10

Operations of the Deposit System

The patent microorganism deposit system is intended to ensure that third parties will be able
to work biological inventions. An international depositary authority (IDA) as defined under the
Budapest Treaty must store deposited microorganisms for at least for thirty years, and also forfive years from the latest furnishing. During that period, deposited microorganisms must be
available for furnishing. On the other hand, some users say that preparing the quantity ofsamples required by a depositary institution before patent filing is a heavy burden. Therefore,
reduction of burden in depositing is being requested in the field of biotechnology, which is making
remarkable progress.
With regard to these issues under consideration, this study has determined the deposit
systems of major countries and overseas institutions, the actual conditions of deposit/furnishingby overseas IDAs and the needs of users in Japan, and examined which operations of the deposit
system can reduce the burden of deposit at the time of patent filing while maintaining the
purpose of the deposit system, in light of consistency with the provisions of the Budapest Treaty.

I

Introduction

Under
the
depositsystemfor(*1)
microorganisms
in patent filing, amicroorganism
pertainingtoamicroorganism-related invention is deposited
to a depositary institution, and is madeavailable for furnishing under certain
conditions. Thereby, the system secures theexistence of the microorganism pertaining to
the relevant invention and enables third
parties to work the invention.
In Japan and Europe, there is arequirement to deposit a specified quantity of
microorganisms before filing. However, it has
been pointed out that preparation for deposit
places a burden on applicants, including
universities and venture companies, since,for some microorganisms, much time andlabor and many facilities are required toassure the quantity of microorganisms
required at the time of deposit.
On the other hand, taking the purpose of
the deposit system into consideration, it isnecessary to pay attention to availability forfurnishing and the provisions of the
Budapest Treaty when considering the
aforementioned reduction of burden, because(*1)

deposited microorganisms must be available
for furnishing to third parties over the entire
duration of the patent and because domestic
patent microorganism depositary institutions
are international depositary authorities(IDAs) under the Budapest Treaty.
From the above points, the deposit
systems of major countries and overseas
institutions, the actual conditions ofdeposit/furnishing at overseas IDAs and theneeds of Japanese users were determined,
and the operations of the deposit system thatcan reduce the burden of deposit at the timeof patent filing while maintaining the
purpose of the deposit system was consideredin light of consistency with the provisions of
the Budapest Treaty. The consideration was
conducted by holding a committee consistingof people of learning and experience, etc. whohave expert knowledge relating to themicroorganism deposit system.
This report summarizes the results of theabove.

II

PatentSystemMicroorganism

Deposit

The patent system is a system to grantMicroorganisms mean biological materials in general, which are subject to the patent microorganism deposit system,
including animal cell cultures (including embryos) and plant cell cultures, in addition to bacteria.
●

