The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or Budapest Treaty, is an international treatysigned in Budapest, Hungary, on April 28, 1977. It entered into force on August 9, 1980, and was later amended on September 26, 1980. The treaty is administered by the World Intellectual Property Organization (WIPO).

As of July 2019, 82 countries are party to the Budapest Treaty.^[1] The accession to the Treaty is open to States party to the Paris Convention for the Protection of Industrial Propertyof 1883. The African Regional Industrial Property Organization (ARIPO), the Eurasian Patent Organization (EAPO) and the European Patent Organisation (EPO) have filed a declaration of acceptance under Article 9(1)(a)^[2] of the Treaty.

The treaty allows "deposits of microorganisms at an international depositary authority to be recognized for the purposes of patent procedure".^[3] Usually, in order to meet the legalrequirement of sufficiency of disclosure, patent applications and patents must disclose in their description the subject-matter of the invention in a manner sufficiently clear and complete to be carried out by the person skilled in the art (see also: reduction to practice). When an invention involves a microorganism, completely describing said invention in the description to enable third parties to carry it out is usually impossible. This is why, in the particular case of inventions involving microorganisms, a deposit of biological material must be made in a recognised institution. The Budapest Treaty ensures that an applicant, i.e. a person who applies for a patent, needs not to deposit the biological material in all countries where he/she wants to obtain a patent. The applicant needs only to deposit the biological material at one recognised institution, and this deposit will be recognised in all countries party to the Budapest Treaty.

International depositary authority[edit]

The deposits are made at an international depositary authority (IDA) in accordance with the rules of the Treaty on or before the filing date of the complete patent application. Article 7 of the Budapest treaty outlines the requirements for a facility to become an International Depositary Authority. As of July 23, 2018, there were 47 IDAs in approximately 25 countries worldwide.^[3]

Depositable subject matter[edit]

IDA's have accepted deposits for biological materials which do not fall within a literal interpretation of "microorganism". The Treaty does not define what is meant by "microorganism."

The range of materials able to be deposited under the Budapest Treaty includes:

cells, for example, bacteria, fungi, eukaryotic cell lines, plant spores;
genetic vectors (such as plasmids or bacteriophage vectors or viruses) containing a gene or DNA fragments;
organisms used for expression of a gene (making the protein from the DNA).

There are many types of expression systems: bacterial; yeast; viral; plant or animal cell cultures;

yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes;
purified nucleic acids; or
deposits of materials not readily classifiable as microorganisms, such as "naked" DNA, RNA, or plasmids

PATENTED MATERIAL DEPOSIT

The Istituto Zooprofilattico Sperimentale della Lombardia e dell’Emilia Romagna “Bruno Ubertini” (IZSLER) aquired the status of International Depositary Authority under the Budapest Treaty on February 9, 2015.

The Budapest Treaty

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure was introduced in 1980 in an effort to implement such recommendations. The States party to this Treaty constitute a Union for the international recognition of the biological material deposit to overcome the difficulties which arose from different national patent regulations.

According to the Treaty, certain scientifically recognized independent culture collections could obtain the status of an "International Depositary Authority" (IDA) for microorganisms, sets out the minimum standards for such collecting authorities, and also sets out the guidelines for the deposit. Under the Treaty a deposit made in the IDA is recognized as valid by all Contracting States of the Budapest Union. Such an institution acquires the status of “international depositary authority” through the furnishing, by one of the Contracting States, of assurances to the Director General of the World Intellectual Property Organization (WIPO) (http://www.wipo.int/portal/en/index.html) to the effect that the said institution complies and will continue to comply with definite requirements, including, in particular, that it will be available, for the purposes of the deposit of microorganisms, to any “depositor”, that it will accept and store the deposited microorganisms and that it will furnish samples thereof to anyone entitled to such samples but to no one else.

Secrecy

According to Rule 9 of the Budapest Treaty, IZSLER keeps strict secrecy regarding the deposit, its nature and the depositor. All material and information is handled strictly confidentially. Furthermore, strains deposited under the Budapest Treaty will by no means included in the IZSLER catalogues or any openly available lists.

Patent Deposit Requirements

1) Biological Material accepted as Patent Deposit

IZSLER accepts and store as patent deposits: 1) animal bacteria isolated from tissues and organs and from food, 2) human and animal viruses of level risk 1 and 2, 3) bacteriophages and 4) plasmid in host strain or as purified DNA . No mixed microbiological cultures will be accepted. They will be accepted if sent separately. IZSLER reserves the right to refuse any biological resources that represent a high hazard or that, for technical reasons, cannot be processed. IZSLER accepts for deposit all microorganisms and viruses classified in the level risk 2, according to EEC Directive 2000/54/EC on the Protection of Workers from Risks Related to Exposure to Biological Agents at Work of 18 September 2000.

