL
microorganisms, it is natural to take sufficient
safety measures in relation to relevant facilities
and management thereof in storing and furnishingsuch microorganisms. However, from theperspective of preventing increase in costs, it isvital not to take excessive measures. It isconsidered necessary to continuously examine
the detailed and efficient management ofdeposited microorganisms corresponding to their
BSLs.
3

Other Points at Issue

system users in Japan and abroad by promoting
enhancementofconvenience,
including
acceptance of applications in foreign languages(English).
Incidentally, some pointed out the following
as the problems of the patent microorganism
deposit system which are to be discussed in the
future: (1) the problem of discrepancy between
identification of classification of a new
microorganism and identification of classification
toward patenting, (2) interlocking of deposit
information and patent information, (3) problems
arising from both the domestic and international
deposit systems, (4) collection of all cultures
which have ceased to be deposited and cultures
which have been withdrawn, and (5) the propriety
of depositing all patented cultures, etc. by gene
information. In addition, problems were raised inrelation to the Budapest Treaty which has notbeen revised since its coming into force.
Therefore, it is considered necessary to continue
to discuss the desirable patent microorganism
deposit system for the future not only from theperspective of the Japanese system but also fromthe international perspective.
(Senior Researcher: Takayuki TONDA)

Patent microorganism depositary institutionsin Japan have persons who have requested
furnishing submit a certificate of consent, etc. tothe effect that they comply with the regulations
stipulated by laws and regulations, etc. andinform such persons of the risk of being sued in
the case of a violation of the regulations, etc.
However, as problems concerning requests forfurnishing are those that go beyond Japan, it isconsidered necessary to deepen discussions on
measures, which can be additionally taken fromthe perspective of enhancing the effectiveness oftheregulations,fromtheinternational
perspective through collaboration with othercountries.
At the same time, from the perspective ofenhancing convenience for the users of thedeposit system, it is considered necessary to
examine the propriety of introducing reductionand exemption measures while paying attention
to the benefit principle and compliance with the
Budapest
Treaty,onthepremiseofreconsideration of fees through improvement of
the efficiency of operations. In addition, it is also
considered necessary to discuss the ideal burdenof fees for deposit of patent microorganisms in an
integrated manner in discussions on the future
biopolicy.
Moreover, it is also important to expand●

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7 ●