IIP Bulletin 200878 ●an exclusive right to a person who has
developed new technology, in return for
publication of the technology. Therefore, adescription (specification) of a patentapplication must disclose the relevant
invention as to enable any person ordinarily
skilled in the art to which the invention
pertains to work the invention. However, formicroorganism-related inventions, there arecases where a person skilled in the art cannot
work the relevant invention due to suchcircumstances as not being able to easily
obtain the relevant biological materials, nomatter how particularly the description
states the invention. Under the patent
microorganism
depositsystem,themicroorganism pertaining to the invention isdeposited to a depositary institution, and themicroorganisms are furnished to third
parties under certain conditions, so thatthird parties will be able to work theinvention in such a case as mentioned above.
In Japan, a person who intends to file apatentapplicationforaninvention
pertaining to a microorganism must attach toan application a copy of the certificate ofacceptance issued by an IDA as provided by
the Budapest Treaty (international deposit)
oradocument
provingthatthemicroorganism has been deposited in an
institution designated by the Commissionerof the Japan Patent Office (domestic deposit)
with respect to the deposit of the
microorganism, except when a person
ordinarily skilled in the art to which theinvention pertains (a person skilled in theart) can easily obtain the microorganism(Article 27-2(1) of the Ordinance for
Enforcement of the Patent Act). In addition,
regarding deposited microorganisms, any
person intending to work an invention
pertaining to a deposited microorganism forexperimental or research purposes who falls
under any of the following cases may receive
the furnishing of the microorganism (Article27-3(1)):(i) When registration establishing a patentright for the invention pertaining to themicroorganism has been effected;●(ii) When the person has received a warningwith documents stating the contents oftheinvention
pertainingtothemicroorganism pursuant to the provisionof Article 65(1) of the Patent Act;(iii) When the microorganism is necessary to
prepare a written opinion set forth in
Article 50 of the Patent Act (including
cases where it is applied mutatis
mutandis pursuant to Article 159(2) of
said Act (including cases where it isapplied mutatis mutandis pursuant to
Article 174(2) of said Act) and Article
163(2) of said Act).
This patent microorganism deposit
system has been adopted in many countries,
in addition to Japan. However, in the case offiling patent applications pertaining to thesame microorganism in multiple countries, if
it is necessary to deposit the relevant
microorganism
toseparate
depositary
institutions designated by each country, theprocedures will be very cumbersome.
Therefore, the Budapest Treaty was signed
mainly in order to make the Contracting
States mutually recognize the effects ofdepositing a microorganism in any IDA forthe purpose of patent procedure, with regard
to the deposit of microorganism that isrequired for the purpose of the patent
procedure in each country. If an applicant
deposits a microorganism in any IDA, theContracting States of this treaty shall deal
with the case as if the microorganism wasdeposited for the purpose of their own patent
procedure. The Contracting States are notallowed to set requirements that are different
from those stipulated in this treaty andregulations
as
well
as
additional
requirements.
Then, furnishing/deposit under the
Budapest Treaty is to follow the following
procedures.
In depositing, a depositor has to submit arelevant microorganism and a document
containing a commitment not to withdraw
the deposit during the after-mentioned
duration of the storage as well as
bibliographic items. In doing so, the relevant
79 ●IIP Bulletin 2008

IDA may request the depositor to submit therequired quantity of microorganisms in theform that is required to implement the treaty.
The IDA conducts a viability test on thedeposited
microorganism,
acceptsthemicroorganism as long as the microorganism
has not been clearly lost, and issues acertificate of acceptance to the depositor. If it
turns out that the deposited microorganism
cannot be furnished during the duration of
the storage, the IDA will communicate withthe depositor to that effect, and the depositor
may make a new deposit of the same
microorganism as the one deposited before
within the prescribed period. In making a
new deposit, the depositor signs a document
stating
that
the
newly
deposited
microorganism is the same as the one
pertaining to the original deposit, andsubmits it to the IDA.
The duration of the storage of
microorganisms at IDAs is at least thirty
years from the date of deposit, and if arequest for furnishing is made, the duration
is further extended to five years from thedate of receipt of the latest request.
In addition, it is prescribed that, foraccepted microorganisms, IDAs shall conduct
a viability test (i) immediately after deposit
or transfer, (ii) at a reasonable interval or
whenever necessary for a technical reason, or(iii) whenever requested by the depositor of
the microorganism.
Furnishing is the obligation of IDAs, andIDAs must promptly furnish samples ofdeposited microorganisms by an appropriate
method. It is prescribed that IDAs furnish
samples upon request of the interested
industrial property office, the depositor itself
or the party who has obtained approval toreceive furnishing of samples from thedepositor, or the party legally entitled (inJapan, a person who falls under any of theitems of Article 27-3(1) of the Ordinance for
Enforcement of the Patent Act).
The details of the deposit procedure, etc.
at IDAs in Japan are provided for by the“Implementation Guidelines for the Deposit,
etc. of Microorganisms Conducted by●