Biological resources can be sent frozen or freeze-dried and their storage will be made at -20°C, -80°C and in vapour phase nitrogen according to the method that allows a long term preservation of vitality and maintenance of the characteristic of the material.

Every deposit is assigned a unique accession number on arrival that is provisional until the patent has proved viable and purity evaluated following quality control testing, depending on the type of patent deposit.

The average time requested for testing the viability is: 14 days (up to 3 weeks) for bacteria, 20 days for viruses and bacteriophage, and 8-10 days for plasmids.

Once viability testing has been completed by IZSLER, a certificate of deposit with viability testing results is provided to the depositor.

2) Guidelines for submission of biological material

All deposits must be preceded by:

Biohazard Risk Assessment Form

BP/1 Statement in the case of an Original Deposit (Rule 6.1)

To ensure that the material arrives safely and is handled appropriately, the following guidelines should be followed.

The material should be clearly labeled and identified. The designation on the vial labels should agree with the strain designation that have been listed on the deposit forms. When packaging vials, put all similarly labeled vials together in the package. When shipping frozen material, use enough dry ice in an insulated shipping container to ensure the material is adequately frozen upon arrival at IZSLER, taking into account any delays in transport;
provide material only in the required form and quantity;
provide a biohazard statement;
pay all necessary fees including all charges for the transportation of deposits to IZSLER;
observe the terms and conditions of the Budapest Treaty;
accept the terms and conditions of deposit of samples in IZSLER;
deposits must be covered by the appropriate regulatory documentation before being accepted.

3) Quality testing of Patent Deposits

Type of Patent Deposit	Quality Controls Tests Performed
Virus	Viability of virus performed according to instructions provided by the depositor on the patent deposit form
Bacteria	Viability test Purity test
Bacteriophage	Viability of bacteriophage performed according to instructions provided by the depositor on the patent
Plasmid in host strain/Plasmid DNA	Viability test/Transformation of plasmid DNA in a suitable host strain

In general, IZSLER does not prepare batches of bacteria and viruses and when the batches are exhausted it requests the depositor to make a new deposit. Only in particular case and following previous written consent of the depositor, IZSLER can prepare a new batch of the material. However, the depositor has to control the quality characteristics of the material. A portion of each original material supplied by the depositor is stored as master deposit.

4) How to submit Patent Deposits

Complete the following forms: Biohazard Risk Assessment Form and BP/1 Statement in the Case of an Original Deposit (Rule 6.1). In particular, depositor has to declare: the quantity and form of the material to be deposit, the characteristics and biological risk of the material. The Biohazard Risk Assessment is a legal requirement in accordance with the Italian Health and Safety Laws. When completing the risk assessment, ensure that the possible pathogenicity of the microorganism to humans is indicated.
Submit completed forms to IZSLER.
Await notification from IZSLER prior to sending the patent deposit.
Acept the fees charged and comply with the requirements of the Budapest Treaty and of IZSLER (notified to WIPO).
Use correct packaging: packages should be clearly labelled with the storage temperature, sender’s contact information and the reference number. Transport of infectious material in Italy is subjected to the package conforming to international regulations of the transport of hazardous materials.
A patent deposit cannot be accepted unless 12 identical samples prepared from a single batch are supplied.
In case of bacteriophage, 12 frozen vials (1 mL each with a titre of at least 108 pfu/mL) are needed.
In case of plasmids in host strain, 12 lyphilized vials plus 3 agar cultures. In case of plasmids as purified DNA, 12 frozen vials (25 micrograms each). A suitable host strain needs to be deposited in an active form (2 slants).
Overseas depositors must contact IZSLER in advance, at least 48 hours before, for advice about the shipping of the microorganisms. IZSLER must be informed of the number of ampoules being sent, the method of transportation and the estimated time of arrival. If dispatch is by air, must be told to IZSLER the flight number and destination, waybill number and handling agent for delivery.

A batch may be rejected if:

The package is damaged in any way that could compromise containment
Appropriate transport temperatures have not been maintained
Vials are not completely sealed
Vials are not clearly labelled
12 identical vials prepared from a single batch have not been provided.