IIP Bulletin 2008

International Depositary Authorities inJapan Based on the Budapest Treaty on theInternational Recognition of the Deposit ofMicroorganisms for the Purposes of Patent
Procedure (Public Notice No. 290 of the
Ministry of Economy, Trade and Industry of2002),” while the details of the deposit
procedure, etc. at depositary institutions
designated by the Commissioner of the Japan
Patent Office as prescribed in Article 27-2 ofthe Ordinance for Enforcement of the Patent
Act are provided for by the “Implementation
Guidelines for the Patent Microorganism
Deposit System, etc. (Public Notice No. 291 of
the Ministry of Economy, Trade and Industryof 2002).” In both implementation guidelines,
the deposit procedure, etc. conforms to thedeposit/furnishing procedures under the
aforementioned Budapest Treaty. However,regarding deposit at depositary institutions
designated by the Commissioner of the Japan
Patent Office (domestic deposit system), theduration of the storage depends on the fee.
That is different from deposits at IDAs
under the Budapest Treaty (international
deposit) in that a depositor can request
continuation of deposit according to need
(Article 6 of the Implementation Guidelines
for the Patent Microorganism Deposit System,etc.).

III Domestic Patent Microorganism
Depositary Institutions and Actual
Conditions Thereof
1

International
PatentOrganism
Depositary (IPOD), National Instituteof Advanced Industrial Science andTechnology (AIST)The IPOD is located in Tsukuba City,
Ibaraki Prefecture, which is the central baseof the National Institute of Advanced
Industrial Science and Technology. It has
been
carrying
out
deposit/furnishingbusiness for microorganisms since July 1968.
(1) Operations
Acceptable samples of microorganisms
80 ●are microbial cells (bacteria, fungi, yeasts,
actinomycetes and plasmids (not in hosts)),
animal cell cultures (animal cell cultures andembryos) and plant cell cultures (plant cell
cultures, seeds, algae and protozoa) (*2).
The quantity of samples required at thetime of deposit is five or more sample tubes inprinciple for bacteria, actinomycetes, fungi
and yeasts (form: freeze-dried, L-dried, slant
or frozen), plant cell cultures (form: callus ina test tube), and algae and protozoa (form:
slant or liquid medium), 20 or more sample
tubes for animal cell cultures (including
hybridomas; form: frozen), 25 or more sample
tubes for plasmids (not in hosts; form: DNA
solution, dried or frozen) and embryos (form:
frozen), and 100 or more bags (25 seeds perbag) for seeds (form: dried seeds). (*3)
Regarding bacteria, actinomycetes, fungi,
yeasts, plant cell cultures, algae and protozoa,
samples are in principle replicated throughsubculturing, and replicated samples are also
usedforfurnishing.
For
these
microorganisms, replication is conducted inconjunction with a viability test at the time ofacceptance of microorganisms, and 16
replicated samples are manufactured. In
addition, when the aforementioned replicatedsamples run short due to furnishing, samples
are replicated again. For animal cell cultures(including hybridomas),(*4) embryos and seeds,
samplesarenotreplicatedthroughsubculturing, and the original samples are
furnished.
For bacteria, actinomycetes, fungi,
yeasts, plant cell cultures, algae, protozoa
and seeds, a secular viability test is
conducted in the first, third, fifth, tenth,fifteenth and twentieth year after storage, in
addition to a viability test at the time ofdeposit. For animal cell cultures (including
hybridomas) and embryos, a secular viability
test is conducted once or twice (the period is
not predetermined), in addition to a viability
test at the time of deposit, and for plasmids, aviability test is conducted only at the time ofdeposit. In addition, for all kinds ofmicroorganisms, a viability test is inprinciple also conducted at the time offurnishing. Therefore, in furnishing, twosample tubes are consumed: one for
furnishing and one for a viability test.
(2) Past record of acceptance/furnishing
The number of acceptances between
January 1 and December 31, 2006 is 637,
including both domestic deposits andinternational deposits. The total number ofstored strains as of December 31, 2006 is
13,780. In addition, the number of cases offurnishing between January 1 and December
31, 2006 is 209 (total of domestic andinternational cases).
It was estimated that strains for whichfour or more requests for furnishing are madeaccount for less than 1% of all stored strains,
as a result of estimation of the distribution of
the number of requests for furnishing in 30
years. This was based on the distribution of
the number of requests for furnishing at the
IPOD in three years (2004 to 2006) (strains
for which one or more requests were madeaccount for 3% of all stored strains) and theaverage number of stored strains in thatthree years (13,778), on the following
assumption: (i) the probability of receiving
requests for furnishing is not biased amongdeposited strains and (ii) the same
distribution of the number of times offurnishing as that between 2004 and 2006 is(*2) However, the kinds of microorganisms that are not acceptable are provided below.
・ Microorganisms that cause harm to health or the environment or have a property that is likely to cause harm
thereto (meaning microorganisms that are classified into safety level 3 or 4 in the safety level classification table of
the National Institute of Advanced Industrial Science and Technology)
・ Microorganisms that require containment measures level P3, P3A or P3P as prescribed in Article 5 of the
Ministerial ordinance stipulating containment measures to be taken in type 2 use of LMOs for research anddevelopment. (Ordinance No. 1 of the Ministry of Education, Culture, Sports, Science and Technology/Ministry of
the Environment of 2004)(*3) Some of deposited samples are stored without being used for replication of samples through subculturing, furnishingand viability test.
(*4) According to the IPOD, this measure is taken from the perspective of securing authenticity of stored strains since, foranimal cell cultures, quality may differ with respect to each subculturing lot.
●81 ●IIP Bulletin 2008