Patent Depository storage fees

Patent Depository fees	Euros (€)
Bacteria
Freeze dried	608.80
Frozen at -80°C	701.27
Frozen liquid nitrogen	1448.27
Viruses
From embryonated chicken embyos	788.92
From cell coltures	1086.96
Bacteriophages
Frozen at -80°C	701.27
Frozen liquid nitrogen	1448.27
Plasmids
Freeze dried	608.80
Frozen at -80°C	701.27

Viability fees

Viability testing	Euros (€)
Issuance of viability testing	60
Bacteria	100
Virus	150
Bacteriophage	100
Plasmid	110

Distribution fees

Furnishing of a sample (Plus shipping cost)	Euros (€)
Bacteria	105
Virus	400
Bacteriophage	400
Plasmid	105

Other fees

Communication of information or issuance of an attestation € 50

Fees are added with Value Added TAX (VAT) according to Italian regulations.

Converting a previous deposit

Deposit of other types (open deposit, safe deposit) can be converted by the depositor into deposit under the Budapest Treaty. In this event the batch has to be moved from the previous to the new deposit. In alternative, the depositor prepares a new batch to be deposited under the Budapest Treaty.

To ask for a deposit, please use the following forms:

Form BP/2 Statement in the Case of a New Deposit with the Same International Depositary Authority (Rule 6.2)

Form BP/3 Statement in the Case of a New Deposit with Another International Depositary Authority (Rule 6.2)

Form BP/4 Receipt in the Case of an Original Deposit (Rule 7.1) (International Form).pdf

Form BP/5 Receipt in the Case of a New Deposit (Rule 7.1) (International Form)

Form BP/5 Receipt in the Case of the New Deposit (Rule 7.1) International Form)

Form BP/6 Receipt in the Case of a Transfer (Rule 7.1) (International Form)

Form BP/7 Communication of the Later Indication or an Amendment of the Scientific Description and/or Proposed Taxonomic Designation (Rule 8.1)

Form BP/8 Attestation Concerning the Later Indication or an Amendment of the Scientific Description and/or Proposed Taxonomic Designation (Rule 8.2)

Form BP/9 Viability Statement (Rule 10.2) (International Form)

Form BP/10 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.1)

Form BP/11 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.2(ii))

Form BP/12 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.3(a))

Form BP/13 Request for the Furnishing of Samples of Deposited Microorganisms (Rule 11.3(b))

Form BP/14 Notification of the Furnishing of Samples of Deposited Microorganisms (Rule 11.4 (g))

International Depository Authority and its Role in Microorganism’s Deposition

Abhishek Parashar corresponding author

1

Author information Article notes Copyright and License information Disclaimer

Go to:

Introduction

Intellectual Property Right (IPR) is a lawful right given to inventors for their intellectual work. It includes Patents, Trade secrets, Copyrights, Trademarks, Plant varieties protection, Industrial designs and Geographical indicators. New invention is required for growing economy like India as it gives competitive edge form the rivals. Further as heavy investment is involved in new inventions, the inventor should have the right to get monitory benefits for his/her work. In this regard patent and other IP rights give necessary protection of original work from its misuse and at the same time provide monitory gain from the invention. In 1948 after World War II General Agreement on Tariffs and Trade (GATT) was made for International trade purposes [1]. GATT was eventually replaced by World Trade Organization (WTO) in 1995, which included Intellectual Property Right (IPR) for the first time in trade [2].

As per Article 27(3)(b), of Trade Related Aspects of Intellectual Property Right (TRIPS) agreement microorganisms, non-biological and microbiological processes can be patented [3]. India also follows the rules and regulation of TRIPS agreement and allows only that work to get patent that has commercial application, novelty and non-obvious in nature [4]. However, it is a very tedious job to get patent for live organisms. It is only given to those inventions that includes genetic modification and insets valuable characters in microorganisms that were initially not present in natural form of that organism such as attenuation in bacterial strain making it less infective which is required during vaccine preparation (Tuberculosis vaccine) [], genetic modified oil eating bacteria [6] etc. In 1980, USA was the first country that had decided to grant the patent on live microorganisms, a genetically modified Pseudomonas bacteria was granted patent because of its ability to degrade harmful organic compound produce during oil spills [6]. One of the mandatory obligation for grant of patent for an invention is its repeatability by a person who has knowledge in that field, with work related to non-biological in nature, testing of invention is an easy process as most of the ingredient of work is stable in nature. But working with microorganisms is a very different phenomenon as bacteria always change their character in native environment due to selective pressure causing difficult to repeat the experiment that was previously performed/claimed by the inventor. To resolve those issues it was decided that inventor must deposit microorganisms in pure and viable form for its patent purpose in a depository house also known as bacterial depository bank or International Depository Authority (IDA) as per the rules and regulations set by International body in the form Budapest Treaty [7]. Further, single deposition of sample will be sufficient for its recognition for patent purpose by other countries that are part of this treaty.

1. Budapest Treaty

The proposal for International treaty on deposits of microorganisms was first put forward by United Kingdom. The treaty was adopted in 1977 at Budapest and came into existence in 1980. At that time 18 countries ratified this treaty such as France, USA, UK, Italy etc. The main objective of this treaty is to deposit live microorganisms for their patent purpose. To deposit live microorganisms in one place, member country has to develop IDA where depositors can safely deposit live microorganisms [7]. Today more than 80 countries are part of this treaty and there are 39 IDAs in 22 countries. To get the membership of Budapest treaty, each country has to ratify Paris convention which is related to protection of work having industrial application. Budapest treaty is not only restricted to microorganisms but plant and animal cells, hybridoma cell, cell lines, RNA, plasmids etc., can also be deposited in IDA. In 2001, India became part of Budapest treaty and currently there are two IDAs, Microbial Culture Collection (MCC) in National Centre for Cell Science (NCCS), Pune and Microbial Type Culture Collection and Gene Bank (MTCC) at Institute of Microbial Technology (IMTECH), Chandigarh respectively [8]. Along with two IDAs, India has thirteen more culture collection centers known as designated repositories, storing different kinds of biological resources and are recognized by National Biodiversity Authority (NBA) [9].

1.1 Key features of Budapest treaty:

1) IDA formation and recognition of single deposition of microorganisms for patent purpose:Budapest treaty has given clear rules and regulations of creating and maintenance of IDA, daily working protocol of IDA and guidelines to depositor. It was decided that each member country will make IDA for microorganisms deposition with full infrastructure facility, also the IDA will accept microorganisms from depositors of native country as well as outside from country. One of the burning issue that was solved in this treaty was to stop multiple deposition of sample in more than one IDA for patent purpose. The treaty says that single deposition of sample for patent purpose in IDA will be enough to give recognition by other member countries of Budapest treaty [10].

2) Broad definition of microorganisms: Budapest treaty has not defined the definition of microorganisms; because of this situation today not only microorganisms but plasmid, cell lines, fungi, yeast, RNA, plant and animal cells etc., can also be deposited.

3) Safe deposition of microorganisms: It is the duty of IDA to safely deposit microorganisms without affecting its viability and purity.

4) Deposition and furnishing of samples: A brief rule and regulation is given for deposition of samples. Further, sample can be stored up to 5 to 30 years in IDA. Also, IDA has to furnish samples to depositor or concern authority as per the requirement.

2. What is an IDA?

Any culture collection center can become IDA but it has to give assurance to members of Budapest treaty and World Intellectual Property Organization (WIPO) that it will deposit microorganism from any depositors, it will accept and store microorganism in safe and proper manner and furnish the sample to any authorized person as per the requirement in strict manner, obeying all the rules and regulations of Budapest treaty [11].

2.1 Main functions of IDA:

1)

Storage of microorganisms for patent purpose;
2)

Long term storage of microorganisms in safe manner;
3)

Furnishing of samples as per the requirement;
4)

Creates an environment of good microbiological practices;
5)

Identification and characterization of samples;
6)

Gives accession number to samples;
7)

Maintain secrecy of deposited microorganisms;
8)

Provides human resource work such as training program related to microbial techniques;
9)

Protection of environment;
10)

Proper transport of sample.

2.2 Convention on Biological Diversity (CBD) and IDA: CBD was signed by more than 200 countries during Earth summit at Rio de Janeiro, Brazil in 1992 [12]. The agreement gives the right to nations to conserve their biodiversity. The aim includes: conservation of biological resources, sustainable use of biological diversity and equal sharing of benefit among the people who are using the genetic resources of biodiversity. IDA which is used for safe and long term deposition of microorganisms can work as preservation house for microbial population. In view of above situation two organizations World Federation of Culture Collections (WFCC) and World Data Centre for Microorganisms (WDCM) were established. The WFCC is an institution that helps in establishment of culture collections centers. It gives different guidelines for establishment, authentication and maintenance of cultures in culture centers. Also, creates an online networking between culture centers for better communications. WFCC has created WDCM whose main role is to maintain statistical data of culture collection centers, for example how many people are working, what kind of cultures are maintained in each culture centers, different facilities provided by culture centers etc. In 2003 India has established, National Biodiversity Authority (NBA). NBA is an autonomous body of government of India and it’s headquarter is in Chennai. The main function of NBA is to implement CBD agreement at regional level in India. For CBD implementation more efficiently, NBA has created 29 State Biodiversity Boards (SBBs) and 37,769 Local Level Biodiversity Management committees (BMCs) [13], [Table/Fig-1]. SBB takes suggestion from NBA regarding conservation of biodiversity at state level while BMC is involved at ground level in promoting conservation, sustainable use and documentation of biological diversity. In situ conservation protects the natural habitat of the species, while ex situ includes captive breeding programme for animals, zoo, botanical garden, in vitro production of plants, bacterial and other biological material storage and propagation in culture collection centers (IDA) etc.