maintained for 30 years.
Incidentally, at the IPOD, there havebeen no cases where a new deposit became
necessary since many requests for furnishingwere made, with respect to the kinds ofmicroorganisms that are not subcultured.

2

National Institute of Technology and
Evaluation, Patent Microorganisms
Depositary (NPMD)The NPMD is located in Kisarazu City,
Chiba Prefecture, where the Department of
Biotechnology of the National Institute ofTechnology and Evaluation (NITE) is located.
It
has
been
carrying
out
depositing/furnishing for microorganisms
since April 2004.
(1) Operations
Acceptable samples of microorganisms
are microbial cells (bacteria, fungi, yeasts,
actinomycetes, bacteriophages and plasmids(in hosts or not in hosts)) and animal cell
cultures(animalcell
culturesandembryos).(*5)
The number of sample tubes required at
the time of deposit is 20 or more for all kindsof microorganisms.(*6) Acceptable forms arefrozen, freeze-dried or L-dried for bacteria,
actinomycetes,
fungi,
yeastsandbacteriophages, dried or frozen or DNA
solution for plasmids, and frozen for animal
cell cultures (including hybridomas) andembryos.
Regarding furnishing, the original
samples deposited by depositors are
furnished since the NPMD does not replicate
samples through subculturing for any kind of
microorganism.
In terms of viability tests, for driedsamples, irrespective of the kind of
microorganism, an accelerated test designed
to see the degradation level of samples under
severe storage conditions (temperature, etc.)
is conducted once in order to verify whether
the samples can endure 30-year storage, in
addition to a viability test at the time ofdeposit. Moreover, for frozen samples,irrespective of the kind of microorganism, aviability test is conducted in the fifth year ofstorage to verify whether the samples canendure 30-year storage, in addition to a
viability test at the time of deposit.
Incidentally, since a viability test is also in
principle conducted at the time of furnishing,
two sample tubes are used in furnishing: onefor furnishing and one for a viability test.
(2) Past record of acceptance/furnishing
The number of acceptances between
January 1 and December 31, 2006 is 147,
including both domestic deposits andinternational deposits. The total number ofstored strains as of December 31, 2006 is 262.
In addition, the number of cases of furnishing
between January 1 and December 31, 2006 is
one (total of domestic and international
cases).