An external file that holds a picture, illustration, etc.
Object name is jcdr-11-DE01-g001.jpg

Open in a separate window

[Table/Fig-1]:

NBA and its role in biodiversity conservation. NBA-National Biodiversity Authority, SBB- State Biodiversity Board, BMC- Biodiversity

Management Committee

2.3 Process involved in microorganisms deposition to IDA: There are several rules and regulation that have been included in this treaty for both depositors and culture collection center (IDA) for microorganism’s deposition in appropriate manner [14]. A brief process of microorganism’s deposition in IDA is as follows [Table/Fig-2]:

An external file that holds a picture, illustration, etc.
Object name is jcdr-11-DE01-g002.jpg

Open in a separate window

[Table/Fig-2]:

Process of microorganism’s deposition in IDA.

2.3.1 Depositor’s obligation [Table/Fig-3]: Rule 6.1(a): Depositor submits an IDA application form called BP1 (Budapest) mentioning his/her name, signature and address, full description of microorganism, chemicals, media and protocol for its proper storage in IDA. The form mentions information whether the said material is hazardous in nature or not or any other information in this regard. Further depositor has to mention in the form whether the culture is in pure or in mixed form and conditions for its long term storage.

[Table/Fig-3]:

Rules and regulations for sample deposition and holding in IDA.

Rules	Type of Functions	Different Forms use in IDA
Rule 3	Kinds of microorganisms accepted by IDA	Form BP2 & 3
Rule 4	New deposition of original sample	Form BP6
Rule 5.1	Transfer of samples from one IDA to another IDA	Form BP1
Rule 6.1(a)	Process of original sample deposition by depositor
Rule 6.3(a)	Sample deposition in agar slant /liquid suspension/ lyophilized form
Rule 6.4(a)	Refusal of taking microorganisms for deposition in IDA
Rule 6.4(b),(c) and (d)	Deals with acceptance of original deposit in IDA	Form BP4,5 & 6
Rule 7.1	After receiving and accepting the sample from depositor, IDA provides a hand written official receipt to depositor
Rule 9.1	Deals with storage of microorganisms in IDA	Form BP9
Rule 10.1 and 10.2	Viability testing of sample	Form BP10
Rule 11	Furnishing of sample by IDA

New deposition of original sample: Rule 4 says a new deposition of original sample can be performed in following situations:

1) If IDA is not able to furnish the sample for some reasons such as the stored microorganism is no more viable; 2) Sample is not given to foreign country where depositor wants to use it due to export or import restriction or if the status of IDA of the culture institute is cancelled.

In all these situations depositor has the right to make new deposition of the original sample by giving signed statement that the new deposited sample is equivalent to original sample. Form BP2 is used if the deposition is made in same IDA, while form BP3 in case of new IDA.

Rule 5.1: This rule comes when it is necessary to transfer samples from one IDA to another IDA. There could be many regions when this situation can arise such as when culture centre having IDA status fails to work under rules and regulations of Budapest treaty and its IDA status has withdrawn. In that case instead of new deposition of original samples, samples can be transferred to old IDA to new IDA. The new IDA has to inform depositors by giving following information in International form BP6:

1)

Name and address of new IDA where his or her sample has been deposited;
2)

Name and address of depositor;
3)

Date of transfer of sample from previous IDA to substituted IDA;
4)

Identification reference given by the depositor for that microorganism;
5)

Accession number given by IDA;
6)

Accession number given by the previous IDA;
7)

Name and address of previous IDA;
8)

Scientific description of the microorganism.

Rule 6.3(a): This rule deals with, in which form the sample will be deposited to IDA. IDA may ask depositors to provide sample in agar slant/liquid suspension/lyophilized form, sample may be required in specific number of replicates etc.

2.3.2 IDA obligation [Table/Fig-3]

Language: In most country English is used as communication language. However, country wise language can also be used such as Japanese language is being used in IDA of Japan for sample deposition.

Rule 3: This rule says any culture collection center which acquires the IDA status should mention what kinds of microorganisms will be accepted for deposition under Budapest treaty, fees for storage and furnishing of samples, extension of list of kinds of microorganism accepted, official language of the said institution etc.

Rule 6.4(a): It deals with refusal of taking microorganisms for deposition in IDA in specific situations. There are situations when IDA does not accept microorganisms such as if the microorganism type is different from mandate of IDA, due to specific property of bacteria that makes it very difficult to be cultivated by the IDA personal despite that microorganism comes under IDA mandate for deposition or in case if microorganism is missing from the sample or breakage of sample during its shipment.

Rule 6.4(b), (c) and (d): Rule 6.4(b) and (c) deals with acceptance of original deposit in IDA. The depositor has to give all the required information as per the rule 6.1(a) and rule 6.3(b) in order to get the sample deposition in IDA. Rule 6.4(d) is used when a deposition is made in non-IDA culture collection institute, but if the culture collection is converted to IDA in that case the depositor has to follow all the requirements as mentioned in rule 6.1(a) and 6.3(b) to deposit sample in IDA.

Rule 7.1: After receiving and accepting the sample from the depositor, IDA provides a hand written official receipt also known as international form BP4 to depositor mentioning following information:

1)

Name and address of the IDA;
2)

Name and address of the depositor;
3)

Date of deposition of the sample;
4)

Any identification reference given by the depositor;
5)

Any taxonomic or scientific information which is mentioned by the depositor, obeying the rule 6.1(a);
6)

Accession number given by the IDA to that deposit.

Form BP/4 is very important document which certifies that the sample is deposited in IDA by the depositor; obeying all rules and regulations of Budapest treaty.

Rule 9.1: This rule deals with storage of microorganisms in IDA. IDA has the responsibility to store the sample in safe and viable manner for its further use. The sample can be stored up to five to thirty years in IDA as per the requirement. In no case, secrecy of deposited sample is disclosed by IDA and Rule 9.2 has given specification in this regard. IDA does not give any information regarding microorganism that has been deposited for patent purpose, only in exceptional cases information can be given such as if the information is required by Industrial Property Office (IPO) for patent purpose or concern authority of IDA.

Rule 10.1 and 10.2: Viability testing of sample by IDA is required for proper storage of sample. Each sample that is deposited to IDA is tested for their viability at regular interval. The test depends on kind of microorganism that has been deposited and condition of storage. IDA not only perform viability test but also gives written report to depositor or any concern authority about the condition of sample if the concern authority ask for that. As per rule 10.2 following information should be present in viability test statement:

1)

Name and address of IDA issuing it;
2)

Name and address of depositor;
3)

Result of viability test (sample is viable or not);
4)

Accession number of sample given by IDA;
5)

Date of viability test;
6)

Information about the condition at which viability test was performed.

Rule 11: This rule talks about furnishing of sample to depositor or organization or person authorized to IDA. There are three rules in this regard Rule 11.1, Rule 11.2 and Rule 11.3. Rule 11.1 are used to give microorganism from IDA to IPO of contracting country in following situations:

IPO will request the IDA to give microorganism for patent procedure of a depositor who has filed an application for patent of that microorganism in said office; further sample will only be used by IPO for patent procedure. Rule 11.2 says IDA has to furnish the sample on request of depositor. Rule 11.3 says that sample can be provided to any person or organization by IDA only when it is certified by IPO, mentioning that the said microorganism is filed for patent purpose in that office.

Rule 12: Each IDA takes some fee in response to storage of microorganism. Fee can also be charged during viability testing and furnishing of samples.

For example MCC, Pune charges INR 2000 to 3000 for supply of culture. Charges on sample deposition depend on nature of deposition, no fee is taken for general deposition and INR 10,000 is taken for safe deposition. In case of patent, deposition the fee can be up to INR 20,000 per sample.

3. Microbial Resources Centers (MIRCEN)- Developed countries have money as well as good infrastructure facilities that helps in formation of IDA but poor countries and third world nations do not have capacity to invest on IDA. A proper awareness on IPR, monetary help, and creation of good infrastructure is required in those countries, as most of them have economy based on agriculture. In a partnership with the United Nations Environment Programme, and the United Nations Development Programme (UNDP), 34 Microbial Resources Centers (MIRCENS) have been established worldwide. MIRCEN was formed to give developing countries help in preserving and utilization of useful bacteria [15]. Although it was made for developing countries, developed countries such as United State has American Type Culture Collection (ATCC) which works as both IDA and MIERCEN centers. It has following objectives:

1)

Provide infrastructure help in developing countries to develop culture collection centers;
2)

Main emphasis has given to Rhizobacteria for its preservation, utilization and making in biofertilizer;
3)

Give proper training to human resource for suitable working of bacterial deposition centers;
4)

Establish International collaboration between developing countries for knowledge sharing of useful bacteria.