IV Actual Conditions ofUsers of the System
1

Domestic

Outline of the Survey

In considering the operations of thepatent microorganism deposit system, aquestionnaire survey was conducted withdomestic users in order to gain a specificunderstanding of the actual conditions ofburden on depositors and the needs ofdepositors.

(*5) However, the following kinds of microorganisms are not acceptable:
・ In the case of genetically modified organisms, microorganisms which require containment measures level P3, P3A or
P3P or higher level (“Ministerial ordinance stipulating containment measures to be taken in type 2 use of LMOs forresearch and development. (Ordinance No. 1 of the Ministry of Education, Culture, Sports, Science andTechnology/Ministry of the Environment of 2004)” based on the “Act on the Conservation and Sustainable Use of
Biological Diversity through Regulations on the Use of Living Modified Organisms”).
・ Microorganisms which belong to level 3 or higher level of biosafety level (BSL) to human being, which is set by the
Department of Biotechnology of NITE.
(*6) Deposited samples are provided for furnishing and viability tests (including accelerated test), and two sample tubes
each are stored at the NPMD (Kisarazu City, Chiba Prefecture) and the Tohoku Regional Office (Sendai City, Miyagi
Prefecture) without being used for furnishing and viability tests.
●

IIP Bulletin 200882 ●

The survey targets were 390 applicants(including juridical persons, etc.) who filed
applications (only those that have been
published) relating to microorganisms thathave been deposited to domestic IDAs
between 2004 and 2005. Out of the 390
applicants, 115 persons (companies) gave
valid responses.

2

Survey Results

About 40% of users consider preparationof the number of samples required at the timeof deposit to be a burden. This feeling iscommon for all categories of respondents(large companies, SMEs/venture companies,etc.). Then, about 80% of those who feelburdened believe that the burden will be
reduced through reduction of the number ofsamples required.
Regarding the time necessary for
preparing samples required at the time ofdeposit, the subculturing process accounts forthe large portion of the time for preparing
samples. In particular, this tendency isstrong for animal cell cultures (including
hybridomas). In addition, the major factor
that
restricts
theprogressofthesubculturing process is the growth rate of
microorganisms. However, in some cases, theprogress of said process can be delayed due toshortage of processing equipment for
manufacturing samples of microorganisms(freeze drier, Tesla coil, etc.).
In addition, the effects of reducing the
manufacturing time and the effects ofreducing actual working hours that areachieved if the number of samples required
for a deposit is reduced tend to be larger foranimal cell cultures (including hybridomas).
The rate of the respondents who know
the existence of manufacturers of samples fordeposit was low at 32%. On the other hand,
many of the respondents who answered that
they
knew
the
existenceofsaid
manufacturers use outsourcing in preparing(*7)

samples of bacteria. Reasons for using
outsourcing are to make up for a shortage offacilities,tomanufacturesamples
appropriately, to divert human resources toother work, and so on.
Though nearly 90% of depositors store
deposited microorganisms themselves evenafter depositing them, the duration of thestorage is up in the air in many cases.
Moreover,few
depositors
store
microorganisms in consideration of the
Budapest Treaty and the duration of patentrights.

V

Overseas Patent
Deposit Systems

1

Outline of the Survey

Microorganism

The overseas system survey(*7) was
conducted
targeting13
countries(organizations) – the United States, Canada,
Europe, Germany, the United Kingdom,France, the Netherlands, Belgium, Italy,
Bulgaria, Russia, China and South Korea –with focus on systems relating to deposit(including new deposit) and furnishing. The
aim was to use the survey results not only asa reference for understanding the operations
at overseas IDAs but also as basic
information in considering the operations of
the deposit system in Japan.