4. Indian Scenario on Culture Collection

According to World Data Center for Microorganisms (WDCM) [16], India is among the top five countries that store or hold maximum numbers of microbial cultures [Table/Fig-4]. Today, India has 30 culture collection centers that store approximately 194174 cultures as per WDCM record [Table/Fig-5]. While all over world there are 713 culture collection centers in 73 countries [Table/Fig-6]. Out of 2556283 numbers of microbial culture collections, 1045361 is contributed by bacteria while 783450, 37916 and 31833 comes from fungi, virus and cell lines respectively.

[Table/Fig-4]:

Top five countries in world that hold maximum numbers of cultures.

Rank	Country	Total number of hold of Cultures
1	USA	261637
2	Japan	254830
3	India	194174
4	China	187794
5	South Korea	167090

[Table/Fig-5]:

List of important culture collection centers in India.

Name of the Institute	Type of Collection	WDCM Registration number
DMSRDE Culture Collection, DRDO, New Delhi	Lichens, Fungi	166
National Collection of Dairy Cultures, Karnal, Haryana	Bacteria, Fungi, Yeasts	775
Culture Collection, Department of Microbiology, Bose Institute, Kolkata	Bacteria, Fungi, Yeasts	119
National Bureau of Agriculturally Important Microorganisms, Mau	Agriculturally Important Microbes	1060
Institute of Microbial Technology, Chandigarh	All kinds of Microbes	773
Indian Type Culture Collection, IARI, New Delhi	Bacteria, Fungi	430
NII Microbial Culture Collection, Kerala	Bacteria, Fungi, Yeasts	961
Microbial Culture collection, Pune	Microbes	930

[Table/Fig-6]:

List of some important culture collection centers in world.

Name of the Institute	Type of Collection	Total number of deposits	WDCM registration number
American Type Culture Collection(ATCC), USA	B, F, Y, A, V, Protozoa, Cell lines, Plant tissue, Seed	72000	1
Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ), Germany	B, F, Y, P, Cell Lines, V, Archaea	23000	274
CAB International (CABI), UK	B, F, Y, Plant parasitic Nematodes	28000	214
NBRC Culture Collection, Japan	B, Y, V, Microalgae, Human cDNA Clones, Archaea	126000	825
National Center for Agricultural Utilization Research (NCAUR), USA	A,B,F,Y	94000	97
Centraalbureau voor Schimmelculture (CBS), Netherlands	F,Y	72000	133
Universiteit gent- laboratorium voor microbiologie, Belgium	B	25000	296
B- Bacteria, F- Fungi, Y- Yeast, A- Algae, V- Virus

Open in a separate window

4.1 The Microbial Type Culture Collection and Gene Bank (MTCC): MTCC culture centre was established in 1986 at IMTECH, Chandigarh and is jointly funded by DBT and CSIR [17]. In 2002, WIPO has given the centre the status of IDA (WDCM registration number 773) and it was first centre in India that got this status. Currently, MTCC has stored almost 20000 cultures from Actinomycetes, bacteria, fungi, yeasts and plasmids of hazard group 1 (not dangerous to humans) and 2 (may cause human disease but rarely spread in human community and treatment is available). It performs following functions.

1) Sample deposition: There are three kinds of deposit that MTCC takes: general deposits, safe deposits and patent deposits [18].

a) General deposits: Here, researcher can deposit the valuable culture of identified strain for safe storage in MTCC. Depositor has to give culture data sheet, mentioning the relevant information of strain and provide the strain in freeze-dried form to the center. MTCC does not charge any fee for this deposition and store samples up to five years.

b) Safe deposits: Cultures are stored in secure place and only depositor has access to it. MTCC charge an annual fee from depositor and an agreement is signed between depositor and MTCC. In most cases safe deposits are made for five years.

c) Patent deposits: Microorganisms are deposited for patent purpose in a confidential manner in MTCC for upto 30 years. A onetime fee is also given by depositor to MTCC in this regard. Cultures can be deposited for International and national patent filing as MTCC is recognized as IDA by WIPO.

2) Supply of cultures: MTCC also supplies the cultures for research purposes. It supplies the cultures in freeze dried form while cultures of fungi and yeast in active form after the request from the researcher. It takes some fee in this regard.