2

Survey Results

In the United States and Canada, “beinga biological invention” was the only pointthat was cited as a case where deposit isnecessary. However, in other surveyedcountries, the unavailability of the relevant
microorganism was also cited.
With regard to the time limit for deposit,
it is necessary to make a deposit before thefiling date (priority date) in the countries
other than the United States. (In the UnitedStates, the time limit is up to the granting of

The survey was conducted based on the Guide to the Deposit of Microorganisms under the Budapest Treaty(published by WIPO; fiscal 2007 version) and literature search of patent law, etc. of each country as well as aquestionnaire survey to overseas patent offices. (Answers were obtained from seven countries: the United States,
Canada, Germany, the United Kingdom, Belgium, Bulgaria and South Korea.)●83 ●IIP Bulletin 2008

a patent, but deposit before the filing date isrecommended.)
The duration of deposit is “30 years fromthe date of deposit, or five years from thelatest furnishing” in most countries subject tothe survey, as prescribed in the provisions of
the Budapest Treaty. Seven countries
answered that if furnishing becomes
unavailable during this duration and a new
deposit is not made, in the patent acquisition
procedures, the relevant application will berefused, while after acquisition of a patent,
the relevant patent will be invalidated.(*8)
Deposited
microorganisms
becomeavailable for furnishing after publication(*9)
or granting of a patent. (*10) However, in somecountries, deposited microorganisms can be
furnished only to experts during the period
after publication but before granting of apatent. (*11) Moreover, in most countries, thepurpose of furnishing is limited toexperiment and research purposes, andtransfer to a third party is prohibited. (In the
United States, there are no special
limitations.)
In some countries, it is necessary toreport a new acceptance number that isallocated in a new deposit in cases where a
new deposit is made. (*12)

the DSMZ (Germany), the ECACC (United
Kingdom), the NIBSC (United Kingdom), the
CNCM (France), the CBS (the Netherlands),
the BCCMTM (Belgium), the ABC (Italy), the
NBIMCC (Bulgaria), the VKPM (Russia), theNMI (Australia), the CCTCC (China), the
CGMCC (China), the KCCM (South Korea),
the KCLRF (South Korea) and the KCTC
(South Korea). The survey focused on items
concerning operations relating to reduction of
burden of deposit (the number of sample
tubes required at the time of deposit,
replication of samples through subculturing,furnishing, viability test, etc.).

2

Survey Results

The literature search revealed that
handling methods at IDAs were roughly
dividedintothemethodforfungi/yeasts/bacteria/actinomycetes/plasmids,
method for animal cell cultures/hybridomas
and method for others, and that in the groupof fungi, yeasts, bacteria, actinomycetes andplasmids, demand for deposit was highest forbacteria. In consideration of these results, foritems for which handling differs dependingon the kind of microorganism, handling ofbacteria and that of animal cell cultures(including hybridomas) are only summarized.

VI Operations at Overseas IDAs
1

Outline of the Survey

In order to use the survey results as areference in considering the operations of thedeposit system in Japan, a survey(*13) was
conducted targeting 17 overseas IDAs: theATCC (United States), the NMLHC (Canada),(1) Number of samples required at the timeof deposit
The number of samples required at thetime of deposit varies to a great extent among
IDAs, specifically, one to 25 sample tubes indepositing bacteria and seven to 25 sample
tubes in depositing animal cell cultures. In
addition, six IDAs(*14) answered that the(*8) This is the answer provided by countries from which the questionnaire could be collected, specifically, the UnitedStates, Canada, Germany, the United Kingdom, Belgium, Bulgaria and South Korea. However, in the United States,
there was also an answer to the effect that even if the relevant microorganism becomes unavailable for furnishing,
there will be no problem both in the patent acquisition procedures and after acquisition of a patent if the
microorganism is available for commercial use.
(*9) Canada, Europe, Germany, the United Kingdom, France, the Netherlands, Belgium, Italy, Russia, Bulgaria, South
Korea and China.
(*10) The United States.
(*11) Canada, Europe, Germany, the United Kingdom, France, the Netherlands, Belgium and Italy.
(*12) The United States, Canada, Europe, the United Kingdom, France, the Netherlands, Belgium and South Korea.
(*13) The survey was conducted based on the Guide to the Deposit of Microorganisms under the Budapest Treaty(published by WIPO; fiscal 2007 version) and literature search by websites, etc. of those IDAs as well as aquestionnaire survey to overseas IDAs. (Answers were obtained from 11 IDAs: the ATCC, the NMLHC, the ECACC,
the DSMZ, the CNCM, the BCCMTM, the ABC, the CBS, the NMI, the KCTC and the NIBSC.)(*14) The ATCC, the DSMZ, the BCCM, the ABC, the CBS and the NMI.
●IIP Bulletin 200884 ●number of samples required at the time ofdeposit was set in consideration of the pastrecord of furnishing with respect to the kindsof microorganisms that are not subcultured.
(2) Replicationofsamplesthroughsubculturing
While some IDAs(*15) do not subculture
any kind of microorganism in principle, someother IDAs(*16) replicate not only bacteria but
also
animalcell
culturesthroughsubculturing. Whether to replicate samples
through subculturing differs depending on
the IDA. However, some of IDAs that do not
conduct subculturing in principle also
conduct subculturing if samples run shortdue to furnishing, etc. and the relevant
depositor requests subculturing. (*17)
Reasons for not subculturing animal cell
cultures, etc. include “to avoid lawsuits frombeing filed against the IDA” and “it isdesirable to furnish originally deposited
samples since depositors are supposed todeposit relevant microorganisms under
optimum conditions to work patented
inventions pertaining to the microorganisms.”
As far as the survey was conducted, IDAs
that replicate samples through subculturingconduct an authenticity check by relevant
depositors with respect to replicates madethrough subculturing.
(3) Furnishing
At 11 IDAs that answered thequestionnaire, replicates are furnished withrespect to microorganisms for which
replication
throughsubculturingisconducted, and originally deposited samples
are furnished in cases where replication is
not conducted. In addition, it is presumed
that similar handling is adopted at six IDAs
from which answers to the questionnaire
could not be obtained.
(4) Viability test
Regarding viability tests, the number

varies among IDAs, specifically, from once toseven times (including a viability test at thetime of deposit). In addition, some IDAs do
not conduct a viability test even at the timeof furnishing. (*18)

VII Consideration of Measures for
Reducing Burden on Users of the
System1

Consideration of Reduction of the
Number of Samples Required at theTime of Deposit

In order to reduce burden at the time ofdeposit, it is conceivable to reduce thenumber of samples required at the time ofdeposit on the premise of the points cited in(i) to (v) below, taking into account thecondition of burden at the time of depositthat was revealed through the userquestionnaire survey, consideration of thepast record of requests for furnishing whenoverseas IDAs determine the number ofsamples required at the time of deposit, andthe operations, etc. of replication of samples
through subculturing.
(i) For the kinds of microorganisms thatparticularly require a great deal of labor for
replication
throughsubculturing(forexample, animal cell cultures), it is, inprinciple, considered favorable to ensure that
deposited microorganisms are furnishedwherever possible, since it leads to reductionof burden on depositary institutions anddepositors with regard to subculturing andconfirmation of authenticity of samples
replicated through subculturing.
Incidentally,
for
the
kinds
of
microorganisms for which subculturing istechnically easy and of which authenticity isextremely unlikely to be damaged (forexample, bacteria and yeasts), it is notconsidered necessary to persist in furnishing
the original samples.

(*15) The ATCC, the NMLHC and the ECACC.
(*16) The CNCM, the KCTC and the KCLRF.
(*17) The ATCC and the NMLHC.
(*18) The ECACC and the CNCM.
●