3) Characterization of Samples

a) Phenotypic characterization: It includes morphological, physiological, biochemical and antimicrobial susceptibility test. The test includes, Gram staining, morphology study, colonial pigmentation, motility, oxidase, H2S, indole, urease and catalase production, growth at different temperatures (4-37°C), salt concentrations and different pH are examined, citrate utilization, nitrate reduction etc.

b) 16S rRNA analysis: This method is used for identifying and classifying of bacteria. 1500 bp of gene for 16S rRNA gene is amplified by universal primers and send for sequencing. The obtained DNA sequence is matched with other bacterial DNA sequence database to check whether the bacteria are novel or already known.

c) Fatty acid methyl esters test: They are present in phospholipid bilayer with proteins on bacterial membranes. The presence of diverse molecules on membrane of bacteria in different combination gives every bacterial species unique identification property. Fatty acid profiles are usually determined by using Gas Chromatography (GC) method.

d) MALDI-TOF analysis: Like DNA fingerprinting, Matrix-Assisted Laser Desorption/Ionization-Time Of Flight (MALDI-TOF) method known as protein fingerprinting. Bacterial protein is taken, converted to volatile form and fragmented to different sizes of polypeptide chains, which moves according to mass by charge ratio (m/z) from negative charged plate to positive charged plate, heavy polypeptides move slowly while lighter ones move quickly (time of flight is calculated) and then send for sequencing. Identified sequences are compiled together and searched for its similarity or dissimilarity with other sequences present in protein database of bacteria for identification purpose.

4) Other services: MTCC also performs some other services such as bacterial DNA isolation for genomic DNA sequencing purpose, G+C (Guanine+Cytosine) content percentage and ratio count of sample DNA which helps in identification of microorganism and freeze drying of microbial culture for their long term storage. Using advance methods such as Biolog (a biochemical test) and Vitek (growth-based method) are being used for bacterial identification. It also provides training programmes and workshops on microbial culture techniques for human resource development.

4.2 Microbial Culture Collection (MCC): MCC culture collection center is situated in NCCS, Pune and is funded by Department of Biotechnology (DBT). In 2011, it was recognized by WIPO as IDA and is registered in WDCM with registration number 930. At present MCC accepts bacteria, yeasts, fungi and plasmids in a host and/or as isolated DNA preparations belonging to hazards group 1 and 2 as per classification in India []. MCC works in same manner as MTCC by obeying the all rules and regulations of Budapest Treaty. However, few services such as phenotypic characterization, Biolog test and Vitek system are still to be included at the institute.

Go to:

Conclusion

IDA plays an important role in conservation of microbial population. A culture collection center not only stores valuable microorganisms but also stores other useful biological materials which can be used in research, agriculture, industry, and pharma sector etc. Everyday new microorganisms are being discovered; IDA provides a platform for storage of these bacterial strains in pure form thus preventing loss of biodiversity. The stored bacterial strains can further be utilized for the research and potential application. To convert a culture collection centre into an IDA requires huge financial support, infrastructure and manpower which itself is a big challenge. Budapest treaty gives provision for interstate deposition of microorganisms in IDA. Valuable bacterial strains found in countries where there is no IDA can be deposited in IDA of other countries.

It is important to understand that the misuse of IDA should also be avoided. IDA stores both pathogenic and non-pathogenic bacteria; pathogenic bacteria could be used in making biological weapons. In upcoming years, more and more countries will ratify the Budapest treaty and give emphasis on storage of valuable microorganisms at culture collection centers for their better utilization.

Budapest Treaty

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure, signed on April 28, 1977, was amended on September 26, 1980. The Budapest Treaty eliminates the need to deposit microorganisms in each country where patent protection is sought.

Under the treaty, the deposit of a microorganism with an "international depositary authority" satisfies the deposit requirements of treaty members' national patent laws. An "international depositary authority" is capable of storing biological material and has established procedures that assure compliance with the Budapest Treaty. Such procedures include requirements that the deposit will remain available for the life of the patent and that samples will be furnished only to those persons or entities entitled to receive them.

The establishment of "international depositary authorities" offers several advantages to both patent applicants and contracting states. Patent applicants benefit because the need to deposit in many countries in which they seek patent protection is dramatically reduced. Since a single deposit in any "international depositary authority" will satisfy the national disclosure requirements of any member state, patent applicants' costs are much lower. Using a single authority as a deposit increases the deposit's security, and provides a mechanism of distribution of the deposit. Contracting states benefit because they can rely on the treaty's uniform standards to assure effective deposit and public availability. They no longer need to independently establish a 'recognized' depositary to meet national patentability disclosure requirements.

As of January 1, 2009, there are 72 Contracting Parties to the Budapest Treaty and 37 "international depositary authorities" in 22 different countries.

[1]

[2]

[3]

Budapest Treaty

Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Summary of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (1977)

Budapest Treaty

Contents

International depositary authority[edit]

Depositable subject matter[edit]

PATENTED MATERIAL DEPOSIT

The Budapest Treaty

Secrecy

Patent Deposit Requirements

1) Biological Material accepted as Patent Deposit