85 ●IIP Bulletin 2008

(ii) In deciding on the number of samples
required at the time of deposit with respect tothe kinds of microorganisms for which
replication through subculturing is inprinciple not conducted, reduction of thenumber of samples required at the time ofdeposit is promoted in consideration of thepast record of furnishing. In general,
requests for furnishing are not supposed to
exceed a maximum of three times.
(iii) On the other hand, it is possible toenable a choice between making a new
deposit and subculturing by a depositary
institution in cases where many requests forfurnishing are made and samples stored for
furnishing based on the original prediction
run short.
(iv) In replicating samples throughsubculturing, it is considered desirable to ask
the relevant depositor to check theauthenticity of samples replicated throughsubculturing, from the perspective ofensuring the authenticity of replicatedsamples and preventing problems related toauthenticity.
(v) Reduction of the number of samples
required at the time of deposit is expected tocause an increase in the possibility ofoccurrence of a new deposit. Therefore,
depositors can be informed of the need to
store
deposited
microorganisms
inpreparation for a new deposit.
Incidentally, before reducing the numberof samples required at the time of deposit,
there should be a discussion bearing in mind
the following points.
(1) Risks arising from reduction of thenumber of samples required at the timeof deposit
Before reducing the number of samples
required at the time of deposit, the number ofcases of furnishing should be estimated sothat considerable new deposits are notrequired, and the reduction should beconsidered based on the estimation. In doingso, it is also considered necessary to respondwith respect to each kind of microorganism inlight of the property of each.
However, since it is true that thepossibility of a new deposit increases, thepossibility of a new deposit should bespecifically publicized in writing or by othermeans at the time of deposit. (*19) In thisregard, it is considered desirable to makeclear the conditions for deposit between thedepositor and the depositary institution at
the time of deposit in order to clarify
risk-sharing between the depositor and thedepositary institution. However, in doing so,
the aforementioned conditions for deposit
should be reasonable and satisfying for both
the depositor and the depositary institution
since the depositor has no choice of
depositary institution in some cases.
In addition, regarding costs for a new
deposit or replication through subculturing,
it is considered necessary to examine thesharing of burden among depositors, those
who request furnishing and depositary
institutions, including the idea that if suchcosts arise due to many requests forfurnishing, those who request furnishingbear the costs.
(2) Estimation of the number of requests
for furnishing
The probability of receiving a request for
furnishing is sometimes biased depending on
the strain. In addition, it is also necessary to
pay attention to the point that there is no
guarantee that the probability is the same
every year. However, strains for which many
requests for furnishing are made areconsidered to be very few in proportion as thetotal number of deposited strains.
(3) Authenticity check at the time ofreplication through subculturing
It is difficult to objectively determine theauthenticity of microorganisms replicatedthrough subculturing, and determination is
expected to differ depending on the property(*19) It is conceivable that if the number of samples for furnishing has decreased, the IDA can communicate with thedepositor to that effect and promote the depositor to prepare for a new deposit.
●

IIP Bulletin 200886 ●of the microorganism that is related to therelevant invention. On the other hand,depositary
institutions
do
not
have
information about the properties of deposited
microorganisms that are related to therelevant inventions. Therefore, it is notdepositary institutions but depositors thathave to determine the authenticity of
replicated microorganisms.
Then,takingintoaccount
thatfurnishing will become impossible ifauthenticity cannot be guaranteed in
replication through subculturing and a new
deposit is not made, depositors should
maintain the condition in which theauthenticity of microorganisms replicatedthrough subculturing can be guaranteed or inwhich a new deposit of the same
microorganism is possible, throughout the
duration of storage or the duration ofpatents.

2

Consideration of Publicizing the
Existence of Manufacturers of Samples
for Deposit

According to the results of the userquestionnaire survey, it can hardly be said
that the existence of manufacturers ofsamples for deposit is widely known.
However,
outsourcing
ofsamplemanufacturing by depositors suffering fromshortage of equipment and materials, etc. is
expected to have a certain effect for reducing
their burden.
Therefore, it is conceivable to publicize
the existence of manufactures of samples fordeposit to the extent that fairness among the
manufactures is not damaged. However, indoing so, the need to clarify the quality of
manufacturers,
includingkinds
ofmicroorganisms that can be subcultured,work procedure and costs, in some way
should also be taken into consideration.
(Senior Researcher: Hiroyuki ITAGAKI)●

87 ●IIP Bulletin 2008